PHYSICAL TESTING

Overview Group

Overview

 

Hardness Testing

Tablet hardness - sometimes also referred to as tablet break force - measures the mechanical integrity of a tablet. Dr. Schleuniger Pharmatron hardness testers with precision measuring technology, EP & USP compliant design and Swiss quality components guarantee highest accuracy for test results you can rely on. Since 1972, measuring of weight, thickness, width, diameter and hardness of virtually all tablet shapes from round to oval, oblong and special shapes is our core competence.

 

Disintegration Testing

Disintegration testing determines whether tablets or capsules disintegrate within a defined period of time when placed in a liquid medium. Dr. Schleuniger® Pharmatron disintegration testers as required by current Pharmacopeia provide a reproducible and standardized method of ensuring that disintegration has taken place. In automatic tablet disintegration testing, the disintegration time including disintegration characteristics is recorded automatically.

 

Friability Tester

Front loading of tablets and automatic discharge. Easy menu navigation with SingleButton™ operation. Flexible operation including timer, counter or speed mode Calculation of percent friability and Test Report printed Fully menu-guided qualification procedure.

 

Powder and Granulate Flow Tester

The PF 1 powder flow tester has been specifically designed for standardized testing in full compliance with Pharmacopeia requirements as laid down in USP <1174> and EP 2.9.36. Its optimized design allows for different, yet easily repeatable test conditions and methods for powder flow characterization. Change-over between configurations is simple with quickchange components that do not require any additional Tools.

 

Tap Density Tester

Full compliance with all USP, EP, ASTM and DIN EN ISO requirements. One single cylinder station for all measurement methods. Simple handling with “easy to lock” cylinders and SingleButton™operation. Automatic calculation and print-out of test results and Professional reporting and data management.

 

Cap Torque Tester

Precise measurement of cap torque. Flexible bottle holder. Universal or custom-made cap adapters. Ideally suited for child-resistant closures. Motorized drive for high repeatability. Printing of reports

 

Online Content Uniformity (CU) with NIR

Regulatory authorities require the accurate analysis of finished pharmaceutical goods to confirm the products’ content uniformity and physical characteristics. Traditionally, content uniformity analysis has been performed offline by liquid chromatography. This time-consuming and operator-intensive process requires a manual collection of samples during a batch followed by laboratory Analysis. 

Near-infrared (NIR) transmission spectroscopy has proven to be a reliable, rapid and non-destructive alternative for routine tablet content uniformity testing along with moisture and excipient analysis. The TANDEM IIIA combines Bruker’s MATRIX FT-NIR spectrometer with an AutoTest 4 tablet tester by Dr. SchleunigerR Pharmatron into one fully automated tablet testing system. Whether operated stand-alone or fully integrated with a tablet press, the system provides real-time information about a tablet’s content uniformity (CU) and physical properties such as weight, thickness, diameter/length and hardness. While collecting real-time process data helps you to improve your process understanding, the TANDEM IIIA also allows control of the tablet compression process and can be easily deployed as an integral part of your continuous manufacturing strategy using a standardized OPC protocol.

 

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