Company Profile. mdi products meet or exceed industry standards and many of these are recognized as the best available in the world.

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2 Company Profile Advanced Microdevices (mdi) is a leader in innovative membrane technologies. Starting from a single person R&D operation in 976, mdi has developed into a dedicated team of 4 plus with more than 5 products. The company's core competence is its ability to develop new membrane technologies and innovate existing ones to deliver advantages to the customer for high end purification and separation applications in a wide range of industries such as pharmaceuticals, biopharmaceuticals, biotechnology, food and beverage, hospitals, and immunodiagnostics. As membranes end up being incorporated into user friendly devices, plastic design and moulding and sealing technologies become an integral part of the chain to deliver value to the customer. Realizing this, mdi has grown into a vertically integrated company that helps deliver prototypes rapidly for quicker conversion to products for the market. mdi products are used for critical applications in pharmaceutical and biopharmaceutical industries, such as sterilization of injectable drugs, sterility testing, sample preparation of drugs that are tested with highly sophisticated instrumentation, and development of new drug entities and formulations. mdi also offers world class membranes for making reliable immunoassays for testing of diseases at patient bedside. mdi products meet or exceed industry standards and many of these are recognized as the best available in the world. World Class MP Compliant Multilocation Facilities (2, sq. ft.) These products are manufactured by highly trained manpower in modern MP facilities with large ISO class 7 production areas under ISO 9:28 certified quality management system and are backed by state of the art QC testing, microbiology, reliability and validation laboratories. A strong pipeline of new products is constantly being developed in its well equipped R&D labs.

3 Table of Contents eneral Multiple Use Autoclavable / Steam Sterilizable PTFE Filter Devices Page o. Technologies 2 AseptiVent TF- 25mm, 37mm, 5mm 42 Quality Assurance 3 AseptiVent TF Capsule Filters 44 Validation Services 4 AseptiVent TF Large Capsule Filters 45 Customer Support 5 AseptiSure TH Mini Cartridge Filters 46 Filter Selection and Sizing 6 AseptiSure TH Cartridge Filters 47 Filter Sizing: Linear Upscaling from R&D to Production Process 7 AseptiSure TF Mini Cartridge Filters 48 AseptiSure TF Cartridge Filters 49 Easy Connect 8 Filters for of Liquids: PES Filters 9 Filters for Clarification and pre-filtration Filter Selection Chart 5 ClariPro K Capsule Filters 52 ClariPro K Large Capsule Filters ClariSure K Mini Cartridge Filters 54 ClariSure K Cartridge Filters 55 ClariCap S Capsule Filters 56 ClariCap S Large Capsule Filters 57 ClariSure S Mini Cartridge Filters 58 ClariSure S Cartridge Filters 59 ClariSure P Mini Cartridge Filters 6 ClariSure P Cartridge Filters 6 ClariCap PP Capsule Filters 62 ClariCap PP Large Capsule Filters 63 Filter Selection Chart AseptiCap KL/KS- 25mm, 5mm AseptiCap KL/KS Capsule Filters 3 AseptiCap KS Large Capsule Filters AseptiCap KO Capsule Filters 5 7 AseptiCap KSO Capsule Filters 8 AseptiCap KSO Large Capsule Filters 2 AseptiSure HS Mini Cartridge Filters 22 AseptiSure HS Cartridge Filters 23 AseptiSure HSR Mini Cartridge Filters 24 AseptiSure HSR Cartridge Filters 25 AseptiSure KS Mini Cartridge Filters 26 AseptiSure KS Cartridge Filters 27 Filters for of Liquids ylon-66 Filters ClariSure PA Mini Cartridge Filters 64 ClariSure PA Cartridge Filters Microglassfiber Disc Filters 66 Filters for Polishing and Clarification Filter Selection Chart 29 AseptiCap L/S Capsule Filters 3 AseptiCap S Large Capsule Filters 3 AseptiSure S Mini Cartridge Filters 32 AseptiSure S Cartridge Filters 33 ylon-66 Disc Filters 34 Filters for of Air/as Filter Selection Chart 5 67 Filter Selection Chart 68 ClariSure PP 69 ClariSure PL 7 ClariSure DP 7 Chemical Compatibility 72 End Connection Availability Chart for Capsule Filters 74 Dimensions: Capsule Filters Single Use amma Sterilizable PVDF Filter Devices AseptiVent VF - 25mm, 37mm, 5mm 37 AseptiVent VF - Capsule Filters 39 AseptiVent VF - Large Capsule Filters 4 mdi PROCE FILTRATIO PRODUCT UIDE Page

4 mdi Technologies mdi offers customized solutions to enhance process efficiency, productivity, product quality, and consistency for wide range applications in biopharmaceuticals, pharmaceuticals, biotechnology, microelectronics, and immunodiagnostics. Research and Development A unique multidimensional research and development facility at mdi, involving teams specializing in critical areas of membrane technology, biotechnology, electronics, chemistry, and mechanical engineering, continuously strives with an integrated approach to develop advanced, innovative and customized products. These filters have innovative design inputs to deliver unique performance advantages over competing products in terms of higher retention efficiencies, flow rates, throughputs, and lower filtration losses. This unparalleled capability to develop custom products and solutions is a continuous source of pride and drives the mdi team to push the boundaries of technology and maximize value for the user. Page 2 mdi PROCE FILTRATIO PRODUCT UIDE

5 mdi Quality Assurance mdi Microfiltration products are well designed with built-in quality assurance. The careful selection of raw materials, validated production processes and Quality Management System certified by ISO 9:28 ensures consistently high quality products. mdi products meet 2 CFR, ASTM, compendia requirements and meet global regulatory expectations. Facilities mdi filters are produced and packaged in facilities meeting MP requirements such as Clean Rooms with Class, and Class areas for critical processes. Deep Characterization and Certification Apart from retention efficiency and other functional parameters such as flowrates, temperature/hydraulic stress etc., mdi filters are deeply characterized for critical areas of concern such as biosafety, bioburden levels, endotoxin levels and extractables. Quality Control The filters go through stringent in process and final product testing and quality is ensured by in place QMS. Traceability Each sterilizing grade cartridge and capsule filter has unique identification number and is accompanied with individual certificate of quality. mdi PROCE FILTRATIO PRODUCT UIDE Page 3

6 mdi Validation Services As per regulatory requirements, the pharmaceutical industry has to provide a high level of assurance that the sterile drug product, manufactured through aseptic processing, offers the identity, strength, quality, and purity it purports to have or is represented to posses (Ref. USFDA 2CFR 2.(a). Consequently it has become increasingly critical to establish/quantify the impact on the drug due to its interface with various process components under different process conditions. Sterilizing grade filters are of critical importance in aseptic manufacturing, and it is the drug manufacturer s responsibility to show that the selected filter is able to sterilize the product under the process conditions and it does not affect the purity, quality and strength of the drug product. Validation Services mdi asertain Filter validation services are designed to meet customer specific needs and help achieve regulatory compliance. These include the following: Studies establishing filter integrity test values specific to drug product Filter fluid interaction studies - Physico-Chemical compatibility studies - Extractable/Leachable studies - Adsorption studies Microbial retention studies Throughput Studies All of these studies are executed as per pre-approved test methodologies to establish the test conditions and acceptance criteria. mdi also offers post validation support for regulatory audits. Validation uides mdi filters are validated as per global regulatory requirements. These filters, in compliance with the Regulation Title 2 of Federal Regulations (CFR) Part 34.42, have been registered at the U.S. Food and Drug Administration through Drug Master File # DMF 5554 Detailed documentation on validation of mdi filters for sterilization of fluids (air/gases and liquids) in form of Validation uides is also available. Page 4 mdi PROCE FILTRATIO PRODUCT UIDE

7 mdi Customer Support mdi technology executives assist in problem solving and process upgradation through experience sharing and developing customized products and systems. Some of these customer support activities are: Customized Filtration Solutions mdi offers customized solutions for complex filtration problems. mdi technology executives will help you in finding solutions to filter difficult to filter fluids & minimizing filtration losses. Filtration System Design Designing an efficient filtration system is an integral part of process optimization for minimizing filtration costs, increasing yields and reducing process time. mdi offers technical support for selection of filter materials by performing throughput studies to optimize filter train and filter sizing. Installation and Qualification mdi provides well documented installation, operational and performance qualification guidelines for all the equipment and systems it offers. Regulatory Assistance mdi provides complete regulatory assistance to it's customers. mdi products and validation services meet global regulatory expectations. Technical Seminars Technical seminars at customer s location are organized to help the users understand the per formance characterization of product in use, differentiate between various options available in the market and select the best solutions to suit their requirements. These interactions help create optimized systems and also upgrade current processes in terms of performance and cost effectiveness. mdi PROCE FILTRATIO PRODUCT UIDE Page 5 Page 2

8 Filter Selection and Sizing Highly regulated process industries such as pharmaceuticals and biopharmaceuticals work with a very wide variety of process streams/fluids under different process conditions. They continuously face with the challenge of achieving their process objectives efficiently and cost effectively. Microfiltration is a key process step to achieve critical process objectives that range from sterilization of process fluids to bioburden reduction, polishing and clarification. These process streams can range from easy to filter water for injection to difficult to filter colloidal solutions, emulsions, liposomal drug delivery systems or large molecule high value therapeutic proteins and vaccine concentrates. Such a wide spectrum of process streams, coupled with different process objectives, is quite a challenge for the process owner. Selection of the right filters and their sizing to meet various process needs is thus critical to successfully achieve the desired objectives. For establishing filter type, the following important questions need to be answered with respect to the process:. What is the objective of filtration? Bioburden reduction Particle removal Clarification 2. What is the fluid to be filtered? Liquid or gases What are the fluid properties such as ph, viscosity, temperature and surface tension 3. What will be the process conditions? Will the filtration system be inline steam sterilized or autoclaved? Will the system be sanitized with chemicals or hot water? What are the sterilization/sanitization conditions? Are the filters going to be used once or multiple times? How many times the system will be sterilized /sanitized? What is the maximum operating temperature? What is the allowable maximum allowable differential pressure? Page 6 mdi PROCE FILTRATIO PRODUCT UIDE 4. Is it going to be a continuous process or batch filtration? 5. What will be the batch volume for full scale process filtration? 6. What is the maximum allowable filtration time or the minimum desired flow rate? Once the filter type with respect to MOC, pore size etc. has been established the next step is to establish the filter size. Filter sizing, although to some extent is dependent on factors such as minimum desired flow rate, fluid viscosity as well as temperature, a critical parameter is the contamination profile of the fluid to be filtered. The nature and quantum of contaminants defines their interaction with the filter, which in turn defines the throughput one can achieve from a given filtration area for the fluid in question. An understanding of this behavior will help define not only the right sized filtration system but also the right combination of pre-filters and final filters to achieve desired/optimum throughput. mdi offers filter sizing services to product development labs and process owners in full scale manufacturing. These involve small scale throughout studies to establish suitable and cost effective filtration system. Different lab scale filter and pre-filter combinations are used to maximize throughputs. The selected combination is, based on desired batch volumes or throughputs, linearly extrapolated to establish filter size. For more information please contact our local technology executive or write to us at info@mdimembrane.com

9 Filter Sizing: Linear Upscaling from R&D to Production Process Researchers in DDS and formulation development are concerned about the impact of filter fluid interaction on stability, purity, strength etc. of the drug product. They take a keen interest in filter selection at the formulation development stage itself. Although preliminary compatibility data support initial filter selection, for stability studies, detailed filter validations are required to provide enough documented evidence to justify specific filter use. i md EE 5 m S.2µ 9 DK S 5JDK 45 DK i md, 25 cm² i DDKKS57 DK S 65.2µ EE 5 J- m 6 9 2, 5 cm² ED µm 4 S.2 - DK KS 5J D K84 D i md All materials of construction of core, sleeve, end caps, support layers and housing as well as manufacturing process is identical for all filter devices starting from 5 cm² to 8 cm² hence process scaling can be facilitated without triggering additional validation studies for given process conditions. mdi provides complete documentation for each of the filters thereby reducing the additional validation cost and time. mdi offers a wide range of filters to provide linear scale up from lab scale to production process. While scaling up the process, the appropriate filter size can be selected by increasing the effec tive filtration area of filter proportionate to the process fluid volumes. 5 mm, 2 cm² µm S 5J DK 64 DK 25 mm, 5 cm² md A critical requirement that needs to be addressed at this stage is of scalability from R&D to pilot scale to full scale production processes. Any change in filter MOC for full scale processes will require additional validation., cm² 8, 2 cm², 6 cm² mdi PROCE FILTRATIO PRODUCT UIDE Page 7

10 Easy Connect Wide Range of End Connections Customized Connectivity Pharmaceutical and Biopharmaceutical processes involve transfer of high value fluids through multiple process steps. Making high quality, reliable, flexible and functionally convenient connectivity with filters is of utmost value. mdi Capsule filters can also be customized to offer different inlet-outlet combinations to meet the unique connectivity needs in process assemblies. For example, stainless steel components with sanitary flange connections are sometimes required to be connected to single use disposable systems through quick-connectors or hose barb connections. mdi Capsule filters offer a wide range of reliable end connections for functional convenience and customized connectivity. Validated for Performance ½ Sanitary Flange to ½ Barb Hose High Security ½ hose barb connection ¼ SHB Quick Connector Page 8 mdi PROCE FILTRATIO PRODUCT UIDE i DDKK645 Single Stepped Hose Barb md ½ HB ½ Sanitary Flange to ¾ Sanitary Flange mdi ½ Sanitary Flange DKS.2µm DK355J- 58 ¾ Sanitary Flange ES m S 2µ 8 DK S. J- 6 md i DDKK845 ED S 2µm DK S. 4 J- These end connections are manufactured with tight dimension tolerance and are validated for strength and connection integrity under conditions of extreme use.

