Previous Blogs

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By Dr. Bettine Boltres

August 24, 2020

Putting together a risk assessment for nitrosamines in your final drug product is an extensive undertaking. Many contributing factors need to be considered, such as the drug substance’s manufacturing process, excipients, buffers, water, production equipment and environment, transportation conditions, packaging, and more. Within this scope, primary packaging components, such as elastomeric closures, also could contribute nitrosamines or precursors.

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By Mary Tan

August 03, 2020

A good elastomer stopper for a vial container system needs to have the right properties. These properties are largely determined by the elastomer formulation, which comprises the base elastomer, fillers, plasticizers, and curing agents. The interplay among these components is crucial, as they determine performance. For example, hardness is affected by filler type and level, as well as by curing agent and level. West understands these issues, and therefore is able to develop formulations to offer maximum performance. An example is the formulation 4040/40, which was designed according to quality-by-design (QbD) principles.

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By Global Communications

April 21, 2014

West’s Mike Schaefers and Heike Kofler recently published a chapter entitled, “Primary Packaging Components Elastomeric Closures for Pharmaceutical Applications” to APV Basics Pharmazeutische Packmittel (Elastomeric Pharmaceutical Packaging).