Synopsis

Pharmaceutical cleaning and subsequent verification and validation have always been time consuming and a costly operation in multipurpose pharmaceutical plants. It has a significant impact on plant efficiency, utilities and resources. About 50% of time is spent doing cleaning, resulting in a massive impact on downtime, costs and changeovers. This presentation will cover the PMTC approach towards understanding the cleaning process in order to develop efficacious cleaning procedures and robust verification methods. It will also cover the benefit of the use of PAT tools for real time monitoring and verification of cleaning to reduce the cleaning times, costs and wastes and to develop more sustainable processes. The methodology is based on computational and experimental methodologies to optimise the cleaning processes and offers a deep understanding of the mechanisms by which the residues are removed. The implementation of the method in industrial setting helped the centre achieving very impactful outcomes by reducing the changeovers by ~10% /year, solvent usage by ~40% and changeover times by an average of two weeks.