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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.

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Capabilities and Expertise

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