Shelf Life Studies
DDL conducts accelerated aging testing to establish shelf life and expiration dates for medical devices, packaging and products.
When establishing shelf life claims, it must be recognized that the data obtained from accelerated aging testing is based on conditions that simulate the effects of aging on the materials. The resulting creation of an 'expiration date' or shelf life represents a conservative estimate of shelf life and is tentative until the results of real time aging studies are completed on the product or product/package combination. Since the results of accelerated aging testing produce a conservative estimate of the actual shelf life of the materials, tolerances for the temperature and humidity are only provided to ensure that the chamber operates within a satisfactory range. Out of tolerance excursions for less than 6 hours in duration for either temperature or humidity are acceptable and do not adversely affect the estimate for shelf life. |
For more information on DDL's expertise in determining shelf life and expiration dates for medical devices, packaging and products, contact us today.
