Packaging and Device / Combination Product Testing
West as the Scientific Destination
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
- Lab Services Key Areas of Subject Matter Expertise
Case Studies
New and Novel Techniques
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
Downloadable Resources
Supplier to the
Top 75
Pharmaceutical and Biotech Injectable Companies