Validation support for laser diffraction particle sizing
Support available for companies upgrading from Malvern Instruments' discontinued Mastersizer 2000 to the more flexible and powerful Mastersizer 3000
Reading Scientific Services Ltd (RSSL) now provides direct support to customers in the pharmaceutical industry for the transfer of validated particle sizing methods to the latest generation of laser diffraction instrumentation. This follows the recent announcement from Malvern Instruments that the company’s Mastersizer 2000 ceased production in early 2015 and has been superseded by the more flexible and powerful Mastersizer 3000.
The Mastersizer 3000 software offers many method development and analysis support capabilities to assist customers in transferring methods from the Mastersizer 2000, including the ability to open Mastersizer 2000 record files, reanalyse Mastersizer 2000 results and also apply Mastersizer 2000 analysis methods to Mastersizer 3000 data. As a result, many customers have already transferred seamlessly to the new system.
However, there remains a need for method validation or equivalency studies to be performed, especially when transferring methods for pharmaceutical product analysis. This is particularly true when measuring materials containing nano-sized particles or using dry powder dispersion, as this is one application where the Mastersizer 3000 offers significantly improved performance compared with the Mastersizer 2000.
'Depending on the phase of drug product or API development, it may be necessary to re-validate methods which need to be transferred from the Mastersizer 2000 to the Mastersizer 3000, whether fully, or at least as part of an equivalency study,' says Chris Aiken, Head of RSSL's Physical Chemistry laboratory. 'Method parameters will generally need to be understood and optimised, with consideration of the differences between the instruments relating to measurement range and dispersion capabilities.'
RSSL operates both of the Mastersizer platforms, and is a partner laboratory for Malvern in the UK, offering support to customers and other laboratories to guide them through the method development and transfer/validation process. 'Method transfer and validation should be considered by many laboratories who currently use Mastersizer 2000 methods well in advance of the end of Malvern’s period of guaranteed service support for the Mastersizer 2000 in March 2022,' notes Aiken.
