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Frequently Asked Questions

 8. Why is materials selection important in relation to extractables and leachables?

The choice of which materials are to be used when developing a product can have a huge baring on the final leachables profile for that product. As well as being chosen on the basis of their physical properties so they can perform their respective function(s) correctly, the materials used should also be selected based on their compliance with relevant industry standards. This is a minimum requirement in the pharmaceutical industry, and should also be considered best practice with respect to ENDS and e-liquids.

 

In addition, where possible, information on what testing has been conducted on the material should be sought from the supplier, especially any extractables testing. Where this information is available, at worst it provides an insight into some of the potential leachables that may be in the final product. If the suppliers extractables data is of a high enough standard, it may help to reduce the time and resources required to completely 'derisk' a material from an extractables and leachables perspective.  

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