11 Filters for of Liquids: PES Filters mdi produces a wide range of amma sterilizable and steam sterilizable PES membrane capsule and cartridge filters to meet filtration requirements of biopharmaceutical and pharmaceutical processing. These filters meet key process requirements such as high retention efficiency, very high protein recoveries, extremely low extractables, high throughputs, wide chemical compatibility etc. mdi PES filter devices are available as: Filter amma Sterilizable Capsule Filters Autoclavable Capsule Filters Steam Sterilizable Cartridge Filters High Temperature Resistant Steam Sterilizable Cartridge Filters Applications Single Layer AseptiCap KL- Multiple Layer AseptiCap KS - AseptiCap KSO - AseptiCap KL AseptiCap KS AseptiCap KO AseptiCap KSO AseptiSure KS AseptiSure HS AseptiSure HSR Sterile Filtration of: Cell culture media Cell culture media containing serum Media additives Final product concentrates Buffers Adjuvants Small Volume Parenterals Large Volume Parenterals Water for Injection Quality Assurance These filter devices are manufactured in Class, clean rooms under ISO 9 : 28 certified quality management systems and are validated to meet compendia and regulatory requirements. Assurance Toxicity Passes Biological Reactivity Test, In Vivo, as per USP <88> for Class VI plastics Cytotoxicity Passes Biological Reactivity Test, In Vitro, USP <87> for Cytotoxicity Bioburden Bioburden level is < cfu/filter device as per ASI/AAMI/ISO 737- : 995 Bacterial Endotoxin Aqueous extracts exhibit <.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test on Fiber Releasing Passes test as per USP and comply with USFDA 2 CFR Part 2.72 for fiber release Extractables with WFI Passes test as per USP Oxidizable Substances Within limits as specified in USP Particle Shedding Passes USP test for particulates in injectables TOC/Conductivity at 25 C Meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a specified volume of purified water flush Indirect Food Additive All components meet the FDA Indirect Food Additive requirements cited in 2 CFR ood Manufacturing Practice These products are manufactured in a facility which adheres to ood Manufacturing Practices mdi PROCE FILTRATIO PRODUCT UIDE Page 9

12 Filter Selection Chart Application Area Key Application Requirements amma Sterilizable Capsule Filters - Mycoplasma removal (in case of Mammalian Cell Culture) Steam Sterilizable Capsule Filters Cartridge Filters AseptiCap KS -. µm PES Capsule Filter AseptiCap KS. µm PES Capsule Filter AseptiSure HS AseptiSure KS. µm High Temperature. µm PES PES Cartridge Filter Cartridge Filter - Microbial retention (in case of Microbial Fermentation) AseptiCap KS - PES Capsule Filter AseptiCap KS PES Capsule Filter AseptiSure HS AseptiSure KS High Temperature PES PES Cartridge Filter Cartridge Filter Sterile filtration of growth regulators - Absolute retention - Low protein binding AseptiCap KS - PES Capsule Filter AseptiCap KS PES Capsule Filter AseptiSure HS AseptiSure KS High Temperature PES PES Cartridge Filter Cartridge Filter Sterile filtration of alkaline/acidic solutions for ph control - Absolute retention - Compatible with -4 ph AseptiCap KSO- PES Capsule Filter AseptiCap KO/KSO PES Capsule Filter AseptiSure HSR High Temperature PES Cartridge Filter - Bioburden reduction AseptiCap KS - or.45 µm PES Capsule Filter AseptiCap KS or.45 µm PES Capsule Filter AseptiSure KS or.45 µm PES Cartridge Filter AseptiSure HS or.45 µm High Temperature PES Cartridge Filter Buffer filtration - Bioburden reduction - Absolute retention AseptiCap KS - or.45 µm PES Capsule Filter AseptiCap KS or.45 µm PES Capsule Filter AseptiSure KS or.45 µm PES Cartridge Filter AseptiSure HS or.45 µm High Temperature PES Cartridge Filter Sterile filtration of vaccines and therapeutic proteins - Absolute retention - Low protein binding - Low holdup volume AseptiCap KS - PES Capsule Filter AseptiCap KS PES Capsule Filter Biopharmaceuticals Media preparation Cell Harvesting Pharmaceuticals Large Volume Parenterals - Absolute retention - High throughputs AseptiSure HS AseptiSure KS High Temperature PES PES Cartridge Filter Cartridge Filter Small Volume Parenterals - Absolute retention - Low Protein Binding - Wide Chemical Compatiblity AseptiCap KS - PES Capsule Filter AseptiCap KS PES Capsule Filter AseptiSure HS AseptiSure KS High Temperature PES PES Cartridge Filter Cartridge Filter - Absolute retention AseptiCap KS - PES Capsule Filter AseptiCap KS PES Capsule Filter AseptiSure HS AseptiSure KS High Temperature PES PES Cartridge Filter Cartridge Filter WFI Page mdi PROCE FILTRATIO PRODUCT UIDE

13 AseptiCap KL/KS 25 mm and 5 mm Microbially Validated as per ASTM F USFDA 2 CFR 2.3 (b) (6) Specially designed filters for process development and formulation development labs with identical materials of construction for easy scale up to large capsule and cartridge filters. USFDA 2 CFR mm is a specially vented device, for use with peristaltic pump, to ensure easy removal of entrapped air in the upstream. Radiation Sterilizable: AseptiCap KL/KS - Autoclavable: AseptiCap KL/KS Hydrophilic PES Final Filter Pore Prefilter Pore (In case of AseptiCap KS). µm.45 µm,.45 µm.8 µm,.65 µm,.45 µm.8 µm,.65 µm Integrity Testing/Retention Bubble Point Microbial Retention > 3 psi (2.8 Kg/cm²) with 5% IPA/Water Solution > 5 psi (3.52 Kg/cm²) with Water > 3 psi (2. Kg/cm²) with Water LRV >7 for Acholeplasma laidlawii (ATCC 2326) per cm² LRV >7 for Brevundimonas diminuta (ATCC 946) per cm² LRV >7 for Serratia marcescens (ATCC 4756) per cm² 25 mm 5 mm Effective Filtration Area (ominal) 5 cm² 2 cm² Max. Operating Temperature Hold-up Volume(with air purge) Burst Pressure 55 C 6 C 75 Psi (5 25 C 42 Psi (3 3 C <5 µl <3 µl > 4 Kg/cm² > 8 Kg/cm² By Irradiation AseptiCap KL/KS - amma Irradiatiable up to 5 ky By as AseptiCap KL/KS: Sterilizable by Ethylene Oxide AseptiCap KL/KS - : Autoclavable at 25 C for 3 minutes, cycle after amma Irradiation By Autoclave AseptiCap KL/KS: Autoclavable at 25 C for 3 minutes, 25 cycles These cannot be In-line steam sterilized Shelf Life ph Compatibility 2 years after gamma sterilization 3 years after Ethylene Oxide sterilization Compatible with ph range of - mdi PROCE FILTRATIO PRODUCT UIDE Page

14 Water Flow Rates AseptiCap KL - 25 mm AseptiCap KL - 5 mm µm Water Flow Rate (ml/min) Water Flow Rate (ml/min) 2 AseptiCap KL/KS and AseptiCap KL/KS -, 25 mm AseptiCap KL IKL AseptiCap KS ( Upstream) AseptiCap KS (.45 µm Upstream) AseptiCap KS (.65 µm Upstream) IKS AseptiCap KS (.8 µm Upstream) IKS5 Pore Dia 25 mm 6 IKS Radiation Sterilizable Inlet/Outlet Pack. µm 36 Female Luer Lock M Yes R on Sterile Male Luer Slip o EO Sterile 2 2 /8 Hose Barb H amma Sterile 3.45 µm 4 IKS3 Example IKL 6 M R 4 AseptiCap KL/KS and AseptiCap KL/KS -, 5 mm AseptiCap KL AseptiCap KS ( Upstream) AseptiCap KS (.45 µm Upstream) AseptiCap KS (.65 µm Upstream) AseptiCap KS (.8 µm Upstream) Pore Dia VKL 5 mm VKS. µm 36 ¼ SHB B ¾ Sanitary Flange S* 2 Radiation Sterilizable.45 µm VKS Inlet/Outlet Pack Yes R on Sterile o EO Sterile 2 amma Sterile 3 2 VKS3 VKS5 Example VKS 36 * ¾ Sanitary Flange connection is available as outlet only ote: amma Sterile filters can not be amma Irradiated again Example for on Sterile: VKS36BBR2 Example for amma Sterile: VKS36BB32 For End Connection availability and dimensions with different sizes refer Pages Page 2 mdi PROCE FILTRATIO PRODUCT UIDE 2

15 AseptiCap KL/KS, 2,, 8 Microbially Validated as per ASTM F USFDA 2 CFR 2.3 (b) (6) Polyethersulfone membrane capsule filters are self contained, ready to use, disposable filtration devices that contain a mini cartridge filter element sealed inside a polypropylene housing. These offer highest packing density of the membrane resulting in a very compact capsule offering long service life. AseptiCap KL/KS DKS5EE DKS.2µm DK455J- 9 DKS.2µm DK355J- 58 DKS.2µm mdi DK845J4 DKSED Autoclavable: DKS57EE AseptiCap KL/KS -.2µm mdi DKS DK655J- 69 Radiation Sterilizable: USFDA 2 CFR Hydrophilic PES Support Layers Polyester Final Filter Pore Prefilter Pore (In case of AseptiCap KS). µm.45 µm,.45 µm.8 µm,.65 µm,.45 µm.8 µm,.65 µm Integrity Testing/Retention Bubble Point Microbial Retention > 3 psi (2.8 Kg/cm²) with 5% IPA/Water Solution > 5 psi (3.52 Kg/cm²) with Water > 3 psi (2. Kg/cm²) with Water LRV >7 for Acholeplasma laidlawii (ATCC 2326) per cm² LRV >7 for Brevundimonas diminuta (ATCC 946) per cm² LRV >7 for Serratia marcescens (ATCC 4756) per cm² Effective Filtration Area (ominal) Vent and Drain cm² 5 cm² cm² 2 cm² /4 Hose Barb with Platinum Cured Silicone O ring for 2, and 8 Capsule Filters Max. Operating Temperature 8 < 3 psi (2 Kg/cm²) 6 psi (4 3 C By Irradiation AseptiCap KL/KS - amma Irradiatiable up to 5 ky By as AseptiCap KL/KS: Sterilizable by Ethylene Oxide AseptiCap KL/KS - : Autoclavable at 25 C for 3 minutes, cycle after amma Irradiation By Autoclave AseptiCap KL/KS: Autoclavable at 25 C for 3 minutes, 25 cycles These cannot be In-line steam sterilized Shelf Life ph Compatibility 2 years after gamma sterilization 3 years after Ethylene Oxide sterilization Compatible with ph range of - mdi PROCE FILTRATIO PRODUCT UIDE Page 3

16 Water Flow Rates AseptiCap KS -, Capsule Filters AseptiCap KS -, 2 Capsule Filters Water Flow Rate (lpm) Water Flow Rate (lpm) EE Water Flow Rate (lpm) QQ Water Flow Rate (lpm) End Connection : A: ¼ Stepped Hose Barb Q: Single Step ½ Hose Barb E: ½ Sanitary Flange J: Quick Connector S: ¾ Sanitary Flange AseptiCap KL/KS and AseptiCap KL/KS - AseptiCap KL DKL (Single Layer) AseptiCap KS DKS ( Upstream) AseptiCap KS DKS (.45 µm Upstream) Pore 5. µm 36 ¼ SHB A 2 52 ¼ MPT B µm 2 AseptiCap KS DKS3 (.65 µm Upstream) AseptiCap KS (.8 µm Upstream) Inlet/Outlet DKS5 ½ MPT C ½ Hose Barb D ½ Sanitary Flange E ¾ Sanitary Flange S Quick Connector J Single Step ½ Hose Barb Q Radiation Sterilizable R Yes o Bell Pack Yes B on Sterile o Bell EO Sterile 2 amma Sterile 3 DKS DD R ote: amma Sterile filters can not be amma Irradiated again Example for on Sterile: DKS6DDR Example for amma Sterile: DKS6DD3 For End Connection, bell availability and dimensions with different sizes refer Pages Page 4 mdi PROCE FILTRATIO PRODUCT UIDE QQ EE AseptiCap KS -, 8 Capsule Filters AseptiCap KS -, Capsule Filters AA JJ QQ JJ EE AA QQ 2. AA EE

17 AseptiCap KS,, 2, 3 Microbially Validated as per ASTM F USFDA 2 CFR 2.3 (b) (6) AseptiCap KS - Autoclalvable: AseptiCap KS Radiation Sterilizable: USFDA 2 CFR EE 55 µm 4 S.2 6 LK S 5JLK 95 LK These are large disposable Polyethersulfone membrane capsule filters for high value biopharma manufacturing processes, providing a unique combination of high throughputs and low hold up volumes. These capsule filters offer serial filtration incorporating a large pore size upstream membrane to protect the downstream membrane and do away with the time and expense associated with assembling, cleaning and validating stainless steel housings. Hydrophilic PES Support Layers Polyester Final Filter Pore Prefilter Pore. µm.45 µm,.45 µm.8 µm,.65 µm,.45 µm.8 µm,.65 µm Integrity Testing/Retention Bubble Point Max. Air Diffusion Flow for Capsule Filters Microbial Retention > 3 psi (2.8 Kg/cm²) with 5% IPA/Water Solution > 5 psi (3.52 Kg/cm²) with Water > 3 psi (2. Kg/cm²) with Water < 29 5 psi (3.52 Kg/cm²) with Water < 3 37 psi (2.6 Kg/cm²) with Water < psi (.54 Kg/cm²) with Water LRV >7 for Acholeplasma laidlawii (ATCC 2326) per cm² LRV >7 for Brevundimonas diminuta (ATCC 946) per cm² LRV >7 for Serratia marcescens (ATCC 4756) per cm² Effective Filtration Area (ominal) cm² 6 cm² 2 cm² 8 cm² /4 Hose Barb with platinum cured Silicone O ring Vent and Drain 8 < 3 psi (2 Kg/cm²) Max. Operating Temperature 6 psi (4 3 C By Irradiation AseptiCap KL/KS - amma Irradiatiable up to 5 ky By as AseptiCap KL/KS: Sterilizable by Ethylene Oxide AseptiCap KL/KS - : Autoclavable at 25 C for 3 minutes, cycle after amma Irradiation By Autoclave AseptiCap KL/KS: Autoclavable at 25 C for 3 minutes, 25 cycles These cannot be In-line steam sterilized Shelf Life ph Compatibility 2 years after gamma sterilization 3 years after Ethylene Oxide sterilization Compatible with ph range of - mdi PROCE FILTRATIO PRODUCT UIDE Page5

18 Water Flow Rates. µm AseptiCap KS -, Large Capsule Filters AseptiCap KS -, Large Capsule Filters 3.9 EQ EE QQ Water Flow Rate (lpm) End Connection : Water Flow Rate (lpm) Q: Single Step ½ Hose Barb E: ½ Sanitary Flange EQ: ½ Sanitary Flange Inlet Single Step ½ Hose Barb Outlet AseptiCap KS and AseptiCap KS- AseptiCap KS LKS ( Upstream) AseptiCap KS LKS (.45 µm Upstream) AseptiCap KS LKS3 (.65 µm Upstream) AseptiCap KS (.8 µm Upstream) Pore Inlet/Outlet *. µm µm ½ Sanitary Flange Single Step ½ Hose Barb E Q Radiation Sterilizable Inline / T-line R Yes o Inline T-line** T Pack on Sterile EO Sterile 2 amma Sterile 3 LKS5 LKS 54 Pressure Drop(Kg/cm²).6 EE Pressure Drop(Kg/cm²) AseptiCapKS -, 3 Large Capsule Filters Water Flow Rate (lpm) AseptiCap KS -, 2 Large Capsule Filters.6 5. Water Flow Rate (lpm) QQ EE QQ QQ EE Pressure Drop(Kg/cm²) 5. 2 EE R T * is available in In-line Capsule Filters Only ** T-line Capsule Filters are available with ½ Sanitary Flange connections Only ote: amma Sterile filters can not be amma Irradiated again Example for amma Sterile: LKS542EE3 Example for on Sterile: LKS542EER For End Connection availability and dimensions with different sizes refer Pages Page 6 mdi PROCE FILTRATIO PRODUCT UIDE

19 AseptiCap KO, 2,, 8 Microbially Validated as per ASTM F USFDA 2 CFR 2.3 (b) (6) USFDA 2 CFR µm.2 66 LO 5J DK 74 DK AseptiCap KO capsule filters incorporate a low protein binding PES membrane with polypropylene drainage layers to ensure ph compatibility from -4 making these ideal for alkaline fluid streams. Hydrophilic PES Support Layers.45 µm Filter Pore Integrity Testing/Retention > 5 psi (3.52 Kg/cm²) with Water > 3 psi (2. Kg/cm²) with Water LRV >7 for Brevundimonas diminuta (ATCC 946) per cm² LRV >7 for Serratia marcescens (ATCC 4756) per cm² Bubble Point Microbial Retention cm² 5 cm² cm² 2 cm² Effective Filtration Area (ominal) /4 Hose Barb with platinum cured Silicone O ring for 2, and 8 Capsule Filters Vent and Drain Max. Operating Temperature 8 < 3 psi (2 Kg/cm²) 6 psi (4 3 C By as Sterilizable by Ethylene Oxide By Autoclave Autoclavable at 25 C for 3 minutes, 25 cycles. Can not be in-line steam sterilized Typical Water Flow Rates (, 8 ) C Shelf Life 3 years after Ethylene Oxide sterilization ph Compatibility Compatible with ph range of -4 AseptiCap KO DKLO Pore Inlet/Outlet Pack 5 ¼ SHB A on Sterile µm 2 ½ Hose Barb D EO Sterile ½ Sanitary Flange E ¾ Sanitary Flange S Quick Connector J Single Step ½ Hose Barb Q DKLO 57 DD For End Connection availability and dimensions with different sizes refer Pages mdi PROCE FILTRATIO PRODUCT UIDE Page 7

