Shelf Life & Accelerated Aging
Every medical device is required to be labeled with an expiration date that is supported by shelf-life data. Accelerated-aging tests are employed to generate this data for design-history files, technical dossiers, and 510 (k) submissions, while concurrently running real-time studies.
For many medical devices that are manufactured from metals and robust plastics, the evaluation time for a product’s shelf life can be significantly shortened by aging the materials at elevated temperatures (often as high as 55oC). Other products, such as biologic materials or products made of thermally sensitive materials, require a more thorough aging study design with environmental chambers relevant to more unique product requirements.
With more than 5,600 m3 (200,000 ft3) of environmental chamber space worldwide, meeting ASTM, ISO, and ICH conditions, Eurofins Medical Device Testing has the largest global capacity for accelerated and real-time shelf-life studies. Eurofins’ chambers are housed in secured areas, continuously monitored and integrated into a fully validated, computerized, Laboratory Information Management System (LIMS).
Choose Eurofins Medical Device Testing to help you:
- Establish product shelf life under both accelerated and real-time conditions.
- Meet regulatory requirements following ISO 11607-1, ASTM F1980, or any custom-testing protocol needed to establish your product’s expiration date.
- Get comprehensive analysis through one provider, including package integrity, sterility, and product functionality testing such as mechanical, electrical, and physicochemical testing.
- Access study progress through our secure online data access portal, LabAccess.comSM.
- Ensure easy monitoring of multiple long-term studies and a device’s overall protocol plan using a document control system.
- Utilize an International Shipping Specialist to ship products anywhere in the world, navigating permitting, importing and customs.
- Support protocol writing and method development/validation.
Storage Systems & Capacity:
- Over 200,000 ft3 of storage space in more than 100 chambers worldwide.
- Temperature mapped and validated environmental chambers with full redundancy on critical systems, including backup power generators.
- With 40 established conditions, ranging from vapor phase liquid nitrogen through 60oC, additional custom conditions are available.
- Light chambers for assessments of photosensitive materials.
- cGMP retain program management