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>
Needle and Spike Access Functional Suitability Tests
- 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>