Aptar Pharma reviews the importance of silicone levels on vial stoppers

When developing new injectable drugs, manufacturers must consider the importance of primary packaging to  ensure the drug is protected from the initial filling process to being administered to a patient. Silicone is added to every elastomeric closure component and is essential to ensure the products perform well on filling lines and in conjunction with the glass container. The PremiumCoat® platform of vial stoppers, pre-filled syringe plungers and services combine a state-of-the-art Bromobutyl formulation with a market proven ETFE film that help limit the transfer of extractables and leachables into the drug formulation.

In this article, Aptar Pharma uses inductively coupled plasma optical emission spectrometry (ICP-OES) to demonstrate that our proprietary manufacturing process optimizes the distribution of silicone oil on our PremiumCoat®. By limiting the quantity of silicone that comes in contact with the drug product, PremiumCoat® derisks the development of sensitive drugs.