3M Purification Filter Systems for Pharmaceutical Separations. Innovative Filtration. Performance. Quality. Service.

Transcription

1 3M Purification Filter Systems for Pharmaceutical Separations Innovative Filtration Performance. Quality. Service.

2 3M Purification Core Filtration Applications: Page A. Adsorptive Depth Filtration 3 Optimised colour reduction Precipitate control Streamlined process 3M Purification - Over 98 Years of Solutions When looking for pharmaceutical fi ltration solutions, the industry has turned to 3M Purifi cation for performance. 3M Purifi cation has achieved a leadership position by striving to be the best supplier of high-quality products designed to provide cost effective solutions. Some fi lter manufacturers offer a limited range or a single fi lter option. 3M Purifi cation understands that each application is unique and there is always an alternative. 3M Purifi cation has both the experience and advanced material technology throughout its products to provide quality improvements and dramatic cost savings for the customer. 3M Purifi cation is a leader in advanced depth fi lter systems and membrane-based separations, offering a wide range of products for all stages of pharmaceutical processing and sterile fi ltration from bench-top to pilot-scale to manufacturing-scale operations. Active Pharmaceutical Ingredients (API s) refer to the active chemicals used in the manufacture of drugs. API s are synthesized via a series of unit operations that include key fi ltration steps to produce the active ingredient of a drug product. 3M Purifi cation s core fi ltration technologies address the most demanding applications in pharmaceutical processing for small molecule and API applications. Regulatory requirements demand the highest quality product standards along with documented evidence of manufacturing processes. 3M Purifi cation products in the pharmaceutical industry meet the demands of regulatory agencies throughout the world and are used by the largest and most respected pharmaceutical manufacturers in the industry. B. Solids Removal, Recovery and Reclaim 5 Effective removal of bulk catalyst Reduced exposure concerns Efficient operation C. Solvent and Bulk Chemical Filtration 6 Broad chemical compatibility Improved throughputs Variety of filter options D. Endotoxin and Bioburden Reduction 7 Effective prefiltration Bacteria control Improved downstream protection E. Sterilising Grade Filtration (liquid and gas) 8 FDA compliant Higher capacity Lower cost of ownership F. Utilities and Plant Services 9 Increased efficiency Higher throughputs Fewer change-outs G. Filter Validation 10 Products and services Full documentation Consultation 2

3 3M Purifi cation Innovative Filtration Filter Systems for Pharmaceutical Separations A. Adsorptive Depth Filtration 1. Colour Reduction Activated carbon is used in the pharmaceutical industry to remove impurities from active ingredient manufacturing. These impurities are typically derived from chemical reactions that produce coloured by-products. These coloured by-products must be removed to maintain drug purity and produce high-quality, on-spec intermediate compounds. Activated carbon use in powdered form presents three primary areas of concern to the pharmaceutical manufacturer, namely operator exposure to carbon dust, the quality of the process and the operating costs associated with the use and handling of bulk activated carbon. 3M Purification s ZetaCarbon media incorporates the latest in depth filtration technology to decolourise and remove contaminants from pharmaceutical process streams. Figure 1: ZetaCarbon Colour and Dissolved Solids Reduction API Synthesis Reactor Bulk Catalyst Filtration and Reclaim ZetaCarbon Depth Filter Housings Figure 2: Grades of ZetaCarbon Media R1X Viscosity of 60 to 80 cp R3X Viscosity of 20 to 60 cp R5X Viscosity of 1 to 20 cp Microns ZetaCarbon Media Benefi ts Optimised Process Carbon type is selected based on colour removal effi ciency Activated carbon is fi xed in fi lter matrix and the fl ow is forced through the matrix at constant fl ux Increasing process effi ciency Reduced Operator Exposure To Carbon Dust Carbon dust is virtually eliminated due to carbon incorporated into depth fi ltration media Cleanliness Cleaning and handling concerns with bulk activated carbon are minimised Cleaning validation between batches is streamlined Shorter Batch Times Batch times are reduced as colour removal takes place at constant rate Bulk activated carbon fi ltration step eliminated ZetaCarbon media are available in different filtration ratings in order to deal with products of different viscosity. The figure to the left is used to determine optimum filter selection. Different types of carbon can be specified as required. This can minimise validation for easy ZetaCarbon media implementation into the process. Table 1: ZetaCarbon Filter Media Product Description Ratings/Grades Available Applications ZetaCarbon Carbon-based adsorptive depth fi lter Various carbon grades & porosities Colour & odour reduction 3

