Merck Millipore BioMonitoring

Transcription

1 Merck Millipore

2 Application finder Milliflex Quantum Rapid Detection System Milliflex Rapid System Milliflex Hardware / Media / Consumables MicropreSure System Microfil Hardware & Consumables MAirT cassettes / RtU plates M Air T / MAS100 Eco / MAS100NT / CG / Iso Sampling Solutions On-line sampling Microbiological Analysis Bioburden testing Microbial limit testing Water testing Food & Beverages samples Sterility testing Environmental Monitoring Air Monitoring for viable Particles Air Monitoring for non viable particles Surface monitoring Validation and Consultancy Services Validation Support Equipment maintenance and repair services Method and application development Autoclave Monitoring 432

3 TM Steritest Media / Consumables / Hardware Sterikon Plus Bioindicators S-Pak Consumables / Hardware Petridish / Petrislides / Petripads Lateral Flow test kits HY-LiTE & HY-RiSE EZ-Pak Consumables / Hardware ESP Valves Dip & Swab samples / Contact Slides Dehydrated Culture Media, Supplements & Biological Raw Materials APC SmartTouch & ErgoTouch Pro II Anaerobic Jar / consumables Ampoule Media TM 55-Plus Monitor Merck Millipore India 433

4 Dehydrated Culture Media & Biological Raw Material Gold Standard in Microbiology Traditional culturing is proven Gold Standard practice in microbiology. Even though many rapid technologies have emerged leading to time reduction and higher sensitivities but the final confirmation is based on traditional culture based tools. This reliance calls for high quality and consistent performance of culture media. We make it happen through highly controlled and coordinated approach in vendor selection, raw material selection & testing, processing, product development and ensuring traceability for every action. Worldwide, granulated media are still considered as best culture media for its quality and consistent performance. Your appreciation and acknowledgment lead us to extend our commitment to provide this international quality at competitive prices. With this determination, Merck Millipore invested in Goa production facility and started manufacturing of Dehydrated Culture Media & Base Materials. Today, we produce more than 160 products. These products are produced and tested according to harmonized methods of USP/EP/BP/JP, ISO, BIS and other regulatory guidelines and also comply with recommendations suggested in ISO Product range confirms to applications performed in pharmaceutical, food, beverages, academic and Institutional laboratories. Complete audit safety and security No false positives and false negatives Flexible option for alternate vendor qualifications Customized packing Customized media development 434

5 Dehydrated Culture Media acc to USP/EP/JP/BP Harmonized Methods of Microbial Limit Testing The goal of global pharmacopoeia harmonisation is to promote consistency of microbiology methods used by companies throughout the world. USP chapter <1196> and EP chapter <5.8> contains detailed descriptions of chapters affected by harmonization while USP (Version 34) chapters <61> & <62> and EP (Version 7.6) chapters 2.6.1, , indicate in detail the changes in methods for microbial enumeration tests and tests for specified microorganisms. Among other modifications, the harmonized methods provide much more detail in terms of demonstrating method suitability (method validation) and media-growth promotion. As a reliable partner for pharmaceutical companies, Merck supports its customers in meeting the new requirements of the harmonized pharmacopoeia: Merck is able to provide you a comprehensive product portfolio of qualified Dehydrated Culture Media for microbiological control of pharmaceutical products in powdered and granulated forms. Merck Millipore India Global acceptance Complete audit safety and security Pack size flexibility Granulated and powdered options Environment friendly with Simplified Certificate of Analysis Transparent system during your audits 435

6 Soyabean Casein Digest Medium & D-Mannitol - Tripple wrapped, Gamma Irradiated Aseptic Fill Simulation This process is a critical requirement for sterility assurance to test overall process sterility by performing a simulated production (media fill) using microbiological growth medium, in place of actual product. Media fills are a worst case challenge to a process, as pharmaceutical products typically do not support microbiological growth. This has caused concern from some drug manufacturers as microbiological culture media can themselves be a potential source of viable contamination. The production of dehydrated culture media is not a sterile process and biological components can contribute viable contamination. An effective approach to prevent media related contamination and eliminate the handling involved with traditional media preparation is terminal sterilization of the dehydrated culture media by irradiation. Merck Millipore is your first choice for innovative quality products for your sterility assurance program. Our irradiated animal and non-animal derived Tryptic Soy Broth products will insure the integrity of your aseptic process simulations. These formulations are rigorously validated for sterility, growth performance and filtration characteristics. These products comply with the compendia and guidance documents for media fill applications worldwide. Tryptic Soya Broth in irradiated & triple wrapped forms is available in 500gm & 05 kg packs and granulated & powdered presentations. Granulated and powdered options Excellent filterability leading to cost reduction Complete documentation to ensure audits security 436

7 Chromogenic & Fluorogenic Culture Media Innovation with Tradition Chromogenic substrates have proved to be a powerful tool in the identification of microorganisms due to the detection of specific enzymes produced by the target microorganism. These enzymes cleave the chromogenic substrate that points up the microorganism by color differentiation of the grown bacterial colonies. Chromogenic media offer enhanced bacterial identification over tradition culture media through colour differentiation. The intensity and specificity of the colours of chromid media optimise microbial enumeration, making it easy to rapidly identify bacterial colonies. The manufacturing process for food and water often result in metabolic injury to the microorganisms and/or reduction of microbial members. Sub lethal microbial injury is caused by chemical or heat treatment as well as storage under frozen, dried or chilled conditions. Traditional culture media used for the detection of coliforms/ E. coli often contain ox bile or bile salts to inhibit Gram-positive bacteria. These strong inhibitors however may limit the growth of the targeted microorganisms if they are already sub lethally damaged. Carefully selected inhibitors are used in manufacturing of chromogenic media to ensure growth and recovery of these damaged microorganisms. Merck Millipore India 437

8 Sterikon Plus - Bioindicators Autoclave Monitoring A biological indicator can be used to assist in the performance qualification of the sterilization equipment and in the development and establishment of a validated sterilization process for a particular article. Biological indicators are used in processes that render a product sterile in its final package or container, as well as for the sterilization of equipment, materials, and packaging components used in aseptic processing. Biological indicators may also be used to monitor established sterilization cycles and in periodic revalidation of sterilization processes. Biological indicators may also be used to evaluate the capability of processes used to decontaminate isolators or aseptic clean-room environments. The Sterikon plus Bioindicator consists of an ampoule that contains a nutrient broth, sugar, a ph indicator and spores of a non-pahogenic organism, Geobacillus stearothermophilus ATCC 7953 (sporulation optimized). The thermal resistance is such that the spores are completely killed after 15 minutes, when heated in compressed steam at a temperature of 121 ± 0.5 C (245 kpa). At lower temperatures or lower exposure times a small number of spores can survive and are capable of growing. This can be detected by incubating the ampoules at 60 C ± 2 C for 48 hours. Sterikon plus is recommended for routine autoclave monitoring for sterilization efficiency. Clear cut visible results, no errors in interpretation Results available in 24 hrs No need for confirmation No risk of contamination as these are sealed ampolues No need of separate positive controls 438

9 TM EZ-Fit Manifold For Universal Laboratory Filtration EZ-Fit is a filtration manifold used for universal laboratory filtrations. The unique design optimizes workflow & maintenance and reduces risk of contamination. The EZ-Fit Manifold is the best filtration support in the market, ideal for municipal water, beverage, and pharmaceutical industries. Its unique features allows efficient hardware cleaning & decontamination reducing the false results and optimizing laboratory operations. It supports : Monitor 55 +, Microfil, Microfil V/S, Standard glass funnels, Stainless steel funnels Different filtration heads fit to both reusable & disposable filtration devices Each component can be removed quickly and easily without the use of tools Vacuum tubing uses quick fit connections Easy access to all inner parts facilitates efficient cleaning, which prevents biofilm buildup All manifold components can be autoclaved Low height for ease of use in LAF Merck Millipore India 439

10 EZ-Pak Dispenser Curve & EZ-Pak Membrane The Next Generation Membrane Dispenser EZ-Pak Dispenser Curve provides portable, hands free, sterile, individually packed membrane dispensing. EZ-Pak membrane cartridges can be loaded in less than 30 seconds membranes are dispensed per charge. EZ-Pak Dispenser Curve automatically collects the protective packaging. Ease of use in LAF Cableless Easy membrane decontamination High speedmembrane dispensing No touch operation Industrial infrared sensor One handed membrane transfer Small foot print TM EZ-Stream Vacuum Filtration Pump Laboratory Filtration Pump that transfers Filtered Liquids Directly to Waste EZ-Stream Vacuum Filtration Pump is specifically designed for microbiology analysis. The compact design makes the pump ideal for use on both the work bench & in the laminar flow hood. Direct transfer ensures no handling of liquid waste Complies with ISO Standard for microbiological analysis (does not exceed 700 mbar) High performance flow rate Noise reduction design (less than 60 db) Compact Maintenance-free technology 440

