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We recently sat down with Dr. Bettine Boltres, our contact for scientific affairs and technical solutions for glass. In her role she is supporting pharmaceutical companies to address glass-related topics from a scientific perspective and to gain a deeper understanding of the material that holds their valuable drug products. Having done this for many years, we wanted to know what the most frequently asked questions are that she encounters. Please read Part 1 of our two-part series around the 10 most commonly asked questions around glass vials:
I am the Head of Procurement for Civica, one of West’s customers.
Civica is working to solve two big problems in U.S. healthcare - drug shortages and predatory pricing. Our mission is to ensure quality generic and biosimilar medications are available and affordable to everyone.
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."1 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.
Regulations and guidance on combination products continue to evolve both domestically and abroad. As the regulatory guidance and expectations around drug-device combination products continues to develop, the topic of Essential Performance Requirements (EPRs) has been applied to drug-device combination products in the United States market. EPRs should be chosen based on a risk-based process and documented to show they are appropriate for the specific combination product application. This includes addressing risk-based scientific and technological considerations of the combination product system. Understanding how to identify EPRs as well as determining the analytical approach and control strategies for EPRs is critical to the development of a combination product. Extractables and leachables analysis of the materials in devices and primary containment systems for combination products is also a key factor and needs to be part of the testing strategy.
I am the Production Manager at our Waterford manufacturing site in Ireland. I have worked at West since 2018 and was the Area Manager for Waterford’s Finishing Department until I was promoted in November 2022.