Pharma test PTB 330 5-in-1 hardness tester
The Pharma Test PTB 330 is a high-precision, multi-functional semi-automatic tablet physical property tester designed for immediate process control (IPC), quality control (QC), and research and development (R&D) in pharmaceutical manufacturing. The instrument supports comprehensive five-in-one parameter testing, enabling rapid and accurate determination of tablet weight, thickness, diameter/length, width, and hardness (bursting force) in a single testing process.
I. Fully compliant with the United States Pharmacopeia (USP) <1217>, the European Pharmacopoeia (EP) <2.9.**, the Japanese Pharmacopoeia (JP) and the Chinese Pharmacopoeia, providing a compliant and highly standardized physical measurement basis for various types of solid preparations.
II. The five-in-one integrated testing mechanism can complete the determination of tablet weight (external balance), thickness, diameter/length, width, and hardness in one go, greatly simplifying the analysis steps and effectively improving the throughput of testing.
III. It features a dual fracture mode of "linear force increase (LFI, 10–100 N/s)" and "linear velocity increase (LSI, 0.1–3.0 mm/s)" to accurately simulate different tablet making conditions and perfectly adapt to various special-shaped tablets, oblong tablets and hardness-sensitive formulations.
IV. Supports real-time connection and weight transmission with external high-precision electronic analytical balances (such as Sartorius, Mettler Toledo, etc.), and features automatic zeroing and a residue collection chute, eliminating the need for manual repetitive keying and calculation errors.
V. Equipped with a clear and intuitive digital operating screen and complete statistical calculation functions (automatically calculates the average, standard deviation SD, coefficient of variation %RSD, and maximum/minimum values), and can be expanded to connect to printers, PT-Node smart networking modules, or LIMS/ELN systems to ensure data integrity.
Equipment Introduction
Multi-Parameter 5-in-1 Physical Testing:
◦Simultaneous measurement of multiple items: A single machine can completely measure the "hardness (bursting force), thickness, diameter/length, width" and "weight" of the tablet, greatly simplifying the laboratory operation process and measurement time.
◦ Intelligent connection to external balances: Standard RS-232 / USB interface, which can be seamlessly connected to major brands of analytical balances (such as Sartorius, Mettler Toledo, etc.), and the weight data is automatically transmitted and recorded in real time, eliminating errors caused by manual copying.
High-precision dual breaking force testing modes (LFI & LSI):
◦ Linear Force Increase (LFI): Provides linear constant force of 10 to 100 N/sec, with precise setting of the pressurization rate, fully meeting the requirements of European and American pharmacopoeias for hardness testing of specific preparations.
◦ Linear Speed Increase (LSI): Provides a constant displacement propulsion of 0.1 to 3.0 mm/sec, perfectly simulating the tablet pressing conditions of a tablet press, and is especially suitable for various special-shaped tablets and controlled-release tablets.
◦ Precision stepper motor transmission: It adopts a high-end German stepper motor and ball lead screw drive, which provides smooth and vibration-free operation and provides extremely high repeatability and high sensitivity automatic crack point detection.
Intuitive color touchscreen GUI & Method Management:
◦ User-friendly graphical interface: Equipped with a high-contrast color touchscreen, the interface is intuitive and clear, and supports quick setting of various sample shapes (round, oval, rectangular, irregularly shaped tablets).
• Quality control tolerance warning settings: Sample nominal values and T1/T2 (warning/action) tolerance upper and lower limits can be pre-entered, and the pass/fail judgment is made in real time by color during the test.
Real-Time Statistics & Data Calculation:
◦ Fully automated statistical calculation: After the sample test is completed, the microprocessor automatically calculates key quality control data such as mean, standard deviation (SD), relative standard deviation (%RSD), maximum value (Max), and minimum value (Min) in real time.
◦Multi -source data output: Supports connection to local thermal/dot matrix printers to output complete test reports, and can also directly export test data through digital interface.
