Autoclave Bags Made from Tyvek®/HDPE - Designed for Steam Sterilization and Cleanroom Transfer Applications

In pharmaceutical and other controlled manufacturing environments, steam sterilization remains one of the most widely used methods for ensuring product safety and process reliability. Packaging materials used in these applications must allow efficient steam penetration while also maintaining microbial barrier performance, cleanliness, structural stability and process consistency throughout sterilization, cooling, transfer and storage.

Our Autoclave Bags, manufactured from DuPont™ Tyvek® 1073B and HDPE film, are specifically developed for moist heat sterilization processes. Combining high breathability, reliable sealing integrity, low particulate generation and stable high-temperature performance, they provide a dependable sterile barrier solution for pre-filled syringe components, rubber stoppers, aluminum caps, cleanroom components and other sensitive items used in pharmaceutical production environments.

The product is designed to support GMP-controlled manufacturing processes and cleanroom handling requirements.

KEY FEATURES

Excellent Breathability and Microbial Barrier Performance

The microporous structure of Tyvek® 1073B allows saturated steam to penetrate efficiently during sterilization while enabling rapid moisture release during cooling. At the same time, the material provides an effective microbial barrier after sterilization, helping reduce the risk of external contamination throughout handling, storage and transport.

Adhesive-Free Composite Structure for Cleaner Packaging

The pouch structure is produced through thermal sealing between Tyvek® 1073B and HDPE film, without the use of chemical adhesives. This helps minimize the risk of extractables, chemical residues and contamination.

Tyvek® offers low linting performance together with high mechanical strength, while the HDPE layer contributes additional support and dimensional stability under sterilization conditions.

Stable Performance Under Steam Sterilization Conditions

The packaging system is suitable for standard steam sterilization at 121°C for 20 minutes and has additionally undergone enhanced validation at 125°C for 30 minutes to simulate temperature fluctuation scenarios commonly encountered in practical sterilization processes.

Fully Verified and Traceable Quality Control

The product has undergone a comprehensive validation programmer including:
• Seal strength testing
• Seal integrity testing
• Insoluble particulate evaluation
• Visible foreign matter inspection
• Microbial limit testing
• Bacterial endotoxin testing
• Sterilization compatibility evaluation
• Accelerated and real-time ageing studies

ISO Class 5 Cleanroom Manufacturing Environment

Bag converting operations are carried out under ISO Class 5 cleanroom conditions to minimize particulate and microbial contamination during production.

TECHNICAL INFORMATION

Material Structure

DuPont™ Tyvek® 1073B combined with HDPE film through thermal sealing technology without chemical adhesives.

Sterilization Compatibility
• Standard steam sterilization: 121°C / 20 min
• Enhanced validation condition: 125°C / 30 min

Material Characteristics
Tyvek® provides breathability, microbial barrier protection, low linting and high durability, while the HDPE layer enhances rigidity and structural stability.

APPLICATION BENEFITS
• Reliable sterilization efficiency
• Improved cleanroom compatibility
• Enhanced process stability
• Support for GMP compliance
• Extended sterile protection

TYPICAL APPLICATIONS
• Pre-filled syringe components
• Rubber stoppers
• Aluminum caps and closures
• Cleanroom spare parts and components
• Other pharmaceutical and medical cleanroom items

CUSTOMISATION SERVICE
• Custom pouch and reel sizes according to product dimensions and packaging formats
• Standard size options available through the official product catalogue
• Technical support for special sterilization processes and application-specific packaging designs

Note: DuPont™ and Tyvek® are trademarks or registered trademarks of affiliates of DuPont de Nemours, Inc.