20 AseptiCap KSO, 2,, 8 Microbially Validated as per ASTM F USFDA 2 CFR 2.3 (b) (6) mdi AseptiCap KSO are Polyethersulfone membrane capsule filters offering wide ph (-4) compatibility. These filters are specially designed for alkaline fluid streams in bio-pharma manufacturing processes, with added advantages of high throughputs and low hold up volumes. DKSO.2µm mdi DK395J78 DKO57ES USFDA 2 CFR These capsule filters offer serial filtration incorporating a large pore size upstream membrane to protect the downstream membrane for enhanced throughputs. AseptiCap KSO are validated for use in pharmaceutical and biopharmaceutical applications. Radiation Sterilizable: AseptiCap KSO - Autoclavable: AseptiCap KSO Polyethersulfone Support Layers Final Filter Pore Pre-filter Pore.45 µm.8 µm,.45µm.8 µm Integrity Testing/Retention > 5 psi (3.52 Kg/cm²) with Water > 3 psi (2. Kg/cm²) with Water LRV >7 for Brevundimonas diminuta (ATCC 946) per cm² LRV >7 for Serratia marcescens (ATCC 4756) per cm² Bubble Point Microbial Retention Effective Filtration Area (ominal) cm² 5 cm² cm² 2 cm² /4 Hose Barb with platinum cured Silicone O ring for 2, and 8 Capsule Filters Vent and Drain Max. Operating Temperature 8 < 3 psi (2 Kg/cm²) 6 psi (4 3 C By Irradiation AseptiCap KSO - amma Irradiatiable up to 5 ky By as AseptiCap KSO: Sterilizable by Ethylene Oxide AseptiCap KSO - : Autoclavable at 25 C for 3 minutes, cycle after amma Irradiation By Autoclave AseptiCap KSO: Autoclavable at 25 C for 3 minutes, 25 cycles These cannot be In-line steam sterilized Shelf Life ph Compatibility Page 8 mdi PROCE FILTRATIO PRODUCT UIDE 2 years after amma 3 years after Ethylene Oxide Compatible with ph range of -4

21 Water Flow Rates AseptiCap KSO, Capsule Filters AseptiCap KS O, 2 Capsule Filters Water Flow Rate (lpm) Water Flow Rate (lpm) EE Water Flow Rate (lpm) QQ QQ EE 5 2. AseptiCap KSO, 8 Capsule Filters AseptiCap KSO, Capsule Filters AA.5 2 JJ JJ EE AA QQ 2. QQ AA EE Water Flow Rate (lpm) End Connection : A: ¼ Stepped Hose Barb Q: Single Step ½ Hose Barb E: ½ Sanitary Flange J: Quick Connector S: ¾ Sanitary Flange AseptiCap KSO and AseptiCap KSO- Pore Inlet/Outlet AseptiCap KSO DKO (.45 µm Upstream) 5 ¼ SHB A µm 2 ½ Hose Barb D AseptiCap KSO (.8 µm Upstream) ½ Sanitary Flange E 8 57 ¾ Sanitary Flange S DKO5 Quick Connector J Single Step ½ Hose Barb Q Radiation Sterilizable Inline / T-line R Yes o T Inline T-line Pack on Sterile EO Sterile 2 amma Sterile 3 DKO 52 2 EE R ote: amma Sterile filters can not be amma Irradiated again Example for on Sterile: DKO522EER Example for amma Sterile: DKO522EE3 For End Connection availability and dimensions with different sizes refer Pages mdi PROCE FILTRATIO PRODUCT UIDE Page 9

22 AseptiCap KSO,, 2, 3 Microbially Validated as per ASTM F USFDA 2 CFR 2.3 (b) (6) mdi AseptiCap KSO are Polyethersulfone membrane capsule filters offering wide ph (-4) compatibility. These filters are specially designed for alkaline fluid streams in biopharma manufacturing processes, with added advantages of high throughputs and low hold up volumes. LKO54EE USFDA 2 CFR µm mdi LKSO LK445J- 6 These capsule filters offer serial filtration incorporating a large pore size upstream membrane to protect the downstream membrane for enhanced throughputs. AseptiCap K S O are validated for use in pharmaceutical and biopharmaceutical applications. Radiation Sterilizable: AseptiCap KSO - Autoclalvable: AseptiCap KSO Polyethersulfone Support Layers Final Filter Pore Pre-filter Pore.45 µm.8 µm,.45µm.8 µm Integrity Testing/Retention Bubble Point > 5 psi (3.52 Kg/cm²) with Water > 3 psi (2. Kg/cm²) with Water Max. Air Diffusion Flows for Capsule Filters < 3 37 psi (2.6 Kg/cm²) with Water < psi (.54 Kg/cm²) with Water LRV >7 for Brevundimonas diminuta (ATCC 946) per cm² LRV >7 for Serratia marcescens (ATCC 4756) per cm² Microbial Retention Effective Filtration Area (ominal) cm² 6 cm² 2 cm² 8 cm² /4 Hose Barb with platinum cured Silicone O ring Vent and Drain Max. Operating Temperature 8 < 3 psi (2 Kg/cm²) 6 psi (4 3 C By Irradiation AseptiCap KSO - amma Irradiatiable up to 5 ky By as AseptiCap KSO: Sterilizable by Ethylene Oxide AseptiCap KSO - : Autoclavable at 25 C for 3 minutes, cycle after amma Irradiation By Autoclave AseptiCap KSO: Autoclavable at 25 C for 3 minutes, 25 cycles These cannot be In-line steam sterilized Shelf Life ph Compatibility Page2 mdi PROCE FILTRATIO PRODUCT UIDE 2 years after amma 3 years after Ethylene Oxide Compatible with ph range of -4

23 Water Flow Rates AseptiCap KSO, 2 Large Capsule Filters AseptiCap KSO, Large Capsule Filters EE QQ Water Flow Rate (lpm) Pressure Drop(Kg/cm²) EE QQ Water Flow Rate (lpm) AseptiCap KSO, 3 Large Capsule Filters EE QQ Pressure Drop(Kg/cm²) Water Flow Rate (lpm) End Connection : Q: Single Step ½ Hose Barb E: ½ Sanitary Flange AseptiCap KSO and AseptiCap KSO- AseptiCap KSO LKO (.45 µm Upstream) AseptiCap KSO (.8 µm Upstream) LKO5 Inlet/Outlet Pore * E µm ½ Sanitary Flange Single Step ½ Hose Barb Q Radiation Sterilizable Inline / T-line R Yes o T Inline T-line Pack on Sterile EO Sterile 2 amma Sterile 3 LKO 54 2 EE R T * is available in In-line Capsule Filters Only ote: amma Sterile filters can not be amma Irradiated again Example for amma Sterile: LKO542EE3 Example for on Sterile: LKO542EER For End Connection availability and dimensions with different sizes refer Pages mdi PROCE FILTRATIO PRODUCT UIDE Page 2

24 AseptiSure HS Mini Cartridge filters Microbially Validated as per ASTM F mdi Polyetheresulfone (PES) membrane mini cartridge filters Aseptisure HS are high temperature resistant filtration devices. These are designed to withstand high pressure steam sterilization upto 35 C. USFDA 2 CFR 2.3 (b) (6) USFDA 2 CFR Aseptisure HS mini cartridge filters with Polyethersulfone membrane serial layers offer enhanced throughputs, thus ensuring better economics. These are validated for key performance parameters such as retention efficiency, chemical compatibility, extractables, heat stability and flow rates. Polyrthersulfone Support Layers Polyester. µm.45 µm,.45 µm.8 µm,.65 µm,.45 µm.8 µm,.65 µm Final Filter Pore Prefilter Pore Integrity Testing/Retention > 3psi (2.8Kg/cm²) with 5% IPA/Water Solution > 5psi (3.52Kg/cm²) with Water > 3psi (2.Kg/cm²) with Water LRV >7 for Acholeplasma laidlawii (ATCC 2326) per cm² LRV >7 for Brevundimonas diminuta (ATCC 946) per cm² LRV >7 for Serratia marcescens (ATCC 4756) per cm² Bubble Point Microbial Retention Effective Filtration Area (ominal) 2. cm² 2 cm² Water Flow C 9 lpm 5 lpm Max. Operating Temperature 8 < 2 Kg/cm² (3 psi) 5 psi ( C Reverse Pressure < psi (.7 8 C In-line steam sterilizable upto 35 C for 3 minutes at a maximum differential pressure of 5 psi (.35 Kg/cm²), 25 cycles ph Compatibility Compatible with ph range of - AseptiSure HS ( Upstream) CPH AseptiSure HS (.45 µm Upstream) CPH AseptiSure HS (.65 µm Upstream) CPH3 AseptiSure HS (.8 µm Upstream) CPH5 Pore Adapter Elastomer µm E 4463B H.45 µm U Silicone Pack on Sterile CPH 5 Page 22 mdi PROCE FILTRATIO PRODUCT UIDE E

25 PES Cartridge Filter for Liquid Filtration AseptiSure HS Microbially Validated as per ASTM F USFDA 2 CFR 2.3 (b) (6) AseptiSure HS high temperature resistant, serial filtration Polyethersulfone cartridge filters are designed to withstand high pressure differential upto.3 Kg/cm² (5 psi) at high steam sterilization temperatures of upto 35 C. USFDA 2 CFR Hydrophilic PES Support Layers Polyester Final Filter Pore Prefilter Pore. µm.45 µm,.45 µm.8 µm,.65 µm,.45 µm.8 µm,.65 µm Integrity Testing/Retention > 3 psi (2.8 Kg/cm²) with 5% IPA/Water Solution > 5 psi (3.52 Kg/cm²) with Water > 3 psi (2. Kg/cm²) with Water Air Diffusion Flow ( Cartridge Filter) < 29 5 psi (3.52 Kg/cm²) with Water < 3 37 psi (2.6 Kg/cm²) with Water < psi (.54 Kg/cm²) with Water Microbial Retention LRV >7 for Acholeplasma laidlawii (ATCC 2326) per cm² LRV >7 for Brevundimonas diminuta (ATCC 946) per cm² LRV >7 for Serratia marcescens (ATCC 4756) per cm² Bubble Point Effective Filtration Area (ominal) cm² 6 cm² 2 cm² 8 cm² 8 lpm 3 lpm Typical Water Flow Rates 27 C ) 25 lpm 45 lpm Max. Operating Temperature 8 < 3psi (2 Kg/cm²) 5 psi ( C Reverse Pressure < psi (.7 25 C In-line steam sterilizable upto 35 C for 3 minutes at a maximum differential pressure of 5 psi (.35 Kg/cm²), 25 cycles ph Compatibility Compatible with ph range of - AseptiSure HS ( Upstream) CPH AseptiSure HS (.45 µm Upstream) CPH AseptiSure HS (.65 µm Upstream) CPH3 AseptiSure HS (.8 µm Upstream) CPH5 Pore Adapter Elastomer *. µm 36 7P A Silicone 54 7P without fin A Viton SV µm 2 O D EPDM SE 3 56 FEP Encapsulated Viton FV** Pack on Sterile CPH 54 A * 5" are available in A (7P) and A (7P without fin) only ** FV is available in Adapter A (7P) and A (7P without fin) only mdi PROCE FILTRATIO PRODUCT UIDE Page 23

26 PES Cartridge Filter for Liquid Filtration AseptiSure HSR Mini Cartridge Filter Microbially Validated as per ASTM F mdi Polyethersulfone (PES) membrane mini cartridge filters type AseptiSure HSR are designed to withstand high pressure differential upto.3 Kg/cm² (5 psi) at high steam sterilization temperatures of up to 35 C. USFDA 2 CFR 2.3 (b) (6) USFDA 2 CFR These filters with Polyethersulfone membrane and support layers offer ph compatibility from to 4, and are thus ideal for use with acidic as well as alkaline solutions. mdi AseptiSure HSR Mini Cartridge filters are validated for key performance parameters such as retention efficiency, chemical compatibility, extractables, heat stability and flow rates. Hydrophilic PES Support Layers Final Filter Pore Prefilter Pore. µm.45 µm,.45 µm.8 µm,.65 µm,.45 µm.8 µm,.65 µm Integrity Testing/Retention > 3 psi (2.8 Kg/cm²) with 5% IPA/Water Solution > 5 psi (3.52 Kg/cm²) with Water > 3 psi (2. Kg/cm²) with Water LRV >7 for Acholeplasma laidlawii (ATCC 2326) per cm² LRV >7 for Brevundimonas diminuta (ATCC 946) per cm² LRV >7 for Serratia marcescens (ATCC 4756) per cm² Bubble Point Microbial Retention Effective Filtration Area (ominal) 2. cm² 2 cm² Typical Water Flow Rates 27 C) 5 lpm 9 lpm Max. Operating Temperature 8 < 3psi (2 Kg/cm² ) 5 psi ( C Reverse Pressure < psi (.7 25 C In-line steam sterilizable upto 35 C for 3 minutes at a maximum differential pressure of 5 psi (.35 Kg/cm²), 25 cycles ph Compatibility Compatible with ph range of -4 AseptiSure HSR ( Upstream) AseptiSure HSR (.45 µm Upstream) AseptiSure HSR (.65 µm Upstream) AseptiSure HSR (.8 µm Upstream) CHR Pore 2. 5 CHR Adapter. µm µm 2 Elastomer 4463 E 4463B H 444 U Silicone Pack on Sterile CHR3 CHR5 CHR Page 24 mdi PROCE FILTRATIO PRODUCT UIDE E

27 PES Cartridge Filter for Liquid Filtration AseptiSure HSR Microbially Validated as per ASTM F mdi Polyethersulfone (PES) Cartridge filters AseptiSure HSR are high temperature resistant filtration devices. These are designed to withstand high pressure differential at high steam sterilization temperature upto 35 C. These filters exhibit high mechanical stability, and wide chemical compatibility even with alkaline process fluids. USFDA 2 CFR 2.3 (b) (6) USFDA 2 CFR These filters come with Polyethersulfone membrane serial layers and support layers to offer -4 ph compatibility. mdi AseptiSure HSR cartridge filters are validated for key performance parameters such as retention efficiency, chemical compatibility, extractables, heat stability and flow rates. Hydrophilic PES Support Layers Final Filter Pore Prefilter Pore. µm.45 µm,.45 µm.8 µm,.65 µm,.45 µm.8 µm,.65 µm Integrity Testing/Retention > 3 psi (2.8 Kg/cm²) with 5% IPA/Water Solution > 5 psi (3.52 Kg/cm²) with Water > 3 psi (2. Kg/cm²) with Water Air Diffusion Flow ( Cartridge Filter) < 29 5 psi (3.52 Kg/cm²) with Water < 3 37 psi (2.6 Kg/cm²) with Water < psi (.54 Kg/cm²) with Water Microbial Retention LRV >7 for Acholeplasma laidlawii (ATCC 2326) per cm² LRV >7 for Brevundimonas diminuta (ATCC 946) per cm² LRV >7 for Serratia marcescens (ATCC 4756) per cm² Bubble Point Effective Filtration Area (ominal) cm² 6 cm² 2 cm² 8 cm² 8 lpm 3 lpm Typical Water Flow Rates 27 C ) 25 lpm 45 lpm Max. Operating Temperature 8 < 3 psi (2 Kg/cm² ) 5 psi ( C Reverse Pressure < psi (.7 25 C In-line steam sterilizable upto 35 C for 3 minutes at a maximum differential pressure of 5 psi (.35 Kg/cm²), 25 cycles ph Compatibility Compatible with ph range of -4 AseptiSure HSR ( Upstream) AseptiSure HSR (.45 µm Upstream) AseptiSure HSR (.65 µm Upstream) AseptiSure HSR (.8 µm Upstream) CHR CHR Pore * Adapter Elastomer. µm 36 7P A Silicone 7P without fin A Viton SV.45 µm 2 O D EPDM FEP Encapsulated Viton SE CHR3 Pack on Sterile FV** CHR5 CHR 54 A * 5" are available in A (7P) and A (7P without fin) only ** FV is available in Adapter A (7P) and A (7P without fin) only mdi PROCE FILTRATIO PRODUCT UIDE Page 25

