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PROCEDURE The test can be conducted either in 5 initial containers if enough quantity of products is on the market in Every container as well as product or service container can be entered aseptically (i.e., needle and syringe via an elastomeric rubber stopper), or in five sterile, capped bacteriological containers of appropriate dimensions into wh
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Another approach can be made use of if these kinds of tactic satisfies the requirements on the applicable statutes and restrictions.System Validation (PV) may be the documented evidence that the procedure, operated inside of established parameters, can carry out correctly and reproducibly to provide an intermediate or API Conference its predetermin