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    Operator/Process Validation

    Published validation requirements

    There are several published standard methods for operator or process validations for example the NHS UK Pharmaceutical Aseptic Services Committee (formerly UK National CIVAS Group).

    Universal operator broth transfer validation

    These are designed to demonstrate the effectiveness of the aseptic technique used for transfers between different containers; vials, ampoules, infusion bags. The idea is to replace all the liquids in the process with Tryptic Soy Broth as an indicator. TSB is described in the pharmacopoeia as casein soya bean digest broth and is the prescribed medium for the sterility test. After all the transfers are complete, the containers with TSB are incubated for 14 days to check for sterility.

    Method adaptations

    While the CIVAS method is designed to qualify operators for the wide range of tasks that might be found in the aseptic production unit of a large hospital, generally it is appropriate to adapt the method to match closely a specific process. This is also the case in transferring donor or cultured cell products prior to infusion.

    Redipor® Prepared Media – Bespoke Options

    The Redipor range includes a wide range of presentations of Tryptic Soy Broth and sterile irradiated empty vials which can be combined to fit any transfer protocol without unnecessary waste. Occasionally a process will require an unusual container or fill volume, in which case our bespoke service can help – we can fill customer’s own containers with TSB and provide the same batch quality records as for the standard Redipor range.

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