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 Package Integrity - Peel Strength - ASTM Method Package Integrity - Accelerated Aging Q10 Coefficient Method Shelf Life Sterility - Accelerated Aging / Real-Time expiration dating Dye Injection - Leak Test Method Vacuum Challenge, Agar Challenge, Closure Challenge Methods