The universal operator broth transfer validation test was developed by the UK Pharmaceutical Aseptic Services Committee to assess an operators ability to maintain the sterility of materials during the preparation of aseptically prepared injectable dose forms, in order to ensure that no bioburden is introduced.
The test is aimed to be a standard assessment for operators prior to undertaking aseptic preparation activities, and for routine operator monitoring.
The testing protocol can be found here.
One Certificate of analysis: all the components of our kits are made by the same manufacturer. This kit is supplied with one CoA from one manufacturer for the whole kit.
One shelf Life: the kits are batch manufactured which means all the components of the kit have the same 12 month shelf life from manufacture.
No Cardboard: we were asked to manufacture our kit without the use of cardboard in the packaging. Our kits are supplied in special plastic boxes with exceptional packaging to ensure the product arrives in your facility safely.
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