GMP Cleanroom Production Area

• Six cleanroom production suites with dedicated BSCs
• Purification and conjugation suite
• QC/QA laboratory with BSC
• Metal casework with epoxy tops throughout
• BSL3 laboratory area with independent, single-pass air handler and vented BSCs
• Buffer preparatory lab with 2700 and 1200 liter 316L SS buffer production tanks
• Fill / label equipment with buffer & conjugate filling unit, bottle cleaner, accumulator tables, and conveyor line (direct feed from buffer production tanks)
• Steris autoclave made of 316L SS, 24 ft 3 , with cGMP controls
• Steris glassware washer made of 316L SS, 12 ft 3 , with cGMP controls
• Steris autoclave in shipping / receiving area for decontamination and disposal purposes
• MECO RODI purified water system with 316L SS loop (validated distribution loop for WFI upgrade).
• Clean steam generator fed from WFI system

HVAC

• Central plant with redundant, 125-ton Trane chillers; and redundant gas-fired, hot water Aerco boilers
• Six air-handling units housed in the enclosed, mezzanine structure of the facility
• Separate air handlers for manufacturing, administrative, shipping / receiving, and the BSL 3 laboratories

Emergency Power

• Onan / Cummins 500 KW diesel fuel emergency generator, with approximate 24-48 hour run time. Generator provides emergency power to dedicated laboratory equipment, exhaust ventilation systems, and central HVAC plant
• 15 KVA UPS system supporting critical computerized building systems and laboratory equipment

Laboratory Services

• MECO RODI purified water system with 316L SS loop (validated distribution loop for WFI upgrade).
• Atlas Copco pharmaceutical grade compressed air system producing 32 CFM at 125 PSI
• Prevac central vacuum compressor system producing 27” Hg with a 120-gallon storage tank
• CO 2 manifold system with points of use in production laboratories

Shipping / Receiving

• Independent employee entrance to manufacturing portion of facility
• Quarantine caged receiving / shipping areas
• 630 SF refrigerated cold room product storage
• Kit assembly / packaging area
• Warehouse area with vertical rack storage, designed for forklift
• Shipping / loading dock with dock levelers and security cameras
• Waste processing area with Steris autoclave
• QA / QC storage area with –80ºC freezer storage area