Clinical Trial and Small Lot Manufacturing

Clinical Trial
The Clinical Trial Manufacturing (CTM) area is available for production of phase I through phase III material with 2,012 ft² of production space. 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
• Aseptic compounding/processing area
• Class 100K compounding suites
• CIP/SIP station for equipment
  

Utility Panel

• Sterile compressed air, nitrogen, and other gases required for aseptic production
• Supply cooling/heating mediums for pharmaceutical equipment operation Electrical pass-through for control and monitoring of pharmaceutical equipment

Small Lot

This area is available for production of phase I through commercial product. The SLM Department has 8,079 ft² of manufacturing space which includes lyophilization, automated small lot filling and other aseptic compounding operations. HollisterStier has expertise in filling small lots ranging from 1 vial up to 10,000 vials per day.

Manufacturing Services Include:

• Filling flexibility for lot sizes up to 10,000 vials per day
• Sterile filtration
• Inova and Bosch fillers
• Small-Scale lyophilization
• Oversealing, packaging, Ink Jet printing and labeling

Equipment

• Eight filling suites
• Eight sterile filtration hoods
• Inova model VFVM-3000 filler
• Bosch TPF 1000, 2 head filler
• PW and LW Westcappers
• 30 ft² Edwards lyophilizer
• Ink Jet printer
• Autoclaves
• Vial rinser
• Dry heat oven