Block Engineering, the leader in Quantum Cascade Laser (QCL) spectroscopy, announced today that it has signed a Collaborative Agreement with Pfizer, Inc. to develop a QCL-based system for real-time, noncontact Cleaning Verification of vessels during pharmaceutical manufacturing. The technology is based on Block's commercially available LaserScan (TM) 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. Today, 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, noncontact 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 labor, 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.