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Clinical Trial Newly-expanded Clinical Trial area!
The Clinical Trial Manufacturing (CTM) area is available for production of phase I through phase III material. The CTM area was designed to ensure separation of activities and includes facilities for equipment preparation, clean storage, aseptic compounding and aseptic filling. Although operated as a GMP facility, no commercially approved products are manufactured in the CTM area.
Production Capabilities - Small scale vial filling
- IMA Life Sterifill 100 (MAC) filler
- Fully6 servo driven (operator control of all adjustments from outside filler barrier via Human Machine Interface (HMI) panel
- Liquid Products
- Lyophilized products
- Automatic filling with ISO5 stoppering environment
- 2 mL to 100 mL vials
- 80 vials/minute
- Two peristaltic pumps integral to the filler allow for quick change over and control of the filling process
- 2, 30 ft2 Lyophilizers:
- Automatic CIP/SIP
- External condenser
- Cold Shelf loading at -45 degrees C
- Suited to small lots
- 4500 x 5mL/20mm vials
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