In order to test for accelerated aging, we significantly reduce the evaluation time by aging the materials at elevated temperatures. Depending on the nature of the product (thermal sensitivity, biological materials, etc…), Medistri will design a more thorough accelerated aging testing plan that considers all aspects of product requirements.
There are multiple risk-areas to consider to assess the shelf life of a medical device. These include:
- Sterility Challenges
- Packaging Integrity Challenges
It is important to design a testing methodology that considers these endpoints. Medistri’s in-house laboratory provides its customers with temperature and humidity controlled chambers for performing accelerated aging tests within a monitored and controlled environment. Our infrastructure allows us to test different product types, materials & sizes. The most common condition for shelf-life studies are 55°C without added humidity but other non-standard temperatures and relative humidities are also available depending on product specifications.
Designing a accelerated aging testing plan to determine the shelf-life of a product depends on the product specifications and product requirements. At Medistri, we consider both internal & external complexities:
- Components interactions (Internal)
- Material Degradation (Internal)
- Manufacturing (External)
- Sterilisation (External)
- Shipping & Storage (External)
At Medistri, we can help preventing any adverse health effects or damage that may occur due to the use of expired devices through shelf life testing, guaranteing the safety and efficacy of medical devices and, ultimately, ensuring that medical devices' quality remains intact and patients are protected.