Injectable drugs needs to be verified for leachable and extractable

Extractables are compounds that can be extracted from the container closure system when in the presence of a solvent. Leachable are compounds that leach into the drug product formulation from the container closure system as a result of direct contact with the formulation. ETFE is non reactivable compound. As ETFE is barrier between rubber compound and drug product, hence possibility of leach and extract is very very minimum and may be resulting faster drug development.

The other side is Cost of ETFE laminated rubber stoppers are high WRT normal rubber closures. Considering Cost VS drug safety and efficacy is ETFE rubber stoppers is better solution to adopt; at-least for high cost drugs?

The second question is does this barrier coating will help to improve drug shelf life by few months?