DUSSELDORF, GERMANY (April 2005) BOC Edwards Pharmaceutical Systems and Bruker BioSpin GmbH are pleased to announce an exclusive collaboration agreement to further develop the use of time-domain nuclear magnetic resonance (TD-NMR) technology in pharmaceutical packaging equipment. The two companies, who are currently developing a non-contact check-weighing (NCCW) system for a global pharmaceutical manufacturer, are committed to combining research technology and innovative process control equipment to help companies meet the FDA framework for process analytical technology (PAT).
“PAT has highlighted that traditional sample checking, for example the use of a precision balance, is no longer sufficient,” comments Dr. Paul Stewart, director of technology, BOC Edwards Pharmaceutical Systems. “We need to continue to develop ways to support the industry in improving its process monitoring, whilst ensuring that it can maintain the extremely high levels of throughput that are required.”
NMR relies on the interaction of external magnetic fields with atomic nuclei, for example a hydrogen nucleus. The NMR signal received from the sample is proportional to the number of hydrogen atoms and therefore sample mass. NMR is one of the key analytical technologies used in pharmaceutical and academic research as well as in quality control. State-of-the-art NMR methodology and process control equipment have now been combined to provide the industry with NCCW systems that deliver increased quality control and efficiency.
“The NCCW system is the most significant innovation in check-weighing for over 50 years,” explains Stewart. “It provides 100% in-line weight measurement at speeds of up to 400 vials per minute, any problems with the process can be identified virtually immediately and corrected via process feedback to the BOC Edwards filling equipment. As a result manufacturers can greatly reduce the costs associated with out-of-specification (OOS) product and downtime.”
Dr. Dieter Schmalbein, managing director of Bruker BioSpin GmbH concludes, “The fundamental knowledge of nuclear magnetic resonance technology of Bruker BioSpin and the experience in the pharmaceutical industry of BOC Edwards Pharmaceutical Systems are an ideal base to combine process control and highly sophisticated science.”