Sterile Fill / Finish Experience

When it comes to creating the innovative Fill/Finish solutions of tomorrow, expertise is critical. We leverage global market knowledge and engage our network of experts in aseptic filling, high containment, process architecture, and regulatory compliance to provide you with cutting edge designs and recommendations. We bring decades of experience with Fill/Finish Sterile Products Manufacturing Facilities for therapeutic proteins, cytotoxics, vaccines, and pharmaceuticals in a range of dosage forms including lyo vials, syringes, auto-inject cartridges, powder vials, and novel drug delivery mechanisms. We keep pace with the evolving market, offering our clients insight on industry trends, equipment availability, and innovative technology to minimize risk and achieve cost and schedule expectations.

We are currently executing Fill/Finish projects with a requirement for a high level of flexibility, to produce multiple products in vials and syringes. We are also working with our clients to develop facilities to produce high volumes of vaccines at fixed low cost of goods. We work with and challenge equipment vendors to develop new approaches for using existing technologies for different unit operations. The technology options being currently implemented for aseptic filling include plug and play systems that allow modules to be swapped out to facilitate flexibility; robotic systems that minimize changes parts and for container handling flexibility; systems that process ready-to-use components in nested configurations or independently; and systems that have no glove ports for operator interfaces or interventions. With the changing landscape of fill/finish facilities and regulatory drivers, we leverage our relationships with equipment vendors globally to identify, evaluate, and select the most appropriate equipment for each project application.

Novartis Pharma | AG Sterile Fill Finish Renovation | Switzerland

Types of Manufacturing and Support Areas Designed:

  • Product Formulation
  • Prefilled Syringe, Cartridge and Vial Combi Filling
  • Container Inspection
  • Assembly and Labeling
  • Syringe, Vial and Cartridge Packaging
  • Multi-Purpose Flexible Manufacturing
  • Wash / Sterilizer Areas
  • Warehousing – analysis / automation

Eli Lilly | Pre-Filled Syringes | Sesto, Italy

Manufacturing Technology:

  • Containment - Isolator Technology
  • Single Use Technologies
  • Combi Multi-Format Filling Lines
  • Lyophilization
  • Automated Container Inspection
  • Robotic Container Handling
  • Environmental Monitoring
  • Cleaning systems – CIP / SIP / VHP

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