Malvern unveils improved particle size analyser
size analysis of aerosols and sprays.
Like its predecessor, the new Spraytec delivers fully automated in situ analysis of high concentration aerosols and sprays. However, the new model has a data acquisition rate four time faster and covers more than double the size range.
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 Within the draft guidance for the characterization of nasal sprays, for example, the FDA has recommended the use of laser diffraction to determine the droplet size produced for a given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 says its new Spraytec system is unparalleled amongst laser diffraction systems for the measurement of particle size. The brand is already 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 characterisation 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 atomisation and dispersion. This makes the system particularly useful for tracking the production of particles during the actuation of the pharmaceutical device, even the rapid changes in particle size that take place during inhaler operation can be followed. according to Paul Kippax, product manager at Malvern.
In addition, an extended size range from 0.1 - covering most pharmaceutical inhaler particles - up 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," said the company in a statement.
Other new features include the addition of Standard Operating Procedures wizard which 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, according to Malvern.
