Microbial Identification

Re-Use Stress Testing and Evaluation of Disinfectants

Purpose of Test The U.S. FDA and Health Canada require that high-level disinfectants intended to be continuously reused in a clinical setting be evaluated for efficacy after the product has been subjected to simulated re-use procedures. The purpose of this method is to generate a product which has undergone simulated use and periodic bio-burden stressing.… Read More

Categories: Liquid Antimicrobial Efficacy Tests and Microbiology Testing

Tags: Antimicrobial, Antimicrobial Liquid, Cleaning Validation, Medical Device, Microbial Identification, Microbiology Testing, and Test


Reusable Medical Device Disinfection Validations

Low, Intermediate and High-Level Disinfection Validation for a Reusable Medical Device AAMI Method TIR12 AAMI TIR30 Purpose of Test The U.S. FDA requires that disinfection instructions supplied by medical device manufacturers to the end-users of reusable medical devices be validated to assure that they are appropriate for the device. AAMI Technical Information Reports (TIR) 12… Read More

Categories: Microbiology Testing

Tags: Antimicrobial, Cleaning Validation, Medical Device, Microbial Identification, Microbiology Testing, and Test


Disinfection Qualifications for Cleanroom Disinfectants

The following methods are used for Disinfection Qualifications for Clean-Room Disinfectants: USP <1072> ASTM E2614 Purpose of Test An effective disinfection program is critical to assure the quality of the products produced in aseptic processing areas of a Good Manufacturing Practice (GMP) facility. The U.S. FDA requires that, “the suitability, efficacy, and limitations of disinfecting… Read More

Categories: Microbiology Testing

Tags: Antimicrobial, Antimicrobial Liquid, Disinfection Qualification, Medical Device, Microbial Identification, Microbiology Testing, Pharmaceutical, and Test