Merck MilliporeBioMonitoring

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

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Dehydrated Culture Media &Biological Raw MaterialGold 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 11133. Product range confirms to applications performed in pharmaceutical, food, beverages, academic and Institutional laboratories.

Your benefitsComplete audit safety and security

No false positives and false negatives

Flexible option for alternate vendor qualifications

Customized packing

Customized media development

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Dehydrated Culture Mediaacc to USP/EP/JP/BPHarmonized Methods of Microbial LimitTesting

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, 2.6.12, 2.6.13 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 qualif ied Dehydrated Culture Media for microbiological control of pharmaceutical products in powdered and granulated forms.

Your benefitsGlobal 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

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Soyabean Casein Digest Medium& D-Mannitol - Tripple wrapped,Gamma IrradiatedAseptic 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

Your benefits

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Chromogenic & FluorogenicCulture MediaInnovation 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.

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Sterikon® Plus - BioindicatorsAutoclave 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.

Your benefitsClear cut visible results, no errors in interpretationResults available in 24 hrsNo need for confirmationNo risk of contamination as these are sealed ampoluesNo need of separate positive controls

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TMEZ-Fit ManifoldFor Universal Laboratory FiltrationEZ-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

Your benefitsDifferent 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

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TMEZ-Stream VacuumFiltration PumpLaboratory Filtration Pump that transfersFiltered Liquids Directly to Waste

Your benefitsDirect 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

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.

EZ-Pak® Dispenser Curve &EZ-Pak MembraneThe 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. 10000 ®membranes are dispensed per charge. EZ-Pak Dispenser Curve

automatically collects the protective packaging.

Your benefitsEase of use in LAF No touch operationCableless Industrial infrared sensorEasy membrane decontamination One handed membrane transferHigh speedmembrane dispensing Small foot print

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Milliflex PLUS Vacuum Pump

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 timeSanitary design with autoclaveable pump headsModular pump head provides filtration device flexibilityInternal calibration program ensures accuracy

Your benefits

High-throughput Filtration System forBioburden and Water Quality Testing

EZ-Fit Filtration UnitReady-to-use sterilized filtration devices formicrobial enumeration

TMEZ-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 residueFunnel assembly design prevents leaks or sample bypassClear transparent funnel helps accurate visualizationMembrane base shape facilitates easy membrane transferFunnel assembly allows one handed funnel removal.

Your benefits

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S-Pak MembraneTest for Microbial Contamination UsingMembrane Filtration with easeIndividually 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

Your benefits

Autoclave PakMembrane 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 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 non-wetting edge prevents drug intrusion under holder sealing rim.

Hydrophobic Edge Membranes

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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

Your benefits

Swabs and SamplersConvenient, In-Process MicrobiologicalAnalysis

MicropreSure SanitarySampling Valves & AdaptersMicropreSure 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.

Your benefitsUnique design eliminates dead space

Mid-stream sample collectionDesigned for production line sampling

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MAS 100® FamilyLeading Solutions in Air MonitoringGet 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 14698 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

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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 packaging2 2

Datamatrix-code on each platePlus : 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

heipha : Ready-to-use productsHigh Quality Ready-to-use Products forisolators & clean rooms

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RCS® High Flow TouchCompressed 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 14698-1 (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.

Your benefits

ReliableProven technology using standardized agar mediaInnovative battery concept with advanced control optionsCompatible with common sterilization and disinfection methods

FastShort sampling times with a flow rate of 100 L/minConvenient programming with an easy touchFrom preparation to start of measurement within a minute

FlexiblePortable, battery driven and light weightHorizontal and vertical installation, measurement at heights of up to 3 metersUser-defined sampling options like individual volumes, time delay, interval sampling

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Rapid Detection –Precise quantification.“It counts if you have the count of yourmicrobial 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.

Rapid Detection at a glanceNon-destructive method Easy-to-use system requires minimal trainingResults comparable to compendial method Economical, robust systemCompact hardware fits on any laboratory bench Fluorescent staining based system

Visualize plate after staining.View of membrane in the reader.

CFUs are not visibleoutside the reader.

After re-incubation,CFUs are visible to the eye

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Sterility Testing

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 testmethod reproducibility

Comprehensive validation and maintenanceservices to meet regulatory compliance

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.

Unlock the Doors toProductivity

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Easy to use design

Reliable

Safe

Ergonomic

User friendly

Reduced pump height for easy access in Laminar flow hoodsCompatible with vertical and horizontal air flows

The automatic pump head closure ensures quick and easy tube replacement, as well as reliable splitting of liquids samplesHighly precise timer function : small volumes are sampled with high precision

Clean room friendly hardware : air tight housing and passive cooling prevent particle emissionTwo 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 shape allows easy tube loading; no risk of pinching gloves and consequent no test interruptionAdjusting bottle holder and tiltable display for perfect screen visibility

Clear user interface display on 11 cm (4.3 inches) color LCD displayTest methods library : Store up to 250 filtration protocols and follow them step by step on the screen

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TMSteritest EZ DevicesSterility Testing of Filterable Samples

Steritest™ system – meet the industry benchmark

Minimize false positives

Reduce false negatives

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.

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.

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.

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.

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Merck Millipore is a division of

Merck MilliporePrice List 2015 -1 6

One Source.Infinite Solutions.

Price List 2015 - 16M

erck Millipore

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.

Merck Specialities Private LimitedstLloyds Center Point, 1 Floor

Appasaheb Marathe Marg, PrabhadeviMumbai - 400 025Phone : +91 22 6663 9800, Fax : +91 22 6663 9893

For more information, please visit :www.merckmillipore.in

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