Huge GMP revalidation for cleanrooms after major upgrade
Project facts
- ClientCompany involved in production, research and development of biotechnology-based life science products
- ChallengeManaging validation and qualification of cleanrooms and undertaking future annual requalifications
- LocationNetherlands
- SolutionConsultancy, performing measurements and keeping the requalification period as short as possible
The challenge
Our client is involved in production, research and development of biotechnology-based life science products in the Netherlands. They asked Haskoning to manage the validation and qualification of their cleanrooms following the upgrade and to undertake future annual requalifications. An important restriction was that production could be continued throughout the project.
The solution
Service includes consultancy and measurement
A special feature of our service is our ability to provide consultancy, measurements as well as customisation. Maintaining production was an important objective and involved flexibility in schedules – in this case performing measurements at night. We kept the requalification period as short as possible by working with additional people and more equipment.
The production area required more capacity than available, so we trained staff members to perform the necessary measurements for assessing particles, microbiology concentrations and air circulation rates in the correct way.
The result
Time required for annual requalification significantly reduced
We have been working to shorten the time needed for the annual requalification by re-organising paperwork and streamlining protocols. As a result, the time needed was reduced by half. Automated data collection was also introduced wherever possible. The project was completed without interruption of production.
