Sterile barrier system testing
1. Detection Object:
Aseptic Barrier System
2. Detection Items:
1. Film Thickness 2. Visual Inspection of Packaging Seal Integrity 3. Packaging Dye Penetration 4. Soft Packaging Seal Burst Test
5. Unconstrained Packaging Resistance to Internal Pressure Failure 6. Internal Pressure Method for Detecting Large Leaks (Bubble Method) 7. Soft Packaging Seal Performance Test (Seal Performance Test)
8. Microbial Barrier Test 9. Accelerated Aging of Packaging 10. Confirmation of Packaging for Final Sterilized Medical Devices

Testing standards and regulations:
Sterile barrier system testing

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