Sterility Bioburden Sterilization Validations Environmental Monitoring Package Integrity Consulting Services

Sterility testing is conducted to assure compliance with regulatory, international and Pharmacopeia standards. Product samples are examined for viable microorganisms that are capable of growing under the test conditions. Most medical devices are typically immersed in liquid media and incubated under prescribed conditions for up to 14 days. Liquid products can be tested using a membrane filtration technique. 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