11 EZ-Fit Filtration Unit Ready-to-use sterilized filtration devices for microbial enumeration TM EZ-Fit filtration unit is disposable filtration device. It is designed for optimising microbial recovery, reducing contamination & ensuring efficient workflow. Shape of funnel ensures minimum sample residue Funnel assembly design prevents leaks or sample bypass Clear transparent funnel helps accurate visualization Membrane base shape facilitates easy membrane transfer Funnel assembly allows one handed funnel removal. Milliflex PLUS Vacuum Pump High-throughput Filtration System for Bioburden and Water Quality Testing Merck Millipore India Milliflex filtration units are based on membrane filtration, ensures accurate results along with high productivity. Milliflex filtration units with a sealed integral membrane filter eliminate the primary potential source of contamination, making your test results more reliable. Automatic, hands-off filtration reduces testing time Sanitary design with autoclaveable pump heads Modular pump head provides filtration device flexibility Internal calibration program ensures accuracy 441

12 S-Pak Membrane Test for Microbial Contamination Using Membrane Filtration with ease Individually packed Sterile, Gridded membrane Filters optimized for Membrane Filtration method Microbiological analysis of Water and other liquids Sterile, individually packed filters Consistent performance Streamlined traceability Autoclave Pak Membrane filtration is the standard test method for microbial contamination. The test sample is filtered through a microporous membrane, allowing the retention of any microbial contamination on top of the membrane. Filter is then placed on the nutrient medium to promote growth of microorganisms. Merck Millipore offers a choice of two different membranes mixed esters of cellulose or Durapore membrane low binging (hydrophilic polyvinylidene fluoride, PVDF). Hydrophobic Edge Membranes Hydrophobic edge membranes are standard MCE filters with edges rendered hydrophobic to 3 or 6 mm widths. In antibiotic and bacteriostatic drug sterility testing by membrane filter method, the 6 mm wide nonwetting edge prevents drug intrusion under holder sealing rim. 442

13 Swabs and Samplers Convenient, In-Process Microbiological Analysis Merck Millipore's Swab Test Kits provide a reliable and convenient method, based on membrane filtration, for monitoring microbial contamination on equipment and irregular surfaces. Obtaining reproducible results with the Swab Test Kits requires no special training. No media mix No agar plates to prepare Nothing to sterilize or clean MicropreSure Sanitary Sampling Valves & Adapters Merck Millipore India MicropreSure Sanitary Sampling Valves & Adapters are easily attached to a liquid distribution line or a storage tank, the valve directs the outflow to a sampling container. Unique design eliminates dead space Mid-stream sample collection Designed for production line sampling 443

14 MAS 100 Family Leading Solutions in Air Monitoring Get to know the latest generation of Air Samplers! The MAS 100 family includes systems for testing air & compressed gasses in clean rooms, aseptic production areas, Isolators & other controlled environment. The microbial air samplers of the MAS-100 family are designed for your individual air monitoring needs as specified in the new ISO part I & II standards. The MAS-100 ISO NT is designed for the highest demands of aseptic production areas and isolators The MAS 100 NT : Industry standards for routine air monitoring With the MAS-100 Iso MH you can sample up to 4 sample points in an isolator with one pump. Each location can measure up to 10 meters away from the pump The MAS-100 VF system s compact and portable design enables varying sample locations 444

15 heipha : Ready-to-use products High Quality Ready-to-use Products for isolators & clean rooms ICR products for use in isolators & clean rooms Storage at room temperature Long shelf life upto nine months Wide range of neutralisers Broad spectrum of ß-lactam antibiotic substrate High enzyme activity of ß-lactamise Easy discrimination between TSA & SDA plates by colour coding Gamma-irradiated, triple-bagged Transparent, H O -impermeable packaging 2 2 Datamatrix-code on each plate Plus : Lock by turning clockwise for aerobic incubation ( CLOSED ) Plus : Lock by turning counter clockwise for aerobic / anaerobic / microaerophilic incubation ( VENT ) Plus : Safe transport of locked plates Merck Millipore India 445

16 RCS High Flow Touch Compressed Gas monitoring with an easy touch Cleanrooms and isolators in the pharmaceutical, medical and food industries are subjected to thorough microbial air monitoring routines to ensure high product quality, to maintain a safe work environment and to meet regulatory requirements such as ISO (Bio-contamination Control). The new RCS High Flow Touch has been designed to meet these requirements and, furthermore, to provide maximum ease of handling. Employing the renowned RCS High Flow technology, the instrument ensures reliable and reproducible results along with comprehensive validation documentation. Reliable Proven technology using standardized agar media Innovative battery concept with advanced control options Compatible with common sterilization and disinfection methods Fast Short sampling times with a flow rate of 100 L/min Convenient programming with an easy touch From preparation to start of measurement within a minute Flexible Portable, battery driven and light weight Horizontal and vertical installation, measurement at heights of up to 3 meters User-defined sampling options like individual volumes, time delay, interval sampling 446

