Specified to meet the stringent requirements of today’s pharmaceutical industry for secure, reliable particle size analysis, the new Mastersizer 3000 laser diffraction system from Malvern Instruments provides a single platform that can be used throughout the drug development cycle, with easy transfer of methods from R&D right through to QC.
The Mastersizer 3000’s design and capabilities owe much to Malvern’s more than 30 years’ experience of working with the pharmaceutical industry and the company’s deep understanding of the industry’s needs. Most importantly, the Mastersizer 3000 delivers high performance across a very wide particle size range from 10 nm to 3500 microns, with faster-than-ever measurement times and robust, dependable results. Having the best quality data throughout the drug development cycle means critical decisions can be made quickly and with confidence.
The Mastersizer 3000’s Aero S accessory brings the advantages of dry powder dispersion to even the most fragile of pharmaceutical materials, including crystalline active ingredients. The challenge here is to apply enough energy to disperse the sample and loose agglomerates but not so much that breakage of primary particles starts to occur. USP <429> recommends that “the dispersion procedure is adjusted to meet the purpose of the measurement”. The Aero S incorporates the very latest in dispersion research, enabling the Mastersizer 3000 to meet this need by applying gentle but highly effective dispersion, with no impaction surfaces. This results in efficient dispersion of even cohesive or delicate particles, without primary particle damage, and means quick and easy access to the particle size information of interest for an extended range of materials.
Whether measuring dry or wet, the Mastersizer 3000 provides embedded expert guidance and assurance, from method development through to routine measurement. Data integrity is crucial for any analysis, and nowhere more so that in the pharmaceutical industry. During method development, real-time feedback from the Mastersizer 3000 simplifies the identification of a procedure that meets USP <429> and/or ISO13320 standards for repeatability and reproducibility. Such methods are then locked down for transfer or daily use assuring application of a consistent method, but beyond this Mastersizer 3000 provides continuous critical assessment of the measurement data. By alerting the user to any problem with the measurement it reduces the chance of poor quality data going undetected into the information chain.
Since Malvern takes the strict validation requirements of its customers very seriously, full IQ/OQ and PQ validation and documentation is automatically available. The Mastersizer 3000 software also takes full advantage of the security features in the latest windows operating systems to allow full compliance with CFR21 part 11.
Underpinning the performance of the Mastersizer 3000 is Malvern’s extensive applications expertise and a global support network committed to delivering the highest levels of service everywhere in the world. Malvern works with the pharmaceutical industry at the forefront of particle technology, embedding knowledge into its instruments, providing comprehensive on-line tools and support, and making its store of knowledge and experience available through its expert teams and individuals whenever and wherever it is needed.