Medical Product Packaging Tests: Durability Assessment

How Should the Packaging Characteristics of Sterile Products Be? Which Tests Should They Pass?

Characteristics of Sterile Product Packaging

1. Sterility Preservation: The packaging must be able to maintain the sterility of the product for a given shelf life. The product must be protected from microorganisms, particles and chemicals from the external environment.
2. Barrier Properties: The packaging should form a barrier against external factors such as air, moisture, dust and light. Especially moisture and oxygen permeability should be at minimum level.
3. Mechanical Durability: The packaging must be resistant to mechanical impacts, tears and punctures that may occur during transportation, storage and use.
4. Easy Usability: Opening of the package and removal of the product should be easy without compromising sterility.
5. Compliance with Legal and Standards: Packages must comply with international standards such as ISO 11607 (Sterile Barrier Systems Standard) and relevant regulations.

Sterile packaged medical products include single or multi-use syringes, sets, gloves, forceps, needles, surgical gowns, patient bed covers. Especially after packaging, the products must remain sterile until they reach the consumer, such as storage, transportation and sales. The sterile properties of the packaging should not deteriorate due to reasons such as tearing, explosion and leakage.

Packaging is actually the most important stage of the production process. The first task of packaging for medical products is to keep the product sterile.

Tests Performed on Sterile Medical Product Packaging

The packaging of sterile medical products undergoes a series of detailed tests to ensure the sterility and safety of the product. These tests are intended to verify the effectiveness, durability and reliability of the packaging as a sterile barrier system.

• Adhesion Strength of Sterile Packaging Materials:A test to assess the strength and integrity of the seal by measuring the adhesion strength at the joints of the packaging material. The joints of the packaging are subjected to a tensile test by applying a certain force. Strength values are evaluated according to international standards such as ISO 11607-1 and ASTM F88/F88M.

Importance: Insufficient adhesion strength can cause the package to lose its sterile barrier properties and expose the product to the risk of contamination.

• Determination of Leakage on Adhesion Surfaces of Porous Medical Packaging Materials by Dyestuff Penetration: This is a test to detect potential sealing defects at the joints of porous packaging materials. Packaging surfaces are exposed to a liquid containing a dyestuff. If the dyestuff passes through the joints of the packaging, it is understood that there is a sealing problem. It is performed in accordance with the ASTM F1929 standard.

Importance: This test is critical for detecting micro-leaks at the joints of the package that could allow microorganisms to pass through.

• Free Fall Drop Test of Loaded Containers: This test is performed to assess the resistance of the packaging to mechanical stresses such as impacts and falls during transportation and storage. The loaded package (container) is dropped by free fall from a certain height (usually 1-1.5 meters). The physical integrity of the package and the contents are examined for damage. The test is performed according to ASTM D5276 or ISO 2248.

Importance: The resistance of the packaging to physical stresses that may occur in logistics processes guarantees the safety of the product.

Nanolab Laboratories Group continues to provide services within the scope of Medical Device Analysis.

Contact us for more information.

You can follow us on LinkedIn for up-to-date news and posts about our services.

Follow our Instagram account to be informed about our latest blog posts.