Category
Good Manufacturing Practices (GMP)

Year
2018

Advanced pharmacy environment for PMC in Utrecht.

The Princess Máxima Centre (PMC) was opened in Utrecht on 5 June 2018. This new national centre specialises in paediatric oncology. None other than Queen Máxima herself conducted the opening ceremony. PP4C partners Kuijpers and Brecon were responsible for developing the cleanroom of more than 350 m2 for the hospital’s compounding pharmacy. This development was completed in a period of just about four months!

The Princess Máxima Centre has been built opposite the Wilhelmina Children’s Hospital of UMC Utrecht. Although the original idea for the centre was to use the pharmacy facilities at UMC, it was decided in mid-2017 to develop a separate pharmacy. Following a qualitative selection, PP4C (Professional Partners for Cleanrooms) was awarded the detailed engineering contract. When the contract to build the whole facility was awarded, Kuijpers took on the coordination and the installations, while its partner Brecon Cleanroom Systems was responsible for the structural part of the cleanroom. The assignment was clear: designing and building a new compounding pharmacy within the walls of the paediatric oncology centre as well as making sure that it is ready and validated within four months by April 2018.

Seamless links
The expertise and extensive experience of both PP4C partners in developing critical production environments such as compounding pharmacies resulted in a rapid completion of the project. To ensure a swift and successful development, they collaborated with the client (PMC), the hospital pharmacist, a consultant from RTA Medical and the construction company MedicomZes (specialised in healthcare projects). Kuijpers was responsible for constructing all the required mechanical and electrical installations, including facilities for air treatment, climate control, ventilation and lighting. In addition, Kuijpers took care of the computer systems in the building – among which a monitoring system – and linked the pharmacy’s systems seamlessly to the hospital’s main systems.

BCPS modular wall system
For Brecon, the contract comprised more than 350 m2 of modular Brecon Cleanroom ceiling with an HPL finish; this system was finished completely flush in the Class A and B areas. All walls, doors and windows consist of modular BCPS (Brecon Cassette Panel System). In the area where fully automated production takes place, an airtight Metaflex sliding door was installed. All structural elements were prefabricated at the Brecon production site in Tilburg, allowing them to be installed without any problems and within the time limit set. To kick off the project, the floors were levelled by Brecon in December and were then finished in each room using Gerflor Mipolam floor systems, including a hollow skirting finish. HPL furnishings and Pass-Through Cabinets (PTC) were supplied and installed by the Brecon Clean Furniture unit. PP4C partner WERO took care of the final cleaning of the cleanroom prior to the validation.

Unique in Europe
The pharmacy’s cleanroom consists of three sections: one section is used to prepare low-risk parenterals (medicines to be injected) for administration in accordance with the GMP-Z guideline. Another section of the cleanroom is used to prepare cytostatics (medicines used for the treatment of cancer) and other high-risk parenterals. These areas have a separate air extraction and ventilation system. The third section is unique: two so-called RIVA robots have been installed here. They prepare medicines for administration in a fully automated process and subsequently supply them – also fully automated – in labelled syringes, vials or IV bags. As the robots produce a lot of heat, the cooling capacity in this section of the cleanroom was increased significantly.

Strict quality requirements
All systems in the cleanroom comply with the GMP (Good Manufacturing Practice) guidelines, the pharmaceutical industry’s quality assurance system. In the pharmacy, this system involves a series of GMP classifications: from GMP-D in the communal changing rooms up to GMP-A in the rooms where parenterals are prepared for administration. These requirements are strict, which is logical given the expertise of the Princess Máxima Centre in providing highly complex care to children with cancer. Erik Rijpkema, Project Manager at Kuijpers: ‘In order to comply with GMP guidelines, systems must meet the design specifications up to the smallest detail and must be expertly installed. At Kuijpers and Brecon, this checking and verification – commissioning – is always a central theme for cleanroom projects, including in this case. Continuously monitoring the room conditions allowed us to work towards an optimum end result.’