Advanced pharmacy environment for PMC in Utrecht.

The Princess Máxima Center in Utrecht, the new national center specializing in pediatric oncology, opened on June 5, 2018. None other than Queen Máxima performed the opening ceremony. PP4CE partners Kuijpers and SRBA Controlled Environments (SRBA CE) took care of the realization of the more than 350 m² cleanroom for the hospital’s preparation pharmacy. And that in just under 4 months!

The Princess Máxima Center was built across from UMC Utrecht’s Wilhelmina Children’s Hospital. The center’s original idea was to use the UMC’s pharmacy facilities. In mid-2017, however, it was decided to create its own pharmacy. After a qualitative selection, PP4CE (Professional Partners For Controlled Environments) was awarded the detail engineering contract. When the order was issued to build the entire facility, Kuijpers took on the coordination and installations and partner SRBA CE took on the structural part of the clean room. The assignment was clear: design and build a new compounding pharmacy within the walls of the pediatric oncology center and have it ready and validated within four months – by April 2018.

Seamless links

The expertise and extensive experience in realizing critical production environments such as compounding pharmacies, of both PP4CE partners, led to a smooth running of the project. For a quick and successful realization, there was cooperation with the client (the PMC), the hospital pharmacist, a consultant from RTA Medical and builder MedicomZes (specialized in healthcare projects). Kuijpers’ responsibilities included the construction of all necessary mechanical and electrical installations, including facilities for air treatment, climate, ventilation and lighting. Furthermore, Kuijpers took care of the building automation including monitoring installation and seamlessly linked the pharmacy installations with the hospital’s main installations.

BCPS modular wall system

For SRBA CE, the job covered over 350 m2 of SRBA CE ceiling system with HPL finish, and in the Class A and B areas this system was completely flush finished. All walls, doors and windows consisted of the modular BCPS (Brecon Cassette Panel System). An airtight Metaflex sliding door was installed through in the room where the full automatic production takes place. All structural parts were prefabricated at the SRBA CE production site in Tilburg and the installation therefore went without any problem and within the time limit. The floors were leveled by SRBA CE in December as the go-ahead and were finally finished per room with Gerflor Mipolam floor systems, including the hollow baseboard trim. HPL furniture fixtures and pass through cabinets (Pass Through Cabinet) were supplied and installed by the SRBA Clean Interior component. PP4CE partner WERO provided the (final) cleaning of the cleanroom prior to validation.

Unique in Europe

The cleanroom of the pharmacy consists of three parts: in one part, non-risky parenteralia (drugs to be injected) are prepared for administration in accordance with the GMP-z guideline. In another part of the cleanroom, cytostatics (drugs used in the treatment of cancer) and other high-risk parenteralia are prepared. These areas have separate air extraction and ventilation. The third area is unique: two so-called RIVA robots have been installed here. These fully automated prepare drugs for administration and then deliver them – also automated – in labeled syringes, bottles or infusion bags. Since the robots produce a lot of heat, the cooling capacity in this part of the clean room has been significantly increased.

High demands for quality

All systems in the cleanroom comply with GMP (Good Manufacturing Practices) guidelines, the pharmaceutical industry’s quality assurance system. In the pharmacy, this involves a range of GMP classifications: from GMP-D in the (general) changing rooms to GMP-A in the areas where parenteralia are prepared for administration. High requirements, therefore, which is logical in light of the expertise of the Princess Máxima Center: providing highly complex care to children with cancer. Erik Rijpkema, Kuijpers project leader: “To meet GMP guidelines, systems must meet the design specifications in every detail and be professionally installed. That checking and verification – commissioning – always runs like a thread through cleanroom projects at Kuijpers and SRBA CE, also here. By continuously monitoring the room conditions, we worked toward an optimal end result.”