Upon being granted a patent for the core elements of its hardware and software spray pattern and plume geometry measurement systems, ImageTherm has announced availability of SprayVIEW version 4.
SprayVIEW automates, accelerates and increases the accuracy of the testing of pharmaceutical spray drug products, including nasal spray pumps, metered dose inhalers, and oral spray pumps, in accordance with the U.S. Food and Drug Administration (FDA) testing recommendations announced April 2003. SprayVIEW's objective testing methodology enables innovator and generic pharmaceutical companies to more quickly and effectively evaluate drug formulations with a 98 percent accuracy and repeatability rate. It reduces overall lab testing time by 10x, as compared to earlier methods, helping to bring safe and effective pharmaceutical spray drug products to the consumer market faster.
"Since 1999, SprayVIEW has helped pharmaceutical companies, such as GlaxoSmithKline, AstraZeneca and 3M, become more agile and competitive by streamlining their testing and analysis processes," said Dino J. Farina, president of ImageTherm. "We have already seen proven results from 60 worldwide end-user customers throughout North America, Europe, Asia and the United Kingdom using SprayVIEW."
For decades, the pharmaceutical industry has endured the use of thin layer chromatography (TLC)-plate spray pattern, still image photographic testing and paper-based records as drug characterization and reporting techniques. Meanwhile, the FDA now recommends the electronic and automated documentation of spray characterization data for drug products. With existing archaic and time-consuming techniques being very qualitative and subjective, and with the industry's need to address current and future FDA guidelines, pharmaceutical companies require a methodology and associated technology to analyze spray characterization automatically, non-destructively and quantitatively. The unique, patented technology in SprayVIEW enables completely non-intrusive and objective measurements of spray pattern and plume geometry for pharmaceutical sprays.
Version 4 of SprayVIEW improves the acquisition, handling, analysis and reporting of spray test data and allows pharmaceutical companies to maintain compliance with the 21 CFR Part 11 regulation. It revolutionizes test data management and reporting by incorporating a secure Oracle client-server database architecture.
The system: Enables 21 CFR Part 11 Compliance - SprayVIEW 4 allows pharmaceutical companies to fully comply with 21 CFR Part 11 regulations for electronic records and electronic signatures. In SprayVIEW 4, test data and images are collected in a compliant manner and form the basis of the electronic records submitted to the FDA.Offers Improved Data Handling Capabilities - In SprayVIEW 4, all spray data are stored in a secure Oracle database, Version 10g, alleviating companies from the burden of storing large individual files. In addition, the software architecture allows for future inclusion of data from other actuation events (i.e. unit dose measurement, droplet size distribution and cascade impaction).Includes a Method Editor - SprayVIEW 4 decreases the amount of operator time and intervention required during measurement taking by introducing a method editor that automates data acquisitions tasks. The method editor helps the user define the test instructions and then automatically execute them. Automatic system checks and calibrations ensure data integrity.Incorporates Advanced Reporting and Analysis Tools - Advanced software functionality enables users to easily sort, compare and analyze spray data in a Windows-based graphical user interface.
ImageTherm was the first company to develop an integrated hardware and software system for pharmaceutical spray characterization and analysis. R&D directors, lab managers and production managers at innovator and generic pharmaceutical companies use this unique system to simplify the testing of spray pattern and plume geometry by using a laser light sheet to illuminate a non-intrusive plane of spray droplets or particles, enabling faster product time to market with significant improved quality control and regulatory compliance. To date, more than 30 pharmaceutical spray drugs, including Flonase, FluMist, Rhinocort Aqua and Proventil have been tested using ImageTherm's technology.
"With SprayVIEW 4, ImageTherm is setting a new standard for automating the collection and analysis of testing data for spray and aerosol drugs," said Rob Lewis, laboratory services manager at Fleming & Company Pharmaceuticals, makers of Ocean saline nasal spray. "SprayVIEW 4's advanced data handling capabilities, 21 CFR Part 11-compliant methodologies and integration of an Oracle database makes a very impressive package for companies seeking a more efficient, effective way to test and characterize nasal spray and pulmonary pharmaceuticals."
ImageTherm delivers innovative testing and development systems and services that are advancing the science of nasal and pulmonary spray delivery of pharmaceuticals.
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