I Just Need a Rubber Stopper!
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:
- What is the stopper configuration?
- Is the stopper going through a lyophilization cycle or is it for liquid product?
- How is the drug administered?
- Is the product single dose or multi-dose?
- What size needle or spike will be used to puncture the stopper?
Typical questions around sterilization include:
- Are the products terminally sterilized?
- Will the component be gamma irradiated and at what dose?
- Does the component need to be sterilized prior to insertion in the filling line?
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!