Good Manufacturing Practices (GMP)


In mid-2016, Kuijpers was contracted to build a pharmacy for Haagsche Ziekenhuizen. This entailed a technical design & build assignment as well as the construction of the facility. As a PP4C partner, Brecon Cleanroom Systems was asked by Kuijpers to complete the structural work. The contracted parties worked on the project throughout nearly all of 2017. By Christmas, the work was fully validated and delivered to the clients’ great satisfaction. Brecon Bouw en Onderhoud was responsible for the structural assembly work.

The complete technical installation was built on the second floor. The first floor features space for cytostatics and antibiotics and an area for non-hazardous substances. To increase capacity and improve quality, the decision was made to construct four VHP (vaporised hydrogen peroxide) airlocks in the new building. In these VHP airlocks, incoming products are decontaminated with hydrogen peroxide so that they are sterile upon entering the cleanroom. This process must take place under strict conditions and guarantee the safety of end users. The entire decontamination process, including the control of the structural gas-tight doors, is automated using the operating system programmed by Kuijpers. A new water treatment installation was built on the ground floor. This installation produces very clean water (so-called water for injection, or WFI) that is needed for various preparation and cleaning processes. The ground floor additionally includes two rooms for packing, two rooms for non-sterile individual preparations and a small storage space for stock. There is space in the basement for quarantine and storage.

The work entailed 2,100 m2 of GMP cleanrooms for Brecon, divided nearly equally over the ground floor and first floor. The rooms were built according to the requirements of GMP A-B-C and D. The walls were constructed using the semi-flush wall system developed by Brecon (Trimo Sandwich panels), the ceilings in the B and C rooms are equipped with the flush Brecon Cassette Panel System (BCPS) and the circulation space and D-classed cleanrooms are fitted with the required Armstrong Biogard Acoustic system.

The design included a large portion of wall panels with low air intake and approximately 500 m3/hour of return airflow via the integrated air ducts, as well as a large number of technical panels equipped with various utilities. The building features four VHP airlocks, made entirely of stainless steel and fitted with eight certified gas-tight doors. The floors are made of Gerflor Mipolam material and are of course fitted with integrated hollow skirting boards.
A notable aspect was the large number of PTCs (pass-through cabinets) overlaid with HPL, 18 cabinets in total, 7 of which are air-conditioned. All of the cabinets were supplied exclusively by Brecon Clean Furniture.

On behalf of Brecon, PP4C partner Wero Cleanroom Reiniging handled the cleaning work during the construction period. The final cleaning and validation was performed by the client in-house.