At Normec Advipro, commissioning doesn't stop at delivery.
During the construction of a new pharmaceutical facility, commissioning is often seen as the last step before validation. In reality, the process begins much earlier and doesn't necessarily end with the delivery of the installation.
In a recent project, we were involved in the construction of a new facility from an early stage. By collaborating with the main contractor and various subcontractors, we were able to thoroughly prepare the commissioning activities from the outset.
During those first discussions, the value of this early involvement quickly became clear. For example, some contractors weren't yet fully aware of certain User Requirement Specifications (URS) that determined the final operation of the systems. By detecting this early, we were able to respond quickly, clarify the requirements, and prevent problems from emerging only during testing or validation.
This approach requires more than just writing protocols. It means taking ownership of the process. Instead of simply drafting documents based on URSs, we actively engaged with contractors and technical teams to ensure systems were correctly built, installed, and prepared for testing.
Communication with the client played a key role in this. Through regular meetings and clear reporting, we kept everyone on the same page, identified potential risks early on, and were able to jointly define solutions to keep the project on schedule.
On-site, the focus was on developing and executing commissioning tests, including functional and integration testing of the installations. By working closely with engineering, QA, contractors, and project management, we were able to achieve an efficient transition from construction to an operational and validated environment.
To ensure that the controlled environments met all required regulatory standards, additional expertise in cleanroom testing and environmental measurements was brought in at key stages of the project. Normec Advipro’s Mobile Validation Experts (MoVE) team performed a range of tests to verify that the cleanroom environments complied with the specified requirements and were ready for further validation.
But as with many complex projects, the story didn’t end with delivery.
As the project progressed and certain cleanroom areas were taken into operation, previously identified risk areas required further investigation as system performance was assessed under operational conditions. At that stage, our team was re-engaged to support the client in analyzing the situation together with all stakeholders involved.
To gain deeper insight into the root causes, the MoVE team conducted targeted cleanroom testing and environmental measurements. This allowed us to collect objective data and build a clear understanding of the underlying challenges.
Based on these insights, we worked closely with all parties to implement targeted improvements. These actions ensured that the installations met both operational and regulatory requirements, while allowing the client to continue validation activities without unnecessary delays.
The close collaboration between commissioning and MoVE enabled a fast and efficient response, minimizing disruption and reducing the risk of further issues at later project stages. This ultimately contributed to a more robust, compliant, and reliable long-term operation of the facility.
This approach reflects the way we work at Normec Advipro. We support our clients not only in the preparation and execution of commissioning and validation but also remain involved beyond delivery when optimization or troubleshooting is required.
For our clients, this means one important advantage: a partner who not only contributes to the realization of a project but also takes responsibility for its successful long-term performance.
Meet Normec Advipro expert: Yasmina Baki
Yasmina Baki is a consultant at Normec Advipro with experience in commissioning and validation within the pharmaceutical and life sciences sector. During this project, she was involved from an early stage in the preparation and coordination of commissioning activities, working closely with contractors and project stakeholders.
Over the course of the project, Yasmina took on increased responsibility in coordinating commissioning activities, supporting planning, and aligning stakeholders across different disciplines. This hands-on involvement provided valuable experience in managing complex project environments and ensuring system readiness for validation.
About MoVE (Mobile Validation Experts)
Normec Advipro’s Mobile Validation Experts (MoVE) team specializes in cleanroom qualification, environmental measurements, and contamination control, supporting clients in achieving compliant and reliable controlled environments and GMP-critical installations.
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Relevant services
CQV (Commissioning, Qualification, Validation) des équipements de production
CQV (Commissioning, Qualification, Validation) des équipements de laboratoire
Validation de la stérilisation
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