Medical devices are analyzed to determine the physical effects on the sterile barrier system under aging conditions. The information obtained after aging procedures determines the expiration date of medical device sterile barrier systems.
The products are stored under specified temperatures and humidity in accordance with ASTM F1980 standard, taking into account the physical and chemical properties of the products. It is important to determine the samples taken with a statistical justification to show that stability studies cover all products manufactured.
At the same time, a stability protocol for non-sterile products can be prepared by our experts, taking into account the nature of the product.
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