Pharmaceutical cGMP Manufacturing Facility
TESORx, Inc. is constructing a modern manufacturing facility in Clearwater, FL, that will be used for manufacturing the oral testosterone drugs TSX-002 and THG-1001, as well as other potential hormonal products. The facility will house 20,000 SF of cleanroom space, 12,000 SF of warehouse, and 12,000 SF of office space. ASE provided the HVAC and Plumbing design services for the facility.
After assisting the owner with a risk assessment, we were able to implement a more cost effective design concept allowing us to avoid the high cost (200% more tonnage) associated with the common but often unnecessary single pass air design associated with potent compounds.
Risk of Cross Contamination was abated by re-circulation units dedicated to similar products and dedicated ventilation/exhaust systems. We were able to downsize the heating 75% by segregating the systems.
Assisting the owner with properly documenting the SOP and BOD, we were able to eliminate the main systems humidifiers and desiccant dehumidifiers. The small area that did require tight control was handled with dedicated units to just that area.