Process Analytical Technology (PAT)

PMRS Inc. strives for improving pharmaceutical compounding through Process Analytical Technology (PAT). PAT offers many advantages over traditional pharmaceutical manufacturing processes;it has been defined by a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of Critical Process Parameters during the manufacturing process. The PAT platforms at PMRS Inc. make continuous process and real-time release a reality.

One current application of PAT is the verification of blend and content uniformity through Near-Infrared mass spectrometry systems (NIR). PMRS has validated and implemented Prozess Technologie NIR Systems to monitor blend and extrusion content uniformity in real-time. These systems support and will eventually replace blend uniformity (BU) and content uniformity (CU) testing that generally occurs after the completion of a batch or campaign. This immediate knowledge reduces batch risks and provides a higher quality product due to 100% testing. Performing this testing during the batch and not in the analytical lab, after completion of manufacturing, allows for shorter release times and gets your product into the hands of the patient faster.

Near-Infrared mass spectrometry systems also permit material identification testing on incoming raw materials. NIR has several advantages over traditional raw materials testing including faster sample times, rapid identification, and eliminating material consumption and waste. Requiring only a matching spectral signal, NIR is a non-destructive test which removes the drawbacks of other systems. Our systems have been in use on products produced at PMRS for more than 10 years.  The combination of NIR testing of raw materials and uniformity systems allow PMRS to perform pharmaceutical compounding at lower costs and with an exceptional level of quality.

PMRS Inc. has multiple NIR systems at our facility and years of processing and validation PAT experience. Please contact us to learn more about Process Analytical Technology for your project at PMRS.

 

Process Analytical Technology (PAT) was last modified: August 28th, 2015 by pmrsinc
Posted in Analytical, Manufacturing, New, Services.