Ensure Compliance with EU GMP Annex 1: STERIS Purefit™ Sterilization Wrapping

Discover the Future of Sterilization Wrapping

Pharmaceutical manufacturers face significant challenges in preventing contamination during sterile drug production. The European Union Good Manufacturing Practice (EU GMP) Annex 1 mandates a robust Contamination Control Strategy (CCS) to minimize these risks. Legacy wrapping methods often fall short, potentially leading to increased contamination risks, operational inefficiencies and regulatory non-compliance. STERIS Purefit™ Sterilization Wrapping offers reliability and compliance – effectively addressing these challenges.

Highlights from the White Paper

This white paper, developed in collaboration with DuPont, explores the critical aspects of ensuring compliance with EU GMP Annex 1, including:

• Qualified Materials: Purefit™ products are constructed of Tyvek® 1421B material, an uncoated grade specifically intended for use in pharmaceutical sterilization wrapping, known for its low particle generation and effective microbial barrier.
• Design Excellence: Engineered for easy handling, storage, and transport, ensuring sterility throughout the process.
• ISO 13408-1 Compliance: Supports aseptic processing with qualified materials and validated sealing processes.
• Sterilization Compatibility: Designed for use with various sterilization/decontamination methods, including steam and vaporized hydrogen peroxide.