Marlborough, MA--Quantum-cascade laser (QCL) spectroscopy specialist Block Engineering has signed a collaborative agreement with pharmaceuticals maker Pfizer, Inc. (New York, NY; NYSE: PFE; research center located in Groton, CT) 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 Analyzer, which will be tailored to address the specific requirements of this application. The agreement is potentially quite beneficial for Block Engineering, as Pfizer is a large multinational company (with a 2011 revenue of $67 billion).
Accurate cleaning verification of vessels used to make pharmaceuticals is crucial to prevent potential health risks arising from cross-contamination between products. The existing approach to ensure that the walls of these vessels meet tough FDA cleanliness standards is a swab-based technique in which samples are collected and brought to off-line instruments, such as high-pressure liquid-chromatography (HPLC) systems. The ensuing measurements typically take several hours or more per vessel, during which the vessel usually remains idle.
The new QCL-based approach is intended 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. As a result, pharmaceutical manufacturing equipment can be scanned in a matter of minutes and potential areas that require additional cleaning can be identified in real-time without the need to take any samples. Block's device requires no consumables and is based on eye-safe QCL-based IR spectroscopy. Block's devices use QCLs that are tunable within the 5-14 µm range -- the so-called "fingerprint" region that contains the spectral signatures of organic molecules, including pharmaceuticals. Built-in libraries in the Block equipment are typically used to pattern and provide real-time detection and analysis of these molecules.
"Block's QCL-based infrared spectrometers are opening new markets and Cleaning Verification is one of the most exciting and high impact applications," says Petros Kotidis, CEO of Block Engineering. "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."
For more info, see: www.blockeng.com