28 AseptiSure KS Mini Cartridge filters Microbially Validated as per ASTM F mdi Polyetheresulfone (PES) membrane mini cartridge filters AseptiSure KS are serial filtration devices with a larger pore size upstream PES membrane layer to protect the downstream final PES membrane layer from premature clogging and to give enhanced throughputs, thus resulting in better economics. USFDA 2 CFR 2.3 (b) (6) USFDA 2 CFR mdi Aseptisure KS filters are validated for key performance parameters such as retention efficiency, chemical compatibility, extractables, heat stability and flow rates. These are available in a variety of pore sizes to suit specific microfiltration needs in critical and specialized process applications. Hydrophilic PES Support Layers Polyester. µm.45 µm,.45 µm.8 µm,.65 µm,.45 µm.8 µm,.65 µm Final Filter Pore Prefilter Pore Integrity Testing/Retention > 3 psi (2.8Kg/cm²) with 5% IPA/Water Solution > 5 psi (3.52Kg/cm²) with Water > 3 psi (2.Kg/cm²) with Water LRV >7 for Acholeplasma laidlawii (ATCC 2326) per cm² LRV >7 for Brevundimonas diminuta (ATCC 946) per cm² LRV >7 for Serratia marcescens (ATCC 4756) per cm² Bubble Point Microbial Retention Effective Filtration Area (ominal) 2. cm² 2 cm² Water Flow C Max. Operating Temperature 9 lpm 5 lpm 8 < 2 Kg/cm² (3 psi) 5 psi ( C Reverse Pressure < psi (.7 25 C In-line steam sterilizable at 2 C for 3 minutes at a maximum differential pressure of 3 psi (.2 kg/cm²), 25 cycles ph Compatibility Compatible with ph range of - AseptiSure KS ( Upstream) AseptiSure KS (.45 µm Upstream) CPK CPK3 AseptiSure KS (.8 µm Upstream) CPK5 Adapter Elastomer µm E 4463B H.45 µm U CPK AseptiSure KS (.65 µm Upstream) Pore Silicone Pack on Sterile CPK 5 Page 26 mdi PROCE FILTRATIO PRODUCT UIDE E

29 AseptiSure KS Microbially Validated as per ASTM F USFDA 2 CFR 2.3 (b) (6) AseptiSure KS serial filtration Polyethersulfone cartridge filters incorporate a large pore size upstream membrane layer to protect the downstream terminal filtration membrane layer. USFDA 2 CFR Hydrophilic PES Support Layers Polyester. µm.45 µm,.45 µm.8 µm,.65 µm,.45 µm.8 µm,.65 µm Final Filter Pore Prefilter Pore Integrity Testing/Retention > 3 psi (2.8 Kg/cm²) with 5% IPA/Water Solution > 5 psi (3.52 Kg/cm²) with Water > 3 psi (2. Kg/cm²) with Water Air Diffusion Flow ( Cartridge Filter) < 29 5 psi (3.52 Kg/cm²) with Water < 3 37 psi (2.6 Kg/cm²) with Water < psi (.54 Kg/cm²) with Water Microbial Retention LRV >7 for Acholeplasma laidlawii (ATCC 2326) per cm² LRV >7 for Brevundimonas diminuta (ATCC 946) per cm² LRV >7 for Serratia marcescens (ATCC 4756) per cm² Bubble Point Effective Filtration Area (ominal) cm² 6 cm² 2 cm² 8 cm² 8 lpm 3 lpm Typical Water Flow Rates 27 C ) 25 lpm 45 lpm Max. Operating Temperature 8 < 3 psi (2 Kg/cm²) 5 psi ( C Reverse Pressure < psi (.7 25 C In-line steam sterilizable at 2 C for 3 minutes at a maximum differential pressure of 3 psi (.2 kg/cm²), 25 cycles Compatible with ph range of - ph Compatibility AseptiSure KS ( Upstream) CPK AseptiSure KS (.45 µm Upstream) CPK AseptiSure KS (.65 µm Upstream) CPK3 AseptiSure KS (.8 µm Upstream) CPK5 Pore Adapter Elastomer *. µm 36 7P A Silicone 54 7P without fin C Viton SV µm 2 O D EPDM SE 3 56 FEP Encapsulated Viton FV** Pack on Sterile CPK E * 5" are available in A (7P) and A (7P without fin) only ** FV is available in Adapter A (7P) and A (7P without fin) only mdi PROCE FILTRATIO PRODUCT UIDE Page 27

30 Filters for of Liquids: ylon 66 Filters mdi ylon 66 membrane filters are sterilizing grade filters offering absolute retention and wide chemical compatibility. mdi ylon filter devices are available as: Filter Capsule Filters Cartridge Filters Disc Filters Applications Single Layer Multiple Layer AseptiCap L AseptiCap S AseptiSure S of compatible solvents and chemicals of disinfectants in pharmaceutical process and lab areas Filtration of hospital disinfectants Filtration of rinse water for endoscopes and other hospital equipment and surfaces Sterilizing filtration in pharmaceutical for aqueous and non aqueous solutions Quality Assurance These filter devices are manufactured in Class, clean rooms under ISO 9 : 28 certified quality management systems and are validated to meet compendia and regulatory requirements. Assurance Toxicity Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics Bioburden Bioburden level is < cfu/filter device as per ASI/AAMI/ISO 737- : 995 Bacterial Endotoxin Aqueous extracts exhibit <.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test on Fiber Releasing Passes test as per USP and comply with USFDA 2 CFR Part 2.72 for fiber release Extractables with WFI Passes test as per USP Oxidizable Substances Within limits as specified in USP Particle Shedding Passes USP test for particulates in injectables TOC/Conductivity at 25 C Meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a specified volume of purified water flush Indirect Food Additive All components meet the FDA Indirect Food Additive requirements cited in 2 CFR ood Manufacturing Practice These products are manufactured in a facility which adheres to ood Manufacturing Practices Page 28 mdi PROCE FILTRATIO PRODUCT UIDE

31 Filter Selection Chart Application Area Key Application Requirements Capsule Filters Cartridge Filters Disc Filters of compatible solvents and chemicals - Absolute retention - Wide chemical compatibility AseptiCap L/S ylon 66 Capsule Filter AseptiSure S ylon 66 Cartridge Filter ylon 66 Disc Filters of disinfectants in pharmaceutical labs and process areas - Absolute retention - Wide chemical compatibility AseptiCap L/S ylon 66 Capsule Filter AseptiSure S ylon 66 Cartridge Filter ylon 66 Disc Filters Filtration of hospital disinfectants - Absolute retention - Wide chemical compatibility AseptiCap L/S ylon 66 Capsule Filter AseptiSure S ylon 66 Cartridge Filter ylon 66 Disc Filters Filtration of rinse water for endoscopes and other hospital equipments - Absolute retention AseptiCap L/S ylon 66 Capsule Filter AseptiSure S ylon 66 Cartridge Filter Sterilizing filtration of aqueous and non aqueous solutions - Absolute retention - Wide chemical compatibility AseptiCap L/S ylon 66 Capsule Filter AseptiSure S ylon 66 Cartridge Filter ylon 66 Disc Filters mdi PROCE FILTRATIO PRODUCT UIDE Page 29

32 AseptiCap L/S, 2,, 8 Microbially Validated as per ASTM F USFDA 2 CFR 2 (b) (6) AseptiCap L/S ylon 66 membranes capsule filters are sterilizing grade filters offering absolute retention, wide chemical compatibility, and very low hold up volumes. Single Layered: Multiple Layered: USFDA 2 CFR AseptiCap L AseptiCap S 3 D S 84.2 ES 5 µm J 5 5 ylon 66 Support Layers Polyester.45 µm.8 µm,.45 µm.8 µm Final Filter Pore Prefilter Pore (In case of AseptiCap S) md i DDS5 Integrity Testing/Retention Bubble Point (with water) Microbial Retention (LRV >7 for) > 5 psi (3.52 Kg/cm²) > 3 psi (2. Kg/cm²) Brevundimonas diminuta (ATCC 946) per cm² Serratia marcescens (ATCC 4756) per cm² Water Flow Rates AseptiCap L Capsule Filters cm² 9 cm² 8 cm² 27 cm² 2 cm² 7 cm² 4 cm² 2. 2 cm² /4 Hose Barb with Silicone O ring for 2, and 8 Vent and Drain Max. Operating Temperature 8 < 2 Kg/cm² (3 psi) By as DD, Inch DD, 2 Inch DD, 5 Inch DD, 8 Inch 4. 4 Kg/cm² (6 psi 3 C 2. Sterilizable by Ethylene Oxide.2 Autoclavable at 25 C for 3 minutes. Cannot be In-line steam sterilized By Autoclave Water Flow Rate (lpm) End Connection D: ½ Hose Barb AseptiCap L DL AseptiCap S (.45 µm Upstream) DS AseptiCap S (.8 µm Upstream) DS5 Pore Bell Pack 5 ¼ SHB A Yes B on Sterile µm 2 ¼ MPT B o Bell EO Sterile DS Inlet/Outlet 52 ½ MPT C ½ Hose Barb D ½ Sanitary Flange E ¾ Sanitary Flange S Quick Connector J Single Step ½ Hose Barb Q DD For End Connection, bell availability and dimensions with different sizes refer Pages Page 3 mdi PROCE FILTRATIO PRODUCT UIDE Effective AseptiCap L Filtration Area AseptiCap S (ominal)

33 AseptiCap S,, 2, 3 Microbially Validated as per ASTM F USFDA 2 CFR 2.3 (b) (6) AseptiCap S ylon 66 large membranes capsule filters are double layered sterilizing grade filters offering absolute retention, wide chemical compatibility, and serial filtration for enhanced throughputs. USFDA 2 CFR ylon 66 Support Layers Polyester.45 µm.8 µm,.45 µm.8 µm Final Filter Pore Prefilter Pore Integrity Testing/Retention Air Diffusion Flow for Capsule Filters (with water ) < 3 37 psi (2.6 kg/cm²) < psi (.54 kg/cm²) Microbial Retention (LRV >7 for) Brevundimonas diminuta (ATCC 946) per cm² Serratia marcescens (ATCC 4756) per cm² Water Flow Rates AseptiCap S, Large Capsule Filters 3 cm² Vent and Drain 2 6 cm² cm² 8 cm² /4 Hose Barb with Silicone O ring Max. Operating Temperature 8 < 3 psi (2 Kg/cm²) 6 psi (4 3 C By as.8 QQ EE Autoclavable at 25 C for 3 minutes. Cannot be In-line steam sterilized By Autoclave Water Flow Rate (lpm) Sterilizable by Ethylene Oxide.6 8. Effective Filtration Area (ominal) End Connection : Q: Single Step ½ Hose Barb E: ½ Sanitary Flange AseptiCap S (.45 µm Upstream) LS AseptiCap S (.8 µm Upstream) LS5 Pore Inlet/Outlet Inline / T-line * E Inline on Sterile µm 2 T EO Sterile Q T-line 3 56 ½ Sanitary Flange Single Step ½ Hose Barb Pack LS 54 QQ T * is available in In-line Capsule Filters Only For End Connection availability and dimensions with different sizes refer Pages mdi PROCE FILTRATIO PRODUCT UIDE Page 3

34 AseptSure S Mini Cartridge filters Microbially Validated as per ASTM F USFDA 2 CFR 2.3 (b) (6) mdi AseptiSure S ylon 66 membrane mini cartridge filters are sterilizing grade filters offering absolute retention and wide chemical compatibility. These filters offer serial filtration for enhanced throughput. The upstream layer is of larger pore size to protect the downstream final filtration layer. USFDA 2 CFR ylon 66 Support Layers Polyester Final Filter Pore Prefilter Pore.45 µm.8 µm,.45 µm.8 µm Integrity Testing/Retention Bubble Point (with water) Microbial Retention (LRV >7 for) > 5 psi (3.52 Kg/cm²) > 3 psi (2. Kg/cm²) Brevundimonas diminuta (ATCC 946) per cm² Serratia marcescens (ATCC 4756) per cm² Water Flow Rates Effective Filtration Area (ominal).2µm AseptiSure S, Cartridge Filters 2. cm² 2 cm² 2. Max. Operating Temperature 8 < 2 Kg/cm² (3 psi) Max. Differential Pressure < 3.5Kg/cm² (5 25 C Reverse Pressure Inch 5 Inch 2. <.7 Kg/cm² ( 25 C.2 Autoclavable/In-line Steam Sterilizable at 2 C for 3 a maximum differential pressure of 3psi (.2 kg/cm²) Water Flow Rate (lpm) AseptiSure S CP (.45 µm Upstream) AseptiSure S (.8 µm Upstream) Pore Elastomer Adapter E.45 µm* B H 444 U CP5 Silicone Pack on Sterile CP 5 A *.45µm cartridge filter are available with.8µm upstream layer only Page 32 mdi PROCE FILTRATIO PRODUCT UIDE.8

35 AseptiSure S Microbially Validated as per ASTM F USFDA 2 CFR 2.3 (b) (6) AseptiSure S- ylon 66 membrane cartridge filters are sterilizing grade filters offering absolute retention and wide chemical compatibility. These filters offer serial filtration for enhanced throughput. The upstream layer is of larger pore size to protect the downstream final filtration layer. USFDA 2 CFR ylon- 66 Support Layers Polyester Final Filter Pore Prefilter Pore.45 µm.8 µm,.45 µm.8 µm Integrity Testing/Retention Air Diffusion Flow (with water wetted) ( Cartridge Filter) < 3 37 psi (2.6 kg/cm²) < psi (.54 kg/cm²) Microbial Retention (LRV >7 for) Brevundimonas diminuta (ATCC 946) per cm² Serratia marcescens (ATCC 4756) per cm² Water Flow Rates AseptiSure S, Cartridge Filters 2 6 cm² 3 cm² 3 2. Max. Operating Temperature 8 < 3 psi (2 Kg/cm²) Max. Differential Pressure 5 psi 25 C Reverse Pressure < psi (.7 25 C µm µm Autoclavable/In-line Steam Sterilizable at 2 C for 3 a maximum differential pressure of 3psi (.2 kg/cm²) 2 cm² 8 cm².8 Effective Filtration Area (ominal) Water Flow Rate (lpm) AseptiSure S CP (.45 µm Upstream) AseptiSure S (.8 µm Upstream) CP5 Pore Elastomer Adapter * 7P A Silicone µm 2 7P without fin A Viton SV O D EPDM SE FEP Encapsulated Viton FV** Pack on Sterile CP 54 A * 5" are available in A (7P) and A (7P without fin) only ** FV is available in Adapter A (7P) and A (7P without fin) only mdi PROCE FILTRATIO PRODUCT UIDE Page 33

36 ylon 66 Disc Filters - Microbially Validated as per ASTM F USFDA 2 CFR 2.3 (b) (6) membrane disc filters are double layered, hydrophilic, non-media migrating, biologically inert, plain white absolute membrane filters offering wide chemical compatibility. Pore,.45 µm,.8 µm,.2 µm ylon 66 9 mm, 42 mm, 293 mm Integrity Testing/Retention Bubble Point (with Water) Microbial Retention.2 μm > 5 psi (3.5 Kg/cm²) with water.45 μm > 32 psi (2.25 Kg/cm²) with water.2 μm LRV> 7 for Brevundimonas diminuta as per ASTM F μm LRV> 7 for Serratia marcescens as per ASTM F Max. Operating Temperature 8 C continuous 5 Kg/cm² Water Flow Rates (27 Kg/cm²).2 μm.45 μm.8 μm.2 μm 4 ml/min/cm² 37 ml/min/cm² 2 ml/min/cm² 8 ml/min/cm² Autoclavable at 2 C for 3 minutes Pore 9 mm 4 42 mm 6.45 µm mm 9.8 µm 3.2 µm Pack on Sterile Page 34 mdi PROCE FILTRATIO PRODUCT UIDE 3

