TSB 1999/013: Evaluating B2-Coating as an Alternative to Silicone Oil

B2 coating similarities and benefits vs silicone oil, and stability and extractable studies to consider when moving from silicone oil to B2 coating.

In an effort to support customers of West Pharmaceutical Services who may be evaluating B2-Coating as an alternative to silicone oil on an already approved drug product, West Pharmaceutical Services’ Technical Customer Services Group lists the following factors to help you decide what may be appropriate in your evaluation and submission processes...

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