Bioscience Scale-Up Production Facility
Acting as prime contractor on this mechanical-intensive project, Kirlin constructed this clinical production facility within an existing warehouse. Two clean room suites were built to provide a U.S. Food and Drug Administration (FDA)-validated "scale-up" facility for vaccine production in clinical trial research.
Built to exacting standards, the area features air quality ranging from class 100,000 in fermentation rooms to class 10,000 in fill and finish rooms.
The facility complies with all pertinent FDA regulations and features an impressive array of pharmaceutical equipment and utility systems.
These include: 150 liter and 1500 liter fermentors, autoclaves, depyrogenration ovens, a clean steam generator fed by two 150 hp boilers, an oil-free electric air compressor, a water for injection system, a reverse osmosis system, recirculation loop/storage tank for U.S.P. water, medium/low pressure clean system distribution, and medical grade compressed air.