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Synthetic rubber has replaced natural rubber in many fields over the past decades. Very notable are the synthetic halobutyl rubbers used as a base for pharmaceutical elastomer components. They are an excellent choice due to their attributes of low permeability to air and moisture, excellent aging resistance, and low level of extractables. Halobutyl rubbers are available in two types, chlorobutyl and bromobutyl; both can be manufactured by co-polymerization with halogenated monomer.
Elastomer components (such as stoppers, plungers, and lined seals) based on halobutyl rubber contain other ingredients as part of the complete formulation, such as fillers, curing agents, plasticizers, pigments, and antioxidants. These ingredients, properly selected and present at appropriate concentrations, contribute to the final component properties. Since elastomer components contact the drug product, a rigorous and properly executed extractables and leachables study is essential when considering a component for a drug product.
The first step in an extractables and leachables study of a component is evaluation of the theoretical extractables profile. Based on a knowledge of the complete formulation and potential by-products from polymerization and component forming, this profile lists possible compounds that may appear in an extractables study, such as residual solvents, oligomers, monomers, antioxidants, fatty acids, hydrocarbons, halogen ions, silicone oil, or calcium stearate. With the theoretical extractables profile, an extractables study can be designed to detect those compounds that may put the drug product at risk.
Moving from a theoretical extractables profile to a full extractables and leachables study is an offering of West's Analytical Lab Services. West partners with customers to both design and execute these studies. For more on how West can help, contact an Account Manager or Technical Customer Service representative.
A key aspect of supporting our customers consists of the capability to measure essential performance requirements (EPRs) of combination products which requires having the right equipment. To enhance this capability, West has added a Zwick/Roell zwickiLine testing system to its laboratory portfolio.
“Choosing the Right Components for Container Closure Systems,” the second part of our “How to Qualify Container Closure Systems” series, was recently published in the International Journal of Pharmaceutical Compounding. The article addresses ways in which packaging component selection is critical to ensuring that the closure container system will protect and maintain compounded drug quality.<sup>1</sup>
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.
It’s a brave new world for employers. These days, people want more from their employer than a steady job and a paycheck. Today’s employees yearn to connect with a company that aligns with their values, provides a clear and direct strategy, and gives purpose to their work.
For 10 years, West has offered a summer internship in many of its U.S. locations. The Ambassador Internship Program has grown from hiring two interns in its first year to hiring 38 interns in 2018. <br />
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