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Pharmaceutical Manufacturing and Packing Sourcer

Lyophilisation Closures

With no universal lyophilisation closure on the market, Douglas Cusato at Helvoet Pharma reiterates the importance of compendial, functional and stability tests

LYOPHILISED PHARMACEUTICALS

During the design of modern day pharmaceuticals, researchers have to consider a wide range of variables. A simple variable that needs to be considered is the colour of products and their packaging components for identification and marketing. One of the more difficult variables is the type of closure system a product will be packaged in, and how it will be administered. However, most modern day protein/peptide-based pharmaceuticals have been mainly confined to lyophilisation packaging systems. This is due to protein’s inability to maintain a suitable shelf-life in other pharmaceutical packaging environments, such as aqueous mediums in prefilled syringes and vials. Furthermore, oral administration of protein-based pharmaceuticals is not accomplishable, due to the extremely high acidic environment of the stomach.

LYOPHILISATION CLOSURES

Historically, the function of rubber closures was limited to maintaining a seal in the vial or barrel opening, confining a pharmaceutical within a vial or prefilled syringe and permitting proper removal of the pharmaceutical via a hypodermic needle. More recently the rubber closure has become an intricate part of the pharmaceutical closure system, especially regarding lyophilisation stoppers. Modern day lyophilisation stoppers are required to have a low gas and vapour permeability, low affinity to hold moisture, stability in the halfway-down position and vents which are large enough to allow efficient mass transfer during the lyophilisation process.

Also of importance, the closure must be able to establish and maintain seal integrity before and after crimping the aluminum cap. Along with all of these characteristics, a lyophilisation stopper needs to be universally compatible with different lyophilisation machinery. This article discusses topics associated with lyophilisation closures – including compound properties, closure design and coatings.


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Douglas Cusato is a Technical Support Manager with Helvoet Pharma. He joined Helvoet Pharma in August 2006 and is responsible for assisting customers with technical issues such as extractables and leachables, rubber formulation, closure design recommendations and closure coatings. During his academic career, Douglas studied protein to substrate interactions and the proteomic and transcriptomic responses of stressed bacteria. He holds a Bachelor degree in Chemistry from Rutgers University, Camden, New Jersey with an emphasis in Biochemistry. In September 2007 he will begin his Master’s degree at Rutgers focusing on Polymer/Material Chemistry. Prior to joining Helvoet Pharma, Douglas was a co-founder of Metabolic Adaptations, a nutrition company specialising in developing athletic sports drinks; he led the product development and packaging division for several years.
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