title: Development and beyond: Strategy for long-term maintenance of an online laser diffraction particle size method in a spray drying manufacturing process.
abstract: The purpose of this manuscript is to present the intended use and long-term maintenance strategy of an online laser diffraction particle size method used for process control in a spray drying process. A Malvern Insitec was used for online particle size measurements and a Malvern Mastersizer was used for offline particle size measurements. The two methods were developed in parallel with the Mastersizer serving as the reference method. Despite extensive method development across a range of particle sizes, the two instruments demonstrated different sensitivities to material and process changes over the product lifecycle. This paper will describe the procedure used to ensure consistent alignment of the two methods, thus allowing for continued use of online real-time laser diffraction as a surrogate for the offline system over the product lifecycle.
authors.affiliation: Vertex Pharmaceuticals, 50 Northern Avenue, Boston, MA 02210, United States. Electronic address: Joseph_medendorp@vrtx.com.
authors.forename: Joseph
authors.initials: J
authors.lastname: Medendorp
authors.affiliation: Vertex Pharmaceuticals, 50 Northern Avenue, Boston, MA 02210, United States.
authors.forename: John
authors.initials: J
authors.lastname: Bric
authors.affiliation: Vertex Pharmaceuticals, 50 Northern Avenue, Boston, MA 02210, United States.
authors.forename: Greg
authors.initials: G
authors.lastname: Connelly
authors.affiliation: Vertex Pharmaceuticals, 50 Northern Avenue, Boston, MA 02210, United States.
authors.forename: Kelly
authors.initials: K
authors.lastname: Tolton
authors.affiliation: Vertex Pharmaceuticals, 50 Northern Avenue, Boston, MA 02210, United States.
authors.forename: Martin
authors.initials: M
authors.lastname: Warman
mesh_terms: D003890:Desiccation / Q000379:methods*; D007834:Lasers; D009862:Online Systems; D010316:Particle Size; D013678:Technology, Pharmaceutical / Q000379:methods*
keywords: Insitec; Mastersizer; Particle size; Process control; Spray drying