4 Zeta Plus depth filters are available in a variety of configurations including filter sheets and cartridges ranging in size from laboratory to full-scale production. Zeta Plus filter cartridges are the most convenient form for efficient filtration. 2. Reduction of Dissolved Solids Most synthetic drug products utilise a variety of intermediates during processing. These intermediates can include active drug components, solvents or fine chemicals used in processing, excipients and as precursors to final drug formulation. During these steps, dissolved solids in various forms must be reduced to ensure product quality and safety requirements. Sources of contamination can include catalysts used in synthesis, process tanks, valves and piping, raw materials and unwanted by-products produced as a result of multi-step synthesis reactions. 3M Purification s positively charged Zeta Plus depth filters represent an efficient method for dissolved solids reduction in pharmaceutical active ingredient manufacturing. Zeta Plus depth filters consist of a cellulose matrix, inorganic filter aid and a cation resin. The resin component binds the cellulose and the filter aid and imparts a positive charge to the filter medium. Negatively charged contaminants and complexes can then be adsorbed to the Zeta Plus medium by electrostatic attraction. In addition, contaminants of sufficient size can be removed by mechanical entrapment within the Zeta Plus depth filter matrix. Zeta Plus depth filters are provided in a wide range of formulations and grades in order to provide optimal contaminant removal properties. Please reference Table 2 below. Figure 3: Nominal Retention Capacity of Zeta Plus SP Series Filters 05SP 10SP 30SP 50SP 60SP 90SP Microns Zeta Plus Depth Filter Benefi ts Improved Process Efficiency A variety of Zeta Plus media formulations allows for optimal selection to maximise contaminant removal and throughput and improve process effi ciency as compared to bulk, powdered activated carbon. Scalable Allows pilot testing and scale-up with the same materials that will be used in full-scale systems. Easy Validation Regulatory Support File available to ease validation and regulatory submissions by providing vital documentation and traceability. Table 2: Zeta Plus Depth Filter Media Product Description Grades Available Applications LA/SA/CA Series Low extractable levels 30, 50, 60, 90 SP Series CP Series DEL Series VR Series Solids recovery and clarification Optimised for clarification and haze reduction Lipid-specific adsorbent formula Ion-exchange and physical entrapment virus removal mechanisms 05, 10, 30, 50, 60, 90 10, 30, 50, 60, 70 DEL1P, DEL1LP 01, 02, 03, 04, 05, 06, 07 Small and large volume parenterals, dialysates, blood fractions API solutions, blood products Antibiotics, cough syrups, cosmetics, flavours and fragrances Selective removal of lipids and surfactants Virus reduction 4

5 3M Purifi cation Innovative Filtration Filter Systems for Pharmaceutical Separations B. Solids Removal, Recovery and Reclaim Solids removal and recovery is a common application in pharmaceutical production at various stages in the operation. Heavy-metal catalysts are used to promote hydrogenation reactions in active pharmaceutical ingredient manufacture. A variety of carriers or supports are used for the precious metals, including alumina, zeolites and carbon. These precious metal catalyst supports must be removed from the batch prior to downstream processing. Their high cost along with environmental regulations requires these solids to be captured and reclaimed at high yields. An effective filtration system is needed that effectively removes these particles from the process stream and helps protect the operator from contacting these hazardous materials. 3M Purification offers various filtration options for solids removal and recovery applications. Please reference Table 3 below. Figure 4: Solids Removal & Recovery Application Active Ingredient, Catalyst & Solvent Catalyst Removal/Recovery Guard Filter Product Benefi ts CTG System Enclosed Packs Incorporate a totally enclosed fi lter pack with an integral fi lter housing that captures the precious metal carrier particles, prevents contact of the material with the housing and minimises operator exposure. DuoFLO Filter Elements An advanced proven alternative to the use of traditional bag fi lters. DuoFLO fi lter elements provide a 62% increase in fi lter service area and up to 4 times or more service life when compared to commonly used #1 and #2 bag fi lters and will easily retrofi t most existing bag housings. OR CTG-System NB Series Bag Filters Featuring highly reliable and predictable performance fi lter media, these bag fi lters are designed for applications where μm fi ltration at up to 681 l/min. (#2 bag size) is required. Final Product Drier Crystaliser 100 Series Bag Filters Balance of high effi ciencies with very low initial pressure drop offers an easy to use, convenient, high performance alternative to fi lter cartridges. Table 3: Solids Removal and Recovery Filtration Options Product Description Ratings/Grades Available CTG System enclosed packs Enclosed fi lter pack with integral housing which prevents contact of material with housing and limits operator exposure. Can have following cartridges inside the packs: Micro-Klean D, Betapure AU, Betapure NT-P & Betafi ne XL. DuoFLO fi lter elements Polypropylene or polyester felt, with 62% greater surface area than bags NB Series bag fi lters Nominally rated bags, polypropylene or polyester felt 100 Series bag fi lters Single-layer melt-blown polypropylene microfi bre 500 Series bag fi lters Multi-layer melt-blown polypropylene microfi bres Various fi lter media available depending on the fi lter cartridge inside the pack of 1, 2 and 3 high lengths in housing with 1, 3 and 7-around designs μm, #1 and #2 size μm, #1 and #2 size μm at 95% initial effi ciency (#1 and #2 size) μm at 99% initial effi ciency (#2 size only) 500 Series Bag Filters Multi-layer construction provides higher solids capacity than 100 Series bag fi lters. 5

6 Product Benefi ts Coarse Filtration - Bags Filter bags available in various materials offer a range of chemical compatibility with solvents and raw materials. A wide range of capture ratings provides a suitable product for virtually any suitable fi lter bag application. Coarse Filtration - Cartridges 3M Purifi cation cartridge fi lters for coarse particle (>5 μm) reduction provide exceptionally high fl ow rates with low differential pressures, extending fi ltration life and reducing the number of fi lter change-outs. Fine Filtration Betafi ne series cartridges feature absolute rated, polypropylene media that provides a wide range of chemical compatibility. Betafi ne PPG & PTG series fi lters feature graded density polypropylene media that offers higher capacity and throughput. Filters provided with validation support documentation for easy implementation into existing processes. Tank Venting PFS series fi lter cartridges and capsules combine high fl ow with a liquid validated, bacteria retentive, hydrophobic PTFE fi lter membrane. Structural components are polypropylene, optimised for long on-stream air service. C. Solvent and Bulk Chemical Filtration Chemicals and solvents used in pharmaceutical manufacturing include alcohol, acetone, methylene chloride and numerous other bulk chemicals for raw materials. Active pharmaceutical ingredients are synthesized through chemical reactions that use solvents together with other ingredients including catalysts. These bulk chemicals should be free of particulate matter and contaminants prior to their use in manufacturing processes in order to maintain process integrity and overall product quality. 3M Purification cartridge filters are available in a variety of materials of construction for compatibility with a wide range of chemical solvents. Filtration ratings range from coarse to fine and include filter cartridges for tank venting. Please reference Table 4 below. Figure 5: Solvent and Bulk Chemical Filtration Application Receiving Tank Table 4: Solvent and Bulk Chemical Filtration Options Product Description Ratings/Grades Available Application NB Series bag fi lters Nominally rated bags, polypropylene or polyester felt μm, #1 and #2 size Coarse fi ltration Bag fi lters (>5 μm) 100 Series bag fi lters 500 Series bag fi lters DuoFLO fi lter elements Micro-Klean D Betapure NT-P Betafi ne XL Betafi ne PPG & PTG Single-layer melt-blown polypropylene microfi bre Multi-layer melt-blown polypropylene microfi bres Polypropylene or polyester felt, with 62% greater surface area than bags Polypropylene twine/ polypropylene media blanket Multi-layer polypropylene media with fl ow distribution channels Pleated polypropylene, uniform density Pleated polypropylene, graded density Holding μm at 95% initial effi ciency (#1 and #2 size) μm at 99% initial effi ciency (#2 size only) μm, #1 and #2 size 1. Coarse Filtration 2. Fine Filtration 3. Tank Vent 4. Membrane Prefilter (page 7) 5. Final Sterile Filter (page 8) Coarse fi ltration Bag fi lters (>5 μm) Coarse fi ltration Bag fi lters (>5 μm) Coarse fi ltration Bag fi lters (>5 μm) μm Coarse fi ltration Cartridges (>5 μm) μm Coarse fi ltration Cartridges (>5 μm) μm Fine fi ltration (<5 μm) μm Fine fi ltration (<5 μm) PFS Hydrophobic PTFE membrane 0.2 μm, sterilising grade Tank venting Tank Point-of-Use 6

