The biomanufacturing GMP facility

3. Utilities

HVAC:

The heating, ventilation and air conditioning (HVAC) system is designed to reach the specifications required for the various processes, and to avoid cross-contamination between BL2 and BL3 rooms. The entire facility is classified as Class C or 10,000 with the exception of the gowning and ungowning rooms (Class D or 100,000). The two aseptic filling suites are classified as A/B or 100. The BL2 rooms have Class 100 B laminar flows and the BL3 rooms have Class 100 A "Biohazards laminar flows".

Water systems:

The facility's technical area produces its own pure steam and water for injection (WFI) which feeds the pure steam network and the WFI distribution loop, as well as points of use within the facility.

Liquid nitrogen:

A fully automated system controls the filling of the storage containers with liquid nitrogen for the safe storage in nitrogen gas phase.

Monitoring:

The facility's environmental conditions and the functional parameters of critical services and equipment are monitored and reported to a control PC with weekly back-up for long term archiving.

Henogen's clean rooms allow the manufacture of clinical or other bioproducts in accordance with cGMP standards.

Henogen’s GMP facility is dedicated to the production of biopharmaceuticals and the purification of macromolecules, whether proteins, DNA or viral vectors, for clinical use. The facility fully complies with European Union directive 2003/94/CE, which set principles and guidelines for good manufacturing practices of drugs for human use.