- GALENIC INSTRUMENTS
- DISSOLUTION TESTING
- OVERVIEW ALL PRODUCTS
PTB-M is a manual hardness testing instrument for tablets. The instrument is made in strict compliance with the EP [2.9.8] and USP  Pharmacopoeia. PTB-M is very easy to use. Simply place the sample on the testing platform and rotate the knob manually. The jaw will move and force will be applied to the sample. The force is monitored electronically and displayed at the moment of breakage.
PTB-M manual hardness testing instrument
The hardness value is displayed on the four digit LED display in either Newton (N), Kilopond (Kp), StrongCobb (Sc) or Pounds (Lb). The units can be changed by the press on one button on the instruments control panel. The instrument is battery operated. A power adapter may also be used and is included in the standard supply scope. The results can be documented by connecting a PT-RP80 report printer to the serial printer port of the PTB-M.
Calibration and Validation
Using the certified PTB-CAL15 weight set, calibration of PTB-M can be carried out on site and requires only a few minutes. 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 traceable counterweights.
Further Features and Options
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-MT3 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. The PTB-M offers a built-in calibration and validation program for the hardness test station. To validate the hardness test station the PT-MT3 magnetic tablet or different certified counterweights are used. Use the PT-MT3 to qualify the correct breakpoint detection, the PT-MT3 instrument works like a tablet, it withstands force and after "breaks". For the two point adjustment (zero and reference) of the load cell inside the hardness station a certified reference weight of 10 kg is used. For validation purposes the use of 5 up to 30kg certified weights is recommended. All adjustment and calibration results can be printed and countersigned.
PTB-M with a connected ticket printer
|Display||LED Display, 4 digits showing hardness result|
|Data Entry||Functional keys|
|Standard Force Range||5.0 to approximately 300N (500N optional)|
|Maximum Sample Size||28 mm diameter|
|Printer||Printer port to connect PT-RP80 report printer|
|Interface||RS-232 COM port|
|Calibration Guidance||Built-in calibration procedure for the digital load cell|
|Adjustments||Two point adjustment - zero and 10kg|
|Calibrations||Multiple point for load cell precision using certified weights (CAL15/30)|
|Force Detection Reproducibility||PT-MT3 Magnetic Tablet and suitable support|
|Bench Space Requirement||275cm x 90 x 100 mm (Length x Width x Height) without external printer|
|Certification||All components certified to USP / EP requirements|
|CE / EMC Certification||All CE / EMC Certification provided|
|Validation||All IQ & OQ documents included|
We reserve the right to make technical changes without any prior notice.
The PTB-M comes ready to use with the following standard scope of supply:
In addition to the standard scope of supply Pharma Test offers a broad range of accessories and options including: