TOUR Info Index  ©2001UnimaxNYC

 

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. 
Packages that are found to be bent, damp and etc. are considered no longer fit for service and require re-processing. If pouches are roughly treated there may be no shelf-life at all.  All packages need to be inspected before use for integrity and any that show signs of challenge must be marked for re-processing.

Storage of all sterilized items should be designed to insure minimal handling during retrieval. 

Examples of poor storage: 
1)  picking up many packages to thumb through them to find the right size. This is mishandling sterile pouches and threatening the integrity of the packages through: friction of the packages being rubbed together,  hand pressure and air. 
2)  Stuffing or squashing them into a tight container decreases package integrity. 

Sterilized product must be retrievable with the least amount of handling and the least amount of air and moisture exposure.  This requires a separate closed cabinet or draw.

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.
If your spore test were to fail, and you had not dated or lot numbered your items, everything in your shop would need to be re-sterilized.

Pouches, such as those by 

Crosstex, made in the USA 
(a Quality Management System certified ISO 9002-EN 46002—
Medical Devices Directive 93/42/EEC manufacturer), 

have gone through certifiable testing and are guaranteed to retain sterility for one year provided they are properly cared for, stored, sealed and handled to prevent damage. 
We recommend the use of ISO certified manufactured products for sterility assurance. Since there are many manufacturers a comparison of product can easily identify those that are made to exacting specifications and which are not.

Good packaging vs. Bad packaging and handling from front and rear.
All pouches are not created equal. 
Only use Crosstex.  We only use Crosstex.  No compromise.

Other brand Crosstex Other brand Crosstex

It is your responsibility to maintain their condition through proper sterilization, packaging, handling, storage and use.