- lay-out -
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