Physical testing refers to the monitoring of physical characteristics of a drug product, typically oral dosage forms such as tablets and capsules. Physical testing examines the physical attributes of the drug form, such as disintegration, powder flowability, tablet dimensions, and tablet breaking force.
Automated Disintegration Testing
The new Disi AutoSense™ delivers fully automated disintegration testing in compliance with USP <701> and <2040> and their harmonized EP and JP methods. Controlled by sophisticated software, the system measures and stores test data while displaying in‐process disintegration values graphically in real time. 21 CFR Part 11 compliance is enhanced by secure audit trails, data security, and advanced user permissions settings. Every AutoSense system is supported by Teledyne Hanson’s world-renowned installation, qualification, and maintenance support services.
The Flodex is a simple-to-use tool that helps you determine a reliable and repeatable flowability index over an arbitrary scale of 4 to 40 to use as a specification for your raw materials. This one simple test takes in account the numerous parameters that affect powder flowability such as particle size and shape, “fines,” unit surface, actual and bulk density, porosity, settling, and electrostatic charge.
Accurate evaluation of a tablet’s physical characteristics, especially tablet breaking force (hardness) is essential to product development, manufacturing, and quality control. Tablet breaking force is a crucial characteristic in the manufacturing of solid dose formulations, affecting bonding and integrity of the final form, and its ability to withstand the stresses of production, packaging, and transportation. An incorrect degree of hardness further affects the dissolution properties of the tablet, potentially causing it to release active pharmaceutical ingredients too quickly or too slowly.
XTRX500 Sample Preparation Extractor
Traditional methods of sample extraction are often tedious and time-consuming, especially with problematic drug formulations that may take many hours to dissolve. Teledyne Hanson’s new Sample Preparation Extractor (XTRX500) provides an advanced, efficient solution for rapid extraction through an innovative, proprietary combination of high frequency pulverization and forced jet mixing in a compact, programmable platform.