Think about package validation early in product development

Nov 4, 2013 | News

Think about package validation early in product developmentSome medical device manufacturers may not start to consider package validation testing until they’re already far down the road in device design and development. If so, they could be losing time, money, and market opportunity as a result of shoddy or incomplete testing and failure to achieve regulatory compliance.

Of course, as a medical device company, you can’t actually test until you’ve got a product prototype far enough along to meet FDA ISO 11607 standards which, in short, require that a manufacturer “must ensure the product and package system combine to create a total product that performs efficiently, safely, and effectively in the hands of the user.”

A lot of medical device companies worry about performing proper package validation to meet regulatory requirements for sterile medical packaging. That’s why it’s important to pick the right consulting partner – one with comprehensive medical device development, quality assurance, manufacturing, and regulatory compliance experience.

If you’re concerned about FDA regulatory compliance, here are the medical device and package testing basics so you’ll know what needs to be addressed:

Package validation testing This essentially ensures the integrity of your package’s seal – is it sealed properly, leak-free with a sterile barrier, and safe from outside contamination? This test will ensure your package’s overall integrity during processing, handling, and throughout its shelf life.

Ship testing This process should include ASTM D4169 or ISTA procedures to address things such as shock/drop, vibration, environmental conditioning, and package compression.

Aging studies This falls under the ASTM F1980-022 test methodology and uses high temperatures to accelerate the aging process and document product shelf life and expiration times. It’s based on a thermodynamic concept that uses a rise in temperature to accelerate aging and simulate the passage of time. This is necessary because most medical products have a shelf life of several years, which can, of course, create some significant delays in product development and introduction unless the process is sped up.

Sterilization This is one of the most important validation activities – it ensures that the sterilization process you use will be effective, consistent, reliable, and will not adversely affect your device or packaging.

Biocompatibility This test falls under ISO 10993 and determines if your product can have any potentially harmful physiological effects. The testing should cover any possible effects from your product’s components. All testing requirements are based on ISO 10993 but might include skin irritation, sensitization or implantation issues.

As you can see, medical device and package validation testing is a critical component in the design, manufacture, and packaging of any medical device. That’s why is so important to consider regulatory compliance early in product development. Remember that the ISO 11607 test standard is only a framework to help guide package validation methodology. To ensure that your product development process is smooth, efficient, and successful, consider hiring a regulatory compliance consultant with the experience and expertise to help you thoroughly and successfully meet every FDA requirement.

If you’d like to learn more about MEDIcept’s services and how we can help you test and launch your next medical product, visit our website or call us at 508-231-8842.