PMTC Core funded Project 1
Plant Cleaning and Changeover: Is the most recent program to be initiated and includes methodology development, applied mathematical models and development of novel spectroscopic techniques, the work is resourced across Bernal Institute and CIT. Cleaning and subsequent verification and validation has always been a time consuming and costly operation in multipurpose Pharmaceutical plants. 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. In many plants average cleaning changeover cycles can take ~15 days, which represents a significant proportion of plant utilisation time in a yearly cycle, more than 50% in some cases.
PMTC designed and published A best practice guideline document detailing good practice for cleaning, validation and verification. The document contains, cleaning methodologies and presents calculations in a structured, common format. It also makes clear distinctions for handling small molecules, large molecules and investigational new products where appropriate.
A third workstream initiated in early 2017 is developing a point-and-shoot device to replace swabbing for cleaning verification which will enable at-line detection thus reducing wait time and allowing access to difficult to reach places in the equipment train. The aim is to build a bench top prototype to determine the detection/sensitivity of DUVRRS for use with pharmaceutical excipients, APIs and cleaning agents.
A fourth workstream also initiated in 2017 aims to support the improvement of new cleaning methodologies by developing, validating and analysing mathematical models of the interactions of adherents and cleansers on different surfaces. The program will develop and analyse mathematical models of the key physical processes of cleaning. These models will be informed and validated by discussions with industry partners and by comparison with data from an experimental rig that will be constructed at the PMTC. The rig will simulate various aspects of cleaning processes (on a smaller scale) from the pharmaceutical industry.
Partnerships with GSK, MSD, Pfizer, Janssen, Helsinn Birex, Roche, Avara, Lilly, Novartis, Ecolabs, Carbon Group, Steris, have been established.