Extractables & Leachables Case Study: Accurate Data, On Time, with High Touch

Extractables & Leachables Case Study: Accurate Data, On Time, with High Touch
Smithers helps medical device and pharmaceutical product manufacturers bring innovative, compliant, and highly effective products to market with our world-class expertise and extensive independent testing capabilities for combination products and drug delivery devices. We can assist throughout your product development cycle, with testing services from concept, material selection, design for manufacture, manufacture, packaging (primary and secondary) through to distribution testing for supply chain validation.

We were recently delighted to be able to support a client who was upscaling a biopharmaceutical process. The process utilised Single Use Technology (SUT) and the design of the SUT needed to be changed to support the increased capacity. The client contacted Smithers, a trusted expert, to conduct the appropriate extractables and leachables (E&L) assessment of a large SUS system to meet FDA and EU regulatory requirements. 

This case study provides insights into the client's experience with the Smithers process. 

Download the case study:

Smithers-E-L-Case-Study

Download the case study:

Smithers-E-L-Case-Study
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