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  • Writer's pictureSanichem Resources

Sterility Validation: Bacteriostasis & Fungistasis

Updated: Mar 15, 2023

The Bacteriostasis and Fungistasis (B&F) test is also known as the Sterility Suitability test. The test is performed on a sterile product for the purpose of finding if any inhibiting factors exist in the product which would invalidate a sterility test. The test method will therefore confirm the presence or absence of inhibitory substances in the medical devices that could affect the result of sterility test. The test is usually required during the course of validation or maintenance of a sterilization cycle; and is done on any product that needs any form of sterility testing.

In Sanichem Resources, we could help you to:

  • Understand Bacteriostasis and Fungistasis testing.

  • Performing analysis on Bacteriostasis and Fungistasis Testing

  • Fulfill regulatory requirements for ISO 11135

  • Ensure Safety of products released.

Our test method are based on requirements of:

  1. ISO 11737-2:2019

  2. USP 43-NF 37:2019

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