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| Shelf life is more event related than time related. | ||||||||||||
| Shelf life refers to the period
of time a sterilized or disinfected item is safe to use.
How long an item remains suitable for use is more event-related than time-related. Actual sterility of a packaged item may be indefinite depending on the package materials, the item itself and the handling and storage. Some manufactured items have a label claim of “Sterility guaranteed unless packaged is punctured or broken.” This labeling claims indefinite shelf like under the condition of proper handling. Other processed items indicate a specific date after which sterility is no longer guaranteed. This expiration date is not an indication of sterility but package integrity which must be maintained by you. Nor does this mean the items suddenly becomes contaminated and unusable after that date. It means the package has gone through rigorous testing to simulate challenges equal to a specific period of time. To guarantee your product sterility proper handling and storage is required. Contamination occurs when microorganisms are introduced into a package
through puncture, dropping on the floor, rough handling, bending,
creasing, getting wet or damp, pressure and impacts. Storage of all sterilized items should be designed to insure minimal handling during retrieval. Examples of poor storage: Rotation of stock entails a system of adding newer sterilized items to an inventory to enable the use of the oldest first to prevent stale dating. When we go to the supermarket we always do the opposite: we look for and select the items that are freshest. In contrast we should select the oldest dated sterile items and use them first. All sterilized items not intended for immediate use must be dated. Since in-house processing is not routinely biologically tested for every
lot the date of sterilization must be put on the bag. The purpose of lot
dating is so that if the next
test fails only those items sterilized during that period have to be
re-processed and not your entire inventory. If you did not lot date
the items you would not know during what period the items were sterilized
and therefore your entire inventory is suspect and the entire inventory
must be repackaged and reprocessed. Many health departments
require biological testing monthly. Pouches, such as those by
It is your responsibility to maintain their condition through proper sterilization, packaging, handling, storage and use. |
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