Contract development and manufacturing organisation DPT Laboratories is using Spraytec laser diffraction particle size analysers from Malvern Instruments at two different locations.
Dr Vitthal Kulkarni, scientific advisor at DPT, said that the Spraytec systems are used in product development as well as for stability studies and routine quality control during manufacture.
He said: 'We use the Spraytec systems in all our nasal spray work.
'They allow us to examine the homogeneity of the products in terms of the droplet size distribution and enable us to meet FDA [Food and Drug Administration] testing requirements,' added Kulkarni.
FDA guidance for nasal sprays recommends the use of laser diffraction to determine the droplet size produced for a given device and formulation.
According to Kulkarni, the software automates all parts of the measurement process, including extraction, allowing DPT to ensure the effective measurement of a good spray plume.
'The system's standard operating procedures are especially good in the QC environment, and the fact that the software is 21CFR Part 11 compliant means that it can be used throughout the development and manufacturing processes,' he added.
Spraytec is designed to provide real-time particle size measurement for particles in the size range 0.1 to 2,000 microns, enabling the capture of the fine detail of aerosol formation and dynamic droplet behaviour.
This allows each phase of liquid atomisation to be measured and identified during nasal spray operation in line with the FDA guidance.
