A major upgrade for our client’s cleanrooms prompted the need for quick, efficient and effective GMP validation.

Our client is involved in production, research and development of biotechnology-based life science products in the Netherlands. They asked Royal HaskoningDHV to manage the validation and qualification of their cleanrooms following the upgrade and to undertake future annual requalifications. 

Service includes consultancy and measurement

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. 

“A special feature of our service is our ability to provide consultancy, measurements as well as customisation”, explained Petra Van Hauwe-Verhoeven, Cleanroom Qualification & Validation Expert at Royal HaskoningDHV. “Maintaining production is always an objective and involves 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.”

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 will be reduced by half. Automated data collection is also introduced wherever possible.

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