Sterility Sterility Bioburden Sterilization Validations Environmental Monitoring Package Integrity Consulting Services Sterility testing is conducted to assure compliance.... APPLICABLE TEST PROFILES USP STERILITY - PRODUCT IMMERSION USP STERILITY - MEMBRANE FILTRATION USP STERILITY - PRODUCT FLUSH ANSI/AAMI/ISO DOSE AUDIT - B-1 METHOD ANSI/AAMI/ISO DOSE AUDIT - VDmax METHOD STERILITY - SPORE STRIP IMMERSION ...

Consulting Services Sterility Bioburden Sterilization Validations Environmental Monitoring Package Integrity Consulting Services Ethide offers a wide range of consulting services... to the Medical Device and allied industries. We specialize in sterilization validation protocol development for Ethylene Oxide and Radiation Sterilization processes. Written...

Sterilization Validations Sterility Bioburden Sterilization Validations Environmental Monitoring Package Integrity Consulting Services ETHYLENE OXIDE STERILIZATION VALIDATION... requirements and offers guidance for the validation of ethylene oxide sterilization processes that rely on a microbiological challenge to monitor the sterilizing cycle. Part... with established international and FDA guidelines. APPLICABLE TEST PROFILES BIOBURDEN TESTING BIOBURDEN VALIDATION TESTING BIOLOGICAL INDICATOR ENUMERATION USP STERILITY - PRODUCT...

Package Integrity Sterility Bioburden Sterilization Validations Environmental Monitoring Package Integrity Consulting Services Physical tests are an essential part... of the evaluation of the integrity of sterile medial device packages and packaging materials. The selection of test methods should take into consideration the materials, package design, type... of sterilization and shelf-life stability. Several tests are offered which follow ANSI/AAMI/ISO, ASTM, PDA and FDA recommended practices and guidelines. APPLICABLE TEST PROFILES...

Bioburden Sterility Bioburden Sterilization Validations Environmental Monitoring Package Integrity Consulting Services Bioburden testing is designed to enumerate viable... device recovery rate techniques and methods. Continuous monitoring programs can be established to be used as Quality Control tools and to assure compliance with sterilization...