Medical device product stability testing constitutes a crucial element of the regulatory process, ensuring the ongoing safety and efficacy of these devices and products over their lifecycle. This testing assesses the performance of medical device products under various environmental conditions, offering essential insights into shelf life, storage recommendations, the sustained safety and their efficacy throughout their intended use.
During the COVID pandemic SMTL coordinated several stability studies of medical devices and PPE products for the UK Government, NHS and industry. Working with accredited colleagues, SMTL can offer real-time and accelerated stability studies.
Real-time stability testing involves placing the product under recommended storage conditions and testing it at periodic intervals until it no longer meets the specified criteria. Real time aging programs provide the best data to ensure that sterile barrier system and medical device materials do not degrade over time.
However, due to market conditions in which products may become obsolete in a short time, and the desire to get new products to market in the shortest possible time, real time aging studies do not meet this objective. Accelerated ageing stability studies can provide an alternative means to screen age related medical device issues.
In accelerated stability testing, the product is subjected to elevated stress conditions (such as temperature and humidity) for a shorter duration, allowing for a rapid assessment of its stability under adverse conditions. This allows device stability to be assessed faster and allows shelf-life periods to be assigned which can aid the process of getting the product or device to the marketplace.
The principals of ASTM F1980 are adopted which outlines the testing procedures and requirements. Accelerated ageing techniques assume that the chemical reactions involved in the deterioration of materials follow the Arrhenius reaction rate function. This function states that a 10°C increase or decrease in temperature of a homogeneous process results in, approximately, a two times or 1⁄2-time change in the rate of a chemical reaction (Q10).
Accelerated aging studies can provide an alternative means of screening for possible aging- related failure mechanisms of the medical device. To ensure that accelerated aging studies represent real time effects, real-time aging studies are conducted in parallel to accelerated studies.
If you have products you wish to have tested or any questions please contact smtl.info@wales.nhs.uk
Relevant Standards
ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices