Eurofins Medical Device Testing launches new Package Testing Lab
Package Testing Lab
Eurofins Medical Device Testing's new, state-of-the-art Package Testing Lab provides critical testing support to clients for both the prote...
Eurofins Medical Device Testing's new, state-of-the-art Package Testing Lab provides critical testing support to clients for both the protective properties of packaging and the durability of their labeling. The launch of our new Package Testing expansion at the Lancaster, Pa campus enhances our Chemical Characterization, Microbiology/Sterility, and Biocompatibility service offerings to clients.
Packaging for product protection is a regulatory requirement for both biopharmaceutical products and medical devices. Primary packaging materials, or materials in direct contact or that provide stability protection, must be submitted in applications to regulatory agencies. The primary packaging materials are instrumental in: providing appropriate barrier protection (e.g. maintaining sterility), containing the product from manufacture to point-of-use, protecting the product from damage, and sometimes aiding in the use of the product (e.g. dosing or assisting in maintaining sterility for use in an operating room).
Labeling on packaging is also regulated for biopharmaceutical and medical device packaging. Labeling is important for branding, instructions-for-use, and for tracking product information (e.g. lot numbers, expiry dates, and serial numbers). Labeling must be durable and still be legible at the point-of-use. Unreadable labeling has led to numerous product recalls.
Eurofins Medical Device Testing's Package Testing Lab has three main offerings: Conditioning/Shelf-life Testing, Performance Testing, and Materials Testing.
Our new lab has several environmental chambers for both material conditioning and for conducting accelerated shelf-life testing for medical devices. Most standards used in packaging material testing require that the materials be pre-conditioned to ensure consistency in testing. The lab is equipped with chambers reflective of many climatic regions for conditioning. Our 60°C chamber is used for testing packaging materials under accelerated conditions for Medical Devices to confirm shelf-life.
Performance Testing in our new lab has two main focuses: distribution testing and label durability testing. The distribution testing consists of a series of equipment that is used to simulate the effects of the stresses of shipping on products. The lab is able to simulate drops, vibrations associated with air or truck transport, and pressure changes that can be seen in product transportation. Distribution testing is a great indicator of label durability as vibration and dropping often lead to degradation of labeling. In addition to distribution testing, our lab is equipped with a rub tester that will be used to test label durability.
Material Testing is used to verify the properties of packaging materials. Our Package Testing Lab can perform tensile testing, torque testing, tear testing, burst testing, and bend testing, to name a few. Understanding these properties and how they may change over time, or after exposure to sterilization, is critical in properly designing effective packaging.
After any shelf-life testing or performance testing, further product testing is often required. Eurofins Medical Device Testing's Package Testing Lab is able to conduct further post-testing product tests to ensure the product packaging has been properly designed. Testing can include visual inspection, operational testing, product property testing, sterility testing, and seal integrity testing.
Published by Eurofins Medical Device Testing on Dec 17, 2019