Block Engineering, the leader in Quantum Cascade Laser (QCL) spectroscopy, has signed a collaborative agreement with Pfizer, Inc. to develop a QCL-based system for real-time, non-contact Cleaning Verification of vessels during pharmaceutical manufacturing. The technology is based on Block's commercially available LaserScan Analyzer, which will be tailored to address the specific requirements of this application.
Accurate Cleaning Verification of vessels has a significant impact in pharmaceutical manufacturing, due to the potential health risks of cross-contamination between products. In order to ensure that the walls of these vessels meet tough FDA cleanliness standards, swab-based techniques are applied to collect samples and bring them to off-line instruments, such as High Pressure Liquid Chromatography (HPLC) systems. These measurements typically take several hours or more per vessel during which the vessel usually remains idle. The key value proposition of the proposed technology is to eliminate this bottleneck and provide a handheld, battery-operated, barcode-scanner-like device capable of providing real-time, non-contact verification of the cleanliness of the vessel walls. Using the proposed technology, pharmaceutical manufacturing equipment could be scanned in a matter of minutes and potential areas that require additional cleaning will be identified in real-time without the need to take any samples. Block's device requires no consumables and utilizes next generation, eye-safe QCL-based infrared spectroscopy.
"Cleaning Verification is a critical step in the drug manufacturing process and Pfizer is committed to the development of technologies that could decrease inspection times, reduce costs and improve supply assurance," said Steve Hammond, Head of the Process Analytical Sciences Group (PASG) and senior director in the Global Manufacturing Services organization at Pfizer. "Block's groundbreaking technology fits well within Pfizer's Process Analytical Technology (PAT) initiatives and I look forward to working with them towards the development of this instrument."
The expected benefits of this novel approach include a reduction in the labour, material and consumables required today for swab-based verification. Furthermore, significant plant utilization increases can be achieved and drug supply assurances can be confidently offered. Key initiatives in the pharmaceutical industry today for Work-in-Progress inventory reduction and just-in-time-inventory implementation will significantly benefit from the proposed technology, as the manufacturing equipment idle time is reduced.
Petros Kotidis, CEO of Block Engineering informed, "I am very pleased to announce the strategic agreement with Pfizer towards the development of this breakthrough instrumentation. Block's QCL-based infrared spectrometers are opening new markets and Cleaning Verification is one of the most exciting and high impact applications. Pfizer's dominant and pioneering position in the introduction of next generation process analytical technologies will be a critical element in the success of this product."
The fundamental principle behind Block's technology and the currently commercially available LaserScan Analyzer is QCL-based infrared spectroscopy. When infrared light from the QCL reflects off of substances, it gets absorbed or reflected at rates that are absolutely unique to and characteristic of the substance. Therefore, when the reflected light is collected by the LaserScan's built-in detectors, a "fingerprint"-like pattern emerges, which contains all the necessary information for detection or analysis of the substance. Built-in libraries are typically used to pattern and provide real-time detection or analysis. Block's devices use unique QCLs, which cover the widest spectral range in the world within the 5-14 µm range and provide rapid sub-second, real-time measurements in handheld configurations.
Block Engineering, LLC is a leading manufacturer and marketer of high performance Quantum Cascade Laser (QCL) and FTIR spectrometers for commercial, industrial, military and government customers.