Alliances - Proveris Scientific
Proveris Scientific delivers innovative testing and development systems and services that are advancing the science of nasal and pulmonary spray delivery of pharmaceuticals. The privately-held company, founded in 1995, is headquartered in Sudbury, Mass. The company’s products and methodologies enable 21 CFR Part 11 compliance and are ISO9001:2000 certified. Proveris Scientific’s preferred, proven systems are in use by leading global pharmaceutical companies, including GlaxoSmithKline, AstraZeneca, Wyeth, IVAX, and the FDA.
Malvern Instruments now offers the Proveris Scientific SprayVIEW® NSx nasal spray actuation system for the Malvern Spraytec particle size analyzer.
The Spraytec system uses the technique of laser diffraction for high speed droplet size measurements in concentrated sprays and aerosols. It is being widely adopted within the pharmaceutical industry for the characterization of nasal sprays, inhalers and nebulizers. The alliance with Proveris Scientific adds significant new capabilities within the Spraytec product range, further enhancing the ability of manufacturers to meet the requirements set out in the FDA’s draft guidance covering the testing of nasal aerosols and sprays (see www.fda.gov/cder/guidance/5383DFT.pdf).
The SprayVIEW NSx actuator provides researchers with a precise means of controlling the actuation of nasal pump sprays during product testing, eliminating user bias and ensuring that meaningful product comparisons can be made. The system allows users to specify both the velocity and acceleration of actuation, providing a realistic mimic of how a patient may use a given device. In addition, an integration kit (the SprayVIEW NSx-MS) is available that allows accurate positioning of the actuator within the Spraytec’s optical bench. This includes software feedback of the distance between the nasal spray nozzle and the laser diffraction measurement zone.