PRO-TECH owns and operates its own ISO 17025 certified laboratory on premises. Unlike many contract packaging companies, we offer testing and validation capabilities in-house as part of the core services we provide our customers. By having this expertise in-house, we are able to save customers time and money as we ensure the safety of their medical device.
We believe that a good contract packaging partner thinks holistically about the medical device itself, the packaging that will protect it, and the distribution challenges that come along with getting the final product safely into the hands of the end patient. By offering a full suite of services and thinking about the entire medical device packaging ecosystem, we can anticipate obstacles and provide integrated solutions tailored to the needs of our customers.
LAL (Limulus Amebocyte Lysate)
TOC (Total Organic Compound)
pH Osmolarity and Osmolality Ultraviolet/Visible Spectroscopy
Viscosity – Rotational Methods
Bubble Leak Test
Peel Strength Test
WHAT IS VALIDATION PACKAGE TESTING?
It is the process of confirming that the medical device packaging works the way it was intended, and that the sterile barrier is maintained. Various tests are commonly used to ensure that the device is protected from sterilization until final usage by a physician.
ISO and ASTM standards, at a minimum, are used as benchmarks to make certain that the proper qualifications are met. ISO 11607 provides guidance specifically for validating terminally sterilized medical device packaging. ISO 11607 testing includes these key areas:
- Performance/Dynamics Testing
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.
- Stability Testing (accelerated and real-time aging)
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.
- Distribution Simulation
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.
- Package Seal Strength Testing
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 Testing
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.
PRO-TECH Design has highly experienced team members who regularly administer package testing for validation. In our ISO 17025 certified laboratory, we can conduct many of these tests in-house. In addition, we work with third party testing agencies to manage validation and package testing if needed.
Here is a list of the common validation tests that we conduct in-house and the ASTM standards that apply to them: