Tests are part of quality control processes for medical packaging. One of the tests is accelerated ageing conducted according to ASTM F1980, the Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
Samples are drawn from production lots and are subjected to accelerated ageing tests. Samples are subjected to high temperatures for certain duration. This test simulates the effect of natural process of ageing and manufacturer derives data that helps in predicting the effect of ageing on the medical sterile packaging product. This test gives assurance that the product can be stored for extended duration without any significant deterioration in performance and quality and that the product will be safe to use after storage. The data gives information that the packaging is sterile and works as specified for its lifetime. There are twin advantages of accelerated ageing tests. One is that the manufacturer is sure that the medical packaging remains sterile for its rated lifetime. The second one is that he does not have to wait for a long time to get proven results as happens in real time ageing process and thus he can market products quickly. Tests are based on the assumption that a rise of 10 deg. C. in temperature results in about twice the rate of chemical reaction. The test may be conducted in dry conditions or in humidity chambers. These parameters of accelerated ageing include time, temperature and humidity. For testing purposes the parameters may be changed such as raising the temperature and cycling duration in order to know how the material withstands such tests.
While accelerated ageing can give an indicator of the product’s quality, it may not be absolutely reliable because real life situations may vary. Temperature variations may not be constant. Besides, there may or may not be periods of high humidity. Therefore, real time ageing test is also part of the quality assurance procedure. In this system the product undergoing testing is stored in the natural conditions and checked periodically for rate of deterioration of specified parameters. It may take anywhere from one to three years to conduct real time ageing tests. It is inherently slow and a manufacturer may not find it economically viable to wait for the result, which is the reason for accelerated ageing tests, a commonly accepted procedure in medical packaging industry.
Real time ageing test supplements accelerated ageing test and both are necessary for the quality control process.