The Pharma Test PTZ AUTO EZ series of fully Automated Tablet & Capsule Disintegration Testing Systems are specifically designed for pharmaceutical quality control (QC), in-process control (IPC), and drug development laboratories. The equipment integrates a high-precision independent lifting drive mechanism, patented electronic sensing endpoint determination technology, and a high-efficiency constant-temperature water bath circulation system into a robust and compact body. It can determine the disintegration endpoint of various tablets, capsules, and pills in a fully automated and highly reproducible manner. This equipment fully complies with the pharmacopoeia standards of various countries, including USP <701>, USP <2040>, EP <2.9.1>, JP and ChP, and can completely eliminate the subjective error of human visual judgment. It is an indispensable core tool for solid preparation quality inspection and disintegration kinetics research.

I. Independent multi-station and automatic lifting mechanism provides 1 to 4 sets of completely independent test workstations, each of which can be set with test parameters independently; after the test is completed, the electric basket automatically rises out of the liquid surface to prevent the sample from being over-soaked.

II. The patented PT-MKT electronic endpoint determination and in-situ temperature measurement, combined with the patented electronic sensing basket and conductive pressure plate, automatically locks the second-level collapse endpoint of each tube, eliminating subjective errors of the naked eye; the basket has a built-in temperature sensor to monitor the actual solvent temperature inside the cup in real time.

III. High-efficiency uniform constant temperature water bath and dual safety protection: Built-in 1000W heater and circulating water pump (temperature control 25.0～45.0°C, stability ±0.3°C), coupled with anti-dry-burn pressure switch and thermal fuse for dual hardware protection, to ensure uniform temperature control and safe operation.

IV. Large-screen smart interface and global regulatory compliance: Equipped with a 9-inch backlit screen and multi-method/access management; compliant with USP <701>/<2040>, EP, JP, and ChP pharmacopoeia standards; supports optional PTZ32 software to meet FDA 21 CFR Part 11 data integrity and full IQ/OQ validation.

Software Introduction

• Fully automated hardware control and multi-station independent management.

  • Remote Bidirectional Communication & Auto-Stop Control : Seamlessly connects to the PTZ AUTO EZ host via RS-232 or USB interface, allowing direct software-based start-up and monitoring of tests. Supports independent operation of multiple test stations; each station automatically stops and rises above the liquid surface after completing its disintegration endpoint, preventing excessive sample immersion.

  • Modular Method Library & Quick-Start Workflow : Supports unlimited method creation, archiving, and quick retrieval. Users can customize tablet dosage forms, solvent types, maximum test time, upper and lower limit acceptance specifications (Min/Max Limits), and prerequisite test parameters. Simply enter the batch number and operator signature to start the analysis with one click.

• Patented electronic end-point detection and in-situ medium temperature monitoring (PT-MKT Auto End-Point Detection & In-Situ Medium Temperature Monitoring)

  • Precision Electrical Contact Disintegration Detection : Fully integrated with the PT-MKT / PT-MKT33 automatic sensing basket, it forms a short-circuit loop through the contact of a special metal bottom mesh and a built-in conductive ring pressure plate, automatically and accurately locking the disintegration endpoint of each tube (6 tubes in total) within seconds, eliminating subjective errors caused by manual visual judgment, and is widely applicable to film-coated tablets, uncoated tablets and capsules.

  • Continuous In-Situ Medium Temperature Monitoring : The sensing basket has a built-in high-precision temperature sensor that can record the actual temperature of the disintegrating medium in the beaker in real time and continuously (not just the water bath temperature), ensuring full compliance with the strict temperature requirements of the pharmacopoeia.

• Real-Time Dynamic Visualization & Batch Comparison Statistics

  • 6-Zone Real-Time Plan View Graphics: The software's main screen provides an intuitive top-down dynamic graphic of the 6 holes of the basket. Once the sample collapses, the corresponding hole immediately turns red and the collapse time is locked. The software also automatically calculates the average value, maximum value, and minimum value.

  • Advanced multi-batch trend statistics and reporting (Batch Comparison Trend Analysis & Comprehensive Reporting) : Built-in powerful batch comparison statistics module, which can automatically draw collapse time graphs including upper and lower limit specifications and multi-batch trend comparison graphs, and produce standardized validation and quality control reports with rich graphics and text.

• Fully compliant with FDA 21 CFR Part 11 and GLP Data Integrity Compliance

  • Strict user access control and electronic signature management (Multi-Level User Access Control & Electronic Signatures) : It has system administrator and multi-level operator access control settings. Tests or data recording cannot be started without entering user codes and batch numbers, and a strict responsibility traceability mechanism is implemented.

  • Tamper-proof Data Storage & Traceable Reporting : All test data is encrypted and written to the storage device in real time. The original data cannot be modified or deleted. Test methods and environmental parameters are fully recorded, fully complying with cGMP, GLP and ALCOA+ data integrity specifications, and providing complete IQ/OQ software verification support from the manufacturer.