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Evaluation of Sterilization Wrapping
For Compliance with EU Annex 1
GxP
IntroductionPackaging Qualification to Minimize the Risk of Particulate ContaminationPackaging Qualification to Minimize the Risk of Microbial ContaminationPackaging Qualification to Minimize the Risk of Endotoxin/Pyrogen ContaminationPackaging Qualification to Minimize the Risk of Chemical ContaminationValidation of Packaging Sealing ProcessIntegrity of the Sterile Protective Barrier SystemConclusion
Keywords: Autoclave pouches | Sterilization wrapping | Tyvek | Annex 1 | Contamination Control Strategy
Abstract
This article gives guidance for evaluating sterilization packaging materials specifically, as part of the Contamination Control Strategy (CCS) to ensure compliance with EU Annex 1. The following evaluation and rationale are the opinion of the authors and should be used as guidance in creating each manufacturer’s individual CCS and associated risk assessment.
Aaron Mertens and Renee Buthe · STERIS
Correspondence:
Aaron Mertens
STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060
aaron_mertens@steris.com
 | Aaron Mertens has over 24 years of experience in pharmaceutical manufacturing, with expertise in cleaning, disinfection, sterilization and contamination control. He has held several positions within the pharmaceutical industry, with experience working at pharmaceutical manufacturing organizations representing quality assurance programs and working with global industry regulatory agencies. He holds a bachelor’s degree in genetics. Currently he is a member of STERIS Life Sciences Technical Services Team and is a member of |
