Parenteral Manufacturing

Lyophilization

Jubilant HollisterStier’s Spokane facility offers two GEA 385 ft2 and two BOC Edwards 220 ft2 lyophilizers in the high-speed commercial filling suites.

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.

High-speed commercial filling suites at our Spokane facility

Our lyophilizers are
fully automatic and include:

  • Automatic load/unload of vials
  • Cold shelf loading capabilities down to -45°C
  • Dehumidification system designed by our expert engineers
  • Over 1,200 square feet of combined lyophilizer shelf space
  • Non-destructive lighthouse analysis for monitoring container closure integrity

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.

Clinical Batch Manufacturing – Lyophilization

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:

  • 30 ft2 IMA Edwards Lyofast 3 Freeze Dryer
  • -45°C cold shelf loading
  • Room dehumidification provided
  • CIP and SIP
  • 0.4 – 20mL
  • All hydraulic cylinders are protected / isolated RAID 5 PC providing increased data reliability and performance

Temperature controlled cold shelf loading capabilities

Automated batch reports generated for:

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

Spokane Facility

  • 30 ft2 IMA Edwards Lyofast 3 Freeze Dryer
  • -45°C cold shelf loading
  • Room dehumidification provided
  • CIP and SIP
  • 0.4 – 20mL
  • All hydraulic cylinders are protected / isolated RAID 5 PC providing increased data reliability and performance
Vial Size Quantity (max per batch for 385 ft2 lyos)
2mL 153,000
3mL 114,000
10mL 82,000
30mL 36,000
100mL 14,000

Montreal Facility

Commercial Lyophilization

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

Minimizing risk of product degradation and contamination

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