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Introduction
Packaging materials used in pharmaceutical moist heat sterilization processes are exposed to elevated temperature, moisture and pressure conditions. Packaging performance therefore needs to be evaluated under both standard and practical operating conditions.
Material Structure
The evaluated packaging structure consists of DuPont™ Tyvek® 1073B and HDPE film thermally sealed together without chemical adhesive layers.
Moist Heat Sterilization Conditions
Internal evaluations were performed under 121°C / 20 minutes moist heat sterilization conditions. Additional testing under 125°C / 30 minutes was conducted to simulate possible sterilizer temperature drift scenarios.
Seal Integrity Evaluation
Seal strength and dye penetration evaluations were conducted after sterilization in order to observe packaging integrity performance under elevated temperature conditions.
Wet-State Evaluation
Additional internal testing simulated practical production situations where sterilized packaging may be removed from the sterilizer before complete cooling and drying. Packages were observed under approximately 90°C wet-state conditions to evaluate microbial barrier related performance.
Accelerated Aging Evaluation
Accelerated aging studies were conducted under controlled conditions to simulate long-term storage performance and evaluate packaging stability after sterilization.
Cleanroom Production Environment
Production activities are carried out under controlled cleanroom conditions, including ISO Class 5 cleanroom control for bag forming operations.
Conclusion
Internal evaluation activities indicated that the Tyvek®/HDPE packaging structure supports pharmaceutical moist heat sterilization applications requiring breathable packaging performance, seal integrity and clean handling characteristics.
Note: DuPont™ and Tyvek® are trademarks or registered trademarks of affiliates of DuPont de Nemours, Inc.
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