Cascade TEK performs shelf-life and Accelerated ageing tests to help identify the potential for seal and burst strength, leaks, film delamination in medical device and pharmaceutical packaging. This series of tests are popular in biomedical research, pharmaceutical and medical device packaging & are required by the FDA.
Popular Accelerated Aging Test Protocols
- ASTM F-1980-99, Standard Guide for accelerated ageing of sterile medical device packages
- ANSI / AAMI / ISO 11607-1997 1st Edition - Packaging for terminally sterilized medical devices
- FDA Q1B - Photostability Testing of New Drug Substances and Products
Photostability Testing
Cascade TEK is also equipped to perform Photostability testing to standards of the International Conference on Harmonisation (ICH). The ICH Harmonized Tripartite Guideline on Stability Testing of New Drug Substances and Products notes that light testing should be an integral part of stress testing. Cascade TEK's Stability Chambers include Fluorescent light systems with Daylight lamps for full spectrum, Artificial daylight stability testing and Ultraviolet A lamps for near ultraviolet testing to meet FDA and ICH requirements.
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