PTB 111E is designed to test the hardness of any solid sample up to 300 or alternatively 500 or 800N (Newton) and to be easy to use. The instrument meets the requirements of the current EP <2.9.8> and USP <1217> Pharmacopeia. The test result is immediately displayed on the bright and well legible LED display of the instrument. PTB 111E is a dual force mode instrument that offers the possibility of testing the hardness of solid in either adjustable constant force or constant speed mode. The instrument is equipped with a printer port to record the results and a RS-232 COM-port for data transfer. We offer the optional PTB32 software package to store and handle the results from the PTB 111E instrument. An upgrade to add 21 CFR Part 11 compliance to the PTB32 software is available as well.
Enter the nominal test information for hardness as well as a batch number via the PTB 111E keyboard. Select the unit to measure, KP (Kilopond), N (Newton) or Sc (Strong Cobb), now place the sample onto the sample dish and start the test. The force jaw will move forward, touch the sample and apply force to the tablet until it breaks. This way the hardness (tablet breaking force) is measured. Once all samples have been tested, simply press the <STOP>-key and automatically the results including statistical information are printed via a connected printer. The auto re-start option allows a faster test and higher throughput of samples compared with a manual start procedure. Depending on the actual tablet hardness you can test between 6 to 10 samples per minute.
The flexibility of the instrument and the reproducibility of the results have made this and other models of this series, like the PTB 311E become one of the most sold tablet hardness testing instruments worldwide.
PTB 111E offers an integrated program for adjustment and 3-point calibration. For the static adjustment of the built-in digital load cell a certified 10kg reference weight is required. Static calibration and qualification of the load cell is performed using certified reference weights of 5, 10, 15, 30 and 50kg. To calibrate the breakpoint detection and reproducibility of the instrument we offer the PT-MT3 magnetic test tablet. PT-MT3 is also used for a dynamic calibration of the load cell, instead of using the reference weights. Dedicated reports document the validation of the Instrument.
A Note on Calibration and Regulatory Requirements
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
- 300, 500 and 800N max. hardness range models available
- Dual force mode instrument with linear speed increase and linear force increase modes
- Multiple point validation procedure built-in
- Programmable print-out of force increase curve
- Set to test tension strength of oblongs and caplets available