How to Scientifically Choose Between Single and Double Sterile Barrier Systems When Customizing Medical Blister Packaging?

As a professional medical blister box manufacturer, we deeply understand the critical impact of customizing medical blister packaging on sterilization efficacy. Today, we will explore the differences between single-layer and dual-layer sterile barrier systems and share insights on optimizing blister box design to ensure sterilization compliance and product safety.

Single-Layer Barrier System: Simple Process, Low Validation Cost

• Suitable for low-risk, short-term-use medical devices.

• Ethylene Oxide (EO) sterilization demonstrates good penetration, requiring no extended aeration time.

• Validated sterilization parameters can be directly reused, reducing additional validation costs.

Dual-Layer Barrier System: Enhanced Protection but Greater Sterilization Challenges

• Suitable for high-risk, long-term implantable, or complex devices (e.g., cardiovascular stents, orthopedic implants).

• EO sterilization penetration becomes more difficult, necessitating adjustments to process parameters:

• Deeper vacuum cycles;

• Longer sterilization and aeration times;

• Increased nitrogen purging;

• Potential increase in EO residue risk, requiring additional biocompatibility testing.

Packaging Size Compatibility

• Avoid "bulging" risks: The breathable area of the secondary packaging (outer box) should be ≥ that of the primary packaging (inner box) to ensure pressure balance during vacuum cycles and prevent seal failure.

• The breathable membrane design of the blister box must align with the sterilization method (e.g., high-breathability materials for EO sterilization).

Key Points for Sterilization Validation

• Biological Indicator (BI) Placement: Place BIs both inside the primary packaging and outside the secondary packaging to ensure sterilization efficacy.

• EO Residue Testing: Dual-layer packaging may increase residue risks, requiring strict monitoring and compliance with ISO 10993-7 standards.

• Accelerated Aging Testing (ASTM F1980): Validate the seal integrity and sterile barrier performance of the packaging after long-term storage.

Material Selection Recommendations

• Use high-breathability materials (e.g., Tyvek®) to ensure EO gas penetration.

• Alternatively, consider puncture-resistant, moisture-proof medical-grade paper-plastic bags or aluminum composite films for additional protection.

• Customized Packaging Design: Recommend single-layer or dual-layer barrier solutions based on device characteristics.

• Sterilization Compatibility Testing: Assist in optimizing blister box structure to ensure EO/radiation sterilization efficacy.

• Comprehensive Validation Support: Provide packaging integrity testing (ASTM F2096), breathability testing, and more to ensure compliance with ISO 11607 standards.