Sterile Fill - Finish - Vial Fill Line

Typical Project Features:

  • Sterile Injectables Production
  • US FDA / EU Regulatory Compliance
  • Weigh / Dispense and QC Sampling
  • Formulation / Compounding
  • Product Filling
  • Lyophilization / Freeze Drying
  • Secondary Packaging
  • Process Utility Systems
  • Building Utility Systems
  • HVAC Systems
  • Automated Production
  • Cleanroom Spaces
  • QC Laboratories
  • Locker Rooms and Gowning
  • Warehouse and Cold Storage
  • Potent Compound Containment
  • Solvent / Flammables Handling
  • Emergency Back-up / Redundant Systems
  • Flexible, Multi-Product Operations

Sterile Fill/Finish Overview:

CE&IC is recognized as a leader in the planning and design of sterile fill/finish (drug product) manufacturing processes and facilities. We’ve had the opportunity of working with our clients on a wide range of projects within this technology area. These projects have ranged from developmental pilot scale operations through large scale commercial production. Some of these projects have involved retrofits within existing facilities and others have involved brand new stand-alone facilities/campuses.

We can assist our clients in delivering their Sterile Fill/Finish projects from feasibility studies and concept development through detailed design, construction assistance and commissioning. Our clients’ projects typically include a full range of manufacturing unit operations such as weigh and dispense, compounding/formulation (traditional and aseptic), sterile filtration, vial washing, depyrogenation, primary filling, capping, freeze drying, inspection and secondary packaging. These facilities also often include various manufacturing support functions such as QC laboratories, warehouse, locker rooms and gowning, process and plant utilities, airlocks and logistics corridors, CIP systems, equipment cleaning and storage, office and support spaces, etc. CE&IC has been highly effective in working with our clients over the past 35+ years to successfully implement efficient, robust and cost effective manufacturing processes and facilities.

Following is a listing of some typical sterile fill/finish unit operations and product delivery types where CE&IC has previous experience:

  • Weigh / Dispense
  • Formulation / Compounding
  • Product Filling (Isolator or RABs)
  • Lyophilization / Freeze Drying
  • Vials
  • Syringes
  • Cartridges
  • LVP’s