Equipment and Processing Report
PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the January 2010 edition from Malvern and OYSTAR.
Software facilitates chromatographic measurements
Malvern’s (Malvern, England) OmniSEC software supports gel-permeation chromatography (GPC) and size-exclusion chromatography (SEC) in quality-assurance applications. It enables proteins’ absolute molecular weight to be measured accurately with light scattering. The product also can determine the solution’s concentration and oligomeric composition. In addition, the software displays the size of proteins, thus enabling scientists to check for denaturing, oligomers, aggregates, and contaminants.
The product’s polymer-branching view helps indicate the density of drug-delivery matrices. Scientists can use the view to determine whether an active ingredient loads equally in the matrix at different weights.
The system simplifies GPC and SEC by selecting the baseline and integration limits automatically. Scientists can obtain results with two mouse clicks and do not need to adjust the software during operation. The product can be used for lot release at production sites.
OYSTAR USA Process Division
Machine performs efficient granulations and particle coating
The Hüttlin HDGC fluid bed from the OYSTAR USA Process Division (Fairfield, NJ) allows operators to perform fluid-bed drying, granulation, and coating in one product container. The device’s Diskjet air-distribution plate includes laser-cut, 150-µm wide slots positioned radially at a 45° angle. The slots enable process air to move product upward in a circular motion, unlike the convection movement in a typical fluid-bed dryer. The slots also move the product at a higher velocity than a typical unit does. The circular motion and higher speed facilitate fast and homogeneous mixing.
The Hüttlin HDGC machine uses the same nozzles, which are embedded in the Diskjet at a 45° angle, for bottom-spray coating and granulation. The nozzles include a microclimate compressed-air supply that helps prevent nozzle blockage. Because of the circular motion, product passes in front of the nozzles more frequently than it does in a typical fluid-bed dryer, thus reducing granulation time by about 30%, according to the company.