Manufacturing Facility

Oakwood Laboratories has completed a new aseptic facility designed for the development, manufacture, fill and finish of small scale liquid and lyophilized parenteral products.

The facility comprises 16,000 square feet including microbiology and analytical laboratories, raw material weighing area, non-aseptic compounding room, aseptic equipment preparation and staging areas, aseptic filling room, aseptic lyophilization area, vial capping room, shipping, receiving and warehouse space.

Manufacturing FacilityOakwood's aseptic facility enables us to offer the following client services for small volume parenterals:

  • Liquid and suspension fill and finish
  • High potency [non-cytotoxic] compounds
  • Aseptic formulation and process development
  • Freeze Dry Cycle Development
  • Stability, toxicology, Phase 1, 2, 3 clinical batches
  • Commercial supplies
  • Analytical chemistry support
  • Microbiology support

Manufacturing FacilityOur aseptic facility maintains the following systems and equipment:

Systems

  • Water for Injection
  • Clean Steam
  • Clean Nitrogen
  • Clean Compressed Air

 Equipment

  • Cozzoli vial washer
  • Gruenberg depyrogenation oven
  • Steris steam sterilization autoclave
  • Hull Freeze Dryer (128 sq.ft. shelf space)
  • Chase Logeman filling line with Oden filling head
  • West capping machine

Presentation of Oakwood Laboratories Manufacturing Capabilities


Oakwood Labs

Oakwood Laboratories was founded as the research division of Ben Venue Laboratories, the largest and most experienced parenteral company in the world. In 1997 it was spun off as a separate entity when Ben Venue was acquired by Boehringer-Ingelheim. Oakwood's founders, Edward C. Smith and Mark T. Smith were C.E.O and the Director of Business Development of Ben Venue and were responsible for starting Ben Venue's generic division, Bedford Laboratories.