Contract Manufacturers of Sterile Injectables and Non-sterile Products
Automatic cold shelf loading and unloading, and clean in place and steam in place dehumidification systems are just some of the features that our large lyophilizers provide. For clinical trial products, a 30 ft2 lyophilizer is available.
Products that require loading onto pre-frozen shelves at temperatures as low as -45°C can be accommodated. HollisterStier collaborated with our vendors to design a low humidity (down to 5% RH) and low temperature custom environment (10-12°C) in the vial loading area to eliminate concerns with frost build-up on the shelves.
Vials are processed and filled using Jubilant HollisterStier’s high-speed parenteral manufacturing lines. Upon filling and partial stoppering of the vials, they are automatically conveyed to a clean room complex under ISO5 (class 100) conditions. The vial sizes can range from 2mL to approximately 100mL.
Within our Spokane facility’s Clinical Trial area, a 30 ft2 IMA Edwards Lyofast 3 Freeze Dryer is available for clinicalmanufacturing. Our CTM area lyophilization capabilities include:
Automated batch reports generated for:
The Lyophilization suite at our Montreal facility is integrated into our high speed filling line. Robotic loading systems results in accelerated freezing time, minimized product degradation and reduced risk of microbial contamination.
Two BOC/Edwards lyophilizers with production capacity of 374ft2 of freeze-drying shelf space (120 and 254 ft2)
Semi-automated inspection of vials for quality assurance
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