The packaging of medical devices must be able to keep the product sterilized and functioning during transportation and storage. According to regulatory and standards, the manufacturer is obligated to validate that the medical device package is able to do so.
Carmel Labs offers its clients a full professional service in the field of loads and tests required for validation of the medical device packaging, based on standards.
• Distribution Cycle Simulation, according to ASTM D 4169 standard (typical cycle DC13)
- Drop testing (1) of loaded containers by free fall, based on ASTM D5276, D5487.
- Comperssion reststance of a container under a constant load (“Vehicle Stacking”), based on ASTM D642.
- Fixed displacement vibration, based on ASTM D999.
- Determination of the effects of high altitude by vacuum method, based on ASTM D6653.
- Random vibration of shipping containers (“Vehicle Vibration”), based on ASTM D4728.
- Concentrated impact, based on ASTM D6344.
- Drop testing (2) of loaded containers by free fall, based on ASTM D5276, D5487.
• Simulation of extreme conditions in temperature and humidity during transportation based on ASTM D4332
• Accelerated aging of sterile barrier system (accelerated shelf life), based on ASTM F1980.