Malvern Instruments has released new ‘third anniversary’ accessories for the Mastersizer 3000, helping to reduce the time and cost of developing and validating robust methods for pharmaceutical particle size analysis.
Particle size analysis is a critical activity for the pharmaceutical industry due to the correlations between particle size and bioavailability.
Hydro Sight, an innovative, lens-less imagery accessory enables real-time visual monitoring of dispersion, providing information to swiftly optimize and validate a method. The Hydro SV (small volume) cell allows method development and reliable particle size analysis, with only a few milliliters of a sample.
Pharmaceutical portfolio manager for Malvern Instruments, Dr Paul Kippax said: "In combination, these accessories considerably ease the burden associated with routine particle sizing within the pharmaceutical industry.
"Developing, validating and transferring particle sizing methods efficiently and cost-effectively is essential for this sector.
"Used together the accessories support a QbD approach from the very earliest stages of drug development."
A key step in laser diffraction particle sizing is to achieve appropriate dispersion to ensure that the measured particle size is representative of the sample and relevant to the application.
Hydro Sight is a cutting-edge accessory that images particles in real-time, as they undergo wet dispersion in the analyzer.
Measurements of size and shape (elongation) distribution in combination with a unique ‘dispersion index’ provides continuous insight into dispersion behavior. It also confirms the consistency and completeness of the dispersion process.
An advanced anomaly detection function automatically records images of outlying particles, which are unusual sizes or shapes. The resulting information cuts the cost and time associated with method development, analytical troubleshooting, method validation and the transfer of analytical techniques from research and development through to quality control.