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Introduction
In pharmaceutical manufacturing environments, packaging materials used during moist heat sterilization processes must support steam penetration, microbial barrier performance, cleanliness control and stable handling throughout sterilization and transfer operations.
Product Structure
The breathable sterilization packaging is manufactured using DuPont™ Tyvek® 1073B and HDPE film. The two materials are thermally sealed together without chemical adhesive layers.
Material Characteristics
Tyvek® 1073B provides a porous structure that supports steam penetration and moisture release while maintaining low linting and microbial barrier performance. The HDPE layer contributes additional support and handling stability during sterilization and transportation.
Moist Heat Sterilization Compatibility
The packaging is designed for pharmaceutical moist heat sterilization applications under 121°C / 20 minutes sterilization conditions. Additional internal evaluation was also conducted under elevated conditions at 125°C / 30 minutes to simulate possible temperature drift during sterilization.
Cleanroom Manufacturing
Bag forming operations are performed under ISO Class 5 cleanroom production conditions in order to help reduce particulate and microbiological contamination risks during manufacturing.
Applications
Typical applications include pharmaceutical rubber stoppers, caps and cap assemblies, prefilled syringe components and other clean components requiring breathable sterilization and clean transfer packaging.
Note: DuPont™ and Tyvek® are trademarks or registered trademarks of affiliates of DuPont de Nemours, Inc.
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