3000m2 cleanroom completed three months earlier for Produlab!

Produlab Pharma develops, registers and produces veterinary medicines for renowned pharmaceutical companies. Penicillin-containing medicines are prepared in the current factory in Raamsdonkveer. Produlab Pharma wanted to further increase production capacity and has built a new ultra-modern, penicillin-free production facility. The new building covers an area of ​​12,000 m2 including 3,000 m2 of GMP cleanrooms. Kropman Contamination Control (KCC) has been heavily involved in the design and realization of this new build.

“Produlab Pharma wanted to expand their production capacity. The project was twofold: expanding and separating production. We did realized this and now we also maintain the production facility. Kropman Contamination Control has a great deal of technical knowledge of and experience with these types of multidisciplinary projects. This enables us to engineer, build, commission and coordinate the entire project. This makes it easy for Produlab Pharma, because they only have one point of contact. The end result: Produlab Pharma has an GMP approved state-of-the-art production location. ”
Daan van der Hagen, project manager clean utilities.

From detailed design to complete documentation

Kropman Contamination Control first realized the detailed design in collaboration with Produlab Pharma. Kropman Contamination Control then supplied a large number of systems based on this design from purchase to delivery. Finally Kropman commissioned these systems, performed the relevant SAT tests and provided the complete GEP and GMP documentation.

Achieving the tight schedule was crucial for Produlab Pharma and Kropman Contamination Control delivered upon their promise. The challenge was to deliver the project 3 months ahead of schedule and this goal has been achieved. A joint effort by Produlab Pharma and Kropman Contamination Control enabled the first products to be successfully reported as ready at the desired moment. This shorter construction time was partly realized thanks to a positive and very constructive collaboration with the Produlab Pharma project team.

CEO of Produlab Pharma, Mr. A.R. van den Doel thinks the collaboration with Kropman Contamination Control has been excellent. Kropman Contamination control has realized a state of the art paperless pharma plant and realized that 3 months prior to the deadline.

Project details

The project included the following systems:

• Cleanrooms GMP grade-D, -C, -B & -A

• HVAC systems

• Black Steam system

• Process Cooling water, chilled water & hot water systems

• Compressed Air, Nitrogen & Vacuum systems

• Building Management System

• Environmental Monitoring System (hardware part)

• Electrical systems

• Purified water generation & distribution system

• Pure steam generation & distribution system

• Water For Injection (WFI) generation & distribution system

• Bulk Raw Material

• Detergent

• Vessel Docking Stations

• 2000L Formulation & Holding vessels

• Clean In Place system (CIP)

• Clean Out of Place system (COP)

• Clean Out of Place - Steam Out of Place system (COP-SOP)