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PTB-M

PTB-M manual tablet hardness testing instrument


PTB-M

PTB-M manual tablet hardness testing instrument

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 [1217] 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


Test Procedure

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



Features
  • Fully USP [1217] and EP [2.9.8] compliant
  • Hardness Range: 5 N to approx. 300 N (500N optional)
  • Accuracy: 0.1 N
  • Resolution: 0.1 N/0.01 Kp
  • Test tablet sizes of up to 28mm diameter
  • Includes a 4 digit LED display and indicator for selected unit
  • Connect PT-RP80 report printer to document the results (optional)
  • Calibration program included


Advantages
  • Compact, portable instrument
  • Features the same high quality force sensor as other Pharma Test hardness testers
  • Very easy to use, immediate results
  • Entry of time and date
  • Can be operated by 9V battery or using supplied power adapter
  • Select result display unit from Newton (N), Kilopond (Kp), StrongCobb (Sc) and Pounds (Lb)
  • Documentation of all results using the optional PT-RP80 report printer
  • Easy to calibrate

Technical Specifications

Parameter Specification
Display LED Display, 4 digits showing hardness result
Data Entry Functional keys
Standard Force Range 5.0 to approximately 300N (500N optional)
Accuracy 0.1N
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.



Included in the Standard Supply Scope

The PTB-M comes ready to use with the following standard scope of supply:

  • Removable broken sample container and cleaning brush
  • Power adapter
  • Comprehensive documentation folder including:
    • User manual
    • QC/DQ testing certificate
    • IQ documentation
    • OQ documentation
    • Conformity Declaration
    • CE/EMC Declaration
    • Instrument logbook

Downloads
Brochure PTB-M



Options

In addition to the standard scope of supply Pharma Test offers a broad range of accessories and options including:

  • 500N (PTB-M500) extended force range
  • PT-RP80 report printer to document results
  • Recommended spare part set
  • Full range of certified validation tools available



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