Pharma test PTZ Auto EZ Automated Disintegration Tester
The Pharma Test PTZ AUTO EZ fully automated disintegration tester is designed for pharmaceutical quality control (QC), process control (IPC), and various solid dosage form R&D laboratories. It can be used for fully automated disintegration endpoint testing of tablets, capsules, and pills. This instrument fully complies with international standards and specifications such as the United States Pharmacopeia (USP) <701/2040>, the European Pharmacopoeia (EP) <2.9.1>, the Japanese Pharmacopoeia (JP), and the British Pharmacopoeia (BP).
I. Equipped with a patented optical/electronic contact automatic endpoint detection sensing basket (PT-M-DISC), it automatically and accurately records the individual sample and total disintegration time the moment the sample completely disintegrates and passes through the bottom sieve, completely eliminating subjective bias and timing errors caused by manual visual judgment.
II. It features an independent control test workstation design (optional 1, 2, 3 or 4 work slots). Each workstation can independently set the lifting stroke frequency, test time and water bath circulation temperature control, which greatly improves the efficiency of simultaneous testing of multiple samples.
III. The entire machine adopts an intuitive large-size touch operation interface, which supports editing, quick storage and one-click calling of multiple product detection methods, and provides real-time collapse process and temperature monitoring curve dynamic display.
IV. Built-in multi-level user access control, electronic record approval, and tamper-proof full-featured audit trail functions, fully compliant with GMP and FDA 21 CFR Part 11 data integrity regulations.
Equipment Introduction
Fully Automated Disintegration Endpoint Detection
Patented Contact-Sensing & False-Positive Prevention Mechanism : Equipped with a patented optical/electronic contact-sensing basket (PT-M-DISC), supporting a programmable "continuous contact confirmation mode." By customizing the number of consecutive judgments, it effectively eliminates false endpoint misjudgments caused by floating debris or instantaneous contact in traditional designs based on height-based judgment mechanisms, ensuring that samples in all corners of the basket completely disintegrate without residue, and accurately determining the true disintegration time of individual samples and batches.
Elimination of Subjective Bias: Completely eliminates subjective biases from manual visual judgment and manual timing errors, significantly improving the reproducibility and data reliability of sample testing.
Independent Modular Testing Stations
Flexible multi-station configuration (1, 2, 3, 4 Station Options): Offers 1, 2, 3 or 4 independent test slots, which can be flexibly configured according to laboratory throughput requirements.
Independent Parameters & Temperature Control: Each workstation has an independent control system that allows for setting different lifting stroke frequencies, test times, and water bath circulation temperature control, supporting simultaneous multitasking inspection of different batches.
Intelligent Touchscreen Operation
User-Friendly GUI: It adopts a large-size color touch screen, with an intuitive and user-friendly interface, and provides full-process graphical guidance.
Method Storage & Rapid Recall: Supports the creation and storage of multiple product testing methods, allowing for quick recall of test parameters with a single click, simplifying daily operations.
Real-Time Curve & Progress Monitoring: During the inspection process, the collapse process of samples in each tank, individual time countdowns, and real-time temperature curves of the water bath are displayed synchronously and dynamically.
Compliant with the Global Pharmacopoeia and Data Integrity Compliance regulations.
Global Pharmacopoeia Compliance: Fully compliant with the United States Pharmacopeia (USP) <701/2040>, the European Pharmacopoeia (EP) <2.9.1>, 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.
Unalterable audit trail: Completely records all test data, operation logs, alarm processes and calibration records, in compliance with GMP/GLP and ALCOA+ data integrity principles.
PTX32 Software Introduction
Pharma Test PTX32 is a professional-grade Windows operating system control and data analysis software specifically designed for the testing of physical properties of solid dosage forms. PTX32 boasts excellent multi-instrument integration capabilities, an intuitive graphical user interface, powerful statistical process control (SPC) analysis functions, and strictly adheres to FDA 21 CFR Part 11 and cGMP/GLP data integrity standards. It is an ideal core solution for pharmaceutical R&D, in-process control (IPC), and quality control laboratories (QC) to achieve standardized and digital transformation of testing.
I. Universal Instrument Integration & Centralized Control
Seamless cross-platform instrument compatibility: Supports multiple solid testing devices from Pharma Test (including PTB hardness/multi-parameter tester, PTF brittleness tester, PT-TD tap density tester, PT-LT vacuum leak tester, etc.), enabling centralized management on a single software platform.
