Pharma test PTB 500 automated hardness tester
The Pharma Test PTB 500 Multi-Parameter Fully Automated Tablet Hardness and Physical Properties Tester is designed for high-throughput physical testing of tablets in pharmaceutical quality control (QC), process control (IPC), and various solid dosage form R&D laboratories. This instrument fully complies with international standards and specifications such as the United States Pharmacopeia (USP) <1217>, the European Pharmacopoeia (EP) <2.9.8>, the Japanese Pharmacopoeia (JP), and the British Pharmacopoeia (BP).
I. Supports 5-in-1 full-parameter automated testing: Integrates weight, thickness, diameter/length, width and hardness measurement, and can be directly connected to a precision analytical balance for automatic transmission of weight data, greatly improving the efficiency of multi-physical property testing.
II. Precision electric stepper drive and dual test modes: Equipped with a high-precision stepper motor mechanism, it provides dual test modes of "Linear Force Increase" and "Linear Speed Increase", with a hardness measurement range of 500 N (upgradeable to 1000 N optional), accurately capturing the initial fracture and final fracture peak.
III. Intuitive Color Touchscreen Human-Machine Interface: The entire machine adopts a large-size color touchscreen. The graphical operation interface supports editing and quick saving and calling of multiple detection methods, and provides real-time fracture force curve monitoring and real-time statistical calculation and analysis (Mean, SD, %RSD, Min/Max).
IV. Strict Compliance and Data Integrity Management: Built-in multi-level user access control, electronic record approval, and a fully functional audit trail mechanism that is tamper-proof, fully compliant with GMP/GLP, FDA 21 CFR Part 11, and ALCOA+ data integrity regulations.
Equipment Introduction
5-in-1 Physical Property Testing
Integrated Multi-Parameter Measurement: A single unit can automatically complete the testing of five key physical parameters of tablets: weight, thickness, diameter/length, width, and hardness.
Seamless Balance Integration: Supports connection to multiple standard analytical balances (such as Sartorius and Mettler Toledo), automatically transmitting weight data after sample placement, completely eliminating manual input errors.
Versatile Dosage Form Compatibility: Patented automatic rotating sample positioning mechanism, perfectly suited for round tablets, oblong tablets, caplet tablets, and special geometrically irregular tablets.
High-precision drive mechanism and dual testing modes.
Stepper Motor Precision Drive: Employs a high-precision electric stepper motor drive, providing extremely smooth and accurate force application, with a hardness measurement range of up to 500 N (upgradeable to 1,000 N optional).
Dual fracture mechanics modes (LFI & LSI Testing Modes): Supports both "Linear Force Increase (LFI)" and "Linear Speed Increase (LSI)" modes to accurately capture the initial crack and final fracture peak of the sample.
Automatic Debris & Broken Tablet Collector: After testing, it automatically guides broken samples and fragments to an extraction collection tank, keeping the testing platform clean and facilitating continuous, large-scale testing.
Intelligent Touchscreen Operation
User-Friendly Touchscreen GUI: Equipped with a large, high-resolution color touchscreen, it provides a fully graphical guide with clear and concise setup steps.
Method Storage & Rapid Recall: Supports the creation and storage of a large number of product testing methods, setting specification limits (T1/T2 alarms and action limits), and enabling quick activation of daily inspections with a single click.
Real-Time Statistics & Force Curves: Automatically calculates the mean, standard deviation (SD), relative standard deviation (%RSD), maximum and minimum values, and plots fracture mechanics curves in real time.
Compliant with the International Pharmacopoeia and Data Integrity Compliance regulations.
Global Pharmacopoeia Compliance: Fully compliant with the United States Pharmacopeia (USP) <1217>, the European Pharmacopoeia (EP) <2.9.8>, the Japanese Pharmacopoeia (JP), the British Pharmacopoeia (BP), and the Chinese Pharmacopoeia.
Electronic Records and Multi-Level Access Control (21 CFR Part 11 Compliance): Built-in multi-level user access control and secure password protection to strictly prevent unauthorized parameter changes and method modifications.
Unalterable Audit Trail: Completely records all test data, calibration history, alarm process and user operation logs, fully complying with GMP/GLP and ALCOA+ data integrity principles.
Product Features
Precise hardness testing ensures consistent tablet quality.
Suitable for tablets of various shapes and sizes
Supports multiple testing modes
Meets diverse needs
The intuitive graphical user interface and large screen design make operation simple and easy to understand.
Overall Specifications
Product Models : PTB 500 / PTB 500-500 / PTB 500-1000
Manufacturer : Pharma Test, Germany
Version Specification : Version 1.0
Product positioning and operating principles :
A semi-automatic multi-parameter analyzer specifically designed for testing the physical properties of tablets, capsules, and irregularly shaped solid preparations.
Equipped with a multi-station rotary sample turntable, it automatically and continuously transports a single sample for testing five major physical parameters.
It integrates a high-precision analytical balance unit, a thickness measurement module, and a comprehensive measurement station for diameter, length, width, hardness, and fracture force.
Once the fractured sample has been tested, it automatically slides into an independent, detachable waste collection box.
International Pharmacopoeia and regulatory compliance :
Fully compliant with the standards and specifications for tablet hardness and physical properties testing in the European Pharmacopoeia and the United States Pharmacopoeia.
Built-in database, electronic signature, and electronic audit tracking system compliant with Section 21, Paragraph 11 of the Federal Regulations of the United States.
