It is essential that medical packages meet expectations in maintaining sterilization of products, providing physical protection and minimizing the risk of contamination. Therefore, a series of performance tests are required for medical packages. Here are some common medical package performance tests:
1. **Barrier Tests**: These tests measure the barrier properties of the package against moisture, oxygen and other gases. Examples include water vapor permeability and oxygen permeability tests.
2. **Microbial Barrier Tests (ASTM F1608)**: Tests the barrier properties of the package against bacteria and other microorganisms.
3. **Sewing Strength and Sealing Tests (ASTM F88)**: These tests evaluate the strength of sealing and package seams.
4. **Impact Resistance Tests**: Evaluates the shock protection capacity of the package.
5. **Aging and Shelf Life Tests**: These tests evaluate the degradation or loss of performance of the package over time.
6. **Penetration and Puncture Tests**: This tests whether the package can be punctured by sharp objects.
7. **Peel Tests**: This test evaluates the opening properties and consistency of sterile barrier systems.
8. **Visual Inspection**: Visual checks are performed to determine package integrity and defects (eg holes, leaks, seam defects).
9. **Large Air Transport Pressure Test**: It is used to test the resistance of the packages of products transported by air cargo against air pressure changes.
10. **Packaging Integration Tests**: These tests evaluate the integration and compatibility of packaging components (eg closures, labels).
11. **Leakage Tests (Immersion, Blue Dye etc.)**: It is used to detect whether the package has any sealing defects.
12. **Compression Tests**: Evaluates how durable the packages are during compression.
All these tests are necessary to determine whether the medical packages meet the requirements. These tests are designed to maintain the sterilization of products, protect them from physical damage and reduce the risk of contamination. Medical package performance tests should be performed according to regulatory standards (ASTM, ISO etc.) and the results should be documented before the product is put on the market.