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West and its partner Daikyo have introduced a superior quality elastomeric piston the Daikyo D Sigma^® 1mL long piston, substantially raising the standard for product acceptance. The D Sigma piston combines Daikyo best practices with a known formulation (D21-7H), Daikyo Flurotec^® film, RB2 Coating, RSV^® and RUV^® processing with key innovation improvements of automated dimensional measurements, tight Acceptable Quality Levels (AQLs), particulate testing per ISO 8871-3, and enhanced vision inspection to achieve high levels of performance and consistency.

Historically, finding suitable containers for complex protein drug products has been difficult, since interaction with elastomeric closures can result in particle formation. These particles indicate an underlying change within the drug product, undermining integrity and risking patient safety. The correlation of silicone coatings with protein aggregation has made some wary of their use; however, an elastomeric closure with no coating or film can be difficult to process. Another concern is that leachables originating from the elastomeric closure can induce particle formation.

With the May 21, 2019 meeting to review the FDA draft guidance governing 503B compounding pharmacies, it has become evident that sterility of drugs produced at such facilities is a major focus of the U.S. Food and Drug Administration (FDA).¹ The meeting discussed the importance of qualifying container closure systems and was aimed at providing more context on what compounding pharmacies need to do.

As the need for higher quality drug delivery and packaging components increases, customers are challenged to meet new standards and comply with additional regulatory requirements. To help our pharmaceutical and biopharmaceutical partners meet these challenges and reduce risk, West has developed next-generation quality for ready-to-sterilize and ready-to-use components.

West is committed to the safe and efficient delivery of drug products to patients. An important aspect of this commitment is engagement in standards-setting organizations; West is a member of the European Pharmacopeia Commission, Group of Experts 16 – who contributed to European Pharmacopoeia 9.5 (effective July 2018).

The coring and fragmentation of elastomer components used in containment of parenteral drug products continues to be a challenge. Many factors influence these phenomena, so it is critical that a pharmaceutical manufacturer understands how a vial system will be used, for example: what is the recommended needle gauge, is it single- or multi-dose, could spikes, vial adapters or closed system transfer devices be used. Cores and fragments can be generated by needle penetration of the elastomer components. Cores are formed by the needle cannula cutting the elastomer – ordinarily they are cylindrical. Fragments are formed via an abrasion phenomenon of the needle penetration – shapes are irregular.