Packaging Compliance Labs offers over 2,000 cu/ft. of accelerated aging capacity and is constantly growing to meet our client’s demands. Our environment validated chambers offer both temperature and humidity controls, to best test shelf life and expiration date claims for medical device packaging systems. Each chamber in our lab has passed IQ/ OQ/ PQ validation to ensure top performance for our clients. Our skilled engineers adhere to ASTM F1980 protocols to determine how the passage of time will affect the sterile integrity of a sterile barrier packaging system as defined in ISO11607. We are A2LA Accredited to ISO 17025 and ISTA Certified.
Key services within our accelerated aging department include:
- Baseline testing designed for values to compare to aged samples
- Integrity tests for baseline values, include:
- Peel Strength Test (ASTM F88)
- Visual Inspection (ASTM F1886)
- Burst Testing (ASTM F2054)
- Bubble Leak Testing (ASTM D3078)
- Dye Penetration (ASTM F1929)
- Test duration and assumption calculations
- Sample size optimization for quality management
- Real time aging
- This is one of the most common mistakes that we see clients make while performing an accelerated aging study. ISO 11607 determines that accelerated aging data is sufficient for market launch as long as real time data is being gathered.
To find out more about this test and how it can help your packaging project, please call or email us. We’re here to help you speed to market!