The equipment and tools to be used must also be specifically defined. Studies have shown that the most effective decontamination procedure is to combine an alcohol pad-swipe (which will remove visible debris from the septa) and a spray (which improves contact).The observer/verifier should pay close attention to the critical pathways, and verify they are maintained in First Air after decontamination. Sterile gloves should be aseptically donned, disinfected frequently as specified in the process instructions, and changed every 20 - 30 minutes.There can be no variation in the factors that present a possibility of microbial contamination, or the compounding process will encompass too many uncontrolled variables, and the results of testing will not be adequately representative of batch quality.For hand-compounded preparations, special efforts are required and quality assurance procedures must be adhered to if sterility testing is to be relied upon as the basis for extending dating.If necessary, diagrams and/or photographs may be included.Any special handling requirements must be described in detail.
In the example just given, the observer/verifier should periodically sample the work surface and gloves .
The Exten DATE™ System produces not only fast and efficient compendial sterility testing of these products, but also includes systematic, step-by-step instruction in performing both this type of compounding, and it's testing in a manner that is meaningful and valid.
Properly used, Exten DATE™ provides real confirmation of the efficacy of these products, rather than a dangerous false confidence that may lead to patient harm.
The work surface should also be cleaned and disinfected and the minimum frequency should also be specified.
(For example, if a group of three items is compounded together, the process might specify cleaning and disinfecting the work surface between groups, and then re-disinfecting the gloves.) .
There is an allowance for the extension beyond these limits if USP -compliant sterility testing demonstrates the sterility of a batch, provided the manufacturer's chemical stability can also be documented.