Intelligent two-way communication mechanism: Real-time data transmission and interaction with the instrument via RS-232, USB or network interface, automatically reading sensor calibration curves and equipment operating status, greatly improving test stability.
II. Standard Inspection Methods Database and Standardized Workflow
Highly flexible method configuration: Supports the creation of proprietary testing SOPs for different formulations, specifications and customer standards, and allows customization of parameters such as breaking force judgment mode, tolerance limits, test rate and batch sample number.
Error-proof one-click call function: Built-in large-capacity method database, operators only need to select the product name to quickly load the corresponding settings. The system has a parameter error-proof verification mechanism to effectively prevent human input errors.
III. Real-Time Dynamic Monitoring & Advanced SPC Analysis
Real-time physical fracture graphical analysis: During testing, high-precision dynamic curves (such as pressure-displacement curves and fracture peak curves) are plotted in real time to accurately capture the micro-fracture and complete fracture characteristics of solid agents.
SPC Statistical Calculation and Acceptance Determination: Automatically calculates statistical indicators such as sample mean (Mean), standard deviation (SD), and coefficient of variation (%RSD), and generates histograms, trend charts, and control charts in real time, quickly determining pass/fail based on specifications.
IV. Strict Compliance with Laws and Regulations and Data Integrity (21 CFR Part 11 & ALCOA+ Compliance)
Multi-level user access control: Built-in strict hierarchical access control structure (administrator, supervisor, operator), supports password security policies, regular expiration updates and idle locking mechanisms.
Full-featured security audit trail: Completely records all logins, test executions, method changes, corrections, and abnormal alerts. All records have a unique anti-counterfeiting timestamp, and tampering and deletion are strictly prohibited.
Anti-tampering report generation and LIMS integration: Automatically generates compliant security PDF inspection reports with electronic signatures, and can be integrated into the laboratory LIMS/ELN system through PT-Node IoT modules or APIs to ensure full control over the data lifecycle.
Product Features
Quickly replace the hanging basket
Easy to install the glass tube
Easy to clean without vibration
Conductivity is set according to the solvent. Number of contacts is set according to the sample.
Full runtime recording
Compliant with 21 CFR 11
Overall Specifications
Product Models : PTZ AUTO 1EZ / PTZ AUTO 2EZ / PTZ AUTO 3EZ / PTZ AUTO 4EZ
Manufacturer : Pharma Test, Germany
Version Specification : Version 2.0E
Product positioning and operating principles :
A fully automated disintegration tester specifically designed for testing the disintegration properties of tablets, capsules, and solid preparations.
It has the function of automatically sensing and detecting the individual disintegration endpoint time of each well sample.
Each testing station is equipped with an independent lifting and reciprocating drive mechanism, allowing for completely independent operation and settings.
When the test is complete, the electric lifting arm automatically lifts the basket completely out of the medium to prevent the sample from being over-soaked.
International Pharmacopoeia and regulatory compliance :
Fully compliant with the disintegration standards of the United States Pharmacopeia and the European Pharmacopeia.
The fuselage structure and contact materials fully comply with the requirements of Good Manufacturing Practices for Pharmaceuticals and Good Laboratory Practices.
Test station and reciprocating stroke specifications :
Workstation configuration: Available in 1, 2, 3 or 4 independently controlled models.
Reciprocating stroke frequency: 30 times per minute
Reciprocating stroke frequency accuracy: ±1 stroke/minute
Reciprocating stroke height: 55 mm
Travel height accuracy: ±1 mm
Test time setting range: 1 second to 23 hours 59 minutes 59 seconds
Fully automated collapse electronic basket mechanism :
Standard configuration includes a standard six-hole electronic testing basket, suitable for general tablet and capsule testing.
The bottom screen adopts a segmented contact circuit design, combined with a dedicated pressure plate with built-in metal rings.
When the sample completely disintegrates, the metal ring of the pressure plate contacts the bottom screen to conduct electricity, accurately determining the individual disintegration endpoint within seconds.
The pressure plate features a symmetrical, non-directional design, and all test holes are universal and compatible with various geometrically shaped tablets.
Each electronic basket has a built-in precision temperature sensor to monitor the actual temperature of the medium inside the beaker in real time.
The specifications and specific gravity of the hanging basket body, stainless steel mesh, and pressure plate fully comply with the latest pharmacopoeia standards.
An optional electronic basket for testing large samples with three holes is available, suitable for large samples with a maximum diameter of 30 mm.
