A multi-purpose system for monitoring pharmaceutical processes
SentroPAT FO NIR is a flexible, robust and reliable system that can be used to monitor a variety of unit operations during the processing of solid dose pharmaceuticals. The system is based on a diode array near infrared spectrometer. In combination with any SentroProbe, and configured with the compliant software package Sentro-Suite GMP, it is a turn-key solution providing valuable process insights from product development to routine operation.
NIR spectroscopy is the most versatile PAT technology available. With a proven track record in many industrial applications, it can be deployed to capture both physical and chemical process parameters. Sometimes, NIR measurements even render more specialized PAT equipment unnecessary.
The core component of the SentroPAT of NIR is a diode array based spectrometer. A key advantage of this technology is the simultaneous measurement of the entire wavelength range within milliseconds. The speed of the measurement makes the system ideal for analyzing fast moving samples, without compromising accuracy. Furthermore, the elimination of spectra acquired during a phase of poor sample presentation is possible with this technology. The long-term stability provided by the technology is complemented by smart internal standards. This results in high reliability of the system and provides a superior system to system comparability. The sum of the outstanding features enables easy method transfer between instruments, production systems and different scales. Based on an optionally install demultiplexer the SentroPAT of can measure sequentially with up to four probes.
The spectrometer module is accompanied by an embedded PC running a standard Windows operating system. An Ethernet connection allows for easy integration into an existing network and enables the use of TCP/IP based communication such as OPC or other standards. The system is quite compact and the housing is GMP-friendly. Smooth surfaces and the IP65 / NEMA 4 enclosure mean quick and easy cleaning, enabling installations directly in the production area but also in the technical area.
A fundamental focus of the design and development of this system was minimizing the maintenance required and cost of ownership. The majority of probes designed for the SentroPAT FO are based on single core optical fibres. These probes can be installed up to 50 m away from the analyser without the need for installation of expensive fibre bundles. The system continuously and automatically monitors all key instrument parameters, resulting in reliable performance for extended periods without user intervention. The only routine maintenance required is light source replacement every 6 to 24 months.
For applications which require long integration times or need the lowest possible spectroscopic noise, the SentroPAT FO can be equipped with a thermoelectric cooler (TEC) module. This module, which allows for operation of the detector at -20°C or lower, minimizing temperature variation of all performance relevant system components and thus shifts the stability of the measurement to a new level.