Use of Biological Indicators in Sterilization Validations . Published:  February 11, 2026 Author:  Jim G. Whitcomb Topics:  Biological Indicators, Sterilization Modalities, Validation Requirements, Sterility Assurance Level (SAL), D-values, z-values, BIER Unit Related Services:  Sterilization Validation Consulting, Biological Indicator Development, Fractional and Sublethal Studies, Bioburden Testing, Routine Sterility Testing Several different modalities are available for the sterilization of medical devices.  The chosen method requires validation to comply with current Good Manufacturing Practices (GMP) and to demonstrate the process renders the product free of viable microorganisms ensuring it produces product that meets requirements for a sterility claim. Since microorganisms are invisible to the naked eye, different techniques have been developed to monitor the survivability of microorganisms when exposed to a sterilization process. Biological Indicators (BI) containing specific

Ask An Expert: Your Routine Microbiological Testing FAQ’s Answered Published:  May 29, 2025 Author:  Anne M. Schuler Topics:  Method Validation, Bioburden Analysis, Sterility Testing, Endotoxin Assays, Lot Release Quantities, Bacterial Endotoxin Testing Related Services:  Quality Control, USP <71>, USP <85>, ISO 11737-3 Frequently Asked Questions About Microbiological Testing for Medical Devices and Pharmaceuticals Medical Device manufacturers must meet rigorous microbiological requirements to ensure product quality and patient safety. This FAQ addresses several important considerations related to sterility, bioburden, endotoxin testing, and method validation—offering guidance on topics that often arise during product development, lot release, and routine quality control. Quick Navigation Why do certain tests require a method validation before performing routine testing? What quantities are required for lot release testing? Do I need bacterial endotoxin

Sterilization Process Validation Published:  April 7, 2025 Author:  Jim G. Whitcomb Topics:  Sterility Assurance Level, Ethylene Oxide (EO), Gamma, E-Beam, Steam, Bioburden Determinations, Protocol Report Generation Related Services:  Quarterly Dose Audits, Cycle Development, Bacterial Endotoxin, Population of Biological Indicators, D-Value Determination Sterilization concepts can be a confusing and formidable challenge for companies looking to establish a sterilized product. For those looking for assistance with establishing a sterilization process for their product, LexaMed can help. LexaMed has the in-house expertise and laboratory testing capabilities to help manage all aspects of sterilization process validations.  For many types of medical devices and pharmaceuticals, a sterile condition is required for obvious infection prevention reasons. The definition of sterile means the absence of viable microbial organisms. While this is a

Cleaning Validation for Reusable Medical Devices Published:  March 20, 2025 Author:  Anne M. Schuler Topics:  reusable medical devices, cleaning validations, reprocessing of reusable medical devices, end-of-life conditioning, AAMI ST98, ISO 17664, medical device IFU, protein analysis, hemoglobin analysis Related Services:  End-of-life conditioning, 21 CFR 801, instruction for use development Reusable medical devices are devices that health care providers can reprocess and reuse on multiple patients.  If they are not properly reprocessed between use, there is a greater likelihood of microbial transmission and a high risk of infection. Cleaning is the physical removal of soil and contaminants, according to the FDA guidance document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff effective cleaning should: