Validated packaging gives you the confidence to bring your device to market. At Pro-Tech Design, testing and validation aren’t outsourced afterthoughts. They happen in-house, in our own ISO 17025 accredited laboratory, giving you faster answers and greater control over your validation timeline. From accelerated aging to seal strength and package integrity testing, our results give you the documentation you need to move forward with certainty.
Our in-house lab performs microbiological, chemical, and mechanical testing. We connect those results to your project through our packaging and assembly services.
Testing validation confirms that your medical device packaging performs as intended and that the sterile barrier holds from sterilization through final use. ISO and ASTM standards serve as the benchmark for this work. Specifically, ISO 11607, the standard for validating terminally sterilized medical device packaging outlines the testing requirements.
How do you know if your packaging system can effectively protect the sterile barrier and its contents? By allowing the packaging system to undergo potential distribution simulation and storage conditions and then performing package testing to ensure the packaging system maintained its integrity.
Package testing performed after stability testing provides evidence that the sterile barrier system is capable of maintaining integrity over time. This is done through both accelerated and real-time aging studies.
Package testing performed after distribution simulation provides evidence that the sterile barrier system is capable of maintaining integrity after handling and distribution. The packages are conditioned to then undergo a variety of simulations from compression testing to drop testing among others.
Seal strength testing is performed via burst tests and/or peel tests. A minimum limit is established and a statistically relevant sample size is tested to ensure the package seals have maintained their strength post stability and/or distribution simulation.
Package integrity is verified via visual inspection of the seals and overall package to ensure there are no visual defects present in the packaging. In addition, bubble emissions testing is performed to ensure that the packaging has maintained its integrity post stability and/or distribution simulation. Bubble emissions testing is also used to confirm visual observations that have the potential to breach sterility. Similar to seal strength testing, the sample size is based on a statistically relevant sample size.
Calculate the accelerated aging time needed for your target shelf life.
Find answers to common questions about Pro-Tech’s in-house laboratory and validation services, or contact us to start a conversation.
Yes, we have an ISO 17025 certified lab in-house and we conduct our own packaging validation and testing, including accelerated and real-time aging, LAL and bioburden testing, and packaging integrity and seal strength testing. If additional testing is required, we work closely with several outside laboratories to manage the testing as needed for customers.
ASTM International is an international organization that develops global testing standards for various industries. Over many years, they have become recognized as the testing standards expert for the medical device industry. As such, most medical device companies, their suppliers, and regulatory bodies use ASTM standards to measure and validate the performance of their products.
ISO 11607 is the ISO standard for terminally sterilized medical device packaging. It provides requirements for testing packaging performance, stability (accelerated and real-time aging), distribution simulation, package seal strength, and package testing. These are all designed to ensure that the package adequately protects the sterile medical device it contains during typical storage, shipping, and distribution conditions.
For more information on our laboratory and validation services, please contact us to help with your next project.
