Clinical Trial Manufacturing

Source: Jubilant HollisterStier Contract 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.

Details

Click Here To Download:
•Fact Sheet: Lyophilization
•Fact Sheet: Clinical Trial
•Fact Sheet: Sterile Ophthalmics & Otics
•Fact Sheet: Jubilant HollisterStier Overview
•Fact Sheet: Non-Sterile Manufacturing
•Fact Sheet: Solid Dose 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

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