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Evaluation of Sterilization Wrapping
For Compliance with EU Annex 1
GxP
Introduction
Packaging Qualification to Minimize the Risk of Particulate Contamination
Packaging Qualification to Minimize the Risk of Microbial Contamination
Packaging Qualification to Minimize the Risk of Endotoxin/Pyrogen Contamination
Packaging Qualification to Minimize the Risk of Chemical Contamination
Validation of Packaging Sealing Process
Integrity of the Sterile Protective Barrier System
Conclusion
Packaging Qualification to Minimize the Risk of Particulate Contamination
Packaging Qualification to Minimize the Risk of Microbial Contamination
Packaging Qualification to Minimize the Risk of Endotoxin/Pyrogen Contamination
Packaging Qualification to Minimize the Risk of Chemical Contamination
Validation of Packaging Sealing Process
Integrity of the Sterile Protective Barrier System
Conclusion
Keywords, Autoclave pouches, Sterilization wrapping, Tyvek , Annex 1, Contamination Control Strategy
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 |
