Aseptic Filling In Vails - Aseptic Fill

Aseptic Filling in Vials - Sterile Liquid Injectables

Dalton is a leader in the sterile cGMP manufacture of aseptically filled or terminally sterilized liquid parenteral vials. With a recently expanded and upgraded cGMP sterile facility Dalton can meet your needs for clinical or small scale commercial products compliantly.

With over 15 years of aseptic manufacturing experience, Dalton has the experience and capabilities to meet your exacting requirements.  We focus on quality, speed and flexibility as part of our integrated sterile manufacturing offering.  Our batch sizes range from small hand fills of 100’s of vials up to approximately 15,000 vials per batch.

We understand the need to conserve your valuable or rare active material, whether it is a large molecule/protein or a complex small molecule. Our filling process was designed with low fill line losses in mind.

Our aseptic filling capabilities include:

  • Flexicon filling line with peristaltic pump system
  • Inert gas back flush capability
  • RABS enclosed fill line
  • Upgraded HEPA systems in suite
  • New vial washing and depyrogenation services
  • New WFI system
  • Sterile Formulation Development Services – simple and complex
  • Lyophilization services

We have validated a number of vial and stopper combinations including:

  • 2 ml (Clear glass)
  • 3 ml (Clear glass)
  • 5 ml (Clear glass)
  • 5 ml (Amber glass)
  • 10 ml (Clear glass)
  • 20 ml (Clear glass)

We also have standard sterile filter assembly combinations validated for sterile production. This means we can accelerate your project and minimize the validation required for your sterile project while maintaining compliance and minimizing costs. Dalton can also carry out ICH stability programs of your clinical batches to support your CMC filing requirements.

For further details visit Stability-Services.