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
CTM Lyophilization
- 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
Automatic batch reports generated for:
- Freeze drying
- SIP and CIP
- Defrost
- Bellow leak rate
- System leak rate
Click here to see our Clinical Trial fact sheet