Parenteral Packaging and Combination Product Functional Suitability Testing Services

Simplify the Journey™  

Collaboration with customers, combined with a thorough understanding of current regulations, enables West to create and execute robust study designs. These studies cover syringes, cartridges, vials and all related components, devices and combination products. Our perfect blend of scientists, product developers and manufacturers empowers the pharmaceutical industry in delivering medications to patients safely and effectively.

Prefilled Cartridges and Needle Based Injection Systems Testing Services (ISO 11608 Series) 

Applicable Products

  • Pen Injectors and Autoinjectors
  • Cartridges and Cartridge Components

Tests Available

  • Instructions for Use (IFU) Testing
  • Break Loose, Extrusion and Lubrication
  • Deliverable and Residual Volume and Multi/Last Dose
  • Liquid Leakage Beyond the Plunger
  • Liquid Leakage Beyond the Septum/Crimp Cap
  • Septum Resealability
  • Septum Coring and Fragmentation
  • Cap Removal and Needle Extension Length
  • Performance vs Accelerated and Long-Term Stability
  • Shipping Simulation
  • Custom Testing for Novel Cartridge-Based Delivery Systems


Ready to Fill and Prefilled Glass and Advanced Polymer Syringes Testing Services (ISO 11040 Series)

Applicable Products

  • Stake Needle Glass and Polymer Syringes
  • Luer Connection Glass and Polymer Syringes

Tests Available

  • Full IFU Testing
  • Break Loose, Extrusion and Lubrication Quantity
  • Deliverable and Residual Volume
  • Liquid Leakage Beyond Plunger
  • Luer Lock Adapter Collar and Tip Cap Pull-off Force and Torques
  • Flange and Luer Cone Breakage Resistance
  • Luer Connectivity
  • Tip Cap Closure System Forces and Torques
  • Needle Penetration and Pull-out Forces
  • Burst Resistance
  • Performance Related Shelf Life and Storage
  • Technical Investigations and Failure Root Cause Analysis
  • Custom Testing for Novel Syringe-Based Systems


Vial Adapters and other Transfer Devices Testing Services

Applicable Products

  • Vials and Vial Adapters
  • Closed System Transfer Devices (CSTDs)

Tests Available

  • Full IFU Testing
  • Break Loose, Extrusion and Lubrication Quantity
  • Deliverable and Residual Volume
  • Liquid Leakage Beyond Plunger
  • Luer Lock Adapter Collar and Tip Cap Pull-off Force and Torques
  • Flange and Luer Cone Breakage Resistance
  • Luer Connectivity
  • Tip Cap Closure System Forces and Torques
  • Needle Penetration and Pull-out Forces
  • Burst Resistance
  • Performance Related Shelf Life and Storage
  • Technical Investigations and Failure Root Cause Analysis
  • Custom Testing for Novel Syringe-Based Systems


Small Scale Container Fill-Finish for Early Compatibility Assessment

Applicable Products

  • Glass Vials, Syringes and Cartridges
  • Daikyo Crystal Zenith® COP Vials, Syringes and Cartridges

Services Available

  • Custom Placebo and Viscosity Standards
  • Vial and Cartridge Filling and Capping Services
  • Syringe and Cartridge Vent and Vacuum Semiautomated Plunger Placement
  • Syringe and Cartridge Systems Plunger Placement in Tub or Discrete Formats

West’s Analytical Services Laboratory supports customers with USP <382> testing needs. This new chapter, Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems, was released December 2020 and will have a 5-year grace period for adherence.

West supports all USP <382> chapter sections referenced below:

Packaging and Delivery System Integrity Tests per USP <1207>

  • USP <1207>

Needle and Spike Access Functional Suitability Tests

  • Fragmentation
  • Penetration Force
  • Needle Self-Sealing Capacity
  • Spike Retention and Sealability Capacity

Plunger Functional Suitability Tests

  • Plunger Break Loose and Extrusion Forces
  • Plunger Seal Integrity

Tip Cap and Needle Shield Functional Suitability Tests

  • Needle Shield Pull-off Force
  • Tip Cap Pull-off Force
  • Luer Lock Rigid Tip Cap Torque

Select West components will be evaluated to demonstrate USP <382> compliance to assist with appropriate component selection depending on the application and intended use.

For more information about USP <382>

Regulatory and Custom Testing Collaboration

Full understanding of product performance relative to widely accepted standards which reduces complexities of product regulatory submissions is critical. Combining accepted standards with customized testing and using proper execution greatly reduces risk to customer timelines and ultimately to the patient.

Focus on Regulatory Testing Standards as a Baseline

  • Global Standards and Regulatory Expectations Interpretation Analysis to Match Customer Needs
  • Utilize Current or Create and Validate New Custom Methods
  • Execute FDA GMP Lab Testing to Create Analysis Reports
  • Interpretation, Consultation and Observations of Results through Subject Matter Experts


Combination Product Problem Solving and Custom Methods Development

New technical challenges and risks are often discovered in all stages of combination product development. West’s Analytical Service Laboratory has expertise in troubleshooting and in developing custom advanced test methodologies for various combination products, including examples below:

  • On-Body Delivery Systems
  • Closed System Transfer Devices (CSTDs)
  • Manual Cartridge-Based Injectors
  • Automatic Syringe-Based Injectors
  • Infusion Spike Systems
Packaging Testing
West and the diamond logo, Simplify the Journey™ and SelfDose™ are trademarks and registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
Mix2Vial® and SmartDose® are registered trademarks of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc.
Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
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