7 3M Purifi cation Innovative Filtration Filter Systems for Pharmaceutical Separations D. Endotoxin and Bioburden Reduction Bioburden reduction is a common application used in the pharmaceutical industry to provide clarification of pharmaceutical process streams. Control of bioburden in pharmaceutical processing is critical in order to maintain product quality and to improve overall process economics. Prefilters are typically used in line with sterilising grade filters to help protect and prolong the life of downstream sterile filters. In some non-sterilising grade applications, prefilters are used as stand alone filters to help protect downstream equipment or as a safety filtration step in the process flow. Effective bioburden reduction/prefilters exhibit the following performance characteristics: High throughput and product yield Long service life Effective protection of downstream sterilising grade filters Chemically compatible with process fluids Please reference Table 5 below for 3M Purification s product portfolio for bioburden reduction and prefiltration. Figure 6: Bioburden Reduction/Prefiltration Application Product Solvent Re-dissolution Table 5: Bioburden Reduction/Prefiltration Options Product Description Ratings/Grades AvailableApplication PLA Series SP Series Betafi ne PPG & PTG Multi-zone, graded density pleated Nylon 6,6 Charge-modifi ed, graded density Nylon 6,6 membrane Pleated polypropylene, graded density 1. Bioburden reduction filter 2. Final sterile filter (page 8) Intermediate Re-crystallisation 0.2, 0.45, 0.65, 0.80 μm Bioburden reduction 0.45 μm Bioburden reduction μm Prefi ltration Product Benefi ts PLA Series A single layer, graded density, pleated Nylon 6,6 membrane fi lter cartridge featuring Advanced Pleat Technology (APT) pleating, provides superior microorganism reduction while substantially increasing the life of downstream sterilising grade fi lters. SP Series A double layer, charge-modifi ed Nylon 6,6 membrane featuring APT pleating, this fi lter offers enhanced particle and pyrogenic reduction via electrostatic charge on the membrane. Dual layering offers higher capacities than single-layer membrane fi lter cartridges. Betafine PPG & PTG A polypropylene media, absolute-rated, graded density high-fl ow fi lter cartridge, Betafi ne PPG & PTG offer superior chemical resistance and durability in demanding applications. 7

