Universal Operator Broth Transfer Validation Kit
All components in one kit from one supplier with one C of A
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.
We were approached by a number of NHS aseptic units to produce this kit for them and in doing so have addressed a number of problems they were experiencing with their current kit. The entire kit is manufactured by bioTRADING and supplied in a plastic box with one certificate of analysis for the whole kit. Our kit also benefits from an extended shelf life.
It is also possible to adapt this kit to your specific needs and indeed this has already been done for many aseptic units. Please contact us with your specific requirements and we will be happy to discuss them with you.