By M.L. Bernuzzi, R&D Manager, Fedegari Autoclavi SpA
Cleaning is an essential practice for any pharmaceutical activity: it is impossible to manufacture drugs in dirty conditions, even if dirt is not evident. Many aspects need to be considered in setting up a cleaning procedure. This is certainly a multidisciplinary issue that involves various company areas: from “Regulations” to Engineering, from Quality Control lab to Production department. Contributions of all these areas together can lead to a robust and reproducible cleaning process.
In these conditions, even regulatory bodies struggle. Essentially, they allow manufacturers considerable flexibility in establishing their own cleaning specifications. The FDA, for example, does not define methods describing how a cleaning process should be validated.
Therefore, there are many aspects to be considered when approaching the issue of pharmaceutical cleaning. First of all, one has to consider where to perform cleaning activity: in-place (CIP) or out-of-place (COP).