Block & Pfizer Develop Pharma Manufacturing System
Block Engineering and Pfizer have joined forces to develop a new light-based system for use in pharmaceutical manufacturing.
Block Engineering; known for its specialism in quantum cascade laser spectroscopy has signed an agreement with the Viagra maker to design a real-time, non-contact system for cleaning verification of vessels used in the production process. The technology is based on Block's commercially available “LaserScan” analyser.
According to Block and Pfizer, accurate cleaning verification of those vessels has a significant impact in pharmaceuticals manufacturing, because of the potential health risks of cross-contamination between products.
Currently, to ensure that the walls of the vessels meet stringent US FDA cleanliness standards, swabs are applied to collect samples for off-line analysis. The swabs are then analysed, typically with wet chemistry instruments like high-pressure liquid chromatography (HPLC) systems.
Those measurements can take several hours or more per vessel, during which time it usually remains idle, creating a production bottleneck. “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,” say Block and Pfizer.
Using QCL spectroscopy should mean that the manufacturing equipment could be scanned for contamination in just minutes, identifying any areas that require additional cleaning without any need for sampling with swabs.
“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 Pfizer’s Process Analytical Sciences Group (PASG).