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Parenteral Packaging and Combination Product Functional Suitability Testing Services
Capabilities
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
USP <382> Testing
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
Additional Expertise
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
Case Studies
Downloadable Resources
* Requires Knowledge Center account to access.
Related Products
By Your Side
By Your Side With Analytical Solutions From West - Performance and Functional Testing of Combination Products
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.
Daikyo® and Crystal Zenith® are registered trademarks of Daikyo Seiko, Ltd.
Daikyo® Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
Mix2Vial® and SmartDose® are registered trademarks of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc.
Daikyo® and Crystal Zenith® are registered trademarks of Daikyo Seiko, Ltd.
Daikyo® Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
Featured Blogs
November 20, 2020
New USP Chapters <381>, <382>, <1382>, and <1381>
Several important changes have been made recently in the United States Pharmacopoeia (USP): Chapter <381> was amended and new chapters <382>, <1382>, and <1381> were created. West has been aware of these changes and is prepared to address them from both a knowledge and a technology perspective.
March 02, 2021
Understanding Risks of Coring and Fragmentation of Rubber Stoppers
When it comes to choosing the right container closure system, a significant amount of focus is directed at addressing issues that may be a risk to safety and efficacy of the parenteral drug before it is introduced to a patient. Examples are testing of container closure integrity (CCI) and drug stability. Prior to drug administration by a health care professional, the rubber stopper is pierced with a needle, at least once. Stopper puncture testing also needs to be considered, especially if the closure system will be used in a multi-dose application.
July 01, 2020
Fill-Finish Engineering and Process Development – A Critical Step to Ensuring Product Quality and Manufacturability
Fill-Finish engineering and process development are a critical step to ensuring product quality and manufacturability for injectable products. Fill-Finish involves technique driven process steps with considerations around patient safety at the forefront of each step. The complexity of aseptic processing and sterile fill-finish operations will continue to grow as more complex drug products enter the pipeline.
November 20, 2020
New USP Chapters <381>, <382>, <1382>, and <1381>
Several important changes have been made recently in the United States Pharmacopoeia (USP): Chapter <381> was amended and new chapters <382>, <1382>, and <1381> were created. West has been aware of these changes and is prepared to address them from both a knowledge and a technology perspective.
March 02, 2021
Understanding Risks of Coring and Fragmentation of Rubber Stoppers
When it comes to choosing the right container closure system, a significant amount of focus is directed at addressing issues that may be a risk to safety and efficacy of the parenteral drug before it is introduced to a patient. Examples are testing of container closure integrity (CCI) and drug stability. Prior to drug administration by a health care professional, the rubber stopper is pierced with a needle, at least once. Stopper puncture testing also needs to be considered, especially if the closure system will be used in a multi-dose application.
July 01, 2020
Fill-Finish Engineering and Process Development – A Critical Step to Ensuring Product Quality and Manufacturability
Fill-Finish engineering and process development are a critical step to ensuring product quality and manufacturability for injectable products. Fill-Finish involves technique driven process steps with considerations around patient safety at the forefront of each step. The complexity of aseptic processing and sterile fill-finish operations will continue to grow as more complex drug products enter the pipeline.
