Eurofins Medical Device Testing’s new Package Testing Lab enhances global services

Lyana Torres, Group Leader, Eurofins Medical Device Testing, LyanaTorres@eurofinsus.com

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

Eurofins Medical Device Testing built 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 Package Testing Laboratory provides additional capabilities to the Chemical Characterisation, Microbiology/Sterility, and Biocompatibility service offerings at the company’s Lancaster, PA, 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 US, EU and Asia Pacific. Eurofins Medical Device Package Testing offers:

Conditioning Accelerated Testing: With over 80,000 ft³ of 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 different conditions their product would undergo. 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, manual handling, and vibrations associated with various forms of transport, as well as pressure changes that can be seen during air or mountainous product transportation.

Materials Testing: Materials 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. For more information visit: www.eurofins.com/medical-device