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Aseptic Filling

Significant expertise and proven track record in developing and manufacturing sterile injectables

Renaissance’s ample sterile capacity and manufacturing expertise is ready to fulfill your demand for injectable manufacturing.

Aseptic Filling Expertise

Critical for successful injectable drug manufacturing, Renaissance has a company-wide culture of compliance and commitment to regulatory excellence, with multiple agency inspections from across the globe, and over 15 customer inspections, performed successfully each year.

Renaissance offers a full spectrum of sterile services capabilities including small molecule and biologic fill capabilities, controlled substances (DEA Schedule I-V), potent compounds (through SafeBridge 3), testing, and formulation development.

We have the ability to handle both aseptic sterile processing and terminal sterilization in conjunction with our RABS filling lines, and recent investments in automation of inspection and packaging will ensure your products get to market faster.

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Experience Matters

Renaissance has decades of experience in development and filling of aseptic products. Our state-of-the-art facilities and equipment can support a broad range of sterile injectable programs from development to commercial manufacturing. Our expertise and strong regulatory track record make us the perfect partner for your sterile injectable programs.

Capabilities

Our state-of-the-art equipment and expertise allow us to support a wide range of aseptic programs.

Aseptic Batching
Batching
  • Small molecules and biologics
  • Controlled substances (DEA Class I-V)
  • WFI (Water for Injection) produced on-site
  • Batch sizes up to 1,500L
  • Jacketed/Insulated mixing vessels for temperature sensitive products
  • Solutions, suspensions, and emulsions

 

Aseptic Filling
Aseptic filling
  • Filling lines utilize RABS (Restricted Access Barrier System) technology
    • IMA Extrema Filler
    • IMA SteriFil Filler
    • High speed filling
      • Up to 400 vials/min
    • Small batch filling
      • Clinical trial and development batches  (5,000 units or more)
    • Glass vials 2, 5, 10, 20, 50, and 100 mL
    • In-line vial washing and depyrogenation

 

Aseptic Packaging
Packaging
  • Fully automated secondary packaging of vials
    • Cartoning
    • Labeling
    • Serialization
  • Cold chain storage (2-8C) for finished product
  • Automated, semi-automated, and manual vial inspection