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Sterility Testing Service

During biopharmaceuticals production, microorganisms can enter, replicate and severely compromising the final product. Even if the product has antimicrobial activity, it may take several hours to destroy an inadvertently introduced microorganism. Regulatory bodies have stringent tests to ensure that contamination has not occurred in medicinal product or medical device by sterility testing of representative samples.

Creative BioMart Microbe has extensive experience in supporting the testing of cell lines, media, in-process products, final products, combination products and medical device according to United States Pharmacopoeia (USP) and Food and Drug Administration (FDA) methodologies. Our consulting laboratory will assist you in determining how to perform the testing based on the governing standards.

  • Direct Inoculation
  • This method is used to test the solid products and medical devices for sterility in clean-room facility. The test sample is directly added into the required media for intermittent and final observations to detect the microbial contamination including both aerobic and anaerobic microorganisms.

  • Membrane Filtration
  • Liquids products are generally filtered through a membrane of proper type in a closed system. The membrane filters are then placed into required media for monitor daily or at regular intervals to look for the presence of microorganisms.

Based on the Individual Testing Requirements, Creative BioMart Microbe Can Test the Products Include but Not Limited to the Following Categories:

  • Raw materials, additives and intermediate products.
  • Pharmaceuticals, microbiological products and medical devices.
  • Any product you offered…

Workflow of Sterility Testing Service in Creative BioMart Microbe

Sterility Testing Service

Creative BioMart Microbe addresses your sterility testing needs of any type. Our expert scientists provide you individual testing requirements and consulting services. Please feel free to contact us, Creative BioMart Microbe looks forward to cooperating with you.

Reference

  1. Akers, M. J.; et al. Sterility testing of antimicrobial-containing injectable solutions prepared in the pharmacy. American Journal of Hospital Pharmacy. 1991, 48(11): 2414-8.
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