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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!
Liquid injectable drugs can be contained in a pre-filled syringe system, a cartridge-based system, or a vial-based system (with a rubber stopper and seal). For a vial-based system, the drugs first are aseptically filled into glass or polymer vials. During the subsequent Fill & Finish operations, the vials are closed temporarily by inserting a rubber stopper into the vial orifice. This is prior to crimping with an aluminum seal, which results in the final integral vial-based container closure system.
Lyophilization is widely used for pharmaceuticals to help preserve parenteral drugs that are unstable in liquid formulation, particularly biologics. Lyophilized drugs have many advantages like prolonged shelf life, easy dissolution and good stability. However, a suitable container closure system is necessary to ensure the successful lyophilization of pharmaceutical products while maintaining product quality.
When selecting the appropriate rubber stopper for any respective vial containment system, there are many aspects to consider regarding the properties of the elastomeric closure. For the purposes of this discussion, the focus will be on the functional performance of the stopper and what key aspects should be considered during the assessment and selection process. Coring and fragmentation, container closure integrity, and machinability of the stoppers will be briefly reviewed.
United States Pharmacopeia (USP) requirements for elastomeric components of container closure systems used for parenteral products are changing. The original USP chapter for elastomeric components used in injectable drug packaging was <381> Elastomeric Components in Injectable Pharmaceutical Production Packaging/Delivery Systems. This addressed characterizing for biological reactivity, physicochemical testing and functionality testing and compliance was typically a supplier responsibility. The new chapter, USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems, will become effective on December 1, 2025. This will update the functionality tests for elastomers, whereas the functionality testing portion of USP <381> will be omitted. Under the new chapter, it will be the drug manufacturer’s responsibility to meet the functionality requirements on the final system.
Many injectable drug products, such as monoclonal antibodies and recombinant proteins, are susceptible to degradation over time when stored at ambient temperature. As such, they are stored, and subsequently delivered, in a lyophilized state - which enables a much longer shelf life. Lyophilization (also known as <em>freeze-drying</em>) is a process by which all water is removed from a drug product. Absent water, all metabolic processes stop, and drug products thus stored in a lyophilized condition are far more stable. At the time of use, the lyophilized drug product is reconstituted with water (or other appropriate solution) and delivered to the patient.
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