The fuselage structure and contact materials fully comply with the requirements of Good Laboratory Practice and Good Pharmaceutical Manufacturing Practice.
Five major measurement parameter technical specifications :
Weight measurement:
Built-in Sartorius analytical balance measurement unit
Measurement range: 0.0001 to 200.0000 grams
Weight accuracy: 0.1 mg
Thickness measurement:
Measurement range: 2.00 mm and above
Thickness accuracy: better than ±0.02 mm
Resolution: 0.01 mm
Width and diameter measurements:
Measurement range: 2.00 mm and above
Measurement accuracy: better than ±0.02 mm
Resolution: 0.01 mm
Supports manual rotation of long and irregularly shaped tablets to assist in measurement width.
Hardness and breaking force measurement:
Standard measurement range: 2.0 to 300.0 Newtons (tolerance ±10 Newtons)
Optional medium-range specifications: 5.0 to 500.0 Newtons (tolerance ±50 Newtons)
Optional large range specifications: 10.0 to 1000.0 Newtons (tolerance ±50 Newtons)
Hardness accuracy: better than 1 Newton
Resolution: 0.1 Newtons
Unit switching:
Length and size units: millimeters, inches
Units of hardness and force: Newton, kilogram-force, Strength Cobb
Dual force application mode and special testing procedures :
Linear strength increase mode:
Force application rate: 5 to 250 Newtons per second
The rate of increase in applied force is precisely controlled in real time by the closed loop of the load element.
Constant speed increase mode:
Drive speed: 5 to 250 mm/min
Stepper motor constant velocity propulsion drive
Both the contact force and the fracture detection force can be steplessly adjusted according to the characteristics of the sample.
Provides a non-destructive elastic compression test procedure specifically for soft capsules, allowing contact with compressed samples without crushing them.
Provides tensile strength testing kits for both strip tablets and capsule tablets.
Operation mode and method learning function :
Quick Test Mode: Simply select the shape and enter the batch number for quick testing upon startup without logging in.
Method test mode: Pre-set geometric shape, target tolerance and acceptance criteria for controlled testing.
Intelligent parameter learning function: After continuously testing several samples, the system automatically calculates the average value and generates new method parameters.
Independent workstation on/off function: Specific measurement workstations can be shut down individually according to experimental needs to directly perform single parameter tests.
Data integrity, electronic signatures, and audit tracking :
Built-in compliant user management, method management, and result storage database.
A three-tiered electronic signature approval mechanism: the establishment or modification of the method requires a three-stage digital signature process from review and approval to release.
The system features complete electronic audit tracking, fully recording user names, timestamps, operation events, and comparisons of data changes before and after.
Audit tracking records support quick filtering based on multiple criteria such as user, product, method, and date, and can directly export documents.
User interface and data transfer :
7-inch high-resolution color backlit touchscreen LCD
Supports external universal keyboard and mouse operation.
Equipped with a universal serial bus and a high-speed local area network communication interface
Supports real-time data transmission to the laboratory information management system
The printing function supports outputting individual sample counts, product information, timestamps, statistical analysis, and the final sample fracture force curve.
Supports external LAN printers, Universal Serial Bus (USB) printers, or optional built-in thermal printers.
Calibration and validation support :
Built-in hardness measurement station with dual-point calibration program (zero point and 10 kg standard calibration)
Supports multi-point linear verification with standard weights of 5 to 30 kg or up to 50 kg.
The thickness, width, and diameter measurement stations are calibrated and adjusted using standard gauge blocks.
Supports the use of magnetic dynamic simulation tablets for fracture point detection, force linearity verification, and periodic validation of mechanical integrity.
The system can programmatically print force increase curves during the testing process to demonstrate the linear performance of the force sensor.
Standard Scope of Supply :
Semi-automatic 5-in-1 Tablet Physical Properties Tester Main Unit
Rotating sample feed turntable
Detachable sample debris collection box
A complete set of validated documents, including operating manuals, design and quality conformity certificates, installation validation documents, operation validation documents, declaration of conformity, electromagnetic compatibility statement, and instrument history logbook.
Optional accessories and expansion kits :
Extended measuring range 500 Newtons measurement module
Extended measuring range 1000 Newtons measurement module
Quick-release base for guide grooves of long and irregularly shaped tablets at the testing station
Recommended original equipment manufacturer (OEM) spare parts and consumables kit
Original manufacturer standard calibration weight set and certification standard blocks
Magnetic dynamic simulation tablet verification tool
Built-in thermal printer
Airframe specifications and environmental requirements :
Airframe Structure: Excellent laboratory-grade compliant 304 stainless steel frame
Power requirements: 115/230 volts, 50/60 Hz AC
Ambient temperature: 15 to 35 °C
Ambient relative humidity: 15 to 80%, non-condensing
Installation table requirements: A stable experimental table capable of supporting at least 50 kg, with at least 10 cm of heat dissipation space around the machine body.
External dimensions: Approximately 500 × 500 × 400 mm (Length × Width × Height)
Packaging dimensions: Approximately 650 × 660 × 440 mm (Length × Width × Height)
Instrument weight: Approximately 25 kg net weight, approximately 30 kg gross weight (excluding optional accessories)
Validation and Certification :
All key and contact components fully comply with the requirements of the United States Pharmacopeia and the European Pharmacopeia.
Possesses complete safety standards and electromagnetic compatibility certifications
Standard configuration includes complete original factory installation and operation confirmation documents.