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Facility

Features

Our facility was designed for flexibility, incorporating the use of removable interior wall sections, access panels in outside walls and roll-up doors for access to utility and manufacturing areas for installation, removal or maintenance of equipment. This versatile facility is amenable to a diverse range of manufacturing processes including fermentation operations, protein production and aseptic fill/finish as well as lyophilization.

Our facility has several specialty manufacturing areas:
  1. Explosion rated rooms, which are equipped with blow-out panels suitable for operations involving solvents and/or flammable material.
  2. Pasteurization room, which allows the room and the tank within it to be heated to 65°C with specialized ducting and HEPA filters.
  3. Negative containment areas, which are under negative pressure to the rest of the manufacturing area and allow processing of items such as biohazardous materials.
A key feature of our commercial manufacturing suites is a central service chase, which spans three levels and is designed to supply utilities to the processing equipment. This central service chase also allows for independent utility changes, minimizing clean operation down time and providing adaptability for routing of process piping.
 

Our processing area was designed with removable clean room walls to allow for creation of custom clean rooms and for easy addition and removal of processing equipment. Each processing area also has dedicated pressurized air locks. The equipment entrance and exit airlocks ensure a controlled flow of materials, equipment and personnel.

Key Features of our facility:

  • 30,000 ft2 (2,800 m2) of clean room class A to C
  • 13,000 ft2 (1,200 m2) of QC and Analytical labs
  • 18,000 ft2 (1,670 m2) warehouse with cold storage
  • 44,100 ft2 (3,700 m2) of office and support space
  • 10 L to 3,000 L stainless steel process tanks
  • 5 CIP units for process equipment
  • Purified water system
  • Water for injection - 120,000 L per day capacity

Adjacent to our processing area are large refrigerated rooms to accommodate processing material and final product. These are high volume storage areas and, due to their proximity to the warehouse, are ideal for the storage of materials requiring strict temperature controlled environments, both upon receipt and in preparation for shipment.