37 Filters for of Air/ases Single Use PVDF Filter Devices mdi amma Sterilizable AseptiVent VF - are hydrophobic PVDF membrane single use capsule filters with a wide range of end connections and different sizes for linear scalability to use with disposable single use assemblies for biopharmaceutical processes. Filter Single Use Multiple Use AseptiVent VF - Autoclavable Capsule Filters AseptiVent TF Steam Sterilizable Cartridge Filters AseptiSure TF High Temperature Resistant Steam Sterilizable Cartridge Filters AseptiSure TH amma Sterilizable Capsule Filters These filters are validated for microbial retention with liquid bacterial challenge test as per ASTM F838-5 to ensure reliable performance under worst case conditions. Multiple Use PTFE Filter Devices mdi produces a wide range of PTFE membrane capsule and cartridge filters to meet filtration requirements of biopharmaceutical and pharmaceutical processing. Applications These filters are validated for microbial retention with liquid bacterial challenge test as per ASTM F838-5 to provide a high degree of sterility assurance for critical applications such as bioreactor/fermentor venting etc. As they offer wide chemical compatibility with organic solvents, these are ideal for manufacture of sterile API. Quality Assurance Sterile air sparging in fermentors and bioreactors Sterile venting of cell factories, bioreactors and fermentors Fermentor exhaust of environmental air in isolators Venting of sterile collection vessels Cleaning sterile surfaces WFI tank venting itrogen blanketing Sterile filtration of API and solvents Dry powder injectable filling Sterile air for dryers and micronizers These filter devices are manufactured in Class, clean rooms under ISO 9 certified quality management systems and are validated to meet compendia and regulatory requirements. Assurance Toxicity Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics Bioburden Bioburden level is < cfu/filter device as per ASI/AAMI/ISO 737- : 995 Bacterial Endotoxin Aqueous extracts exhibit <.5 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test on Fiber Releasing Passes test as per USP and comply with USFDA 2 CFR 2.3 (b)(6) for fiber release Oxidizable Substances Within limits as specified in USP Particle Shedding Passes USP test for particulates in injectables Indirect Food Additive All components meet the FDA Indirect Food Additive requirements cited in 2 CFR ood Manufacturing Practice These products are manufactured in a facility which adheres to ood Manufacturing Practices mdi PROCE FILTRATIO PRODUCT UIDE Page 35

38 Filter Selection Chart Application Area Key Application Requirements amma Sterilizable Capsule Filters Steam Sterilizable Capsule Filters Cartridge Filters Sterile venting for fermentors and bioreactors - Absolute retention - High hydrophobicity - High flow rates AseptiVent VF -γ PVDF Capsule Filters AseptiVent TF PTFE Capsule Filter AseptiSure TF/TH PTFE Cartridge Filter Sterile air sparging in fermentors and bioreactors - Absolute retention - High hydrophobicity - High flow rates AseptiVent VF -γ PVDF Capsule Filters AseptiVent TF PTFE Capsule Filter AseptiSure TF/TH PTFE Cartridge Filter Sterile air for cell factories - Absolute retention - High hydrophobicity AseptiVent VF -γ.2µm PVDF Capsule Filters AseptiVent TF PTFE Capsule Filter Venting of small bioreactors - Absolute retention - High hydrophobicity AseptiVent VF -γ PVDF Capsule Filters AseptiVent TF PTFE Capsule Filter Fermentor exhaust - Absolute retention - High hydrophobicity - High flow rates AseptiVent TF PTFE Capsule Filter AseptiSure TF/TH PTFE Cartridge Filter Venting of sterile collection vessels - Absolute retention - High hydrophobicity - High flow rates AseptiVent VF -γ PVDF Capsule Filters AseptiVent TF PTFE Capsule Filter AseptiSure TF/TH PTFE Cartridge Filter itrogen blanketing in sterile API - Absolute retention - High flow rates AseptiVent TF PTFE Capsule Filter AseptiSure TF/TH PTFE Cartridge Filter Cleaning sterile surfaces - Absolute retention - High flow rates AseptiVent TF PTFE Capsule Filter AseptiSure TF/TH PTFE Cartridge Filter Dry powder injectable filling - Absolute retention - High flow rates AseptiVent TF PTFE Capsule Filter AseptiSure TF/TH PTFE Cartridge Filter WFI tank venting - Absolute retention - High hydrophobicity - High flow rates AseptiSure TF/TH PTFE Cartridge Filter AseptiSure TF/TH PTFE Cartridge Filter AseptiVent TF PTFE Capsule Filter AseptiSure TF/TH PTFE Cartridge Filter Sterile filtration of API/Solvents - Absolute retention Sterile air for dryers and micronizers - Absolute retention - High flow rates - High flow rates Page 36 mdi PROCE FILTRATIO PRODUCT UIDE

39 AseptiVent VF - 25mm, 37mm, 5mm Microbially Validated as per ASTM F USFDA 2 CFR 2.3 (b) (6) AseptiVent VF -γ, amma Sterilizable PVDF membrane vent filters are validated for microbial retention with liquid bacterial challenge test as per ASTM F838-5 to provide a high degree of sterility assurance for critical applications such as small bioreactors, sterile tank venting, bottle venting, barrier filter for vacuum pump etc. USFDA 2 CFR Final Filter Pore Hydrophobic PVDF Support Layers Polyester Integrity Testing/Retention Bubble Point > 8 psi (.27 Kg/cm²) with 5% IPA/ Water Solution Microbial Retention LRV >7 for Brevundimonas diminuta (ATCC 946) per cm² 25 mm 37 mm 5 mm Effective Filtration Area (ominal) 5 cm² cm² 2 cm² Max. Operating Temperature 6 C Burst Pressure.5 Kg/cm² (2 3 C > 4 Kg/cm² > 8 Kg/cm² > 8 Kg/cm² By Irradiation amma Irradiatiable up to 5 ky By Autoclave Autoclavable at 25 C for 3 minutes, cycle after amma Irradiation. Cannot be In-line steam sterilized Shelf Life 2 years after amma mdi PROCE FILTRATIO PRODUCT UIDE Page 37

40 Air Flow Rates AseptiVent VF -, 5 mm Capsule Filters BB.4 5 Air Flow Rate (lpm) End Connection : BB AseptiVent VF -, 37 mm Capsule Filters Air Flow Rate (lpm) B: ¼ Stepped Hose Barb S: ¾ Sanitary Flange AseptiVent VF -, 25 mm AseptiVent VF IVF Inlet/Outlet Pore 25 mm 6 Radiation Sterilizable Pack M Yes R on Sterile Male Luer Slip o* 3 /8 Hose Barb H amma Sterile Female Luer Lock 4 IVF 6 M R 4 *amma Sterile filters cannot be amma Irradiated again AseptiVent VF -, 37 mm and 5 mm AseptiVent VF IVF Pore 37 mm 8 5 mm Inlet/Outlet Radiation Sterilizable Pack ¼ SHB B Yes R on Sterile ¾ Sanitary Flange** S o* amma Sterile 3 2 IVF 8 BB *amma Sterile filters cannot be amma Irradiated again ** ¾ Sanitary Flange Available only in 5 mm Page 38 mdi PROCE FILTRATIO PRODUCT UIDE R 2

41 AseptiVent VF -, 2,, 8 Microbially Validated as per ASTM F USFDA 2 CFR 2.3 (b) (6) AseptiVent VF -γ PVDF membrane vent capsule filters are validated for Microbial Retention with liquid bacterial challenge test as per ASTM F838-5 to provide a high degree of sterility assurance for critical applications. DVL DVL 45Jmdi DV6 E E 57 µm.2 58 USFDA 2 CFR Pore Hydrophobic PVDF Support Layers Polyester Integrity Testing/Retention Bubble Point > 8 psi (.26 Kg/cm²) with 5% IPA/Water Solution Microbial Retention LRV >7 for Brevundimonas diminuta (ATCC 946) per cm² Effective Filtration Area (ominal) cm² 5 cm² cm² 2 cm² /4 Hose Barb with Silicone O ring for 2, and 8 Capsule Filters Vent and Drain Max. Operating Temperature 8 < 3 psi (2 Kg/cm²) 6 psi (4 3 C By Irradiation amma Irradiatiable up to 5 ky By Autoclave Autoclavable at 25 C for 3 minutes, cycle after amma Irradiation. Cannot be In-line steam sterilized Shelf Life 2 years after amma mdi PROCE FILTRATIO PRODUCT UIDE Page 39

42 Air Flow Rates AseptiVent VF -, 2 Capsule Filters, DD psi Inlet psi Inlet psi Inlet 3 psi Inlet Air Flow Rate (m³/h) Air Flow Rate (m³/h) psi Inlet. 3 psi Inlet 7 AseptiVent VF -, Capsule Filters, DD End Connection D: ½ Hose Barb Air Flow Rate (m³/h) AseptiVent VF DVL Pore 5 2 Inlet/Outlet Radiation Sterilizable Pack ¼ SHB A Yes R on Sterile 52 ½ Hose Barb D o* 3 ½ Sanitary Flange E amma Sterile 8 57 ¾ Sanitary Flange S Quick Connector J Single Step ½ Hose Barb Q DVL 57 EE R * amma Sterile filters cannot be amma Irradiated again For End Connection availability and dimensions with different sizes refer Pages Page 4 mdi PROCE FILTRATIO PRODUCT UIDE 5. AseptiVent VF -, Capsule Filters, DD

43 AseptiVent VF-,, 2, 3 Microbially Validated as per ASTM F USFDA 2 CFR 2.3 (b) (6) AseptiVent VF -γ PVDF membrane vent filters are validated for microbial retention with liquid bacterial challenge test as per ASTM F838-5 to provide a high degree of sterility assurance for critical applications. USFDA 2 CFR Pore Hydrophobic PVDF Polyester Support Layers < 3 6 psi (.2 Kg/cm²) Microbial Retention LRV >7 for Brevundimonas diminuta (ATCC 946) per cm² 78 LVL mdi LV375J- Air Diffusion Flow (5% IPA/ Water) ( Capsule Filter) EE 54 LVL.2µm amma Stable Integrity Testing/Retention Effective Filtration Area (ominal) cm² 6 cm² 2 cm² 8 cm² /4 Hose Barb with Silicone O ring Vent and Drain Typical Air Flow Rate 67 P = 2 psi (5 psi inlet) Max. Operating Temperature 8 2Kg/cm² (3psi) 4Kg/cm² 3 C Minimum Acceptable Bubble Point with 5% IPA.26 Kg/cm² (8 psi) By Irradiation amma Irradiatiable up to 5 ky By as Sterilizable by Ethylene Oxide Autoclavable at 25 C for 3minute, Cycle after amma Irradiation. By Autoclave AseptiVent VF LVL Pore ** Inlet/Outlet Radiation Sterilizable Inline / T-line ½ Sanitary Flange Single Step ½ Hose Barb E Q Pack Yes R Inline on Sterile o* T-line T amma Sterile 3 LVL 54 EE R * amma Sterile filters cannot be amma Irradiated again * is available in In-line Capsule Filters Only For End Connection availability and dimensions with different sizes refer Pages mdi PROCE FILTRATIO PRODUCT UIDE Page 4

44 AseptiVent TF 25 mm, 37 mm, 5 mm Microbially Validated as per ASTM F USFDA 2 CFR 2.3 (b) (6) AseptiVent TF Disposable Inline PTFE gas filters are convenient pre-fabricated devices used for sterilization of gases and as a bacterial air vent in various pharmaceutical and biopharmaceutical processes. USFDA 2 CFR Hydrophobic PTFE Support Layers Final Filter Pore.45 µm Integrity Testing/Retention Bubble Point > 22 psi (.54 Kg/cm²) with 7% IPA/Water Solution > psi (.7 Kg/cm²) with 7% IPA/Water Solution LRV >7 for Brevundimonas diminuta (ATCC 946) per cm² LRV >7 for Serratia marcescens ATCC 4756) per cm² Microbial Bacterial Retention 25 mm 37 mm 5 mm Effective Filtration Area (ominal) 5 cm² cm² 2 cm² Max. Operating Temperature 6 C Burst Pressure 42 psi (3 3 C > 4 Kg/cm² By as > 8 Kg/cm² > 8 Kg/cm² Sterilizable by Ethylene Oxide By Autoclave Shelf Life Page 42 mdi PROCE FILTRATIO PRODUCT UIDE Autoclavable at 25 C for 3 minutes, 3 cycles. Cannot be In-line steam sterilized 3 years after Ethylene Oxide

45 Air Flow Rates AseptiVent TF, 37 mm Capsule Filters BB AseptiVent TF, 25 mm Capsule Filters 5 Air Flow Rate (lpm) 5 Air Flow Rate (lpm) CC BB AseptiVent TF, 5 mm Capsule Filters End Connection : B: ¼ Stepped Hose Barb S: ¾ Sanitary Flange C: /8 MPT 4 Air Flow Rate (lpm) AseptiVent TF- 25 mm AseptiVent TF ITF Pore 25 mm 6 Inlet/Outlet Pack Female Luer Lock M on Sterile.45 µm 2 Male Luer Slip EO Sterile 2 /8 Hose Barb H 4 ITF 6 M Pore Inlet/Outlet 4 AseptiVent TF- 37 mm, 5 mm AseptiVent TF ITF Pack 37 mm* 8 ¼ SHB B on Sterile 5 mm.45 µm 2 /8 MPT C EO Sterile 2 ¾ Sanitary Flange S 2 ITF 8 BB 2 * ote: AseptiVent TF- 37 mm is available with BB connection only mdi PROCE FILTRATIO PRODUCT UIDE Page 43

46 AseptiVent TF, 2,, 8 Microbially Validated as per ASTM F USFDA 2 CFR 2.3 (b) (6) AseptiVent TF capsule filters employ hydrophobic PTFE membrane offering absolute retention and very wide chemical compatibility making these useful for sterile filtration of air/gases as well as aggressive solvents. USFDA 2 CFR DTL.2µm DT55A- 57 Hydrophobic PTFE Support Layers Final Filter Pore.45 µm Integrity Testing/Retention Bubble Point (with 7% IPA Wetted) Microbial Retention (LRV >7 for) > 22 psi (.55 Kg/cm²) > psi (.7 Kg/cm²) Brevundimonas diminuta (ATCC 946) per cm² Serratia marcescens (ATCC 4756) per cm² Air Flow Rates Effective Filtration Area (ominal) cm² 5 cm² cm² 2 cm² AseptiVent TF Capsule Filters.6..4 Max. Operating Temperature 8 < 3 psi (2 Kg/cm²) 6 psi (4 3 C By as Inch, DD 2 Inch, DD Inch, DD 8 Inch, DD Autoclavable at 25 C for 3 minutes, 5 cycles. Cannot be In-line steam sterilized By Autoclave Sterilizable by Ethylene Oxide Air Flow Rate (m³/h) Shelf Life 3 years after Ethylene Oxide sterilization End Connection D: ½ Hose Barb AseptiVent TF DTL Pore Inlet/Outlet 5 ¼ SHB A on Sterile µm 2 ¼ MPT B EO Sterile 2 ½ MPT C 8 57 ½ Hose Barb D ½ Sanitary Flange E ¾ Sanitary Flange S Quick Connector J Single Step ½ Hose Barb Q Pack DTL DD For End Connection availability and dimensions with different sizes refer Pages Page 44 mdi PROCE FILTRATIO PRODUCT UIDE /4 Hose Barb with Silicone O ring for 2, and 8 Capsule Filters Vent and Drain

