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The answer is – it depends. Your Technical Customer Service (TCS) representative can help you decide. Butyl rubber, derived synthetically from petrochemicals, is a copolymer of isobutylene, and to a smaller extent, isoprene. Subsequent halogenation results in a halobutyl rubber – typically bromobutyl or chlorobutyl.
Many modern rubber formulations employed in the pharmaceutical industry for closures (stoppers and plungers), employ halobutyl rubbers as the base. Halobutyl rubbers typically have lower levels of extractables compared to other rubbers, and excellent resistance to permeation by water and oxygen. But, when selecting the most suitable rubber formulation for a stopper or plunger, it must be remembered that the formulation comprises more than just the base rubber - it includes fillers, vulcanizing agents, antioxidants, pigments, etc. The sum of these components, and the manner in which compounding is performed, gives the formulation its properties.
Having the right base rubber, but not having the right additives for the full formulation, will result in poor performance. Having the right formulation, and understanding the needs of the drug product, such as compatibility and long-term stability with the formulation, will help to achieve high performance.
Given the myriad of drug products, and the variety of possible interactions, the best way to select the right rubber formulation for a closure is to discuss the options with a West Technical Customer Support (TCS) expert. West has many offerings – choosing the right one aids in achieving that objective that always is most important – patient safety.
For further information and assistance on selecting the proper formulations and rubber for you drug product please contact West’s Technical Services.
There is an increasing trend in the pharmaceutical industry for ready-to-use components for a variety of reasons.
The plunger rod is a fundamental feature of a complete syringe drug delivery system. There are three key functional characteristics that all pharmaceutical manufacturers should consider when determining the appropriate plunger rod for a specific drug product and syringe system.
Market trends toward home use and patient self-administration of drugs used to treat chronic conditions (e.g., multiple sclerosis, rheumatoid arthritis and autoimmune) have made prefillable syringe systems an ideal choice for single-dose drugs. Prefilled syringe systems for vaccines, pharmaceuticals and biopharmaceuticals offer convenient, fixed dosing and are adaptable to automated injection devices.
There is increasing demand for advanced manufacturing technologies for fill-finish operations of parenteral drug products. To meet manufacturing requirements for multiple container and component types, flexible fill-finish equipment is at the forefront of most pharmaceutical, biotech, and CDMOs’ fill-finish strategy. Flexible fill-finish technology is suitable for variable batch sizes allowing for scaling from clinical to commercial in multiple drug delivery presentations. With the ability to launch in vial configurations, prefilled syringes, or other combination products including devices, flexible fillers are beneficial to drug developers who are looking for lifecycle management of their drug products.
Lyophilization (freeze drying) is the process of dehydrating a material at low temperature and reduced pressure. It is used to extend the shelf life of many biologic drug products. Absent water, degradation processes are greatly reduced. In any primary package system (i.e., vial, elastomer stopper, seal) for a lyophilized drug product, of utmost concern are leachables and volatile organic compounds that may migrate from the elastomer stopper into the lyophilized drug product, creating a risk to patient safety.
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