Recently, there has been much excitement and activity here at Pacific BioLabs regarding the future dedicated stability suite. This long awaited project, which should be up and running in about a month, has been a result of increased test requests for shelf life and accelerated aging, especially for medical devices. Clients wishing to obtain data on their products have a choice of different endpoints and test methodologies to choose from, including testing for sterility and package integrity. Other parameters include temperature and humidity, which are controlled with dedicated chambers, monitored 24 hours a day by our Rees environmental monitoring system.
The FDA often requires products to pass stability testing so it is important to keep the end use of the product in mind. Clients should consider simulating conditions, under the proposed directions on the label, in which the product will be exposed to during shelf-life, expiration periods, storage, and transportation. Environmental factors such as extreme temperatures, exposure to air, sunlight, ultraviolet rays, and humidity should also be taken into consideration. Stability testing can be run under a regular time frame or an accelerated period, also known as “stress testing,” in which the lab will run the same test over a shorter period of time, revealing any changes in the product.
We look forward to working with our current and future clients on any stability or accelerated testing needs.