What Is a Process Analytical Technology (PAT)?
PAT, an abbreviation for Process Analytical Technology, is a technology employed for monitoring and analyzing products during the manufacturing process to enhance product quality.
To ensure product quality, quality inspections are typically carried out before shipment. However, conducting inspections only at the final stages of the manufacturing process can lead to inefficiencies, as defective materials, time, and resources may be wasted when defects are discovered.
Therefore, by implementing intermediate inspections for each manufacturing process, PAT allows for the early detection and timely addressing of manufacturing defects, enabling efficient production.
PAT serves as a quality management technique utilized in the manufacturing of pharmaceuticals, chemicals, and food products. At each stage of the manufacturing process, various analytical techniques are employed to monitor the quality of intermediate products in real time. In the event of abnormal quality, PAT immediately issues warnings and prompts corrective actions.
Uses of PAT
PAT is primarily utilized in the manufacturing processes of products such as powders, liquids, and gases. The system monitors the physical, chemical, or biological properties of intermediate products using sensing technologies.
Additionally, PAT systems continuously monitor the values obtained during monitoring. If values exceeding normal parameters are observed, the system issues warnings to operators, prompting appropriate responses, or even automatically halting processes.
For example, in the pharmaceutical manufacturing process, PAT measures physical quantities such as temperature, pressure, and pH to predict the occurrence of defects. In food manufacturing processes, chemical measurements like color and viscosity are taken to predict the quality and detect any abnormalities in taste in the final product. In chemical manufacturing processes, measurements of composition and concentration are taken to evaluate product quality and assess the safety of subsequent processes.
Principles of PAT
PAT is particularly emphasized in the pharmaceutical manufacturing process within various manufacturing sectors.
PAT operates by coordinating three main functions: sensors that measure physical, chemical, or biological characteristics at each manufacturing process, analytical devices that analyze data obtained from sensors, and quality management functions that judge whether the product’s quality is maintained based on the analysis results.
By ensuring that PAT is continually implemented in real-time for each manufacturing process, any issues that arise can be promptly communicated to administrators, allowing for early action and preventing a decline in manufacturing yield.
For instance, when establishing temperature management for a reaction vessel used in a certain manufacturing process, data on the upper and lower limits of temperatures at which products can be manufactured properly are obtained. A management boundary is then set within a stricter range than this, and immediate action can be taken if the process exceeds this limit.
This proactive approach prevents defective products from flowing into subsequent processes.
Types of PAT
PAT is a technology used for quality management in manufacturing processes, and the measurement targets, measurement methods, and analysis methods vary. As long as it aligns with the concept of quality management technology, using various sensors and analytical methods qualifies as PAT.
However, industries with high demand, such as pharmaceutical manufacturing, have commercially available PAT analysis devices that combine specific sensors and analytical equipment to fulfill some of PAT’s functions.
For example, there are composition analysis devices that use in-situ spectroscopy or chromatography. These devices attach sensors to process equipment, allowing real-time analysis results to be obtained as the process progresses. Additionally, PAT analysis devices that utilize Near-Infrared Spectroscopy (NIR) or Raman Spectroscopy (Raman) are available for pharmaceutical development.
How to Choose PAT
PAT is a comprehensive method for quality management in manufacturing processes, combining various products and technologies. Therefore, the choice of PAT varies depending on the type of products and processes being manufactured.
In fields like pharmaceutical manufacturing, if PAT-related products applicable to the company’s manufacturing processes are identified, consulting with the manufacturer or distributor of those products is recommended. Some companies also conduct seminars related to PAT, and participating in such seminars can be effective.