Temperature control system and safety protection mechanism :
Built-in 1000-watt low-noise circulating pump and heating element temperature control system
Water bath temperature setting range: 25.0 to 45.0 °C
Temperature control accuracy: ±0.3 °C
Equipped with an external movable temperature probe, it can monitor and display the actual temperature of the water bath in real time.
Equipped with a pressure-sensing switch, it automatically cuts off heating and pumping when no water circulation is detected.
It features dual electronic fault protection, equipped with a temperature control switch and thermal fuse.
A digital safety sensor is installed at the end of the heating element; heating will be forcibly shut off immediately if the temperature exceeds 60 °C.
Cleaning, maintenance, and sample replacement design :
The acrylic water bath features a quick-release structure, facilitating rapid disassembly, emptying, and thorough cleaning.
The circulating water pipeline is equipped with quick-connect fittings, allowing for rapid disassembly and assembly without leaks.
The automatic lifting basket function upon completion of the test greatly facilitates the replacement of media during the testing process for controlled-release formulations.
User interface and method management :
A 9-inch diagonal color-changing backlit LCD screen with a resolution of 320 × 240 pixels and a display area of approximately 90 × 120 mm.
Alphanumeric keypad with function shortcuts
Built-in memory can store up to 16 complete test methods.
It features password security protection to prevent unauthorized modification of calibration and validation parameters.
It has a programmable operation and effective periodic reminder function.
Data processing, output, and connectivity software :
A complete test report is generated immediately upon completion of the test, recording the sample name, batch number, water bath and medium temperature, maximum set time, individual well disintegration time, extreme value determination, average value, absolute standard deviation, relative standard deviation, and signature field.
Equipped with a standard parallel printer communication port, allowing direct connection to an external printer for report output.
Equipped with a serial communication port, supporting remote computer control and data transmission.
Supports optional dedicated connection software, fully compliant with U.S. Federal Regulations 21(11) electronic records and electronic signature requirements, providing method management, result archiving, multi-batch comparison, and real-time six-channel top-view graphical monitoring.
Model configuration specifications :
Single-station model: 1 set of independent testing stations
Dual-station model: 2 independent test stations
Three-station model: 3 independent test stations
Four-station model: 4 independent testing stations
Standard Scope of Supply :
Disintegration tester main unit
Each testing station is equipped with one standard six-hole electronic testing basket.
Each electronic hanging basket comes standard with one set of 6 glass test tubes.
Each electronic hanging basket comes standard with one set of six collapse guide pressure plates.
Each testing station is equipped with one 1-liter glass beaker as standard.
One bottle of antibacterial agent specifically for water baths.
A complete set of validated documents, including operating manuals, design and quality conformity certificates, installation validation documents, operation validation documents, instrument history logbook, and conformity certificates for containers and mixing tools.
Optional accessories and special components :
Large sample-specific three-hole testing electronic basket
Fully automatic upgrade kit
Dedicated report printer
Universal Sequence Converter
Specifications and footprint of the device :
Airframe Structure: Compliant stainless steel airframe conforming to excellent pharmaceutical manufacturing standards.
External dimensions (an additional 10 cm operating clearance must be reserved on each side):
Single-station model: Approximately 61 × 37 × 54 cm (width × depth × height)
Dual-station model: Approximately 61 × 37 × 54 cm (width × depth × height)
Three-station model: Approximately 76 × 37 × 54 cm (width × depth × height)
Four-station model: Approximately 91 × 37 × 54 cm (width × depth × height)
Packaging dimensions:
Single-station model: Approximately 80 × 51 × 70 cm (width × depth × height)
Dual-station model: Approximately 80 × 51 × 70 cm (width × depth × height)
Three-station model: Approximately 80 × 51 × 70 cm (width × depth × height)
Four-station model: Approximately 107 × 77 × 95 cm (width × depth × height)
Instrument weight:
Single-station model: Net weight approximately 24 kg, gross weight approximately 32 kg
Dual-station model: Net weight approximately 29 kg, gross weight approximately 36 kg
Three-station model: Net weight approximately 38 kg, gross weight approximately 53 kg
Four-station model: Net weight approximately 46 kg, gross weight approximately 109 kg
Validation and Certification :
All contact components fully comply with the requirements of the United States Pharmacopeia and the European Pharmacopeia.
Possesses complete electromagnetic compatibility and safety certifications
Standard configuration includes complete original factory installation and operation confirmation documents.