Debris Slide & Easy Cleaning:
◦ Anti-debris interference mechanism: The measurement platform is equipped with a dedicated inclined guide slide and a detachable residue collection drawer. After the sample is broken, the debris slides off quickly, avoiding dust and debris from interfering with the next precision measurement.
◦ High protection and durability: Constructed with corrosion-resistant pharmaceutical-grade stainless steel and anodized aluminum alloy, it is easy to clean and maintain daily, and fully complies with cGMP laboratory cleaning certification requirements.
International Pharmacopoeia Compliance & Data Integrity (ALCOA+):
◦ Fully compliant with Global Pharmacopoeia: Meets the standards and specifications of USP <1217>, EP <2.9.8>, JP, BP and Chinese Pharmacopoeia (ChP).
◦ Smart Connectivity Expansion Support: Optional connection to PT-Node smart connectivity module or PTX32 professional software, supporting the integration of Audit Trail and LIMS/ELN systems to meet 21 CFR Part 11 data integrity requirements.
Product Features
Integrated measurement: Hardness/Thickness/Diameter; Can be connected to an external balance for simultaneous weight recording.
Supports two test modes: linear force and linear velocity.
Visual guided operation
Real-time calculation of statistical data
Mean and standard deviation
Overall Specifications
Product Models : PTB 330 / PTB 330-500 / PTB 330-1000
Manufacturer : Pharma Test Apparatebau AG (Germany)
Version Specification : Version 2.1
Product positioning and testing functions :
Five-in-one multi-parameter semi-automatic measurement: A single testing station continuously measures the thickness, width, diameter/length, hardness/breaking force, and weight of the same tablet (using an external balance).
Supports dual test activation modes: quick test and method login test.
Supports the measurement of thickness, width, length, and hardness of round, rectangular, and irregularly shaped tablets.
Supports soft capsule elasticity testing: Non-destructive/elastic deformation testing can be performed by setting a specific compression distance.
Flexible test settings: Supports enabling or disabling individual measurement parameters independently (e.g., pure hardness test can be performed independently).
International regulatory compliance :
It fully complies with the pharmacopoeia hardness testing specifications of USP <1217> and EP <2.9.8>.
Compliant with cGMP and GLP standards, all contact and critical components are USP/EP certified.
Hardness measurement range and specifications :
PTB 330 (Standard): 2.0 – 300.0 N
PTB 330-500 (High-range model): 5.0 – 500.0 N
PTB 330-1000 (Ultra-high range): 10.0 – 1,000.0 N
Hardness accuracy: better than ±1 N
Hardness resolution: 0.1 N
Hardness measurement unit: switchable Newton (N), kilogram-force (kp), Strong-Cobb (Sc).
Thickness, width, and diameter measurement range and specifications :
Thickness testing range: 2.00 – 35.00 mm (expandable to 70.00 mm, accuracy better than ±0.02 mm)
Width test range: 2.00 – 35.00 mm (expandable to 70.00 mm, accuracy better than ±0.02 mm)
Diameter/length testing range: 2.00 – 35.00 mm (expandable to 70.00 mm, accuracy better than ±0.02 mm)
Dimensional resolution: 0.01 mm
Length measurement unit: can be switched between millimeters (mm) or inches (Inch).
Weight measurement function :
Measurements can be taken using an external Sartorius or METTLER TOLEDO analytical balance.
Dual weight testing mode: Supports weighing individual samples one by one before placing them on the test stand, or weighing the entire batch of samples together to calculate the average weight.
Dual fracture force application mode :
Linear strength increase mode:
Force application rate range: 5 – 250 N/sec (stepless fine-tuning setting, pharmacopoeia recommends 20 N/s).
The rate of force increase is precisely controlled through the load cell electronic closed loop, resulting in excellent linearity and data reproducibility.
Constant speed increase mode:
Force application speed range: 1 – 5 mm/sec (stepping motor constant velocity linear drive).
