Membrane Filtration Sterility Test

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The membrane filtration sterility test is the regulatory method of choice for filterable pharmaceutical products. The test is particularly suitable for samples containing preservative, bacteriostatic or fungistatic compounds, which inhibit microbial growth of potential contaminants. With membrane filtration, 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 results.

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“Steritest™ EZ devices are made by experts who are familiar with the practical obstacles and know exactly the users’ requirements – from practitioners for practitioners!

The big portfolio of different Merck Steritest™ EZ filtration devices enables us to conduct the tests for almost all kinds of products. There is always a solution, even if the product needs to be dissolved or diluted.”

-- Dr. Timo Krebsbach, Divison Manager Marketing & Sales, Labor L+S AG, Germany

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™ System 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. The detailed Certificates of Quality are available to download from our website.

Steritest™ EZ Devices are Color-Coded for Easy Identification

Blue Base – Steritest™ Devices

Blue Base – Steritest™ Devices
with standard MCE (Mixed Cellulose Esters) membranes for regular pharmaceutical products.
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Red Base – Steritest™ Devices

Red Base – Steritest™ Devices
with special low-binding Durapore membranes for products with inhibitory properties e.g. antibiotics.
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Green Base – Steritest™ Devices

Green Base – Steritest™ Devices
with high chemical compatibility for applications requiring the presence of solvents.
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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.

For more detailed information on our EZ devices being available for your product-specific requirements and how to choose the right device click below:

 
 
Sterility Testing Application Note

Application Note

Will your sterility test always detect contamination?

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Here
Steritest™ Symbio Pumps

What Generation is Your
Sterility Testing Pump?


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Events

Sep 24
24/09/17 - 27/09/17
AOAC Annual Meeting and Exposition
Marriott Atlanta Marquis
Atlanta, GA, USA
Water Purification,Industrial Biomonitoring,Analytics and Sample Preparation North America 20170924
Oct 16
16/10/17 - 18/10/17
12th Annual PDA Global Conference on Pharmaceutical Microbiology
Bethesda North Marriott Hotel
Bethesda, MD, USA
Industrial Biomonitoring North America 20171016
Oct 02
02/10/17 - 06/10/17
EXPOQUIMIA
Fira Barcelona Gran Via
Barcelona, Spain
Water Purification,Reagents Chemicals and Labware,Life Science Research,Industrial Biomonitoring,Analytics and Sample Preparation Europe 20171002