Eurofins Medical Device Testing Launches New Package Testing Lab, Enhances Global Testing Capabilities to Support the Medical Device Industry

Packaging and labelling play an important role in the delivery and use of medical devices, and  the documentation of packaging validations must be submitted in applications to regulatory agencies. Packaging materials and configurations are instrumental in protecting the product from damage as it is transported from a manufacturer to point of use, providing appropriate barrier protection and aiding in the use of the product. Package labelling is also a regulated element for medical devices, which is important for branding, instructions-for-use and tracking product information. Labelling must be durable and remain legible at the point of use, and failures in readability have led to numerous product recalls.

Eurofins Medical Device Testing recently opened a state-of-the-art package testing lab to provide critical testing support to clients for both the protective properties of packaging, as well as the durability of their labelling. The launch of this new package testing laboratory adds to the chemical characterisation, microbiology/sterility and biocompatibility service offerings at the company’s Lancaster, Pennsylvania site. Continually expanding comprehensive medical device testing capabilities among its network of 16 sites globally, Eurofins Medical Device Testing is further positioned to help clients navigate regulatory pathways in the U.S., EU and Asia Pacific.

Eurofins Medical Device Package Testing offers:

• Conditioning/Shelf-life Testing: With over 80,000 ft³ of continuously monitored environmental chambers, clients can subject their products to a broad range of temperature and humidity conditions to assess the robustness of their packaging to withstand long-term storage or distribution to the harshest regions of the world. Real time shelf-life studies can be performed concurrent with regulatory submissions using accelerated aging studies.
• Distribution Testing: No matter how or where your product is shipped, Eurofins Medical Device Testing’s state-of-the-art distribution testing equipment can simulate the stresses of shipping on products. Standard ASTM and ISTA distribution cycles, as well as custom programmes, can be performed that simulate stacking, drops, and vibrations associated with air or truck transport, as well as pressure changes that can be seen during air or mountainous product transportation.
• Materials Testing: Material Testing is used to verify the properties of packaging materials. The laboratory is equipped to perform a broad range of mechanical and material tests on raw materials and finished packaging designs, including tensile, torque, tear, burst and bend testing. Understanding these properties vary between raw material suppliers, how they may change over time, or after exposure to sterilisation, is critical in properly designing effective packaging.

After any shelf-life testing or distribution simulations, further product testing is often required. Eurofins Medical Device Package Testing lab is able to conduct a wide range of testing to ensure the product packaging has been properly designed, such as visual inspections, operational testing, product property testing, sterility testing, seal integrity testing and label testing, including barcode verifications.