Real Time Process Determination (RTPD)
Real Time Process Determination is Niro's answer to Process Analytical Technology (PAT)
The GPS of Fluid Bed Process Control
Real Time Process Determination is a comprehensive software solution that tracks process conditions. It acts as your most experienced operator and provides concise advice on how to run the process.
It is an integrated suite of programs that work along with a GEA Pharma Systems fluid bed processor control system. This includes a program that runs during a fluid bed process and a program for the post batch analysis of the data collected.
A second OIT display is provided for simultaneous viewing of the output of Real Time Process Determination along with the fluid bed processor control screen. The Real Time Process Determination program provides continuous operating guidance to an operator running a fluid bed process. The goal is to control a batch process, through all of the steps and transitions, regardless of variations in ambient or process conditions.
Real Time Process Determination reveals to the operator the current relative humidity inside the processor. It also advises the operator on how much the inlet air temperature, inlet air flow, or spray rate (for processes involving spraying) could be adjusted to hit the target humidity without exceeding preset limits for these parameters plus the product temperature.
The program that runs during a fluid bed process uses current process conditions, information about the material used in the process, and set points from the recipe being run to determine the relative humidity inside the processor and what, if any, action should be taken to achieve the target conditions. This program can handle up to nine different solvents simultaneously.
The program that analyzes the data collected during a batch processes the raw data file and outputs a file that can be used to look at almost every aspect of what happened during the batch using a spreadsheet program.
GEA Pharma Systems is a world leader in advanced solid dosage processing solutions to the pharmaceutical industry. Based on dedication to research and durable quality, GEA Pharma Systems offers a wide range of solutions, from individual pieces of equipment to complete integrated plants, by uniting the state-of-the-art technologies of Aeromatic, Buck, Collette, Courtoy, Fielder, Nica, and Niro.
The goal of Prcocess Analytical Technology (PAT) is to understand and control the manufacturing process, which is consistent with our current drug quality system: quality cannot be tested into products; it should be built-in or should be by design.
Process Analytical Technology (PAT) is a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality. Note that it is important that the term analytical in PAT is viewed broadly to include chemical, physical, microbiological, mathematical, and risk analysis conducted in an integrated manner.
For further information please read the Process Analytical Technology (PAT) Initiative (link opens a new window) from the U.S. Food and Drug Administration.
Detailed article about Real Time Process Determination published in Pharmaceutical Engineering Magazine - March/April 2007 issue (Vol. 27, number 2)
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