The universal operator broth transfer validation aims to assess Operator’s ability to maintain the sterility of materials during the preparation of aseptically prepared injectable dose forms, in order to ensure that minimal bioburden is introduced. The kits provided contain all the necessary bags, vials and syringes to perform a variety of reconstitution and transfer manipulations designed to test the Operator’s ability to prevent microbial contamination of sterile materials.
The procedure is designed to emulate some of the manipulations routinely used in aseptic preparation and handling activities. The test kits are endorsed by the NHS UK Pharmaceutical Aseptic Services Committee and successful completion of the test indicates the achievement of a nationally approved and transferable standard. The kits are a good training aid for new Operators prior to doing a full process run. It assesses their aseptic technique in a short time before passing to larger and longer filling processes.
Kits are supplied by Assured Micro and when a validation session has been performed the manipulated kit is simply returned for incubation. 14-day incubation covering 2 temperatures (7 days at 20-25°C followed by 7 days at 30-35°C) is required, with reading at chosen time points. If all vessels remain sterile after 14 days, the Operator is deemed to have passed the session. Suitability of the media is confirmed via growth promotion using S. aureus and C. albicans. Three consecutive sessions are normally required for an Operator to be validated.
