Pharma test PTB M100 manual hardness tester
The Pharma Test PTB M100 is a lightweight, high-precision, and easy-to-use manual tablet hardness tester designed for on-site sampling (IPC) at the pharmaceutical tablet press, early-stage screening in R&D, academic teaching, and on-site quality inspection.
I. Fully compliant with international standards and specifications of the United States Pharmacopeia (USP) <1217> and the European Pharmacopeia (EP) <2.9.8>, providing a compliant and highly standardized measurement basis for tablet breaking force (hardness) testing.
II. It adopts a manual ergonomic knob/handwheel force application design, combined with a high-precision electronic load cell, which can accurately capture and record the tablet's rupture limit force value in a very short time.
III. Featuring a lightweight, portable design and a portable power supply, it is ideal for at-line inspection (IPC), on-site inspection, or flexible mobile sampling between multiple laboratory stations.
IV. Equipped with a clear and easy-to-read digital display screen and intuitive one-key zeroing function, it effectively reduces human interpretation errors and provides objective and highly reproducible test data for real-time quality control and early-stage R&D of solid formulations.
Equipment Introduction
Compact Portable & Flexible Power Supply Design :
High mobility for production line inspection : The compact and lightweight structure of the machine allows quality control and operators to move between the machines on the ingot production line for inspection.
AC/DC Dual Power Supply : Supports AC/DC dual-mode power supply (built-in rechargeable battery or external power transformer), completely unrestricted by socket location, and provides excellent mobility for on-site inspection.
Intuitive and easy-to-use manual force application and peak force detection :
Ergonomic hand crank propulsion : It adopts a precision ergonomic hand crank propulsion mechanism, which is smooth and effortless, allowing users to easily and smoothly control the force application process.
Microprocessor peak lock : The peak force is automatically and precisely locked by the microprocessor at the moment of sample breakage, completely eliminating operator reading errors.
Enlarged spacing measuring fixture : Optional enlarged spacing measuring tools and clamps are available, suitable for hardness testing of large-size tablets, long strip tablets or animal drugs (veterinary tablets).
High-Precision Electronic Force Sensing System :
Precision digital load cell : Equipped with a high-sensitivity digital load cell, providing a resolution of up to 0.1 N and a measurement accuracy of better than ±1 N.
One-click switching of multiple measurement units : Supports one-click instant switching of various internationally used hardness units such as Newton (N), kilopond (kp / Kilopond) and Strong-Cobb (Sc / Strong-Cobb).
Clear Digital Display & One-Touch Tare Function :
High-contrast LCD screen : Equipped with a high-contrast LCD digital display screen, clearly and instantly displaying the applied force values and the final breaking force results.
Single-key quick zeroing : Features single-key quick zeroing and reset (Tare / Reset) functions, which significantly shortens the test cycle time between samples and improves the efficiency of production line inspection.
Rugged GMP Durability & Easy-to-Clean Design :
Pharmaceutical-grade corrosion-resistant material : The test area is made of corrosion-resistant stainless steel and highly wear-resistant materials, which can withstand wiping with alcohol and disinfectants and meet GMP cleanroom cleaning standards.
Open-type anti-fragmentation structure : The open testing platform and material drop space facilitate the quick cleaning of broken tablet fragments and dust, preventing cross-contamination of samples.
Product Features
Weighing only about 3.5~4.0 kg, it supports rechargeable battery power.
Ergonomic design
Hand-crank knob provides smooth force application
Eliminates human visual reading errors
Resolution up to 0.1 N; accuracy better than ±1 N
Overall Specifications
Product Model : PTB-M100
Manufacturer : Pharma Test Apparatebau AG (Germany)
Version Specification : Version 1.0
Product positioning and operating principles :
Portable manual tablet hardness tester designed for pharmaceutical production line inspection, in-process control (IPC), R&D, and quality control design.
It uses a high-precision load cell (Force Sensor) to sense the breaking force in real time and displays the test results on a large-size color touch screen.
Manual rotary knob feeding mechanism: After the sample is placed on the test platform, rotate the right knob to drive the jaws to apply force to the sample. The operation is intuitive, fast and has an excellent feel.
Flexible mobile testing: The robust and compact body with a built-in rechargeable battery provides approximately 2 hours of independent operation, making it ideal for mobile testing in production workshops and at multiple inspection stations.
International Pharmacopoeia and regulatory compliance :
It fully complies with the European Pharmacopoeia EP <2.9.8> specifications for tablet shatter resistance.
