Package Performance Tests

Medical Device Packaging

In medical devices, packaging tests are also required to ensure that the product reaches the end user intact, in addition to performance and safety control. Packaging tests are especially important for medical devices that must remain sterile and protected from contamination. In addition, the packaging used to prevent physical and chemical damage to the product must be tested.

Packaging used to protect medical devices from environmental conditions may differ depending on the intended use and storage - transportation conditions and may undergo extra controls depending on these differences.

What is Package Performance Testing?

Package performance testing involves a series of test methods that measure the durability of medical device packaging against physical, chemical and environmental conditions. These tests analyze how well the packaging is able to maintain the sterility, integrity and functionality of the product.

Aims:

• To ensure the integrity of the sterility barrier.
• Measure the resistance of packaging to mechanical and environmental stresses.
• To guarantee product safety during storage and transportation.
• Verify compliance with regulations.

What is the Importance of Package Performance Testing?

The packaging of medical devices not only protects the product from external factors, but also ensures that the sterility of the product is maintained. Package performance tests are important for the following reasons:

1. Sterility Assurance: The packaging ensures that the medical device remains sterile, reducing the risk of infection.
2. Mechanical Protection: Prevents physical damage such as impact, compression or vibration during transportation.
3. Regulatory Compliance: Indicates compliance with standards such as ISO 11607.
4. Product Shelf Life: Ensure that the packaging provides effective protection for the life of the product.
5. User Safety: Guarantees that undamaged and sterile products reach healthcare workers.

 
What are the tests performed on packaging to be used for medical devices?

• Microbiology Tests: Tests that evaluate the sterilization effectiveness of medical device packaging and whether it protects against the entry of microorganisms.
• Dye Penetration - Leakage Test: A visual assessment test using dye to detect liquid leaks at seam or seal areas on packaging.
• Explosion Test: A test to measure the internal pressure resistance of the packaging and to check for tearing or opening at a given pressure level.
• Bubble Test: A test in which bubbles are observed to form in a liquid medium, usually under pressure, in order to detect small holes or defects in packaging.
• Seal Integrity Test: A durability test to check whether the sealed areas of the package can maintain their physical integrity and sterile barrier properties.

It is important to work with expert teams and competent laboratories to test and improve the quality and system performance of medical devices. As Nanolab Laboratories Group, we provide Package Performance Testing services in Medical Device Packaging.