Biological Indicator Sterility Testing: A Step-by-Step Guide for Medical Device Manufacturers
Sterility of biological indicator testing is essential in the validation and monitoring of the sterilization process for medical devices, particularly on medical devices with the sterile claim.
This testing verifies the sterilization process lethality by confirming the absence of microbial growth from biological indicators after being exposed to the sterilization process. The unsuccessful inactivation of biological indicators indicates a process failure, thus necessitates corrective action.
This article provides a step-by-step guide for conducting sterility testing on exposed biological indicators.
Conclusion
Sterility of biological indicator testing conforms to a successful inactivation of biological indicator when exposed to a set of sterilization parameters. This confirmation is a vital to define a successful sterilization process. A successful sterilization process allows the assurance of sterilization load’s sterility, thus allowing manufacturers to ensure the safety and efficacy of their products.
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References :
1. ANSI/AAMI/ISO 11138-1:2017, Sterilization of Health Care Products – Biological Indicators – Part 1: General Requirements.
2. ANSI/AAMI/ISO 18472:2006, Sterilization of Health Care Products – Biological and Chemical Indicators – Test Equipment.
3. ANSI/AAMI/ISO 11737-2:2019, Sterilization of Medical Devices - Microbiological Methods – Part 2: Tests of Sterility Performed in the Definition, Validation and Maintenance of a Sterilization Process.
4. The United States Pharmacopeial Convention, Microbiology and Sterility Assurance, USP34/ <1035> Biological Indicators for Sterilization.
5. The United States Pharmacopeial Convention, <55> Biological Indicators – Resistance Performance Test.
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