It fully complies with the United States Pharmacopeia (USP) <1217> Tablet Rupture Force Specification.
It has complete CE and EMC electromagnetic compatibility certifications.
Touchscreen operation and software functions :
A 3.5-inch high-resolution color LCD touchscreen displays the force application process and fracture values in real time.
Multiple hardness unit switching: supports Newton (N), kilogram force (Kp) and StrongCobb (Sc).
Software Virtual Keyboard: When starting a new batch test, you can directly enter the alpha-numeric batch number.
Single-batch rolling datasheet: Supports up to 100 samples per test. Supports defective sample rejection function (rejected data is still fully recorded in the report, but is not included in statistical calculations).
Data storage and reprinting: The latest test results are automatically stored in the host memory and can be reprinted; starting a new test will automatically overwrite the previously stored data.
Password security protection: Date, time, correction and adjustment functions all have password protection mechanisms to prevent unauthorized tampering.
Time and date format: Supports 12-hour/24-hour clock, as well as American and European date formats; features power outage retention function, ensuring that the date and time are not lost when the battery is depleted.
Hardness measurement specifications :
Standard hardness range: 5.0 to approximately 300.0 N
Optional extended hardness range: up to 500.0 N
Hardness accuracy: 1 N
Hardness resolution: 1 N
Sample size support and large sample expansion mechanism :
Standard sample size: Maximum supported tablet diameter 28 mm
Large sample expansion range options (applicable to veterinary formulations, special-shaped tablets, or non-pharmaceutical samples):
Part number 29-01660: Sample diameter 30 to 60 mm (maximum hardness 300 N)
Part number 29-01665: Sample diameter 30 to 60 mm (maximum hardness 500 N)
Part number 29-01690: Sample diameter 60 to 90 mm (maximum hardness 300 N)
Part number 29-01695: Sample diameter 60 to 90 mm (maximum hardness 500 N)
Part number 29-01620: Sample diameter 90 to 120 mm (maximum hardness 300 N)
Part number 29-01625: Sample diameter 90 to 120 mm (maximum hardness 500 N)
Correction, adjustment, and validation mechanisms :
It has a built-in 2-point adjustment program and a 3-point calibration program, and can directly output a report after calibration.
Static weight calibration: Compatible with PTB-CAL 15 standard weight set, the full range static calibration of the load cell can be completed on-site within minutes, meeting the 1 N accuracy requirement of USP specifications.
Routine mechanical simulation ingot verification: Compatible with PT-MET mechanical simulation ingots (available in four nominal values: 50 N, 100 N, 150 N, and 200 N), providing rapid dynamic fracture verification per shift/day of operation.
Data transmission and printing reports :
Serial printer port: Supports connecting external dedicated ticket printers to print test reports instantly.
RS-232 serial communication port: Supports connection to PT-Node smart network adapters, allowing direct printing from a browser to any network printer via a wired local area network (LAN), or integration of data into an external management system.
A complete report should include: instrument serial number, firmware version, batch number (in alphanumeric), test execution date and time, individual measurements, statistical values (maximum, minimum, difference, average, absolute standard deviation, relative standard deviation), inspector's signature, reviewer's signature, and report printing date and time.
Electrical and mechanical specifications :
Power supply: Built-in two 1,100 mWh NiMH AAA rechargeable batteries, supporting simultaneous charging and use (approximately 2 hours of continuous operation on a full charge).
Charging interface: Standard USB-C port and dedicated USB-C power supply
Instrument dimensions: Approximately 27 × 9 × 9 cm (length × width × height, excluding printer)
Packaging and shipping dimensions: Approximately 40 × 30 × 21 cm (Length × Width × Height)
Instrument net weight / gross weight: Approximately 2.0 kg / 3.0 kg
Standard Scope of Supply :
PTB-M100 Tester Main Unit
USB-C power supply
Complete original manufacturer's certified folder:
Original manufacturer's operating manual
Design and factory inspection certificate
Installation confirmation file
Operation confirmation document
Declaration of Conformity
Electromagnetic Compatibility Statement
Instrument Maintenance Log
Optional accessories :
500 N Extended Hardness Range Module
Large sample expansion test modules of 30–60 mm, 60–90 mm, or 90–120 mm
Dedicated external document printer
PT-Node Smart Network Adapter
PTB-CAL 15 Original Standard Calibration Weight Set
PT-MET Mechanical Simulation Tablets (single tablet 50 N, 100 N, 150 N, 200 N or a complete set of 4 tablets)
Original recommended spare parts kit