In terms of quality control, you can’t get more state-of-the-art than a fibre-optics-based spectrometer to analyse solids and liquids. ABB has some illuminating facts about its range of process analysers.

Process Analytical Technology (PAT) monitoring and control (PAT) is one of the key enabling elements of the concept of quality by design (QBD), introduced by the FDA to improve quality insurance and control in pharmaceuticals manufacture. Within that framework, Fourier transform nearinfrared (FT-NIR) analysers such as the FTPA2000-260PH have rapidly found their place as essential components of the PAT toolkit, mainly due to their flexibility and reliability.

This type of analyser is a fibre-optics-based process spectrometer that can be interfaced to a wide range of sampling accessories, including flow-through cells or insertion probes for analysis of solids and liquids.

From its early R&D stages, this analyser allows the user to screen a large number of chemical or physical properties of a formulation. This enables you to identify the critical process attributes (CQAs) and to understand their relationship to critical process parameters (CPPs). Applications developed at laboratory or pilot scale can then be scaled up to manufacture, thanks to ABB’s stringent manufacturing standards and reproducibility specifications, which make all these types of analyser virtual clones of each other.

Multi-purpose spectrometer

This analyser is ideally suited to performing real-time monitoring of pharmaceutical and biopharmaceutical processes. It is also ideal for unit operations, such fermentation, downstream purification, crystallisation, lyophilisation, distillation, drying, granulation, extrusion, blending or milling. Thanks to the accuracy, speed and superior repeatability of the FT-NIR technology, users can substitute this process analyser for their traditional methods based on final-stage quarantine and laboratory testing. It also eliminates safety risks associated with operators’ exposure to potent compounds during manual sample extraction.

A remarkable feature of the analyser is that it can be connected to up to eight sampling points to parallel-monitor multiple operations. Engineering requirements for process implementation are minimised, as the spectrometer can be located in a general purpose area isolated from the process and hazardous areas.

Also, the outstanding signal-to-noise performance of the analyser allows it to transfer optical signals through fibre optics over distances of up to 80 metres – even more for liquid applications.

The most current sampling interfaces are insertion probes which can easily be adapted to the manufacturing process vessel. Optional features, including integrated temperature sensor, automated retraction and self-cleaning capability or optical window purge, can be implemented if required for unattended operations. The FT-NIR measurement technique is intrinsically safe and totally nondestructive.

The integration of spectral records over multiple scans in a dynamic process ensures that the CQA values (updated typically every 30 seconds) are measured over representative samples and therefore extremely reliable.

The main benefit of this spectrometer as a PAT tool is that it performs real-time detection of the process end point and therefore contributes to reducing cycle time for batch operations. It also enables development of innovative pharmaceutical manufacturing strategies based on continuous processes.

Control strategies

Additionally, users benefit from the sensitivity of the FT-NIR technology with respect to chemical and physical variations in the sample matrix. This allows process engineers to develop control strategies based on objective diagnostics that can flag in real-time abnormal process conditions and help identify their root causes. Connection of the analyser to plant IT and control systems is straightforward, as it supports industry-standard communication protocols (OPC, Modbus, CANopen).

In summary, ABB’s process analyser enables reduction and potential elimination of out-of-specification products, reduction of costs and production cycle times (sometimes exceeding 30%), identification of relevant process and product performance attributes, elimination of potential product degradation, avoidance of recalls and improvement in product quality homogeneity. It also provides a closer insight into batch or continuous processes to pharmaceutical manufacturers.