Introduction of a drug product into a container/delivery system (and subsequent packaging) under aseptic conditions is essential to guarantee safety and efficacy. Challenges to fill/finish processes include maintaining sterility of components, equipment and production areas. This section presents papers considering equipment, processing and related topics.
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This video presents recommended procedures to receive plungers and stoppers and introduce them into sterile manufacturing facilities – from Grade D through Grade A. West can assist Customers in developing these procedures.
<p>In this article, industry experts discuss strategies to operate fill-finish operations with best maintenance of sterility.</p>
<p><em>R. Hernandez. BioPharm International, 28 (11), 14-19 (2015)</em></p>
<p>This article considers some of the fill/finish issues particular to biologic drug products, vis-à-vis pharmaceutical products.</p>
<p><em>E. Langer. BioPharm International, 28 (1), 14-17 (2015)</em></p>
<p>This article discusses how proper selection of fill/finish equipment and processes can minimize risk of recalls.
<p><em>R. Hernandez. BioPharm International, 29 (9), 14-21 (2016)</em></p>