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Fill Finish Capabilities

Aseptic Vials Our aseptic fill finish projects for clinical batches can be as small as 100 vial units all the way up to batch sizes reaching over 50,000 vial units. We have 9 formulation suites and 5 independent fill finish suites with 4 automated aseptic filling lines.

Vial Facility Capacity

  • Vials from 0.5 mL to 100 mL
  • Line speeds up to 7,500 syringes/hour
  • Comprehensive range of media fill configurations
  • Limited line loss
  • ISO5 oversealing environment
  • Batch sizes up to 70,000 vials

Technical Capabilities

  • Nitrogen overlay
  • High speed vial labeling
  • Continuous environmental monitoring
  • Peristaltic and rotary piston pumping
  • Integrated from vial washing through capping
  • Single-use disposable technology

Dosage Forms

  • Parenteral products
  • Lyophilized products
  • Viscous products
  • Suspension products
  • Complex formulations of liposomes, adjuvants, crystallized proteins

Aseptic Prefilled Syringes

We offer comprehensive prefilled syringe contract manufacturing services, including parenteral manufacturing, on our high-speed prefilled syringe line. Our prefilled syringe production facilities utilize a Restricted Access Barrier System (RABS) technology to ensure the required sterility for fill finish.

We conduct secondary packaging and visual inspection before releasing prefilled syringes for clinical or commercial distribution.

Prefilled Syringe Capacity

  • Prefilled syringe sizes: 0.5 mL – 5 mL
  • Maximum lot size: 50,000 syringes
  • Line speeds up to 7,500 prefilled syringes/hour
  • Annual commercial capacity of 30+ million units
  • Glass or polymer syringes

Technical Capabilities

  • Non-destructive fill and in-process weight checks
  • Restricted Access Barrier System (RABS)
  • Vacuum filling & vacuum piston placement

Testing for Prefilled Syringes

  • Break-Free, glide force and injection force testing
  • Syringe/container biocompatibility testing and analysis
  • Micro-Flow imaging for sub-visible particle analysis
  • Field Flow fractionation (FFF-MALS) for protein aggregation evaluation
  • Mass spectrometry
  • Evaluation of interactions with silicone oil and tungsten oxides

Terminal Sterilization

Our facility offers terminal sterilization services for syringe and vial configurations. This includes product evaluation, cycle development and final terminal sterilization based on developed and validated cycles.

  • Up to 80,000 x 2 mL vials
  • Up to 5100 x 100 mL vials
  • Up to 55000 x 0.5 mL syringes
  • Up to 35000 x 3 mL syringes