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. 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. Pharma Test Apparatebau AG Siemensstr. 5 63512 HAINBURG GERMANY T: +49 6182 9532-600 F: +49 6182 9532-650 [email protected] www.pharma-test.com THE PHARMA TEST GROUP

PTB-M - Manual Tablet Hardness testing Instrument 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. All instruments...

PTB-M - Manual Tablet Hardness testing Instrument Example Test Report Hardness Tester PTB-M 300N COMPANY NAME:Pharma Test LOCATION:QC Lab INST. SR. NO.:20378 2.81 MODEL NO:PTB-M CAL. DATE:06/06/15 CAL. DUE DATE:06/09/15 TEST DATE: 06/06/15 15:42 PRODUCT:_______________ BATCH :_______________ TEST DETAILS UNIT: N _______________________ SR. NO. HARDNESS _______________________ 1 30.1 2 30.2 3 30.0 4 29.9 5 30.1 6 30.0 7 30.1 8 30.1 9 30.2 10 30.1 _______________________ MAX : 30.2 MIN : 29.9 MEAN: 30.1 PERFORMED BY:_______________ APPROVED BY :_______________

PTB-M - Manual Tablet Hardness testing Instrument 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 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...

PTB-M - Manual Tablet Hardness testing Instrument Technical Specifications Parameter Display Data Entry Standard Force Range Accuracy Maximum Sample Size Printer Interface Calibration Guidance Adjustments Calibrations Force Detection Reproducibility Bench Space Requirement Certification CE / EMC Certification Validation Specification LED Display, 4 digits showing hardness result Functional keys 5.0 to approximately 300N (500N optional) 0.1N 28 mm diameter Printer port to connect PT-RP80 report printer RS-232 COM port Built-in calibration procedure for the digital load cell Two point adjustment...