Introduction of Pharma Pro

Microscopic size and shape analysis of particles can be performed by using powerful “Pharma Pro” Image Analyse software. Thousands of Particles are automatically being detected & analysed in a matter of few seconds. Measurement methods are easily set-up in advance and performed using intuitive software wizard features, easily following the required operating procedures. Access to system configuration, calibration and measurement set-up are managed ensuring “FDA 21 CFR Part 11” compliancy. Results are displayed in both graphical and tabular format, stastical parameters and comparisons for particle size and shape Manufacturing are calculated.

Need for particle size control in the manufacture of Pharmaceutical industry attempts to capitalize on some with less than ideal solubility profiles. The interest in particle size measurements will remain high, particularly in view of FDA trends toward recommending more through descriptions of particle size distributions in submissions in which the emphasis of a drug product claim is based in tightly controlled particle size. Microscopes and digital image Analyse can be used for:

• Determination of particle size distribution.

• Particle shape e.g. aspect ratio (ratio between breath and length) which gives valuable extra information.

• Overview of particles dispersed in liquid or air.

• Observation of foreign particles in the sample (pollution).

• Measurement of object sizes e.g. mesh size of sieves.