The application of Process Analytical Technology (PAT) in pharmaceutical manufacture has gathered momentum over the last decade. Partly, driven by the advent of continuous manufacturing (CM). In this regard, good signal acquisition is of paramount importance when determining the capability and effectiveness of the PAT. This this is of particular importance when utilizing fiber optic probes for spectral collection. [...]
Over the last ten years, the path to effective development of PAT has evolved, driven by the advent of continuous manufacturing. The development and deployment of PAT used for pharmaceutical manufacturing has arrived at a point where application development has been miniaturized and streamlined. The development of devices that can simulate the environment of a fiber optic probe [...]
We look at the tablet press feed-frame as an optimum point for monitoring the quality of a tablet product made using a continuous manufacturing process.Pfizer/ GEA Continuous rig, PAT in a feedframe – Sentronic lollypop design, Feedframe set-up, Tablet press feedframe, Lubrication transition in the feed frame, Diffuse reflection, Optic probe interface - Sampling, Powder “micro-mixing” characterization, Sub dividing [...]
In pharmaceutical manufacturing, probes can rarely be inserted into a process “naked”. The dynamic nature of moving powders calls for a new approach to sampling. In-line applications of PAT require the engineering of a probe interface, for the optimum collection of spectral data. The effective sampling of the process, the amount of material needed to gain the best [...]
An adventure in sampling...We take a look at Pfizers Continuous Rig, the invention of a spider wheel interface, PAT interface for Continuous Mixing, diffuse reflection, optic probe interface - Sampling, powder “micro-mixing” characterization, sub dividing a tablet, development and refinement of the inline spider wheel, “Snow plough” wiper for side illumination probe from Sentronic, feeding, primary mixing and NIR, [...]
The importance of probe interfaces This paper will describe some of the efforts the Pharmaceutical the industry in general, are putting into the concepts of continuous manufacturing, married together with integrated analytics and advanced control systems. The combined technologies enable flexibility and rapid response to demand, and thus low inventory supply streams. The manufacturing plants occupy a small [...]
The PAT community has over the years demonstrated that a spectroscopic system can be designed to collect representative spectral response data on powders. This can be achieved by momentarily stopping part of the flow, or isolating tablet cores holding them still and collecting spectral data of the surface, or collecting transmission data when radiation has passed through a [...]
An Interview with Steve Hammond by Laura Bush Read the full ebook here: spectroscopyonline.com/special-issues-08-03-2019 Implementing process analytical technology (PAT) became a goal in the pharmaceutical industry 15 years ago, with the publication of a guidance document from the U.S. Food and Drug Administration (1). Recently, the industry’s drive to use continuous manufacturing—instead [...]
