Pharmaceutical Manufacturing Facility – Packaging Line C&Q
A large mid-western pharmaceutical company planned to replace an out of date package line casepacker with an existing casepacker that was decommissioned from a different packaging line. Significant constraints existed on schedule because replacing the casepacker required a line shutdown.
To ensure success, a commissioning and qualification (C&Q) plan was developed to ensure shutdown time was minimized. Performance Validation worked with the client and project team to assist in defining the scope, determining user requirements, and determining engineering documentation (qualification) requirements. The following activities and mitigation’s were implemented to maximize project success.
- The C&Q plan was developed to split testing into offline commissioning including functional testing and online qualification testing. The offline commissioning testing ensured a high level of equipment functionality and reliability before the equipment was qualified during the line shutdown.
- A risk based approach to the scope of testing during commissioning was used to ensure the line shutdown time was minimized.
- Coordination between engineering, operations, and vendors was required to plan the shutdown and associated qualification activities. Because of production schedule and vendor availability, the shutdown schedule was moved multiple times. PV provided resource flexibility to ensure the team was supported for any dates required.
The casepacker was successfully installed and qualified on the packaging line. Line shutdown time was minimized, and the project was completed on time and under budget.
To following are some learning points.
- The “split” approach to testing was successfully implemented and is a recommended approach for future similar projects.
- Although testing from commissioning was required to be repeated during qualification after the casepacker equipment was installed on the packaging line, issues were discovered and resolved during the offline testing which minimized the time the line was down. Correcting the issues offline ensured testing performed during the shutdown was efficient, effective and without error.
For additional information, contact:
Division Director, Indiana
Performance Validation, LLC.
5420 W Southern Ave
(317) 727-8495 Mobile