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PAT is defined as a “system for the continuous analysis and control of manufacturing processes based on real‐time or rapid measurements during processing of quality and performance attributes of raw and in‐process materials and processes, to assure end product quality at the completion of the process”.
Optimal manufacturing process control involves testing raw materials, in‐process monitoring and endproduct testing with stringent documentation. Critical sources of variability must be identified and managed. PAT implementation, therefore, requires innovative PAT tools or Process Analytical Instrumentation (PAI) which gives real‐time or near real‐time results by monitoring continuous and episodic operations. In order to specifically implement PAT in testing for Bacterial Endotoxins, the Portable Testing System (Endosafe®‐PTS™) offered by Charles River is an effective Process Analytical Instrument. The PTS™ uses disposable LAL cartridges approved by the USFDA (July 2006) and are pre‐loaded with existing FDA‐approved Endosafe® Chromogenic LAL reagents. The cartridges are calibrated directly to the primary standard (Reference Standard Endotoxin EC‐6). The PTS cartridges are compliant to the current harmonized compendia test for Bacterial Endotoxins. The suitability of the PTS™ Reader comes from its highly flexible platform and portability. It gives a rapid test result time of less than 15 minutes. It eliminates the need for endotoxin standards, preparation of Positive Product Controls (PPC) and validation of accessories‐ all of which need a laboratory clean room setting and extensive analyst training. The PTS™ Reader allows the test to be done near the point‐of‐use and the cartridges can be stored at ambient temperatures for 18 months. The PTS™ allows for single sample analysis, near real time results, and decentralization from QC labs – all of which ultimately contribute to manufacturing process control and a quick response to contamination issues. By implementing PAT and the PTS™ rapid endotoxin testing system, this turnaround time for sample release would be reduced to just 30 minutes allowing manufacturing to move forward without delay.
Using the PTS™/MCS™ systems as Process Analytical instruments can reduce risks in the manufacturing process and improve results in the quality of end‐products.