Medical device manufacturers wishing to gather data on the shelf life of their products may subject their devices to long-term stability studies or accelerated aging studies. There are many different endpoints that can be used to assess the shelf life of a medical device, including sterility or package integrity, so it is important that endpoints and test methodology are decided upon before testing is begun.
For reusable devices, sterilization cycle testing may also be appropriate. This involves subjecting a device to many (for example 50 or 100) cycles of a sterilization or disinfection process to determine whether the device maintains functionality over time.
The microbiological labs at Pacific BioLabs can provide clients with temperature and humidity controlled chambers for storing samples for various types of medical device aging studies on both products and packaging. All chambers are monitored 24/7 by the Rees environmental monitoring system.
Available Medical Device Accelerated Aging Chamber Conditions
- 25C / 60% Relative Humidity
- 40C / 75% Relative Humidity
- Other non-standard temperatures and relative humidities