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Sterile Injectable CDMO Filling Services

Terumo Medical Care Solutions – Pharmaceutical offers Contract Development and Manufacturing Organization (CDMO) services for a range of sterile parenteral products, supporting clinical development through to commercial manufacturing. Polymer prefilled syringes (PFS) and glass vials are filled under isolators with ISO 5 (Class A) environments at Terumo’s modern Japanese or German manufacturing facilities. All Terumo CDMO manufactured sterile products undergo strict visual inspection as part of producing high-quality products for customers and their patients.
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Description
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Characteristics
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Integrated CDMO Services
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Downloads
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GMP Sterile Vial & Syringe Filling CDMO Capabilities
  • GMP clinical to commercial batch sizes available
  • Polymer prefilled syringe (PFS) and glass vial filling options
  • Aseptic filling under ISO 5 (U.S. FDA Class 100) isolators
  • Isolators continuously monitored and laminar airflow is maintained
  • Containers are filled using diving nozzles to control formulation flow and prevent bubbles
  • Subjected to regular in-process controls (IPC), with 100% IPC verification option available
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Sterile CDMO Prefilled Syringe (PFS) Filling Details
  • Terumo PLAJEX™ Cyclo Olefin Polymer (COP) syringes
  • PLAJEX™ Staked Needle Syringes – 1 ml long, 2.25 ml
  • PLAJEX™ Luer Lock Syringes - 0.5 ml, 1 ml long, 2.25 ml
  • Vacuum stoppering for precise stopper positioning after filling
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Sterile CDMO Vial Filling Details
  • Range of glass vial sizes and stoppers
  • 2R, 6R*, 8R, 10R, 20R, 50R* vial sizes
  • Liquid fill or Lyophilization available
  • Vial stoppers - Sterile liquid glass vial stoppers or lyophilization stoppers

* available upon request with new change parts required

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Terumo Pharmaceutical Prefilled Syringe (PFS) Inspection
  • Automated camera systems or manual for 100% particulate and defect inspections
  • Automated camera or manual inspection for stopper position
  • Autoinjector automated inspection of applied labels for lot and expiry date information
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Primary Container Manufacturing (PFS)
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CDMO Drug Product Development and Formulation
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CDMO Aseptic Filling
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Drug Delivery Device Assembly CDMO Services
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CDMO Labelling & Packaging Services
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CDMO Regulatory Support Services
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Terumo Integrated CDMO Brochure
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Download our CDMO services brochure to discover how Terumo Medical Care Solutions – Pharmaceutical can support your contract drug development and manufacturing needs with innovative, tailored solutions.
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CDMO Brochure
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Contact

Contact Terumo Pharmaceutical About Sterile Injectable CDMO Services

We are here to help bring your injectable product to market. Contact Terumo for more information about our integrated injectable product CDMO services.
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