Newsletters >> Spring 2017 >> Medical Device Package Testing

Medical Device Package Testing for protective properties and label durability

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Packaging Lab

Can you think of a product that doesn’t utilize packaging?  Packaging is critical in providing protection for products and in conveying information to consumers.  Eurofins has long been supporting testing to bring exciting products to market, including Biopharmaceuticals and Medical Devices. Now, a new lab has opened within the Eurofins Medical Device Testing team to focus on Package Testing.

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, are 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’ new, state-of-the-art Medical Device Package Testing Lab is able to provide testing support for clients for both the protective properties of packaging and the durability of their labeling. The Package Testing Lab has three main offerings: Conditioning/Shelf-life Testing, Performance Testing, and Materials Testing.

The 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.  The 60°C chamber is used for testing packaging materials under accelerated conditions for Medical Devices to confirm shelf-life.

Performance Testing in the 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, the 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.  The 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. The 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. 

Eurofins Medical Device Testing looks forward to providing expert packaging design assistance and package testing to our clients. For more information, visit Eurofins.com/Medical-Device