8 Product Benefi ts PFS Series Combines high fl ow with a liquid validated, bacteria retentive hydrophobic PTFE membrane for long on-stream service in vent fi ltration and purge nitrogen applications. SP Series Utilises a charge-modifi ed Nylon 6,6 media to retain negatively charged biological and particulate contaminants including endotoxins. PDA Series Incorporates two layers of graded density polyethersulfone (PES) membrane that provide high contaminant capacity, fast fl ow rates and reliable sterilising fi ltration performance. PSA Series Features high throughput capacity, double layer Nylon 6,6 membrane with APT pleating, LifeASSURE PSA series cartridges offer robust 0.1 and 0.2 μm fi ltration and exceptionally long life. E. Sterilising Grade Filtration (liquid and gas) Sterilising grade filtration requires robust filters designed for performance certification to standards established by regulatory agencies, including absolute retention of certain microorganisms and certification of filter integrity by the manufacturer. 3M Purification supplies a variety of filter options for use in sterilising grade filtration applications. The applications for these products include: Nitrogen filtration and tank venting High Purity DI water and WFI systems Parenterals (SVP, LVP) Opthalmics Biologicals Table 6: Sterilising Grade Filtration Options Product Description Ratings/Grades Available Application PFS Series SP Series PDA Series PSA Series Hydrophobic PTFE membrane 0.2 μm Purge nitrogen/ sterile tank venting (1, 5, 8) Charge-modifi ed, graded density Nylon 6,6 membrane Dual-layer, asymmetric polyethersulfone (PES) membrane Multi-zone, graded density Nylon 6,6 membrane 0.2 μm DI/WFI water (2, 7) 0.2 μm Ophthalmic/LVP, SVP (4, 6) 0.1 & 0.2 μm DI/WFI water, SVP, LVP (2, 7) All filters meet FDA definition of 0.2 μm, sterilising grade filter (10 7 CFU/cm²) for B. diminuta retention. Products provided with: 21 CFR materials of construction; USP Class VI biological reactivity test pass, Validation Guide and Drug Master File (DMF). Sterilising grade filters are 100% integrity tested prior to release, ensuring consistent performance to specification. Figure 7: Sterile Filtration Application Active Ingredients 1. Purge nitrogen 2. WFI water 3. Prefilter (page 7) 4. Sterile filter 5. Tank vent 6. Sterile filter 7. WFI filter 8. Air/nitrogen filter Air/N2 WFI Holding Tanks Container & Closure Cleaning Filling Machine Compounding Tank Product Holding Tanks 8

9 3M Purifi cation Innovative Filtration Filter Systems for Pharmaceutical Separations F. Utilities & Plant Services The water, steam and utilities used in pharmaceutical production is typically filtered to remove particles, scale and impurities prior to its use. 3M Purification offers a variety of filter options to meet the needs of these utility applications. Water filtration is perhaps the most common application in the pharmaceutical industry. Different standards for water quality exist in the pharmaceutical industry depending on the application. USP Water for Injection (WFI) - for product formulation, equipment and container cleaning and WFI steam production. USP Purified Water - for equipment and container cleaning, fermenter make-up water (sterile filtered) and clean steam production. Utilities water - for heating/cooling process equipment. Table 7: Water Filtration Options Product Betapure NT-P Betafi ne PPG & PTG PLA Series PFS Series SP Series PDA Series PSA Series Description Multi-layer polypropylene media with fl ow distribution channels Pleated polypropylene, graded density Ratings/Grades Available Application μm 1. Removal of silica particles 2. Carbon fi ne removal 3. Resin trap fi lter μm 1. Removal of silica particles 2. Carbon fi ne removal 3. Resin trap fi lter 0.2, 0.45, 0.65, 4. DI bacterial removal 0.80 μm Multi-zone, graded density pleated Nylon 6,6 Hydrophobic PTFE membrane 0.2 μm 5. Sterile tank vent Charge-modifi ed, graded density Nylon 6,6 membrane Dual-layer, asymmetric polyethersulfone (PES) membrane Multi-zone, graded density Nylon 6,6 membrane 0.2 μm 6. Sterile fi ltration, pointof-use 0.2 μm 6. Sterile fi ltration, pointof-use 0.1 & 0.2 μm 6. Sterile fi ltration, pointof-use High Flow System For process and utility water applications where high fl ow rates are required, the High Flow System is recommended. The High Flow System was designed for water fl ow rates up to 1893 l/min per element and it offers this capability in a compact, easy to use design. Implementation of the High Flow System for process and utility water results in reduced fi lter usage, labour and disposal costs and minimal downtime for fi lter change-outs. Figure 8: Water Filtration Application City Water Feed Sand Bed Activated Carbon Bed Cation Bed Anion Bed Still To Points of Use Parenterals Container Washing CIP/SIP Operations WFI Steam To Points of Use Steam Container Cleaning D.I. Water Holding Tanks R.O. System WFI Holding Tanks 9

