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As customer needs rapidly change to meet these new and unprecedented accelerated timelines, West’s steam-sterilized, ready-to-use Westar^® and Westar^® Select elastomer components play a critical role. They simplify component preparation and allow customers to focus on other aspects of the drug filling process.

Lyophilization (also called 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, drug metabolic degradation processes are greatly reduced. Clearly, it is crucial to know the water content of elastomer stoppers for vial-based primary packaging systems for lyophilized drug products.

Pharmaceutical closures used in aseptic environments must be introduced in a sterile state. The most common methods to sterilize rubber closures (e.g., stoppers) are autoclaving (saturated steam) and gamma irradiation. Both methods can influence chemical (e.g., extractables profile) and physical/functional properties (e.g., break-loose and extrusion forces). Therefore, it is important to choose the right method.

Because differences exist between regulatory agencies from region to region, West regulatory affairs continually stays informed of new developments and changes in order to provide customers with accurate regulatory support regarding packaging requirements.

Drug shortages put patients at risk. Adverse health consequences can occur quickly when shortages make maintaining and/or complying to a therapeutic regimen difficult. In a recent paper, Center for Drug Evaluation and Research (CDER) director, Janet Woodcock and her CDER colleague Marta Wosinska  offered insight into the challenges CDER faces in choosing a course of compliance action when shortages of critical drugs occur.  In the paper, CDER officials cited quality issues as the largest cause (56 percent) of drug shortages in 2011.

As biologics and other injectable drug products gain market share, greater scrutiny is being paid to the interaction between the drug product and its container closure system, including stability during shelf-life and particulate burden, among other critical quality attributes. Over the last several years, drug product recalls have increased due to quality issues, including fundamental weaknesses in primary glass containers that have resulted in problems such as breakage or delamination. Additionally, as more attention is paid to the integration of primary drug containers with devices to form combination products, finding solutions to these problems has taken on an increased urgency in order to protect patients by assuring the integrity and proper delivery of drug products.