Considering the science behind the development of today’s most sophisticated medical devices, one may think that the packaging used to transport the devices is a simple, trivial part of the overall offering. However, one bad package design can nullify the significant R&D invested in the development of medical devices. At Healthpack 2015 in Norfolk, VA, packaging professionals from the medical device industry will be discussing challenges, solutions and legislation aimed at protecting these lifesaving medical devices.
Smithers Pira will be exhibiting at this year’s Healthpack conference located in Norfolk, Virginia from March 3rd – 5th to showcase our expertise in helping clients meet their medical device packaging related challenges. The supply chain can provide medical device manufacturers with some significant hurdles with respect to not only meeting regulations, but also doing so in a safe and cost efficient way.
One of the main challenges is maintaining sterility throughout the supply chain. Obviously, loss of sterility due to packaging issues can be a huge cost to manufacturers. But finding the right mixture of protection for the device as well as doing it in an efficient, cost sensitive way can be demanding.
Smithers Pira provides independent testing and consulting services to ensure pharmaceutical and medical products meet ISO 11607, an international standard that is accepted in the European Union and is an FDA Recognized Consensus Standard in the U.S.
The Smithers Pira Distribution Testing laboratory features state-of-the-art technology and equipment to test, in accordance with ISO 11607, packaging for terminally sterilized medical devices:
- Seal / Closure evaluation (7.3)
- Physical tests for sterile package integrity (7.4)
- Physical tests for packaging performance (7.5)
A variety of specific testing for seal strength, burst, pressure, dye penetration, vacuum, aging, distribution and storage; that fall within the categories listed above, can be conducted by the experienced technical team at Smithers Pira.
In order to dial in the most efficient package, however, a full look at the cost / benefit of a given package can be analyzed [http://www.smitherspira.com/services/distribution-testing/packsmart-calculator] to provide actionable data for the packaging team. This can include the development of custom protocols to investigate the best packaging configuration.
If attending Healthpack 2015, visit the Smithers Pira booth to learn more about how we can assist you with your medical device packaging. Or, visit us at www.smitherspira.com/services/distribution-testing to learn about our full service offering.