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This is a very common statement that we hear in the Technical Customer Support (TCS) group. There are many things to consider when choosing the right component for a drug application. Just like a drug product, different ingredients are used to make the material for an elastomeric component. Each of the ingredients has a specific role to play in the functionality of the component, but also may pose a potential risk to the drug product.
West has a global product requirement questionnaire which aids the TCS group in providing customers with the best possible recommendation for a drug product application. Common things to consider when choosing a stopper include drug application, sterilization method and drug product sensitivities. By answering several common questions, the TCS group can assess your needs quickly. The following are a few of the basic questions:
Typical questions around sterilization include:
Finally, in regard to sensitivities between additives to the component and drug product, West will ask if the drug product is sensitive to zinc. If so, you will not want a component recommendation with zinc as an ingredient.
The best product comes from putting together compatible components from the start. No one knows the products, whether it is the drug product or component, better than the manufacturer. By working together and supplying the necessary information up front, pharmaceutical and component manufacturers may reduce problems further down the line.
It is more than just a gray rubber stopper!
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.