Particle size distribution

Malvern provide comprehensive validation support and all systems comply with 21 CFR part 11.

MALVERN MASTERSIZER 2000

0.02 to 2000 microns, wet dispersions, and dry powders

Reliable particle sizing requires a systematic approach, as is clearly set out in the ISO13320 standard. Key aspects of the measurements are efficient sample dispersion and the use of standard operating procedures. In the design of the Malvern Mastersizer 2000, sample dispersion and standard operating procedures are fully integrated, thereby meeting the need for global comparability of results.

Mastersizer 2000 Particle sizing 0.02 to 2000 microns. Pictured here with the manual wet dispersion unit with the sample dispersed in a standard laboratory beaker.

Efficient dispersion

Particle size measurements need to be made using well dispersed, homogeneous samples without introduced sampling bias. Efficient dispersion is the key, which is why with the Malvern Mastersizer has a range of dispersion units, each optimised for particular types of materials. Samples can be dispersed either wet or dry, using water or solvents, with rapid change over between methods.

Range of dispersion units

HYDRO G and S	SCIROCCO
Wet dispersion units. The G, for general use, 800ml capacity, ideal for denser material. The S, for small volume (50ml) or solvent dispersion.	Automated dry dispersion unit which has the precise control needed for fragile and small pharmaceutical samples.
MICRO PRECISION	AUTOSAMPLER
Accurate scale down. Only 18 ml of water or solvent required. Tiny mg quantities of sample. Ideal for valuable materials.	Fully automates the analysis of dry powders, suspensions and emulsions. 36 sample positions with bar code reader.

ISO and Standard Operating Procedures.

ISO details the requirements for Standard Operating Procedures. The Mastersizer 2000 features a wizard for step by step development of SOPs, which guides the operator through the measurement process. A high level of security ensures that the procedures are always applied, providing global harmonisation of results. The system is fully validated, including compliance with 21 CFR part11. The ISO standard also states the importance of choosing the correct optical model. It recommends that Mie theory be used for particles below 50 microns and that it be applied across the full size range. The extensive Mastersizer data base provides for the full implementation of Mie theory.

MALVERN MASTERSIZER MICRO

0.3 to 300 microns, wet dispersions

The unique folded optics of the Mastersizer Micro gives it a small footprint requiring minimal bench space. Pre programmed icons make instrument set up and analysis easy so that even inexperienced users can perform measurements quickly and reproducibly.

The optics are aligned automatically, and there are no lenses to change. Samples are presented in a standard 800ml lab beaker. The integral 'dip-in' probe provides sample agitation, sonication, and circulation through the flow cell. The cell is very accessible and easy to clean.

The micro utilises Malverns extensive software experience applying full Mie theory algorithms together with the Fraunhofer approximation.

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