To meet the standards of its own Directorate of Veterinary Medicine, as well as those of the European Union, CVL (formerly MAFF), upgraded a laboratory building that functions as a Biological Production Operation.
The renovated building contains facilities for media preparation and sterile processing. It also houses culture and incubation areas, cold rooms and microbiology and chemistry laboratories. Other areas are provided for wash-up, labelling and packaging.
The facility’s clean rooms were designed to achieve Grade B of the EU Guide to Good Manufacturing Practice for Medicinal products.
Two of the four sterile suites were designed to create aseptic environments to contain Category 3 pathogens by negative pressure. The other two suites, used for media preparation and filling, are maintained under positive pressure.
A pressure cascade functioning throughout adjacent areas attains Grade C and Grade D levels of cleanliness.
The Austin Company designed, engineered and constructed the entire renovation project. Austin also provided project management services for the validation of both the facility and its production equipment.
In addition, Austin purchased and installed specialty equipment including autoclaves, safety cabinets, centrifuge, filling machine, drying oven, mobile mixing tanks and clean-in-place systems.