title: Using Residence Time Distributions (RTDs) to Address the Traceability of Raw Materials in Continuous Pharmaceutical Manufacturing.
abstract: Continuous processing in pharmaceutical manufacturing is a relatively new approach that has generated significant attention. While it has been used for decades in other industries, showing significant advantages, the pharmaceutical industry has been slow in its adoption of continuous processing, primarily due to regulatory uncertainty. This paper aims to help address these concerns by introducing methods for batch definition, raw material traceability, and sensor frequency determination. All of the methods are based on established engineering and mathematical principles, especially the residence time distribution (RTD). This paper introduces a risk-based approach to address content uniformity challenges of continuous manufacturing. All of the detailed methods are discussed using a direct compaction manufacturing line as the main example, but the techniques can easily be applied to other continuous manufacturing methods such as wet and dry granulation, hot melt extrusion, capsule filling, etc.
authors.affiliation: Department of Chemical and Biochemical Engineering, Rutgers University, 98 Brett Rd., Piscataway, NJ 08854 USA.
authors.forename: William
authors.initials: W
authors.lastname: Engisch
authors.affiliation: Department of Chemical and Biochemical Engineering, Rutgers University, 98 Brett Rd., Piscataway, NJ 08854 USA.
authors.forename: Fernando
authors.initials: F
authors.lastname: Muzzio
keywords: Batch definition; Continuous Processing; Process analytical technology (PAT); Residence time distribution; Traceability