Used at two different locations within contract development and manufacturing organization DPT Laboratories (San Antonio, Texas), Spraytec laser diffraction particle size analyzers from Malvern Instruments have assured their place in the company’s nasal spray development and manufacturing areas by being both highly effective and very user friendly.
Dr Vitthal Kulkarni, Scientific Advisor at DPT confirmed that the Spraytec systems are used not only in product development, but also for stability studies and for routine quality control during manufacture. “We use the Spraytec systems in all our nasal spray work,” he said. “They allow us to examine the homogeneity of the products in terms of the droplet size distribution and enable us to meet FDA testing requirements.” FDA guidance for nasal sprays recommends the use of laser diffraction to determine the droplet size produced for a given device and formulation.
“The Spraytec is simple to use and we have been able to train our analysts very quickly,” continued Dr Kulkarni. “We are particularly impressed with the software, which automates all parts of the measurement process, including extraction, allowing us to ensure 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 21 CFR Part11 compliant means that it can be used throughout the development and manufacturing processes.”
Spraytec is designed to provide real-time particle size measurement for particles in the size range 0.1 to 2,000 microns, allowing 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.
For further details about Spraytec visit www.malvern.com/spraytec_OINDP
For more information about DPT Laboratories, visit www.DPTLabs.com.
Malvern and Malvern Instruments are registered trademarks of Malvern Instruments Ltd
Spraytec is a trademark of Malvern Instruments Ltd