Good Manufacturing Practices (GMP)


Eurofins Sinensis is a fast-growing company in the field of contract testing and GMP manufacturing services for the Life Sciences sector. It is the parent company of six subsidiary laboratories in the Netherlands which mostly serve their customers independently: Bactimm, MicroSafe Laboratories, ProBase Pharma B.V., Prolepha Labs, Spinnovation and PROXY Laboratories B.V.

In 2017 we were asked to extend and adapt an existing GMP Grade D and C “Sterilization and Cleaning” cleanroom in Leiden to create a GMP Grade B facility. In line with this, it was inevitable that adjustment and expansion of the air ducts would be necessary and the utilities had to be relocated. Another question here was whether the air conditioning unit would be able to supply the required air capacity. In architectural terms the adapted Grade B cleanroom required extra airlocks and a redesigned lay-out. At the end of the day the Brecon Group, in collaboration with PP4C partner Kuijpers, was commissioned to carry out the engineering and construction assignment.

The definitive design was further developed on the basis of a few sketch drawings and a URS. Following completion of the design review and presentation of an impact assessment, the work was then begun. The existing walls and ceilings were dismantled, and were replaced by a new configuration with extra airlocks, a pass-through box and an emergency exit by means of a break wall. Extra utilities and air facilities, correctly commissioned, ensured that following the successful final delivery the cleanroom was qualified without problems in line with the required specifications.

Another successful project realized by PP4C partner Kuijpers and Brecon.