User management and method management :
User permission management: Supports the creation of up to 100 user accounts and passwords, and allows the assignment of combined permissions (execute tests, edit methods, perform corrections, system services and configuration changes, user management).
Method storage capacity: Built-in method management system can store up to 100 test methods.
Single batch testing capacity: Supports continuous testing and statistics of up to 200 samples per test.
User interface and tolerance management :
7-inch high-resolution color backlit touchscreen: provides intuitive graphic guidance and sample placement icons.
Three-level tolerance setting management: Supports setting three-level tolerance ranges of T1, T2 and Invalid (can be set according to absolute value or percentage), and is marked and listed on the screen in real time.
Test restart mode: Supports automatic restart mode (automatic continuous testing at custom time intervals) or manual confirmation restart mode.
Built-in printer and report output :
The integrated miniature thermal printer does not take up additional laboratory table space.
Complete GMP test report output: includes product name, lot number, date and time, user, instrument serial number, firmware version, method parameters, nominal tolerance value, individual values for each sample (including out-of-tolerance markings), detailed statistics (maximum, minimum, range, average, standard deviation, relative standard deviation), and operator/reviewer signature field.
Instrument calibration and validation support :
Built-in guided hardness, thickness, width, and diameter correction and validation procedures.
Dual-point adjustment of the load cell (0 kg and 10 kg standard weights).
Multi-point linearity calibration: Supports full-scale linearity calibration with PTB-CAL15 (5/10/15 kg) or PTB-CAL30 (expanded to 30/50 kg) standard weights.
Dimensional calibration: Standard certified gauge blocks are used to calibrate and adjust the thickness, width, and diameter.
Daily confirmation support: Supports PT-MET mechanical simulation tablets for daily/shift rapid dynamic fracture confirmation.
Data transmission, connectivity, and interface :
2 × RS-232 serial ports: Connect to a computer terminal or an external Epson TM-U220B ticket printer/analytical balance.
1 × USB-C port: Used for test data export and instrument firmware updates.
Supports Pharma Test PT-Node network adapter: Print reports or transfer data directly from the browser to LIMS/external systems via wired LAN.
Materials and structural design :
Airframe: Made of GLP grade AISI 304 stainless steel, which is chemically resistant and easy to clean.
Quick-release sample base: The base with positioning grooves can be replaced to ensure that long or irregularly shaped tablets are accurately positioned and do not slip during the measurement process.
A detachable debris collection box is included as standard.
Optional accessories :
500 N (PTB 330-500) / 1,000 N (PTB 330-1000) Extended Hardness Range Module
Long strip/capsule tablet scoring fracture tension measuring fixture
PTB-CAL15 / PTB-CAL30 Validation Weight Set
PT-MET Mechanical Simulation Tablets Daily Effectiveness Kit
Positioning guide base plate for various long tablets
Original manufacturer's recommended spare parts and consumables package
Electrical and installation requirements :
Power requirements: 100 – 240 VAC, 50/60 Hz wide voltage
Operating environment: Ambient temperature 15 – 35 °C, relative humidity 15 – 80 %rH (non-condensing)
Work surface: Load capacity of at least 50 kg, with at least 10 cm of space reserved around the machine body for heat dissipation and operation, ensuring that the power switch and plug are unobstructed.
External dimensions and weight :
External dimensions: Approximately 260 × 500 × 260 mm (Length × Width × Height)
Packaging and shipping dimensions: Approximately 310 × 660 × 420 mm (Length × Width × Height)
Instrument net weight / gross weight: Approximately 9.5 kg / 12.5 kg (excluding optional accessories)
Standard Scope of Supply :
PTB 330 (or 500N / 1000N) host (including built-in thermal printer)
Debris collection box
Complete original manufacturer's certified folder:
Original manufacturer's operating manual
Factory inspection and design certificate
Installation confirmation file
Operation confirmation document
Original Manufacturer's Declaration of Conformity
CE/EMC Electromagnetic Compatibility Statement
Instrument Maintenance Log