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Lyophilization (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 (> 400 FDA-approved); because absent water, the rates of degradative processes are reduced substantially. Essential to successful lyophilization, and subsequent rehydration, are use of proper containment and reconstitution systems.
These systems, and the components that comprise them, are discussed in detail in the chapter Container and Reconstitution Systems for Lyophilized Drug Products in Lyophilization of Pharmaceuticals and Biologicals (ISBN 978-1-4939-8927-0, Humana Press, 2019) by P. McAndrew (Dir., Scientific Communications), D. Hostetler (Sr. Manager, Integrated Solutions) and F. DeGrazio (VP, Scientific Affairs & Technical Services). This chapter discusses the fundamental chemistry and physics of the lyophilization process. It also discusses (a) influence of component designs (e.g., stopper vent, vial wall thickness, vial adapter spike), and the (b) influence of component materials (e.g., thermal conductivity, water adsorption) on performance. Understanding all these factors facilitates the selection of the right components for lyophilization drug packaging systems.
For more on how West can help with containment and reconstitution systems, contact an Account Manager or Technical Customer Support representative, or visit the Knowledge Center.
One of the challenges a drug manufacturer faces is controlling the drug product at the point-of-use in a hospital or clinical environment. Often the method of vial access is variable, leading to an increased risk of harmful patient outcomes such as stopper cores or fragments entering into the drug product, which can contribute to cardiovascular events. There are a number of causes that contribute to stopper coring and fragmentation in the field that depend primarily on the technique of the practitioner and the properties of the elastomeric closure.
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.
In the next blog of our series on West’s 2017 Corporate Responsibility Report, we are focusing on Compliance and Ethics. As a company that operates in a highly regulated industry to serve billions of patients around the world, it is imperative that West conducts its business in an ethical manner – not because we have to, but because it’s the right thing to do. Read on to learn more about compliance and ethics at West as published in the 2017 Corporate Responsibility Report. <br />
Natural Rubber Latex (NRL) has been a topic of concern in the pharmaceutical industry since the early 1990s. Concerns with allergens prompted labeling guidelines to ensure safe patient treatment. West Pharmaceutical Services’ elastomeric formulations for injectable packaging components for vials and syringes may contain Dry Natural Rubber (DNR) in the form of crepe, but the formulations do not incorporate NRL.
The PDA Annual Meeting, “Modern Sterile Product Manufacture – Exploring Best Practices and Seeking New Approaches,” will be held April 15-17, 2013, at the Peabody Orlando in Orlando, Florida. This meeting will focus on the challenges currently faced by the pharmaceutical industry, advances in modern manufacturing and look ahead to the future of the industry.
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