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Pharmaceutical Manufacturing and Packing Sourcer

Seeking Closure

With growing concerns of interactions between drug products and container closure systems, pharmaceutical companies desire an ideal elastomeric closure. Prior to this increased awareness, the role of elastomeric closures was quite basic. This allowed pharmaceutical companies to develop standard packaging components for their portfolio of injectable drug products. The role of a standard elastomeric closure was limited to confining a pharmaceutical within a given area (for example, vial or syringe), maintaining a seal for vials or syringes, and permitting proper removal of pharmaceuticals via a hypodermic needle.

However, in recent decades, more demands come from pharmaceutical companies to their suppliers, including improved compounds and coatings, more specific closures designs, manufacturing facilities that are GMP-compliant, and validated wash processes that comply with the requirements of FDA and EU guidances. This article discusses the choices pharmaceutical companies are required to review when selecting an elastomeric closure.

CLOSURE DESIGN

Typically, one of the most fundamental decisions to make when choosing an elastomeric closure is the geometrical design. This statement holds true for vial stoppers (includes serum and lyophilisation stoppers) more than it does for syringe components (plungers/pistons, tip caps and needle covers). Vial stoppers are traditionally designed in accordance with ISO standards ISO 8362-2 and ISO8362-5, which promotes compatibility with ISO standard ISO 8362-1 for vials.


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Douglas Cusato is a Technical Support Manager with Helvoet Pharma. He joined Helvoet Pharma in August of 2006 and is responsible for assisting customers with technical issues such as extractables and leachables, rubber formulation and closure design recommendations, and closure coatings. He holds a Bachelor degree in Chemistry from Rutgers University, Camden, NJ, with an emphasis on biochemistry. Commencing September 2007 he began his Masters degree at Rutgers University, Camden, NJ focusing on polymer/material chemistry.
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