Validating cleaning procedures in biopharmaceutical manufacturing facilities

Because failing a protocol acceptance criteria is considered a substantial regulatory risk, companies are forced to spend money and resources even though there is minimal or no product risk.

It is vital for a successful cleaning validation to have appropriate acceptance criteria.

Thus the robustness of a particular cleaning procedure lies in its ability to provide quantitative data that can be compared to a different one altogether.

While this may sound obvious, in practice it is not easy to use a single criterion to assess different procedures as they are mostly validated using different techniques.

This has had a direct impact on the pharmaceutical cleaning validation process particularly about regulatory requirements; the more complicated the manufacturing procedure, the more difficult it is to clean equipment surfaces to meet regulatory standards.

So rather than view cleaning validation as a mere ‘clean-up’ after manufacturing, stakeholders in both academia and the industry have started to consider it as a form of manufacturing on its own.

This article examines using experimental design methods to define different procedures for intermediate bulk container cleaning.

It also mentions that training for personnel involved in pharmaceutical cleaning should be periodically assessed for competence.This article examines a new way of doing this, using experimental design methods to define different procedures for intermediate bulk container (IBC) cleaning.The authors have evaluated this new approach, in which a highly soluble, low-dose product and a relatively insoluble high-dose product constituted experimental input variables.Regulatory scrutiny is more rigorous in a multiproduct facility compared to a single product establishment.Companies are usually cited either for not having a sound cleaning validation or not meeting the protocol acceptance criteria.Apart from being a core aspect of current Good Manufacturing Practice (c GMP) and Good Validation Cleaning Practice (GVCP) in the pharmaceutical industry, pharmaceutical cleaning validation procedures are a necessary regulatory condition that must be met by pharmaceutical companies in getting safe and effectual drug formulations to patients.


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