Manual Tablet Hardness Testing Instrument with Integrated Report Printer
Model: PTB 111EP/111EP-500/111EP-800
Manufacturer: Pharma Test
Country of Origin: Germany
The PTB 111EP, PTB 111EP-500, and PTB 111EP-800 models are highly reliable instruments designed for tablet hardness testing, utilizing dual force functionality. This dual-force program allows measurements with linear speed increase and linear force increase. Hardness tests are conducted according to USP <1217> and EP <2.9.8> Pharmacopeia standards. Each model is equipped with an integrated report printer for convenient documentation of test results.
The instrument features an LED display with function keys that show the test number and hardness result. It includes integrated multi-point validation and calibration processes, with the option for automatic device restart to speed up test sequences. For enhanced efficiency, it also automatically detects the sample diameter.
Testing Procedure
Users can input batch numbers, test parameters, and the desired unit of measurement (KP, N, or SC) via the display and keyboard. The sample is then placed in the test area, and the test begins. The crusher moves toward the sample at a recommended speed of 20 N/sec. Upon contact with the tablet, the force increases at a linear rate until the sample breaks. The breaking force is immediately displayed on the screen and can be printed via the built-in printer.
This process repeats for all samples in the batch. The user can enter a batch number of up to 12 digits. A complete printout of the data includes individual results for each sample, as well as the date, time, serial number of the instrument, batch number, average value, and deviations.
The built-in thermal printer ensures cost savings due to its reduced paper consumption and space-saving design, eliminating the need for an external printer.
Operating Principle
Hardness results are directly influenced by the speed of contact and the rate of force increase. A higher speed reduces reproducibility, which is why these instruments maintain controlled speeds for accurate measurements.
Calibration and Validation
The instruments comply with USP Pharmacopeia requirements, which mandate periodic calibration of the force sensor across the entire measurement range with an accuracy of 1 N. All test results can be easily transferred to PC software for record-keeping.
Technical Specifications
- Hardness Testing Range:
- PTB 111EP: 5.0 to 300 N ±2 N
- PTB 111EP-500: 10.0 to 500 N ±5 N
- PTB 111EP-800: 10.0 to 800 N ±5 N
- Hardness Measurement Options:
- Linear speed increase (Millimeter/Minute)
- Linear force increase
- Force Accuracy: Better than ±1 N
- Resolution: 0.1 N
- Unit Selection: Newton (N), Kilopond (kp), Strong Cobb (Sc)
- Force Measurement Range (Linear Increase):
- PTB 111EP/500: 5–200 N/sec
- PTB 111EP-800: 10–200 N/sec
- Multi-Point Validation: Up to 30 or 50 kg
- Breaking Point Detection Range: Min. 2 mm, Max. 10 mm
- Touch Force Detection: Min. 48 digits (~3 N), Max. 999 digits
- Built-in Printer: Thermo-Printer Miniplus-P3B, parallel, 58 mm width, 30 mm paper roll diameter
- Data Transfer: RS232 port for PC connection, USB for connecting PCL 3-5 printers
- Construction: Stainless steel (304) compliant with GLP standards
- Power Supply: 115V AC or 230V, 50/60 Hz
- Power Consumption: 0.15 A at 230V, 0.30 A at 115V; 35 W
- Main Electrical Fuse: 2 x T1.0 A
Installation Requirements:
- Ambient Temperature: 15–35°C
- Relative Humidity: 15–80%
- Workspace: Bench capable of supporting at least 50 kg, with 10 cm clearance from walls or other equipment, and easy access to main power outlets.
- Dimensions (WxDxH): 500 x 260 x 260 mm (without external printer)
- Weight: 9.5 kg / 12.5 kg
Supplied with:
- Standard jaw set for hardness testing of all sample sizes and shapes
- Broken sample collector
- Information folder including:
- User manual
- DQ/QC testing certificate
- IQ and OQ documentation
- Instrument logbook
- CE certification
- Certificate of compliance
Optional Add-ons:
- Force range extensions: PTB 111EP-500 (500 N), PTB 111EP-800 (800 N)
- PCL5 Laser or Dot-Matrix printer
- Recommended spare parts set
- Tensile test kit for tablet fracture testing