Parenteral Packaging and Combination Product Functional Suitability Testing Services

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>

• West Webinar: Click here to watch On-Demand
• <382> Info Sheet: Click here  for access

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

Pen Injector Case Study

Fill-Finish Case Study

Combination Product Case Study

Closed System Transfer Device Case Study

Vial Adapter Combination Product Case Study

Analytical Services - Packaging and Device Product Testing Information Sheet

West Scientific Insights Lab Information Sheet

<382> GMP Services Information Sheet

*Characterization of Protein Aggregation and Adsorption on Prefillable Syringe Surfaces

*Comparison of Flange Strength and Dimensional Variability in 1 mL Long Syringe Systems Made of Plastic and Glass

*Evaluation of Piston Movement and Container Integrity Under Severe Storage Conditions in Plastic and Glass Prefilled Syringes

*The Effects of Ozone and Various Sterilization Techniques on Elastomeric Rubber Needle Shield and Tip Caps

SmartDose^® Platform

SelfDose™ Platform

Reconstitution and Transfer Systems

Contract Manufacturing 

Vial Containment Solutions

Prefillable Systems 

Challenges