47 AseptiVent TF,, 2, 3 Microbially Validated as per ASTM F USFDA 2 CFR 2.3 (b) (6) AseptiVent TF PTFE large capsule filters offer absolute retention and wide chemical compatibility for sterile filtration of air/gases as well as aggressive solvents in large volume. USFDA 2 CFR LTL mdi LT295C- EE 54 LTL.2µm 8 Hydrophobic PTFE Support Layers Pore.45 µm Integrity Testing/Retention Air Diffusion Flow (7% IPA Wetted) ( Capsule Filter) < 45 6 psi (.2 Kg/cm²) < 45 8 psi (.56 Kg/cm²) Microbial Retention (LRV >7 for) Brevundimonas diminuta (ATCC 946) per cm² Serratia marcescens (ATCC 4756) per cm² Air Flow Rates Effective Filtration Area (ominal) cm² 6 cm² 2 cm² 8 cm² AseptiVent TF, Large Capsule Filters P res s u re D ro p (ps i) Max. Operating Temperature 8 < 3 psi (2 Kg/cm²) 6 psi (4 3 C By as Sterilizable by Ethylene Oxide Autoclavable at 25 C for 3 minutes, 3 cycles. Cannot be In-line steam sterilized By Autoclave Shelf Life EE years after Ethylene Oxide sterilization 5 P res s u re D ro p (K g /c m ²) /4 Hose Barb with Silicone O ring Vent and Drain Air Flow Rate (m³/h) End Connection E: ½ Sanitary Flange AseptiVent TF LTL Pore Inlet/Outlet * µm Inline / T-line ½ Sanitary Flange Single Step ½ Hose Barb E Q Pack Inline on Sterile T-line T EO Sterile 2 LTL 54 EE * is available in In-line Capsule Filters Only For End Connection availability and dimensions with different sizes refer Pages mdi PROCE FILTRATIO PRODUCT UIDE Page 45

48 AseptiSure TH Mini Cartridge filters Microbially Validated as per ASTM F mdi AseptiSure TH PTFE mini cartridge filters are specially designed high temperature resistant PTFE filters which are steam sterilizable at upto 35 C. These filters are validated with liquid microbial challenge test as per ASTM F to offer absolute retention even under high moisture conditions. USFDA 2 CFR 2.3 (b) (6) USFDA 2 CFR These are also validated for other key performance parameters such as chemical compatibility, extractables, heat stability, flow rates, blow through and ability to withstand accidental reverse pressure. These are available in a variety of pore sizes to suit specific microfiltration needs in critical and specialized process applications for air as well as liquid. Final Filter Pore.45 µm Hydrophobic PTFE Support Layers Integrity Testing/Retention Bubble Point (7% IPA/Water ) Water Intrusion Rate 22psi (.54 kg/cm²) psi (.7 kg/cm²) 2. <.3 2.kg/cm² <.6 2.kg/cm² Microbial Bacterial Retention Brevundimonas diminuta (ATCC 946) per cm² (LRV >7 for) Air Flow Rates AseptiSure TH Cartridge Filters Serratia marcescens (ATCC 4756) per cm².6 Effective Filtration Area (ominal) 2. cm² 2 cm² Max. Operating Temperature 8 < 2 Kg/cm² (3 psi) 3.5 Kg/cm² (5 25 C Reverse Pressure Inch.4 5 Inch Air Flow Rate (m³/h) <.7 Kg/cm² ( 25 C Autoclavable/In-line steam sterilizable at 35 maximum differential pressure of 5 psi (.35 kg/cm²) for 3 minutes, 8 cycles AseptiSure TH CPTH Pore Adapter Elastomer E.45 µm B H 444 U Silicone Pack on Sterile CPTH 5 Page 46 mdi PROCE FILTRATIO PRODUCT UIDE E

49 AseptiSure TH Microbially Validated as per ASTM F USFDA 2 CFR 2.3 (b) (6) AseptiSure TH cartridge filters are high temperature resistant PTFE filters which are steam sterilizable at upto 35 C. These filters are validated with liquid microbial challenge test as per ASTM F to offer absolute retention even under high moisture conditions. USFDA 2 CFR Final Filter Pore.45 µm Hydrophobic PTFE Support Layers Integrity Testing/Retention Air Diffusion Flow (with 7% IPA Wetted) ( Cartridge Filter) Microbial Retention (LRV >7 for) < 45 6 psi (.2 Kg/cm²) < 45 8 psi (.56 Kg/cm²) Brevundimonas diminuta (ATCC 946) per cm² Serratia marcescens (ATCC 4756) per cm² Air Flow Rates Effective Filtration Area (ominal) 2 3 cm² 6 cm² AseptiSure TH Cartridge Filters 3 2 cm² 8 cm² 8 < 3 psi (2 Kg/cm²) 5 psi ( C Reverse Pressure Max. Operating Temperature < psi (.7 25 C Autoclavable/In-line steam sterilizable at 35 maximum differential pressure of 5 psi (.35 Kg/cm²) for 3minutes, 8 cycles Inch.4 2 Inch Air Flow Rate (m³/h) AseptiSure TH CPTH Pore Adapter Elastomer * 7P A Silicone µm 2 7P without fin A Viton SV 2 55 O D EPDM SE 3 56 FEP Encapsulated Viton FV** Pack on Sterile CPTH 56 A * 5" are available in A (7P) and A (7P without fin) only ** FV is available in Adapter A (7P) and A (7P without fin) only mdi PROCE FILTRATIO PRODUCT UIDE Page 47

50 AseptiSure TF Mini Cartridge filters Microbially Validated as per ASTM F mdi AseptiSure TF PTFE membrane mini cartridge filters are hydrophobic filters offering absolute retention. These filters are designed for sterilizing filtration of gases. The high quality of membrane and design of cartridge assures long life and ability to withstand adverse process conditions experienced during use. USFDA 2 CFR 2.3 (b) (6) USFDA 2 CFR mdi AseptiSure TF filters are validated for key performance parameters such as retention efficiency, chemical compatibility, extractables, heat stability, flow rates and blow through. Final Filter Pore.45 µm Hydrophobic PTFE Support Layers Integrity Testing/Retention 22psi (.52 Bar) with 7% psi (.69 Bar) with IPA/Water Solution 7% IPA/Water Solution Bubble Point Water Intrusion Rate 2. <.3 2.kg/cm² <.6 2.kg/cm² Microbial Bacterial Retention Brevundimonas diminuta (ATCC 946) per cm² (LRV >7 for) Air Flow Rates Serratia marcescens (ATCC 4756) per cm² AseptiSure TF Cartridge Filters Effective Filtration Area (ominal) cm².6 2 cm² Max. Operating Temperature 8 < 2 Kg/cm² (3 psi) 3.5 Kg/cm² (5 25 C Reverse Pressure Inch.4 5 Inch <.7 Kg/cm² ( 25 C 25 Air Flow Rate (m³/h) Autoclavable/In-line steam sterilizable at 2 differential pressure of 3 psi (.2 kg/cm²) for 3 minutes, cycles AseptiSure TF CPTF Pore Adapter Elastomer E.45 µm B H 444 U Silicone Pack on Sterile CPTF 5 Page 48 mdi PROCE FILTRATIO PRODUCT UIDE E

51 AseptiSure TF Microbially Validated as per ASTM F USFDA 2 CFR 2.3 (b) (6) AseptiSure TF cartridge filters employ hydrophobic PTFE membrane offering absolute retention, wide chemical compatibility, and are validated with liquid bacterial challenge test. USFDA 2 CFR Final Filter Pore.45 µm Hydrophobic PTFE Support Layers Integrity Testing/Retention Air Diffusion Flow (with 7% IPA Wetted) ( Cartridge Filter) Microbial Retention (LRV >7 for) < 45 6 psi (.2 Kg/cm²) <45 8 psi (.56 Kg/cm²) Brevundimonas diminuta (ATCC 946) per cm² Serratia marcescens (ATCC 4756) per cm² Air Flow Rates AseptiSure TF Cartridge Filters 3 cm² 6 cm² cm² 8 cm² Max. Operating Temperature 8 < 3 psi (2 Kg/cm²) 5 psi ( C Reverse Pressure < psi (.7 25 C Inch.4 2 Inch Autoclavable/In-line steam sterilizable at 2 differential pressure of 3 psi (.2 kg/cm²) for 3 minutes, cycles.6 Effective Filtration Area (ominal) Air Flow Rate (m³/h) AseptiSure TF CPTF Pore Adapter Elastomer * 7P A Silicone µm 2 7P without fin A Viton SV 2 55 O' D EPDM SE 3 56 FEP Encapsulated Viton FV** Pack on Sterile CPTF 54 A FV * 5" are available in A (7P) and A (7P without fin) only ** FV is available in Adapter A (7P) and A (7P without fin) only mdi PROCE FILTRATIO PRODUCT UIDE Page 49

52 Filters for Clarification and Pre-filtration mdi offers a range of pre-filters designed to protect the terminal sterilizing grade membrane filters and maximize throughputs. These are biologically inert filters with wide chemical compatibility, offering very high retention efficiency and are available in cartridge filter and capsule filter formats, in different sizes, pore sizes and end connections to suit different needs. Applications These filter devices are available as: Precipitate removal post viral inactivation Product ame Polyethersulfone Capsule Filters with Microglassfiber Upstream Pre-filtration of cell culture media ClariPro K Pre-filtration of serum and other viscous biologicals Pre-filtration of serum solutions Polyethersulfone Cartridge Filters with Microglassfiber Upstream Clarification of cell harvest supernatant ClariSure K Filter Pre-filtration of protein solutions Pre-filtration of high value difficult to filter drug ClariCap S Microglassfiber Capsule Filter solutions ClariSure S Microglassfiber Cartridge Filters ClariSure P Capsule Filters ClariCap PP Cartridge Filters ClariSure PA Pre-filtration of large volume parenterals Pre-filtration of difficult to filter SVP Polishing of turbid solutions Pre-filtration of fermentor air Quality Assurance These filter devices are manufactured in Class, clean rooms under ISO 9 : 28 certified quality management systems and are deeply validated to meet compendia and regulatory requirements. Assurance Toxicity Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics on Fiber Releasing Passes test as per USP and comply with USFDA 2 CFR Part 2.3 (b)(6) for fiber release Extractables with WFI Passes test as per USP Oxidizable Substances Within limits as specified in USP Particle Shedding Passes USP test for particulates in injectables Indirect Food Additive All components meet the FDA Indirect Food Additive requirements cited in 2 CFR ood Manufacturing Practice These products are manufactured in a facility which adheres to ood Manufacturing Practices Page 5 mdi PROCE FILTRATIO PRODUCT UIDE

53 Filter Selection Chart Application Area Key Application Requirements Capsule Filters Cartridge Filters Biopharmaceuticals Precipitate removal post viral inactivation - High retention efficiency - High throughput ClariPro K PES Capsule Filters with Microglassfiber upstream ClariCap S Microglassfiber Capsule Filters ClariSure K PES Cartridge Filters with Microglassfiber upstream ClariSure S Microglassfiber Cartridge Filters Pre-filtration of cell culture media - High retention efficiency - High throughput ClariPro K PES Capsule Filters with Microglassfiber upstream ClariCap S Microglassfiber Capsule Filters ClariSure K PES Cartridge Filters with Microglassfiber upstream ClariSure S Microglassfiber Cartridge Filters - High retention efficiency - High throughput ClariPro K PES Capsule Filters with Microglassfiber upstream ClariCap S Microglassfiber Capsule Filters ClariSure K PES Cartridge Filters with Microglassfiber upstream ClariSure S Microglassfiber Cartridge Filters Pre-filtration of serum solutions - High retention efficiency - High throughput ClariPro K PES Capsule Filters with Microglassfiber upstream ClariCap S Microglassfiber Capsule Filters ClariSure K PES Cartridge Filters with Microglassfiber upstream ClariSure S Microglassfiber Cartridge Filters Clarification of cell harvest supernatants - High retention efficiency - High throughput ClariPro K PES Capsule Filters with Microglassfiber upstream ClariCap S Microglassfiber Capsule Filters ClariSure K PES Cartridge Filters with Microglassfiber upstream ClariSure S Microglassfiber Cartridge Filters ClariCap PP Capaule Filters ClariSure PA Pleated Cartridge Filters ClariPro K PES Capsule Filters with Microglassfiber upstream ClariCap PP Capaule Filters ClariPro K PES Capsule Filters with Microglassfiber upstream ClariCap S Microglassfiber Capsule Filters ClariSure K PES Cartridge Filters with Microglassfiber upstream ClariSure S Microglassfiber Cartridge Filters ClariSure PA Pleated Cartridge Filters ClariSure P Microglassfiber Cartridge Filters ClariSure K PES Cartridge Filters with Microglassfiber upstream ClariSure P Microglassfiber Cartridge Filters ClariPro K PES Capsule Filters with Microglassfiber upstream ClariCap S Microglassfiber Capsule Filters ClariSure K PES Cartridge Filters with Microglassfiber upstream ClariSure S Microglassfiber Cartridge Filters Prefiltration of serum and other viscous biologicals Pre-filtration of fermentor air Pre-filtration of proteinaceous liquids - High retention efficiency - Low hold up volume - High throughput Pharmaceuticals Pre-filtration of high value difficult to filter drug solutions Pre-filtration of large volume parenterals Pre-filtration of difficult to filter SVP like Oxytetracycline Polishing of turbid solutions - High retention efficiency - High throughput - High retention efficiency - High throughput - High retention efficiency - High throughput - Very high retention efficiency for colloidal particles - High throughput mdi PROCE FILTRATIO PRODUCT UIDE Page 5

54 ClariPro K, 2,, 8 USFDA 2 CFR 2.3 (b)(6) USFDA 2 CFR ClariPro K hydrophilic PES membrane capsule filters are ready to use, disposable filtration devices. These filters are specially designed filters incorporating a microglassfiber upstream layer and a downstream PES membrane layer and are used as pre-filters in biopharmaceuticals process development as well as manufacturing processes for difficult to filter solutions. ClariPro K - Autoclavable: ClariPro K DK 35Emdi D6 K Pro m Clari.5µ 79 Radiation Sterilizable:.µm,,.5µm Pore Hydrophilic PES Pre-filter Microglassfiber Support Layers Polyester cm² 5 cm² cm² 5 cm² Effective Filtration Area (ominal) Water Flow Rates.5 µm ClariPro K Capsule Filters /4 Hose Barb with Silicone O ring for 2, and 8 Capsule Filters Vent and Drain < 3 psi (2 Kg/cm²) 6 psi (4 3 C By Irradiation ClariPro K- : amma Irradiatiable up to 5 ky By as ClariPro K : By Autoclave 5 5 Inch, EE ClariPro K- : Autoclavable at 25 C for 3 minutes, cycle after amma Irradiation Water Flow Rate (lpm) Autoclavable at 25 C for 3 minutes, 25 cycle. E: ½ Sanitary Flange Connections ClariPro K DK Pore 5. µm 36 ¼ SHB A 2 52 ½ Hose Barb D.5 µm 4 ½ Sanitary Flange E 8 57 ¾ Sanitary Flange S DK Inlet/Outlet 57 4 Quick Connector J Single Step ½ Hose Barb Q DD Radiation Sterilizable Yes R o* R For End Connection availability and dimensions with different sizes refer Pages Pack *amma Sterile capsule filters cannot be amma Irradiated again Page 52 mdi PROCE FILTRATIO PRODUCT UIDE.3 8 Inch, EE These cannot be In-line steam sterilized.7 2 Inch, EE 5 Sterilizable by Ethylene Oxide ClariPro K : Inch, EE on Sterile EO Sterile 2 amma Sterile Pressure Drop Kg/Cm² Max. Operating Temperature

