Clinical Trial Manufacturing

The Clinical Trial Manufacturing area at our Spokane facility is available for production of Phase I through commercial material with 2,100 ft² of production space.  The area is designed to ensure separation of activities and includes facilities for aseptic compounding and aseptic filling.  A 30 ft² lyophilizer is integrated into this area as well.

CTM Sterile Filling Capabilities

• IMA Life Sterifill 100 (MAC) filler
• Fully Servo driven allowing operator control of all adjustments from outside of the filler barrier via the Human Machine Interface (HMI) panel
• Programmable filling nozzle motion allows “bottom up” filling
• Two Peristaltic pumps integral to the filler allows for quick change over and control of the filling process
• Automatic filling with ISO5 stoppering environment
• 2mL to 100mL vials
• 80 vials/minute

• 30 ft² IMA Edwards Lyofast 3 Freeze Dryer
• Cold shelf loading at -45 °C
• Room dehumidification provided
• CIP and SIP
• 2mL to 100mL vials
• All hydraulic cylinders are protected/isolated
• RAID 5 PC providing increased data reliability and performance

• Freeze drying
• SIP and CIP
• Defrost
• Bellow leak rate
• System leak rate