Plant Cleaning Methodology & Verification
AIM: Cleaning has a massive impact on plant efficiency, utilities and resources. In some cases as much as 50% of time is spent engaged in cleaning resulting in a massive impact on downtimes, costs and changeovers. This has become even more problematic in recent years with an increasing focus on smaller production volumes resulting in increased numbers of changeovers and more time spent devoted to cleaning.
Good Cleaning Validation Practice Document: PMTC commissioned The Compliance Group to deliver a ‘good cleaning validation practice (GCVP)’ document which has been produced based on a review of current guidelines and input from HPRA, the BioPharmaChemical Ireland Cleaning Validation subteam and other industry and can be downloaded from the pane on the right.
Cleaning Methodology: With our partners, Britest Ltd, we have developed methodology for the analysis and design of pharmaceutical plant cleaning processes. Some key features of the methodology are:
- Applicability to different cleaning scenarios, for example drug substance/drug product, or existing processes/new process introductions.
- Accessibility to all key stakeholders in the cleaning process.
- Focus on usability and avoidance of over-complexity.
The methodology has delivered considerable savings to our partners including shorter timelines, and minimised cleaning solvent usage without impacting the quality or robustness of cleaning.