How to test the sealing performance of sterile isolation bags

I. Using Professional Seal Testing Equipment
Sample Preparation:

• Cut the sterile isolation bag to an appropriate size, ensuring the surface is clean and free of contaminants.
• Follow aseptic operating procedures during preparation to avoid contamination.

Equipment Setup:

• Use professional equipment such as the LSST-01 Leak and Seal Strength Tester.
• Set instrument parameters according to sample requirements, including selecting appropriate test modes and pressure ranges.
• Ensure the equipment is calibrated and functioning properly.

Testing Procedures:

1. Burst Test: Place the sample in the instrument and gradually increase internal pressure until the sample ruptures. Record the maximum burst pressure.
2. Creep Test: Apply 70% of the maximum pressure to the sample, maintain for a specified duration, observe pressure changes, and record data.
3. Creep-to-Burst Test: Apply 90% of the maximum pressure and record the time taken for the sample to rupture under this pressure.

Result Analysis:

• Evaluate the packaging’s seal integrity and durability based on test data.
• Compare results across samples to identify potential quality issues and make adjustments.

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II. Vacuum Leak Detection Method
Equipment Preparation:

• Prepare a vacuum leak detector or similar vacuum equipment.

Testing Procedures:

• Place the sterile isolation bag in the vacuum chamber.
• Seal the chamber and activate the vacuum pump to gradually reduce internal pressure.
• Observe pressure changes and check for gas leakage.
• If necessary, use dye or other indicators to locate leaks.

Result Interpretation:

• Stable pressure and no gas leakage indicate good seal integrity.
• Pressure drops or gas leakage indicate seal defects.

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III. Microbial Ingress Method
Testing Preparation:

• Prepare a high-concentration microbial culture medium.
• Immerse the sterile isolation bag in the medium.

Testing Procedures:

• Maintain the bag in the medium under controlled temperature and humidity for a specified period.
• Observe for microbial colony growth in the medium.

Result Interpretation:

• No microbial growth confirms good seal integrity.
• Microbial growth indicates seal defects allowing ingress.

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Key Considerations

• Refer to relevant industry standards (e.g., GB/T 10440-2008, ISO 11607-1) during testing.
• Strictly control test conditions (temperature, humidity, pressure) to ensure accuracy and reliability.
• Select appropriate methods and parameters based on the specific type and application of the sterile isolation bag.

Conclusion
Testing the seal integrity of sterile isolation bags requires methodical selection of techniques and adherence to standards. Rigorous testing protocols and quality control ensure compliance with performance requirements, safeguarding product safety and sterility.