55 ClariPro K,, 2, 3 USFDA 2 CFR 2.3 (b)(6) USFDA 2 CFR ClariPro K hydrophilic PES membrane large capsule filters are ready to use, disposable filtration devices with a microglassfiber upstream layer and a downstream PES membrane final layer. ClariPro K L Autoclavable: i LClKariPro ClariPro K - md Radiation Sterilizable: K 475.5µm J- 7 9 The microglassfiber layer offers high dirt holding capacity and efficient retention of colloidal particles to give clear downstream in case of difficult to filter turbid solutions. The downstream PES membrane offers absolute retention and low protein binding along with high flow rates.. µm,,.5 µm Pore Hydrophilic PES Pre-filter Microglassfiber Support Layers Polyester Effective Filtration Area (ominal) 25 cm² 5 cm² 2 Water Flow Rates 3 cm² 5 cm².5 µm ClariPro K Large Capsule Filters /4 Hose Barb with Silicone O ring Vent and Drain 6 8 < 3 psi (2 Kg/cm²) 6 psi (4 3 C By Irradiation ClariPro K - amma Irradiatiable up to 5 ky ClariPro K By as By Autoclave Inch, EE 2 Inch, EE Inch, EE Sterilizable by Ethylene Oxide ClariPro K - Autoclavable at 25 C for 3 minutes, cycle after amma Irradiation Max. Operating Temperature 8 Water Flow Rate (lpm) ClariPro K Autoclavable at 25 C for 3 minutes, 25 cycles These cannot be In-line steam sterilized E: ½ Sanitary Flange Connections ClariProK LK Pore Inlet/Outlet **. µm µm ½ Sanitary Flange Single Step ½ Hose Barb E Q Radiation Sterilizable Inline / T-line Yes R Inline o* T-line T Pack on Sterile EO Sterile 2 amma Sterile 3 LK 54 EE R T * amma Sterile capsule filters cannot be amma Irradiated again ** is available in In-line Capsule Filters Only For End Connection availability and dimensions with different sizes refer Pages mdi PROCE FILTRATIO PRODUCT UIDE Page

56 ClariSure K Mini Cartridge Filters USFDA 2 CFR 2.3 (b)(6) USFDA 2 CFR ClariSure K hydrophilic PES membrane mini cartridge filters offer a microglassfiber upstream layer with a PES membrane final filter to combine high dirt holding capacities with efficient retention of colloidal particles to give clear downstream in case of difficult to filter turbid solutions.. μm,.2 μm,.5 μm Pore Filter Media Hydrophilic PES Support Layers Polyester Water Flow Rates Effective Filtration Area (ominal) 2. cm² 5 cm².5 µm ClariSure K Cartridge Filters 8 < 3 psi (2 Kg/cm²) 5 psi ( C Max. Operating Temperature Autoclavable/In-line steam sterilizable at 2 C for 3 minutes, 25 cycles Inch Water Flow Rate (lpm) ClariSure K CK Pore Adapter Elastomer µm E 4463B H.5 µm U Silicone Pack on Sterile CK 5 Page 54 mdi PROCE FILTRATIO PRODUCT UIDE Inch E Pressure Drop Kg/Cm² 25

57 ClariSure K USFDA 2 CFR 2.3 (b)(6) USFDA 2 CFR ClariSure K hydrophilic PES membrane cartridge filters offer a microglassfiber upstream layer with a PES membrane final filter to combine high dirt holding capacities with efficient retention of colloidal particles to give clear downstream in case of difficult to filter turbid solutions.. µm,,.5 µm Pore Hydrophilic PES Pre-filter Microglassfiber Support Layers Polyester Water Flow Rates cm² 5 cm² cm² 5 cm² Max. Operating Temperature 8 < 3 psi (2 Kg/cm²) 5 psi ( C Inch Inch Autoclavable/In-line steam sterilizable at 2 C for 3 minutes, 25 cycles 6 3 Inch 7 Effective Filtration Area (ominal).5 µm ClariSure K Cartridge Filters Water Flow Rate (lpm) ClariSure K CK Pore Adapter Elastomer *. µm 36 7P A Silicone 54 7P without fin A Viton SV µm 4 O D EPDM SE 3 56 FEP Encapsulated Viton FV** Pack on Sterile CK A * 5" are available in A (7P) and A (7P without fin) only ** FV is available in Adapter A (7P) and A (7P without fin) only mdi PROCE FILTRATIO PRODUCT UIDE Page 55

58 ClariCap S, 2,, 8 USFDA 2 CFR 2.3 (b)(6) USFDA 2 CFR DS.2µm D765J- 29 ClariCap S Capsule filters employ microglassfiber filter media for efficient retention of colliodal particles to give clear downstream in case of difficult to filter turbid solutions. These specially designed filtration devices are non media migrating with a heat calendered polypropylene layer in the downstream..7 µm, µm,.5 µm, 2 µm Pore Filter Media Microglassfiber Effective Filtration Area (ominal) cm² 4 cm² 8 cm² 2 cm² Water Flow Rates.7 µm ClariCap S Capsule Filters /4 Hose Barb with Silicone O ring for 2, and 8 Capsule Filters Vent and Drain 8 < 3 psi (2 Kg/cm²) 6 psi (4 3 C Autoclavable at 25 C for 3 minutes, 3 cycles. Cannot be In-line steam sterilized Inch, DD 2 2 Inch, DD 5 Inch, DD 8 Inch, DD Water Flow Rate (lpm) D: ½ Hose Barb ClariCap S DS Pore Inlet/Outlet Bell 5.7 µm 4 ¼ SHB A Yes B 2 52 µm 5 ½ Hose Barb D o Bell.5 µm 4 ½ Sanitary Flange E µm 5 ¾ Sanitary Flange S Quick Connector J Single Step ½ Hose Barb Q Pack on Sterile DS 57 5 DD For End Connection availability, Bell and dimensions with different sizes refer Pages Page 56 mdi PROCE FILTRATIO PRODUCT UIDE Max. Operating Temperature

59 ClariCap S,, 2, 3 USFDA 2 CFR 2.3 (b)(6) USFDA 2 CFR ClariCap S large capsule filters are multilayered, high throughput filters, specially designed for difficult to filter solutions. These are high efficiency pre-filters combining the unique abilities of microglassfiber filter media to retain colloidal particles and heat calendered polypropylene filter media to ensure non media migration..7 µm, µm,.5 µm, 2 µm Pore Filter Media Microglassfiber Effective Filtration Area (ominal) 2 3 Water Flow Rates 7 cm² 34 cm² 68 cm² 2 cm² /4 Hose Barb with Silicon O ring Vent and Drain.7µm ClariCap S Large Capsule Filters Max. Operating Temperature 8 < 3 psi (2 Kg/cm²) 6 psi (4 3 C Autoclavable at 25 C for 3 minutes, 3 cycles. Cannot be In-line steam sterilized Inch, EE 2 2 Inch, EE 3 Inch, EE Water Flow Rate (lpm) E: ½ Sanitary Flange Connections ClariCap S LS Inlet/Outlet Pore Inline / T-line *.7 µm 4 ½ Sanitary Flange E 54 µm µm 4 Single Step ½ Hose Barb Q µm 5 Inline T-line T Pack on Sterile LS 54 4 EE T * is available in Inline capsule filters only For End Connection availability and dimensions with different sizes refer Page mdi PROCE FILTRATIO PRODUCT UIDE Page 57

60 ClariSure S Mini Cartridge Filters USFDA 2 CFR 2.3 (b)(6) USFDA 2 CFR ClariSure S mini cartridge filters are multilayered, high throughput filters, specially designed for difficult to filter solutions. It is a very high efficiency pre-filter combining the unique abilities of microglassfiber filter media to retain colloidal particles and heat calendered polypropylene filter media to ensure non media migration..7 μm, μm Pore Filter Media Microglassfiber Water Flow Rates Support Layers Polyester.7 µm ClariCap S Cartridge Filters 8 cm² 2 cm² Max. Operating Temperature 8 < 3 psi (2 Kg/cm²) 5 psi ( C Inch Water Flow Rate (lpm) ClariSure S CPS Pore Adapter Elastomer µm E µm B H 444 U Silicone Pack on Sterile CPS 5 Page 58 mdi PROCE FILTRATIO PRODUCT UIDE Inch Autoclavable/In-line steam sterilizable at 2 C for 3 minutes, 3 cycles 6 E Effective Filtration Area (ominal) 2.

61 ClariSure S USFDA 2 CFR 2.3 (b)(6) USFDA 2 CFR ClariSure S cartridge filters are multilayered, high throughput filters, specially designed for difficult to filter solutions. It is a very high efficiency pre-filter combining the unique abilities of microglassfiber filter media to retain colloidal particles and heat calendered polypropylene filter media to ensure non media migration..7 µm, µm Pore Filter Media Microglassfiber Support Layers Polyester Effective Filtration Area (ominal) Water Flow Rates µm ClariSure S Cartridge Filters 7 cm² 34 cm² 68 cm² 2 cm² 8 < 3 psi (2 Kg/cm²) 5 psi (3.5 3 C Autoclavable/In-line steam sterilizable at 2 C for 3 minutes, 3 cycles Inch.4 2 Inch 7 Max. Operating Temperature 3 Inch Water Flow Rate (lpm) ClariSure S CPS Pore Adapter Elastomer *.7 µm 4 7P A Silicone 54 µm 5 7P without fin A Viton SV 2 55 O' D EPDM SE 3 56 FEP Encapsulated Viton FV** Pack on Sterile CPS 55 4 A SV * 5" are available in A (7P) and A (7P without fin) only ** FV is available in Adapter A (7P) and A (7P without fin) only mdi PROCE FILTRATIO PRODUCT UIDE Page 59

62 ClariSure P Mini Cartridge Filters USFDA 2 CFR 2.3 (b)(6) USFDA 2 CFR ClariSure P mini cartridge filters are specially designed multilayered precision filtration devices. These cartridge filters act as throughput enhancers, specially in case of difficult to filter solutions. A microglassfiber upstream layer retains very fine colloidal particles and a downstream polypropylene layer checks any kind of media migration..5 μm, μm, 2 μm Pore Filter Media Microglassfiber Support Layers Effective Filtration Area (ominal) 2. 8 cm² 6 cm² Max. Operating Temperature 8 < 3 psi (2 Kg/cm²) 5 psi ( C Autoclavable/In-line steam sterilizable at 2 C for 3 minutes, 3 cycles ClariSure P CPP Pore Adapter Elastomer µm E µm B H 2 µm U Silicone Pack on Sterile CPP 5 Page 6 mdi PROCE FILTRATIO PRODUCT UIDE 5 E

63 ClariSure P USFDA 2 CFR 2.3 (b)(6) USFDA 2 CFR ClariSure P cartridge filters are specially designed multilayered precision filtration devices. These cartridge filters act as throughput enhancers, specially in case of difficult to filter solutions. A microglassfiber upstream layer retains very fine colloidal particles and a downstream polypropylene layer checks any kind of media migration..5 µm, µm, 2 µm Pore Filter Media Microglassfiber Support Layers Water Flow Rates Effective Filtration Area (ominal) 2 3 ClariSure P, Cartridge Filters 25 cm² 5 cm² cm² 5 cm² < 3 psi (2 Kg/cm²) 5 psi ( C Autoclavable/In-line steam sterilizable at 2 C for 3 minutes, 3 cycles µm µm. Max. Operating Temperature Water Flow Rate (lpm) ClariSure P CPP Pore Adapter Elastomer *.5 µm 4 7P A Silicone 54 µm 5 7P without fin A Viton SV µm 5 O' D EPDM SE 3 56 FEP Encapsulated Viton FV** Pack on Sterile CPP 55 4 A * 5" are available in A (7P) and A (7P without fin) only ** FV is available in Adapter A (7P) and A (7P without fin) only mdi PROCE FILTRATIO PRODUCT UIDE Page 6

64 ClariCap PP, 2,, 8 USFDA 2 CFR 2.3 (b)(6) USFDA 2 CFR A A DOL µ m 6 7 DOL 45J- 3 P D ClariCap PP capsule filters employ high retention efficiency polypropylene filter media with wide chemical compatibility for pre-filtration and polishing applications. mdi.5 µm, µm, 2.5 µm, 5 µm, µm, 2 µm Pore Filter Media Support Layers Effective Filtration Area (ominal) Water Flow Rates cm² 5 cm² 8 cm² 6 cm² ClariCap PP, Capsule Filters /4 Hose Barb with Silicone O ring for 2, and 8 Capsule Filters Vent and Drain.2 Max. Operating Temperature 8 < 3 psi (2 Kg/cm²) psi (4 3 C Autoclavable at 25 C for 3 minutes, 3 cycles. Cannot be In-line steam sterilized.5 µm µm 2.5 µm 5 µm. Water Flow Rate (lpm) ClariCap PP DOL Pore Inlet/Outlet 5.5 µm 4 ¼ SHB A ¼ MPT B µm 2.5 µm ½ MPT C µm 7 ½ Hose Barb D µm 8 ½ Sanitary Flange E 2 µm ¾ Sanitary Flange S Quick Connector J Single Step ½ Hose Barb Q Pack on Sterile DOL 5 CC For End Connection availability, Bell and dimensions with different sizes refer Pages Page 62 mdi PROCE FILTRATIO PRODUCT UIDE 3.

65 ClariCap PP,, 2, 3 USFDA 2 CFR 2.3 (b)(6) USFDA 2 CFR LOL mdi LP645J- EE 54 LOL.2µm 8 ClariCap PP large capsule filters employ high retention efficiency filter media for wide chemical compatibility, efficient pre-filtration for clarification and polishing applications..5 µm, µm, 2.5 µm, 5 µm, µm, 2 µm Pore Filter Media Support Layers Effective Filtration Area (ominal) cm² cm² 5 cm² Water Flow Rates ClariCap PP, Large Capsule Filters /4 Hose Barb with Silicone O ring Vent and Drain 8 < 3 psi (2 Kg/cm²) 6 psi (4 3 C Autoclavable at 25 C for 3 minutes, 3 cycles. Cannot be In-line steam sterilized µm, EE µm, EE 2.5 µm, EE 5 µm, EE. 7 Max. Operating Temperature Water Flow Rate (lpm) End Connection : E: ½ Sanitary Flange ClariCap PP LOL Pore Inlet/Outlet *.5 µm 4 ½ Sanitary Flange E 54 µm Single Step ½ Hose Barb Q 2.5 µm µm 7 µm 8 2 µm Inline / T-line Inline T-line T Pack on Sterile LOL 54 6 QQ T * is available in In-line Capsule Filters Only For End Connection availability and dimensions with different sizes refer Pages mdi PROCE FILTRATIO PRODUCT UIDE Page 63

66 ClariSure PA Mini Cartridge Filters USFDA 2 CFR 2.3 (b)(6) USFDA 2 CFR mdi ClariSure PA mini cartridge filters are % polypropylene, very high retention efficiency pleated cartridge filters offering large filtration area. These filters have heat stable construction and are used as pre-filters to sterilizing membrane cartridge filters. Water Flow Rates ClariSure PA, 2. Mini Cartridge Filters.5 μm, μm,.2 μm, 2.5 μm, 5 μm, 8 μm, μm Pore Support Layers Effective Filtration Area (ominal) 8 cm² 5 6 cm² Water Flow Rate (lpm) ClariSure PA, Mini Cartridge Filters Max. Operating Temperature 8 < 3 psi (2 Kg/cm²) 5 psi ( C 6. Autoclavable/In-line steam sterilizable at 2 C for 3 minutes, cycles Water Flow Rate (lpm) Pore CPPA.2 CPPA µm CPPA 2.5µm CPPA 5µm CPPA µm 4. Adapter µm E µm B H.2 µm 444 U 2.5 µm 6 5 µm 7 8 µm 7 µm 8 Elastomer Silicone Pack on Sterile CPPA 5 Page 64 mdi PROCE FILTRATIO PRODUCT UIDE 5 E Pressure Drop (kg/cm²).4 ClariSure PA.2 CPPA µm CPPA 2.5µm CPPA 5µm CPPA µm 2. Pressure Drop (kg/cm²) 6. Filter Media

