Facility

- lay-out -

Our facility is based in Maastricht, The Netherlands in proximity of several international airports, close to Brussels (Belgium), Dusseldorf (Germany) and Amsterdam (The Netherlands).

The facility is 1400 m2 (15.500 square feet) and is built to offer flexibility in handling multiple products from different clients. This is guaranteed by our change – over procedure designed to offer the flexibility to use the B rooms for multiple products per day. Also we have 24 hour availability for manufacturing by our dedicated teams. Incubation of cells is done in a D room (with project dedicated incubators) to keep the B rooms assigned for manufacturing purposes.

PharmaCell has three class B rooms (see table Classification) with Laminar Air Flow Cabinets Class A compliant to the European requirements for open handling during manufacturing. A separate wing of the facility is specifically designed for handling virus positive material. The class B room has negative pressure and has a separate flow of materials and personnel compared to the rest of the facility. The clean room also has 1 class C non-cellular room, 2 class D Cell Therapy closed processing rooms, 1 class D equipment preparation room and 1 class D incubator room.

The facility has facility equipment monitoring with automated alarm reporting, HVAC system and uninterrupted power supply connection for all critical material in the clean room and labs. PharmaCell also has cryo-storage capacity, warehouses, QC labs and Process Development labs that are fully controlled under our cGMP compliant quality system. The QC labs separated for cell-related testing and microbiological testing. Our QC labs and Process Development labs contain equipment such as LAFC, incubators, FACS CANTO 6 colors, fluorescence luminescence, UV-visible light spectrometry and endotoxin device.

Classification in Operation (Annex I Manufacture of Sterile Medicinal Products)

FDA >0.5 µm particles/feet3 FDA >0.5 µm particles/meter3 ISO GMP Grade EU GMP (CFU/meter3) Remarks
100 3.520 ISO 5 A <1 Aseptic handling in LAFC
1.000 35.200 ISO 6 Not defined Not defined
10.000 352.000 ISO 7 B 10 Background mandatory in EU*
100.000 3.520.000 ISO 8 C 100 Background mandatory in US*
Not defined Not defined Not defined D 200

*For aseptic preparation and filling

GMP Certification CMF Geleen

The Geleen Cell Manufacturing Facility was first GMP certified in 2012 by the Dutch authorities (IGZ).

Fact sheet

GMP Certification CMF Maastricht

Our Maastricht Cell Manufacturing Facility was first GMP certified in 2006 and has been successfully inspected by the Dutch Authorities (IGZ) on a regular basis thereafter.

Fact sheet