Testing on medical device packaging is essential to ensure the safety and effectiveness of products before their clinical use. Packaging plays a crucial role in protecting medical devices from contamination, physical damage, moisture, and other environmental factors that could compromise their integrity. METROPACK, ISO 17025 accredited, provides you with reliable and precise results in accordance with current regulations (ISO 11607).
Testing the integrity of medical packaging is essential to ensure that the packaging is hermetically sealed and that it retains its integrity during transportation, storage, and use. These tests are conducted to prevent contamination of medical devices and ensure their safety and effectiveness.
ASTM F1929 is the test for detecting leaks in the seals of porous packaging used for medical devices.
Standard Test Method ASTM F88 / EN 868-5 Annex D for measuring seal strength.
The test is applied to both porous and non-porous medical devices.
The loss of integrity of the sterile barrier can occur due to the gradual degradation over time of the physical properties of materials and adhesives, as well as during shipping and handling.
ISO 11607 specifies that packaging must provide physical protection and maintain the sterile barrier intact until its use or expiration date.
Stability tests using accelerated aging protocols involving temperature and humidity allow for anticipation and provide results more quickly than real-time aging.
The transit test for medical devices validates the shipment procedure for cartons or product pallets. The shipment simulation process exposes your packaged products to various conditions and the stresses of transportation and handling. METROPACK offers a selection of ASTM or ISTA test protocols and a variety of preconditioning regimens.