67 ClariSure PA USFDA 2 CFR 2.3 (b)(6) USFDA 2 CFR ClariSure PA cartridge filters are % polypropylene, very high retention efficiency pleated cartridge filters offering large filtration area. These filters have heat stable construction and are used as pre-filters to sterilizing membrane cartridge filters..5 μm, μm,.2 μm, 2.5 μm, 5 μm, 8 μm, μm Pore Filter Media Support Layers Water Flow Rates 2 3 ClariSure PA, Cartridge Filters Effective Filtration Area (ominal) 25 cm² 5 cm² cm² 5 cm² 8 < 3 psi (2 Kg/cm²) 5 psi ( C Autoclavable/In-line steam sterilizable at 2 C for 3 minutes, cycles µm µm 5µm. 7 µm 4 CPPA Water Flow Rate (lpm) Pore ClariSure PA Max. Operating Temperature Adapter Elastomer *.5 µm 4 7P A Silicone 54 µm 5 7P without fin A Viton SV µm O D EPDM SE µm 6 5 µm 7 FEP Encapsulated Viton FV** 8 µm 7 µm 8 Pack on Sterile CPPA 56 5 A * 5" are available in A (7P) and A (7P without fin) only **FV is available in Adapter A (7P) and A (7P without fin) only mdi PROCE FILTRATIO PRODUCT UIDE Page 65

68 Microglassfiber Disc Filters Microglassfiber Disc Filters - F2 F2 filters are high dirt holding microglassfiber disc filters specially designed for pre-filtration of solutions with high dirt load. Pore :.5 µm Special Features High flow rates High dirt holding capacity Fine Microglassfiber Disc Filters - FS FS filters are high retention efficiency fine microglassfiber disc filters. Pore : 2 µm Special Features High retention efficiency Positively Charged Microglassfiber Disc Filters- FSZ FSZ filters are positively charged high retention efficiency microglassfiber disc filters. Pore : 2 µm Special Features Very high retention efficiency for negatively charged particles Pore F2 F2 27 mm 5.5 µm 4 FS FS 42 mm 6 2 µm 5 FSZ FSZ 257 mm mm mm 9 Pack on Sterile 5 3 FS 8 Page 66 mdi PROCE FILTRATIO PRODUCT UIDE 5 3

69 Filters for Polishing and Clarification mdi offers a range of cartridge filters for polishing and clarification applications requiring absolute removal of particulate contaminants. These are non media migrating, biologically and chemically inert, large area filter cartridges, offering very high (99.999%) to moderate high (99.9%) retention efficiencies to suit different applications. s Available: >> ClariSure PP- Pleated cartridge filters >> ClariSure PL- Pleated Profile cartridge filters >> ClariSure DP- Pleated Depth cartridge filters Applications Filtration of organic solvents in non sterile API Polishing filtration of on Sterile API Filtration of precipitating agents Filtration of wash solvents for final non sterile API Filtration of air to dryers and micronizers Final wash water for Ampoule/Vial washing and Bung washing Bottle washing in oral formulations Filtration of feed water for RO plants Quality Assurance These filter devices are manufactured in Class, clean rooms under I S O 9 cer tified qualit y management systems and are validated to meet compendia and regulatory requirements. Assurance Toxicity Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics on Fiber Releasing Passes test as per USP and comply with USFDA 2 CFR Part 2.3 (b)(6) for fiber release Extractables with WFI Passes test as per USP Oxidizable Substances Within limits as specified in USP Particle Shedding Passes USP test for particulates in injectables Indirect Food Additive All components meet the FDA Indirect Food Additive requirements cited in 2 CFR ood Manufacturing Practice These products are manufactured in a facility which adheres to ood Manufacturing Practices mdi PROCE FILTRATIO PRODUCT UIDE Page 67

70 Filter Selection Chart Application Area Key Application Requirements Cartridge Filters Filtration of organic solvents in non sterile API - High retention efficiency - Wide chemical compatibility ClariSure PP Pleated Cartridge Filters ClariSure PL Pleated Profile Cartridge Filters Polishing filtration of non sterile API - Very high retention efficiency - Wide chemical compatibility ClariSure PP Pleated Cartridge Filters ClariSure PL Pleated Profile Cartridge Filters Filtration of precipitating agents - Very high retention efficiency - Wide chemical compatibility ClariSure PP Pleated Cartridge Filters ClariSure PL Pleated Profile Cartridge Filters Filtration of wash solvents for final non sterile API - Very high retention efficiency - Wide chemical compatibility ClariSure PP Pleated Cartridge Filters ClariSure PL Pleated Profile Cartridge Filters ClariSure PP Pleated Cartridge Filters ClariSure PL Pleated Profile Cartridge Filters Filtration of air to dryers and micronizers - Very high retention efficiency Final wash water for ampoule/vial washing and bung washing - Very high retention efficiency - Wide chemical compatibility ClariSure PP Pleated Cartridge Filters ClariSure PL Pleated Profile Cartridge Filters Bottle washing in oral formulations - Very high retention efficiency - Wide chemical compatibility ClariSure PP Pleated Cartridge Filters ClariSure PL Pleated Profile Cartridge Filters Filtration of feed water for RO plants - High dirt holding capacity Page 68 mdi PROCE FILTRATIO PRODUCT UIDE ClariSure DP Pleated Depth Cartridge Filters ClariSure DP Pleated Depth Cartridge Filters

71 ClariSure PP USFDA 2 CFR 2.3 (b)(6) USFDA 2 CFR ClariSure PP cartridge filters are % polypropylene construction precision filtration devices. These are very high retention efficiency (99.999%) pleated cartridge filters offering large filtration area. These filters are used as terminal filters in applications requiring highly efficient particulate removal..5 μm, µm,.2 μm, 2 µm, 2.5 μm, 5 μm μm, 2 μm, 3 µm Pore Filter Media Support Layers Water Flow Rates ClariSure PP, Cartridge Filters Effective Filtration Area (ominal) 25 cm² cm² cm² 5 cm² Max. Operating Temperature 8 < 3 psi (2 Kg/cm²) Max. Differential Pressure 5 psi ( C µm µm 2.5 µm 5 µm Water Flow Rate (lpm) 6 ClariSure PP CPPP Adapter Elastomer.5 µm 4 7P A Silicone 54 µm 5 7P without fin A Viton SV µm O D EPDM SE µm 5 BEO B PTFE ST** 2.5 µm 6 5 µm 7 FEP Encapsulated Viton FV* µm 8 2 µm 3 µm A FV Pack CPPP Pore on Sterile * FV is available in Adapter A (7P) and A (7P without fin) only ** PTFE (ST) gasket seals are available with B Adapter only mdi PROCE FILTRATIO PRODUCT UIDE Page 69

72 ClariSure PL USFDA 2 CFR 2.3 (b)(6) USFDA 2 CFR ClariSure PL cartridge filters are all polypropylene high retention efficiency (99.99%) pleated cartridge filters offering large filtration area. μm, 2.5 μm, 5 μm, μm Pore Filter Media Support Layers Water Flow Rates ClariSure PL, Cartridge Filters cm².42 5 cm² cm² 5 cm² Max. Operating Temperature 8 < 3 psi (2 Kg/cm²) 5 psi ( C µm µm 5 µm Water Flow Rate (lpm) ClariSure PL CPPL Pore Adapter Elastomer µm 5 7P A Silicone µm 6 7P without fin A Viton SV µm 7 O D EPDM SE µm 8 BEO B PTFE ST** FEP Encapsulated Viton FV* Pack on Sterile CPPL 54 7 B *FV is available in Adapter A (7P) and A (7P without fin) only ** PTFE (ST) gasket seals are available with B Adapter only Page 7 mdi PROCE FILTRATIO PRODUCT UIDE SV Effective Filtration Area (ominal) 2

73 ClariSure DP USFDA 2 CFR 2.3 (b)(6) USFDA 2 CFR ClariSure DP cartridge filters are specially designed medium retention efficiency, multilayered, all polypropylene depth cartridge filters offering high dirt holding capacity as well as high flow rates due to their pleated configuration. These filters are primarily used as pre-filters but can also be used as terminal filters for non-critical applications. μm,.5 μm, 3 μm, 5 μm, μm, 2 μm 3 μm, 4 μm Pore Filter Media Support Layers Effective Filtration Area (ominal) 2 2 cm² 4 cm² 3 8 cm² 2 cm² Max. Operating Temperature 8 < 3 psi (2 Kg/cm²) 5 psi ( C ClariSure DP CPDP Pore Adapter Elastomer µm 5 7P A Silicone 54.5 µm 4 7P without fin A Viton SV µm 6 O D EPDM SE µm 7 BEO B PTFE ST** µm 8 2 µm FEP Encapsulated Viton FV* 3 µm 9 4 µm 2 Pack on Sterile CPDP 56 4 A *FV is available in Adapter A (7P) and A (7P without fin) only ** PTFE (ST) gasket seals are available with B Adapter only mdi PROCE FILTRATIO PRODUCT UIDE Page 7

74 Chemical Compatibility Table below shows the chemical compatibility of various process filtration products with some commonly used solvents. All products were exposed to specified chemicals for 72 hours at 25 C. Chemical compatibility data with specific reagents is available on request. AseptiSure Cartridge Filters Reagents ClariSure Cartridge Filters HS/KS KR/HSR/KSR S TH/TF 'O' Rings/asket Seals FEP K S P PA PP PL DP Silicone Viton EP Encapsulated Viton Solvents Acetone Acetonitrile Benzene F F F F F F F Benzyl Alcohol Benzyl Alcohol 4% Diethyl Ether Dimethylformamide Ethyl Acetate Ethylene lycol Hexane F F F F F F F F F F F Iso Propyl Alcohol Methanol Methylene Chloride n-butanol Peanut oil Tetrahydrafuran/Water (5:5) Toluene Trichloroethylene Hydrochloric Acid 37% Hydrofluoric Acid % F F itric Acid 67% itric Acid 7% Sulphuric Acid % F Ammonium Hydroxide 25% Sodium Hydroxide 32% Potassium Hydroxide 32% Acids Bases : ood F: Fair : ot recommended Page 72 mdi PROCE FILTRATIO PRODUCT UIDE

75 Chemical Compatibility Table below shows the chemical compatibility of various process filtration products with some commonly used solvents. All products were exposed to specified chemicals for 72 hours at 25 C. Chemical compatibility data with specific reagents is available on request. AseptiCap Capsule Filters Reagents AseptiVent Capsule Filters KL/KS KO/KSO L/S ClariCap Capsule Filters Disc Filters Microglassfiber Pre-filter Discs TF K S PP F Solvents Acetone Acetonitrile Benzene F F F Benzyl Alcohol Benzyl Alcohol 4% Diethyl Ether Dimethylformamide Ethyl Acetate Ethylene lycol Hexane F F F Iso Propyl Alcohol Methanol Methylene Chloride n-butanol Peanut oil Tetrahydrafuran/Water (5:5) Toluene Trichloroethylene Hydrochloric Acid 37% Hydrofluoric Acid % itric Acid 67% itric Acid 7% Sulphuric Acid % Ammonium Hydroxide 25% Sodium Hydroxide 32% F Potassium Hydroxide 32% Acids Bases : ood F: Fair : ot recommended mdi PROCE FILTRATIO PRODUCT UIDE Page 73

76 End Connections Availability Chart for Capsule Filters Connections Available Inlet/ Outlet 25mm 37mm 5mm /4 SHB I/O χ 3/4 Sanitary Flange I/O χ χ Outlet Only Female Luer Lock Inlet Only χ χ Male Luer Slip Outlet Only χ χ χ χ /8 Hose Barb I/O Small Capsule Filters 2 8 ½ Hose Barb Single Step ½ Hose Barb ¼ Stepped Hose Barb ½ Sanitary Flange ¾ Sanitary Flange ½ MPT ¼ MPT Quick Connector Female Luer Lock Male Luer Slip Outlet Only Bell is available with ¼ SHB outlet in Capsule Filters only Bell is available with ½ Hose Barb outlet in, 2, and 8 Capsule Filters Large Capsule Filters Inline Single Step ½ Hose Barb ½ Sanitary Flange Page 74 mdi PROCE FILTRATIO PRODUCT UIDE 2 T-line 3 2 3

77 Dimensions: Capsule Filters Inline Capsule Filters Inlet/ Outlet 25mm 37mm 5mm /4 SHB I/O - 64 mm 79 mm 3/4 Sanitary Flange I/O mm Female Luer Lock Inlet/ Male Luer Slip Outlet 23 mm - - /8 Hose Barb I/O 36 mm - - Radius 5 mm 23 mm 28 mm Small Capsule Filters 2 8 ¼ SHB I/O 94 mm 22 mm 72 mm 223 mm ¾ Sanitary Flange Inlet I/O 9 mm 3 mm 55 mm 25 mm ½ Sanitary Flange I/O 9 mm mm 6 mm 2 mm ½ Hose Barb I/O 9 mm 2 mm 64 mm 25 mm ½ Single Step Hose Barb I/O 9 mm 3 mm 64 mm 25 mm ½ Sanitary Flange Inlet ½ Hose Barb Outlet 96 mm 8 mm 75 mm 228 mm Radius 3 mm 65 mm 65 mm 65 mm Inline Large Capsule Filters ½ Sanitary Flange I/O 27 mm mm 6 mm 876 mm ½ Single Step Hose Barb I/O 27 mm 332 mm 67 mm 882 mm ½ Sanitary Flange Inlet ½ Hose Barb Outlet 23 mm 332 mm 67 mm 882 mm Radius 78 mm 78 mm 78 mm 78 mm mdi PROCE FILTRATIO PRODUCT UIDE Page 75

78 Shipment details for customers outside India Through Federal Express, UPS, or DHL courier (specify complete street address). By air freight for large quantities (specify airport of discharge). oods usually reach destination within 5- days from date of shipment. products are light weight and air freight charges usually vary between 3% to % of the value. Any duties/taxes in the country of destination are the responsibility of the consignee. Shipment details for customers in India The consignments can be sent through courier. Courier charges will be borne by the customer. Please specify the preferred courier and provide any form and instructions for octroi etc. that may be required for shipment. How to order Orders may be placed by phone/fax/ /mail directly to Sales. Advanced Microdevices Pvt. Ltd. 2-2, Industrial Area, Ambala Cantt , IDIA Tel: , Fax: , orders@mdimembrane.com info@mdimembrane.com Page 76 mdi PROCE FILTRATIO PRODUCT UIDE

79 mdi Quality Quality Policy Quality is built into mdi products and services by not only adhering to well designed quality systems to consistently produce high quality, internationally acceptable products but also by striving to incorporate superior performance parameters into all our products and services and provide our customers with a unique performance advantage in their application. Our quality policy provides a glimpse of our commitment: mdi strives to provide to its customers products and services of highest standards possible, consistently superior, and more satisfying than what is available anywhere else. Stride Towards Excellence At mdi, our mission is to constantly strive to achieve excellence in all our endeavors by establishing systems to create excellent products and services to fulfil the needs of our customers. To achieve this we Frequently compare our products with competing brands Simulate tests for functional use Develop easy-to-use innovative products We are constantly working on improvements and welcome suggestions from our customers. uarantee All mdi products are guaranteed and are backed by our Technical expertise and experience of over 35 years Validated mdi process for consistency and repeatability Strict quality control and quality assurance regimen Certificate of Analysis accompanying all shipments We have an unconditional replacement policy in case of any defects.