Sr. Technical Account Specialist, TCS
January 31, 2019
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.