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Packaging and Device / Combination Product Testing

West as the Scientific Destination 

We partner with clients to understand current regulations and standards to create, execute and interpret the proper study design. These studies cover syringes, cartridges, vials and all related components and devices. We have expert knowledge of the market, widely accepted industry regulations because we are the perfect mix of scientists, product developers and global manufacturers.

Performance and Functionality Test Planning and Analysis

    Why is this important?  Fully understand product performance and related product intent to accelerate regulatory submissions, reduce launch schedule risk and reduce risk to the patient.

    Ready to Fill and Prefilled Glass and Advanced Polymer Syringes and Cartridges (ISO 11040 and 11608 Series)

    • Break Loose, Extrusion and Lubrication Quantity  
    • Deliverable and Residual Volume
    • Liquid Leakage Beyond Plunger and Fluid Pressure 
    • Luer Lock Adaptor Collar and Tip Cap Pull-off Force and Torques
    • Luer Cone Breakage Resistance
    • Luer Connectivity
    • Tip Cap Closure System Forces and Torques
    • Needle Penetration and Pull-out Forces
    • Burst Resistance
    • Flange Breakage Resistance
    • Performance Related Shelf Life and Storage 
    • Technical Investigations and Failure Root Cause Analysis

    Glass and Advanced Polymer Vial Containers and Vial Adapters and other Transfer Devices

    • Residual Seal Force
    • Spike Penetrability
    • Deliverable and Residual Volume
    • Fragmentation
    • Spike Retention and Sealing Capacity 
    • Delamination Analysis Electron Microscopy (ISO-7 Lab)

    Regulatory and Custom Testing Collaboration

    Why is this important? To fully understand product performance relative to widely accepted standards to reduce complexities of product regulatory submissions.Thoroughly applied accepted testing standards combined with customized testing executed properly greatly reduces risk to the patient.

    Focus on Regulatory Testing Standards as a Starting Point     

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

    West as Consultative Problem Solvers

    Why is this important?  West has full understanding of packaging and deliver systems.  West experts are available to reduce product schedule risk, understand technical risks and accelerate product time to market. We have the technology and the expertise.

    Working Together to Solve Problems   

    New Syringe (Latest ISO Based) Method Testing: 

    • Injection Needle Wear Analysis
    • Liquid Leakage and Physical Burst
    • Residual and Delivery Volume
    • Luer Cone Breakage
    • Flange Breakage

    Coming Soon:  Syringe Luer Closure System Forces and Torques

    Coming Soon:  Prefilled Syringe Drug Product Surface Tension Performance Analysis

    Coming Soon:  Syringe and Cartridge Barrel Digital Birefringence Stress Imaging

    Coming Soon:  Prefilled Syringe Silicone Degradation and Protein Aggregation Analysis

    Coming Soon: Device Distribution Simulation and Actual Ship Testing

    Packaging Testing