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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.
Select West components will be evaluated to demonstrate USP <382> compliance to assist with appropriate component selection depending on the application and intended use.
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.
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:
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By Your Side With Analytical Solutions From West - Performance and Functional Testing of Combination Products