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Demands on parenteral drug packaging/delivery elastomer components are increasing with regard to particulate reduction, extractables and leachables, and functional performance. All of these attributes are directly related to the elastomer formulation and its fundamental characteristics. To select the right component for a drug product, these attributes must be understood and controlled.
An elastomer (i.e., rubber), is an amorphous polymer with viscoelastic properties existing above its glass transition temperature. The cross-links between polymer chains help to determine physical properties such as hardness, tensile modulus/strength, elongation and compression set; properties that play a major role in how elastomer components perform. The viscoelastic properties allow for the elastomer component to contact and flow over the surface of a container surface and apply continuous pressure to make an integral seal – which is the basis of their utility in drug packaging/delivery.
The elastomer formulation determines critical properties, such as: (a) hardness (i.e., durometer value), which affects coring resistance, break-loose force (of plungers) and container closure integrity; (b) extractables and leachables profile; and (c) permeability of oxygen and water. When identifying the elastomer component that is right for a drug product, it is important to understand and control the fit and function, as well as the physical and chemical properties that affect machinability and compatibility throughout the lifetime of the drug.
To support this, West supplies Formulation Characteristics for its elastomer formulations – information on chemical and physical properties of elastomer formulations to assist customers in selecting the right component. These can be found on the West Knowledge Center or contact a Technical Customer Support representative.
This past February, our team members around the world came together to help fight hunger in their local communities during our fifth annual global food drive. As the global community navigates the evolving challenges of the COVID-19 situation, having a stable food supply is even more important. We are proud of our team members for their incredible generosity. Their donations are needed now more than ever.
West's Applied Research Team will be presenting two scientific posters at the upcoming International Society for Cell and Gene Therapy 2021 New Orleans Annual Meeting taking place online May 26 – 28, 2021.
Sterilization processes are fundamental and critical in the manufacturing of sterile pharmaceutical products. According to the US Code of Federal Regulations, “Drug product containers and closures shall be clean and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use."<sup>1</sup> When considering elastomeric components, common methods for sterilizing include steam and gamma. This is where the sterilized components with Westar™ Ready to use (RU) and Westar™ Select RU quality levels come in. Westar™ RU and Westar™ Select RU quality level products are supplied ready to be used and help simplify and speed up the drug manufacturing process while maintaining high standards of quality and safety.
Bart Burgess, Director, Business Development, Self-Injection Systems at West, and Peter Krulevitch, Ph.D., Engineering Director, Packaging, Devices & Delivery at Janssen Pharmaceutical Companies of Johnson & Johnson will present “A New Self-Injection Technology and Unique Partnership” at the Drug Delivery Partnership Conference. The conference will be held February 6-8, 2013, at the Hilton San Diego Bayfront, San Diego, CA.
<span style="color: #333333;">Earlier this month, <a href="/services/contract-manufacturing">West's contract manufacturing team</a>—formerly known as <span style="color: #000000;">The Tech Group</span>, officially received its Engineering and Production Technology Leadership award at the Frost & Sullivan Manufacturing Leadership Awards Gala in Carlsbad, California. Winners in this category were honored for embracing new design and production approaches to drive game-changing process improvements. </span>
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