... / ... / Introduction & Facility / Clean Room Facility

Clean Room Facility

Three fully equipped clean rooms for the in house production of ATMP.

The Clean Room Facility for cell and gene therapy is located at the 13th floor of the Ee-building. The cleanroom facility consists of:

  • One ladies- and a gents changing room (1354, 1356) at the entrance.
  • One sterile disposables storage room (1358).
  • Two clean rooms for hematopoietic stem cell processing (1351a and 1351 b) connected with the central hall through a single lock room (1351).
  • Three clean rooms (1357a, 1359a, 1361a) for the production of ATMP, which are each connected with the central hall through a lock room (1357, 1359, 1361).

The three clean rooms for ATMP production are ± 16 m2 each fully equipped for aseptic processing and in vitro culture. All clean rooms and associated lock rooms are qualified as cleanroom class C. An environmental monitoring program is operational to document the quality of the aseptic processing environment and provide information on environmental trends of the clean areas.

The 3 clean rooms for ATMP production are qualified for genetic modifications at ML-I and ML-II level. The entrance to the cleanroom facility is restricted to qualified personnel and regulated through a personal badge. Next to the clean room facility is a quality control laboratory and  a room for the storage of cryopreserved products.

clean room facilities