The packaging shelf life test is a real-time evaluation of packaging material / systems applied by the user (eg hospitals). Test packs are prepared, sterilized and stored under real-time aging conditions for the duration of the test. Weekly environmental monitoring and package rotation are done. After storage, the packages are transferred to our sterility package where the contents are subjected to sterility testing.
To establish sterilization cycle parameters, sterilization validations and penetration studies must be completed before shelf-life testing.
Packaging Shelf Life tests are designed to simulate the use of products in a hospital or clinical situation. Test packs are prepared by the laboratory according to sponsor specifications and placed on the shelf for the specified storage range. Typical storage intervals are 30, 60, 90, 180 and 365 days. A typical package consists of a sterile barrier system (wrap, tray, pouch, etc.) containing a product (real product, counterfeit product, coupons or gauze). Biological and chemical indicators (BI and CI) are typically included to verify that the packages are sufficiently sterilized.
Sterilization practices recommended by AORN define event-related sterility as "shelf life depending on the quality of the packaging material, storage conditions during transport and the amount of product handling". They suggest that the following factors affect shelf life:
Our shelf-life procedures integrate weekly transport and rotation in addition to normal post-sterilization transport transfer to storage racks. All shelf-life packages are stored in open wire shelves providing the highest level of microbial fallout. The cleanliness of the environment is monitored weekly using both passive (fallout) and active (Anderson sampler) collection techniques. Temperature and relative humidity (RH) are recorded weekly to provide complete environmental storage records.
After the specified storage interval, the packages are transferred to our sterility package for testing. Packages containing real product are tested in the same way as routine lot release samples.
Suggested samples: The number of packages to be tested in each storage interval is at the sponsor's discretion. Historically, sets of 3 to 30 have been tested. We recommend that the test plan, including the sample size, be approved with the FDA prior to the commencement of testing.
EUROLAB, with its highly expert team and internationally accredited laboratories, Packaging Shelf Life Test It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
