Context and challenges
This client is a major pharmaceutical laboratory and industry leader in insulin production. This client wanted to set up a new high-speed aseptic filling unit for insulin capsules, in order to increase its production.
The project is part of a global program, aiming at installing the same line in four different countries, using the same strategy. On this site, the project required a building extension of 5,000 m², covering 3 floors.
The client appointed Assystem to undertake the commissioning and qualification phases, the scheduling and execution of the project for HVAC and utilities.
Project scope
- Commissioning and qualification for HVAC (Heating, Ventilation and Air-Conditioning) and ‘clean’ utilities (for injection water, purified water, clean steam, compressed air and nitrogen)
- Validation of a master plan
- Design verification, commissioning (FAT/SATs) Qualifications QI, QO and QP
- Planning and execution of tests
- Validation of installations by the end users
- Analysis of the contractors’ variations: CAPA process implementation (Corrective Actions, Preventive Actions)
- Delivery of the GMP documents (pharmaceutical regulatory requirements)
Results
- Improvements to identify in advance potential issues for the qualification phases thanks to the upstream analysis of engineering data
- Time and cost savings thanks to C&Q activities simplification, in particular functional testing
- Enhancement of project follow up, thanks to the definition of efficient monthly KPIs reviewed during Steering Committees
- Improvement in the root cause analysis thanks to the analysis of contract variations, as for the OOS and CAPA processes
in figures
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