Particle size in sprays and aerosols is important in defining product delivery and performance in an increasing range of pharmaceutical applications. Within the draft guidance for the characterization of nasal sprays, for example, the FDA has recommended the use of laser diffraction to determine the droplet size produced for a given device and formulation. Malvern’s Spraytec system uses laser diffraction to measure particle size and is widely used in the pharmaceutical industry for the analysis of nasal sprays and aerosols, and inhalers. It delivers real-time, high-speed measurements that enable the complete characterization of both continuous and pulsed spray events.
The new Spraytec has an increased data acquisition rate of 10 kHz, which means a 100-microsecond time resolution, allowing extremely accurate analysis of the dynamics of spray atomization and dispersion: even the rapid changes in particle size that take place during inhaler operation can be followed.
An extended size range from 0.1 to 2000 microns, using just two lens systems, enables the routine characterization of broad size distributions, with a dynamic range of more than 1000:1 covered by each lens. Malvern’s patented multiple scattering analysis additionally ensures accurate measurements at high spray concentrations, where traditional laser diffraction systems would fail.
The robustness and simple operation of the Spraytec are important factors in its continued success and both are evident in the new system, from the design of the optical bench through to its software implementation. Automatic alignment ensures fully optimized system set up. A built-in SOP wizard aids method definition and transferability, and gives single-click operation.
For use in regulated environments, full lifecycle documentation, following GAMP guidelines, provides complete design traceability; IQ/OQ documentation is provided for validation plans; and software provides technical compliance with the requirements of 21 CFR Part 11.
USA contact information:
Marisa Fraser, Malvern Instruments Inc.
10 Southville Road
Southborough, MA 01772
Tel: +1 (508) 480-0200
Fax: +1 (508) 460-9692