Medical device packaging must maintain integrity over its claimed shelf-life under the storage conditions specified by the manufacturer. Real time aging programs provide the best data to ensure that packaging performance is maintained over the claimed shelf life, although due to time constraints in the product development process we also offer accelerated aging – fully validated against a real-time counterpart.
Real-time Aging Testing
Smithers performs testing on products at specific intervals over real time storage to provide accurate shelf life conclusions. However, the drive to get new products to the market often means that accelerated aging tests are often run in conjunction with real time aging to validate the product shelf life claims.
Accelerated Aging Testing
Our experts will tailor an accelerated aging test programme to your particular requirements. We perform benchmark testing on products from the same batch before simulated aging to allow comparative post-aging testing at specified time intervals; a testing process which includes burst tests, dye penetration assessments and peel strength testing.
Smithers performs accelerated aging according to ASTM F1980 “Standard Guide for Accelerated Aging of Sterile Medical Device Packaging” and BS EN 868-8 “Packaging materials and systems for medical devices which are to be sterilized.”
|Typical tests include
|Testing Facilities include
- Burst strength
- Bubble leak test
- Dye penetration
- Peel strength
- Visual inspections
- Standard chamber operating range of -70°C to +90°C and 5% to 95% relative humidity.
- Programmable cycling
- Thermal shock facilities capable of -85°C to +220°C
- Lightfastness accelerated daylight exposure
The conditions and duration of storage are determined using the Arrhenius equation since the degradation of packaging materials is assumed to follow the kinetics described by the Arrhenius reaction rate function. For example an increase in temperature of 10°C will cause the reaction rate to double, meaning the accelerated aging period is half of the real time specified. Temperature cycling can better simulate real life and the effects of humidity may also need to be taken into account in some shelf life studies.
Additional Temperature Testing
Smithers is UKAS, ISO 17025 accredited for:
- High and low temperature testing in accordance with BS EN 60068-2-1 and BS EN 60068-2-2
- Humidity testing to BS EN 60068-2-30, BS EN 60068-2-38 and BS EN 60068-78
- Thermal shock testing to BS EN 60068-2-14 and BS EN ISO 11607-1
Quality and Accreditation
Our laboratories are UKAS accredited to ISO 17025, and we can also undertake cGMP compliant testing if required.