10 G. Filter Validation 3M Purification supplies products and services to help pharmaceutical manufacturers ease regulatory compliance and meet the exacting demands of the industry. 3M Purification Validation Support Services streamlines filter regulatory compliance, saving our customers time and money. Our goal is to provide well-designed, properly executed and completely documented test protocols on 3M Purification filter products in their intended applications. Global SASS Group All validation services are provided through our Scientific Applications Support Services (SASS) group, a global organisation of market-focused scientists and engineers that are trained in performing validation support functions. Members of the SASS group are skilled in performing on-site, in-house bench-scale tests and utilise filtration application expertise to partner with customers. SASS works closely with customers to solve difficult filtration challenges and recommend the most efficient, economical filter systems. Global Locations 3M Purifi cation can provide on-site validation support around the world or in one of our stateof-the-art laboratories located in the USA, Japan, India and Brazil. Validation Services Our scope of services in validation support consulting includes: Integrity testing: provides product specific integrity test parameters for the fluids being used in the application. Bacterial retention, chemical compatibility and extractable testing: execution of these tests to confirm a given filter s performance under actual process conditions. USP Biological Reactivity-Class VI Plastics Test Results: Third-party test reports for 3M Purification filters documenting that their components meet the requirements of the USP Class VI Biological Test for Plastics. Regulatory Document Preparation Assistance: 3M Purification specialists bring their familiarity with regulatory documentation to assist customers in their preparation of Customised Validation Support Services based on customer requirements. Validation Products 3M Purification offers a variety of products that support customer validation and ease regulatory requirements: MicroCheck 2 Automated Integrity Tester: Provides fast, reliable and extremely accurate integrity testing of membrane filter cartridges in a compact design. Filter Validation Guides: provide extensive regulatory information for sterilising grade filters. Regulatory Support Files: Provided for filters upstream of sterile filters. IQ/OQ/PQ Documentation: Available to speed regulatory compliance. Quality Management & ISO Standards 3M Purification has maintained its leadership in fluid purification and filtration by continually providing superior products and technical support. 3M Purification filtration systems are designed and manufactured to the most stringent industry standards to assure the reliability of 3M Purification systems that our customers have come to expect. 3M Purification has established a global quality management program which encompasses all facets of its operations. An essential part of the 3M Purification program is the creation of multi-function teams whose combined expertise is devoted to continuous improvement of processes, procedures and quality systems. In addition, the 3M Purification system ensures the active support and participation of senior management. 3M Purification is fully committed to the tenets of the quality management program and provides a support system for the quality process. The majority of 3M Purification manufacturing plants are ISO 9001:2008 registered. At 3M Purification, quality is defined by the never-ending pursuit for continuous improvement in products, services and personnel. 10

11 3M Purifi cation Innovative Filtration Filter Systems for Pharmaceutical Separations H. Lenticular Style Depth Filter Products 3M Purification offers an extensive range of Zeta Plus lenticular-style depth filter capsules and cartridges to meet virtually any process flow requirement. Lenticular style depth filter capsules are designed to facilitate the scale-up of processes between the lab bench and the plant floor. Process-scale cartridges come in a variety of sizes to accommodate a wide range of application conditions to handle the most critical clarification and depth filter applications in pharmaceutical manufacturing. BC25 Diposable Capsules BC1000/2000 Diposable Capsules Cartridges For Lab evaluation and Small volume fi ltration applications For Intermediate or pilot scale-up Filtration applications For linear and predictable scale-up for increased volumes Filtration applications 25 cm² fi lter area BC1000: 650 cm² fi lter area From 650 cm² to 3.7 m² fi lter area depending on the type BC2000: 1300 cm² fi lter area Luer and Sanitary connections Single Pack or 3-pack packaging 8, 12 and 16 cartridges with 2 to 16 cells depending on the type Contact 3M Purification for specific information and product availability. I. Filter Membrane, Media Capsules & Filter Cartridges 3M Purification supplies filter membrane and sheet media filter products in wide variety of formats including disposable capsules and full-scale cartridges. The wide range of product formats allows for simple scale-up from the laboratory bench to fullscale production. 50 mm Disposable Filter Capsules Mini-cartridges & Disposable Capsules Standard Filter Cartridges For laboratory scale fi ltration and for evaluating fi lter For critical small volume fi lter applications For production scale fi ltration media prior to pilot-scale tests Same fi lter media as full size capsules and cartridges Variety of fi lter media options Variety of lengths, end connections and O-ring sealing options to tailor fi lter cartridges to the needs of specifi c applications low hold-up volume method to determine various fi ltration parameters such as retention, compatibility and fi ltrate attributes Mini-cartridges: 2.5 and 5 lengths C style capsules: 2.5 and 5 lengths J style capsules: 10, 20 and 30 lengths 5, 10, 20, 30 and 40 lengths and a variety of end modifications Contact 3M Purification for specific information and product availability. J. Filter Housings & Engineered Systems 3M Purification offers an extensive range of cartridge filter housings to meet almost any process flow requirement. Designed for the production environment, sanitary design cartridge housings are available for laboratory bench to pilot plant to full-scale production. 3M Purification s capabilities also include a full-service Engineering Department that provides custom engineered filter housings with a.o. pumps, gauges, piping, optional feed loops and other options to meet specific needs. High Flow System Cartridges Radially pleated, blown PP microfi bre 1, 2, 5, 10, 25, 40 & 70 μm Utility & process water Housings Carbon steel, 304 SS, 316L SS 1, 3, 5 & 7-around, 40" & 60" versions, vertical or horizontal Utility & process water Filter housings for lenticular cartridges 8ZP1P & 12ZP1P 304 & 316L SS housing 8ZP1P for plug-in style, 8" cartridge, 12ZP1P for 12" cartridge Lab use, small volumes ZPB 316L SS housing for lenticular depth fi lters Swing bolt closure Production depth fi ltration Cartridge filter housings ZMS mini-cartridge 316L SS housing For single, 2.5" or 5" mini-cartridge Small volume, critical fi ltration ZVS & ZMS 316L SS housings for single, 10", 20", 30" or 40" cartridge 316L multi-cartridge fi lter housings are ZWB available in 3, 5, 7 and 12-around Contact 3M Purification for specific information and product availability. ZVS: In-line inlet/outlet ZMS: T -line inlet/outlet Swing bolt closure Intermediate, critical & sterilising grade fi ltration Production-scale critical & sterilising grade fi ltration 11

12 Important Notice The information described in this literature is accurate to the best of our knowledge. A variety of factors, however, can affect the performance of the Product(s) in a particular application, some of which are uniquely within your knowledge and control. INFORMATION IS SUPPLIED UPON THE CONDITION THAT THE PERSONS RECEIVING THE SAME WILL MAKE THEIR OWN DETERMINATION AS TO ITS SUITABILITY FOR THEIR USE. IN NO EVENT WILL 3M PURIFICATION INC. BE RESPONSIBLE FOR DAMAGES OF ANY NATURE WHATSOEVER RESULTING FROM THE USE OF OR RELIANCE UPON INFORMATION. It is your responsibility to determine if additional testing or information is required and if this product is fi t for a particular purpose and suitable in your specifi c application. 3M PURIFICATION INC. MAKES NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR OF ANY OTHER NATURE HEREUNDER WITH RESPECT TO INFORMATION OR THE PRODUCT TO WHICH INFORMATION REFERS. Limitation of Liability 3M Purifi cation Inc. will not be liable for any loss or damage arising from the use of the Product(s), whether direct, indirect, special, incidental, or consequential, regardless of the legal theory asserted, including warranty, contract, negligence or strict liability. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation may not apply to you. 3M is a trademark of 3M Company. Betafi ne, Betapure, DuoFLO, LifeASSURE, Micro-Klean, LifeASSURE and Zeta Plus are trademarks of 3M Company used under license. 3M Belgium NV 3M Purification Hermeslaan Diegem Belgium Tel.: +32 (0) Fax: +32 (0) MPurifi cation.be@mmm.com 3M Nederland BV 3M Purification Postbus AD Leiden The Netherlands Tel.: +31 (0) Fax: +31 (0) MPurifi cation.nl@mmm.com For more contact addresses visit our website cation or cation. Data may be subject to change without further notice. DOC M All rights reserved. LITGNPB1.EU