A Nalys engineer has been working on a 10 months mission as a cleaning/process qualification engineer for one of the major players in the Pharmaceutical industry. His missions: develop and improve the TOC Swab Recovery Studies, validate the cleaning of a new chromatography column and value stream mapping of processes. Let’s have a look on what a cleaning validation engineer journey looks like!
To fulfil his mission, our Nalys engineer had to use his full knowledge of the Validation Lifecycle as well as CQA and CPP of processes. The project environment and its link to Quality Control and production areas also required a strong expertise of the GMP practices and the CAPA processes.
The first step of the project was to insure the definition and validation of the recovery for swab sampling. Then the challenge was to deal with the important amount of samples generated, coupons and resources availability as well as communication with involved department.
In addition to the day-to-day work to make the project go on, Nalys engineer proposed a global 5 months lean approach for QC Lab.
After the initial step of the project, several technical proposals have been made : a residue limit for cleaning agent, a change of the cleaning agent and a recovery for Rinse sampling. Those proposals, associated with a strong team work, allowed the mission scope and responsibilities to growth from a cleaning validation project to a full value stream mapping of processes at customer.
“The initial project scope has evolved and extended, thanks to the Nalys engineer’s good capacities. The project advancement was good and it was nice to see. We benefited from a very perfectionist job but also a regular delivering… Which is perfect for us.”