Medical device packaging must maintain its integrity over the claimed shelf life under the storage conditions specified by the manufacturer. Real-time ageing provides evidence of packaging performance over the intended shelf life, while accelerated ageing can provide earlier supporting data during product development. Accelerated ageing programmes are typically run alongside real-time studies.
The conditions and duration of accelerated ageing are determined using the Arrhenius relationship, based on assumptions about the effect of temperature on material degradation. The ageing factor selected determines the relationship between accelerated and equivalent real-time ageing. Temperature cycling and humidity may also need to be considered depending on the packaging materials, storage conditions and study objectives.
Talk to our experts about your medical device packaging, shelf-life requirements and real-time or accelerated ageing programme.
Real-time Ageing 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 means that accelerated aging tests are often run in conjunction with real time aging to validate the product shelf life claims.Accelerated Ageing 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.Standards
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 | Environmental capabilities include |
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The conditions and duration of accelerated ageing are determined using the Arrhenius relationship, based on assumptions about the effect of temperature on material degradation. The ageing factor selected determines the relationship between accelerated and equivalent real-time ageing. Temperature cycling and humidity may also need to be considered depending on the packaging materials, storage conditions and study objectives.
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 60068-2-78
- 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.Talk to our experts about your medical device packaging, shelf-life requirements and real-time or accelerated ageing programme.
- ISO 11607-1 Testing for Medical Device Packaging
- Medical Device and Pharmaceutical Shipment Studies
- Shelf Life Studies
- Sterile Barrier System Integrity Testing
- Tamper-Evident Packaging Testing
- Temperature-Controlled Vibration Testing for Healthcare Packaging
- Temperature-Controlled Vibration with Pressure Testing for Drug Product Stability
