The WHT 3ME instrument is designed to automatically measure the four parameters weight, height, diameter (or length) and hardness for either round or odd shaped tablet forms. It is in full compliance with EP <2.9.8> and USP <1217> pharmacopeia. It features unique sample positioning “flaps” for correct orientation of oblongs, caplets or other odd shaped samples in the combined hardness and diameter test station. Having a built-in carousel for sample transport, the WHT 3ME can be used with or without an automated batch feeding system. Simply place one sample into each of the 20 available segments of the carousel and start the test. This is especially useful to do a quick trial run on a small batch of samples during R&D or method development.
There are two batch feeders for auto transport of samples directly into the WHT 3ME available: each of the ten sample containers within the WHT SM can have a different method associated with it; the WHT SM1 single batch feeder is able to collect samples directly from a sample chute of a tablet press. In both cases vibration tracks are used to separate the samples and introduce them into the WHT 3ME. The two system components, feeder and testing system, are not connected to each other to avoid vibration transfer, reduce the tare time of the balance and ease cleaning for both units.
The system is controlled by the WHT 32 software which features many adjustable parameters to reliably test most shapes and forms of tablets. WHT32 can be upgraded to be fully 21 CFR Part 11 compliant, including user administration and audit trail features. The testing procedure for each sample is stored as a method including instrument control information such as force increase rate for the hardness test, break detection, transport speed of the feeder, movement of the flaps as well as product descriptive information. All test results are immediately displayed, filed and presented as reports including statistical information and batch comparison features. For further calculations export to Excel is supported. Also available are network and LIMS data transfer options.
A note on calibration: The current USP Pharmacopeia requires the force sensor of a tablet hardness testing instrument to be calibrated periodically over the complete measuring range (or the range used for measuring samples) with a precision of 1N. All Pharma Test tablet hardness testing instrument can be statically calibrated over the complete measuring range by the use of different tracebale counterweights. All instruments support the checking of at least three different points during calibration to prove the linearity of the force sensor. Furthermore, Pharma Test offers the PT-MT magnetic tablets to calibrate the breakpoint detection of the whole tablet hardness testing instrument (force sensor and mechanics of the instrument). All Pharma Test tablet hardness testing instruments are fully compliant to the requirements of the current USP Pharmacopeia.
- Fully USP <1217> and EP <2.9.8> compliant
- Test weight, thickness, diameter and hardness of tablets automatically
- Dual force mode instrument with linear speed increase and linear force increase modes
- Multi and single batch feeders available
- Validation programs for all four testing stations included
- Includes the powerful WHT32 software package
- WHT32 offers full 21CFR part 11 compliance and networkability