17 Rapid Detection Precise quantification. It counts if you have the count of your microbial load much earlier Reaction requires active microbial metabolism for enzymatic cleavage of a non-fluorescent substrate. Once cleaved inside the cell, the substrate liberates free fluorochrome into the microorganism cytoplasm. As fluorochrome accumulates inside the cells, the signal is naturally amplified. The cells are then exposed to the excitation wavelength of the fluorescent dye in the Milliflex Quantum reader so that they can be visually counted. Visualize plate after staining. View of membrane in the reader. CFUs are not visible outside the reader. After re-incubation, CFUs are visible to the eye Merck Millipore India Rapid Detection at a glance Non-destructive method Results comparable to compendial method Compact hardware fits on any laboratory bench Easy-to-use system requires minimal training Economical, robust system Fluorescent staining based system 447

18 Sterility Testing Unlock the Doors to Productivity Merck Millipore has a comprehensive service offering to meet our customer requirements. By bundling our hardware, consumables and services into one package, we offer you the possibility to replace your old equipment with a brand new one and to validate it with great savings. Do not miss this unique opportunity. Sterility testing at a glance Extensive product portfolio meets all requirements for critical and controlled testing environment Consistent, high - quality products for accurate and reliable sterility test results Competence in regulatory and customer specific requirement Product Service Application and method development, PQ consultancy support and training Instrumentation services Validation protocols, on-site equipment validation (IQ/OQ), calibration and preventive maintenance Compact design to ease operations in laminar flow hoods and isolators Step-by-step operator assistance to ensure test method reproducibility Comprehensive validation and maintenance services to meet regulatory compliance 448

19 Easy to use design Reduced pump height for easy access in Laminar flow hoods Compatible with vertical and horizontal air flows Reliable The automatic pump head closure ensures quick and easy tube replacement, as well as reliable splitting of liquids samples Highly precise timer function : small volumes are sampled with high precision Safe Clean room friendly hardware : air tight housing and passive cooling prevent particle emission Two pressure modes : including automatic pumping speed reduction alert the operator, reducing the risk of test interruption and minimizing stress on any microorganism that may be present Ergonomic Ergonomic shape allows easy tube loading; no risk of pinching gloves and consequent no test interruption Adjusting bottle holder and tiltable display for perfect screen visibility User friendly Clear user interface display on 11 cm (4.3 inches) color LCD display Test methods library : Store up to 250 filtration protocols and follow them step by step on the screen Merck Millipore India 449

20 TM Steritest EZ Devices Sterility Testing of Filterable Samples Membrane Filtration Sterility test This is a regulatory method of choice for filterable pharmaceutical products. The test is particularly suitable for samples containing preservatives, bacteriostatic or fungistatic compounds, which inhibit microbial growth of potential contaminants. With membrane filtrations, microorganisms are retained by a 0.45 micron pore size filter and all inhibiting compounds are rinsed using a suitable rinse solution. Appropriate media, which are selected, based upon their ability to support the growth of anaerobic and aerobic microorganisms, are then transferred to the membrane filters. A 14 day incubation period is required to obtain final test result. Steritest system meet the industry benchmark No single sterility testing platform can efficiently and reliably accommodate today's enormous variety of drugs, delivery systems and packages. That's why the Steritest product line includes hardware, a diverse selection of membranes, canisters, adapters and accessories, as well as sterile media and rinse fluids. Each Steritest EZ device is subjected to rigorous in-process and release quality checks including 100% membrane and canister integrity tests as well as intense physical and microbiological testing. Minimize false positives Closed Steritest EZ filtration units reduce the risk of false positive results to avoid costly investigation and possible batch loss. The entire testing process, from aliquoting to reading, is never exposed to the environment. There are no open containers or membrane manipulations, which could increase the risk of adventitious contamination. Reduce false negatives Steritest EZ filtration units are the right answer to the danger that false negative results pose to patients. Through specific membranes, unique sealing technology and optimized device design, the unit allows efficient elimination of bacteriostatic, fungistatic or bactericidal agents present in the pharmaceutical product formulation. 450

21 We provide information and advice to our customers on application technologies and regulatory matters to the best of our knowledge and ability, but without obligation or liability. Existing laws and regulations are to be observed in all cases by our customers. This also applies in respect to any rights of third parties. Our information and advice do not relieve our customers of their own responsibility for checking the suitability of our products for the envisaged purpose. For more information, please visit : Merck Specialities Private Limited st Lloyds Center Point, 1 Floor Appasaheb Marathe Marg, Prabhadevi Mumbai Phone : , Fax : vakils