Pharma test PTWS 1420 14/16-vessel dissolution tester
The Pharma Test PTWS 1420 14-Tank Tablet Dissolution Tester is designed for high-throughput quality control (QC) and pharmaceutical research and development (R&D) comparative testing. The equipment features a 7 × 2 double-row dissolution vessel layout, accommodating 12 test sample vessels and 2 control/standard vessels simultaneously. It can directly perform bioequivalence (BE) or control drug dissolution curve comparisons between two batches (6 + 6) under identical water bath and flow field conditions. This instrument fully complies with the stringent requirements for dissociation tests of solid oral preparations in the United States Pharmacopeia (USP) <711/724>, the European Pharmacopeia (EP) <2.9.3/4>, the British Pharmacopoeia (BP), and the Japanese Pharmacopoeia (JP).
I. 7×2 High-Throughput 14-Vessel Layout: The 7×2 dual-row design includes 12 sample tanks + 2 standard/control tanks. Under completely identical water bath temperature and flow field conditions, two batches (6+6) of bioequivalence (BE) parallel comparison experiments can be performed simultaneously, significantly increasing analytical throughput.
II. Patented MonoShaft™ Quick-Lock System: No need to disassemble the main shaft when changing the agitator (Apparatus 2) or the turntable (Apparatus 1), with precise self-locking at a standard 25 mm bottom height and no need for repeated calibration; extremely low eccentricity (Wobble < 0.2 mm), ensuring high reproducibility of flow field dynamics.
III. Multi-stage electronic lifting and external vibration isolation temperature control (Motorized Lift & External Heating System): Equipped with an electric lifting drive head, supporting multi-stage working and sampling height programmable; featuring an independent external ultra-quiet constant temperature water bath circulation system (accuracy up to ±0.2 ℃), completely eliminating the interference of motor vibration on the dissolution cup flow field and sedimentation attitude.
IV. 7-Inch Touchscreen & Data Integrity: Equipped with a 7-inch solvent-resistant full-color touchscreen (supports operation while wearing laboratory gloves), built-in unlimited user permissions and method library storage; features an tamper-proof full-process audit trail, fully compliant with FDA 21 CFR Part 11, GMP/GLP and ALCOA+ data integrity regulations.
Equipment Introduction
14-Vessel 7×2 Layout & Dual-Batch Optimization (High-Throughput 14-Vessel 7×2 Layout & Dual-Batch Optimization)
14-Vessel Ultra-High Throughput & Flexible Vessel Allocation : Provides 14 dissolution tank positions (configurable as 12 sample tanks + 2 blank/control standard tanks, or 14 tanks for full sample mixing).
Synchronous 6+6 Parallel Batch & Bioequivalence Testing : Under the same water bath temperature and stirring conditions, two complete batches (6+6) can be simultaneously tested for dissolution comparison or bioequivalence (BE) screening, significantly improving laboratory testing efficiency and data consistency.
Patented MonoShaft™ Stirring System & High Precision
MonoShaft™ Patented Quick-Lock Stirring Tools : When changing stirring tools (paddle, basket, paddle-over-disk, etc.), the rotor can be changed simply by unscrewing the fastener with one hand, without disassembling the entire drive shaft.
Factory-locked 25 mm Clearance & Ultra-Low Wobble : After installation, the height is automatically locked at the pharmacopoeia-specified 25 mm (±2 mm), eliminating the need for repeated immersion height calibration and ensuring extremely low axial wobble (Wobble < 0.2 mm), guaranteeing excellent flow field reproducibility.
Compliance, Audit Trail & User Management (21 CFR Part 11 Compliance, Audit Trail & User Management)
Full 21 CFR Part 11 Compliance & Data Integrity : Built-in full-featured audit trail, which records in detail all operational events and before-and-after comparisons of parameter modifications in the instrument, fully complying with FDA 21 CFR Part 11 and ALCOA+ principles.
Unlimited User Accounts & Multi-Level Security Access : Supports the creation of unlimited user accounts and password access levels to ensure system operation security and legal compliance.
Intuitive 7-Inch Color Touchscreen GUI & Smart Scheduler
Intuitive 7-Inch Color Touchscreen & Unlimited Methods : High-resolution color touchscreen with clear operation logic, allowing for smooth operation even when wearing gloves; the system supports storing an unlimited number of test methods.
Automated Wake-Up Preheating & OQ/PQ Calibration Reminders : Features scheduled preheating, automatic wake-up, regular instrument maintenance, and automatic alerts for OQ/PQ calibration expiration.
Intelligent electric lift head with high-precision constant temperature water bath (Precision Motorized Drive Lift & External Ultra-Quiet Heating)
Vibration-Free Motorized Drive Head Lift : Equipped with an electric motor-driven lift head, it operates smoothly and without vibration, ensuring safety and stable flow during the lifting process.
Independent External Ultra-Quiet Heating Circulation Module : This external ultra-quiet heating circulation module provides water bath uniformity up to ±0.2 °C and effectively isolates the flow field interference of the dissolution tank caused by pump operation vibration.
Powerful automation expansion capabilities and advanced system integration.
Versatile Hardware Add-Ons: EPE, TM/TMA & ITM : Optional Electric Automatic Sampling Manifold (EPE), Automatic Dosing System (TM/TMA), and Independent Temperature Monitoring System for Each Tank (ITM).
Seamless Workstation Integration (DSR-M & Online UV/HPLC) : It can be directly connected to the DSR-M automatic sampling and collection instrument, syringe pump or online UV/HPLC system, and seamlessly upgraded to a fully automated dissolution analysis workstation with WinDiss ARGUS computer control software.
Product Features
High-throughput 14-slot layout
(7 × 2 design) Dual-batch simultaneous comparison test
Patented MonoShaft™ technology; Quick-change concentric shaft technology; No need to recalibrate height during replacement.
Complete 21 CFR Part 11
Smart Touch Interface
Data Integrity Management
Overall Specifications
System Model : ADS-L 1420
Manufacturer : Pharma Test Apparatebau AG, Germany
Version Specification : Version 2.0
System architecture and product positioning :
A fully automated online real-time UV-Vis photodissociation detection integrated system designed specifically for high-throughput dissociation analysis and bioequivalence testing.
It consists of a fourteen-cup dissolution tester main unit, a diode array ultraviolet-visible spectrophotometer, a sixteen-channel high-precision peristaltic pump, and fully compliant dissolution management and control software.
It adopts a fully enclosed bidirectional continuous circulation flow path structure, ensuring no solvent loss and maintaining a constant volume during the testing process.
It features simultaneous analysis of multiple drug components, millisecond-level high-speed scanning of the entire spectrum, and automatic turbidity correction capabilities at both wavelengths.
Integrated, single-factory architecture; the entire system comes with a two-year warranty and single-window technical support.
Regulatory compliance standards :
Fully compliant with the standards and specifications of the United States Pharmacopeia, European Pharmacopoeia, Japanese Pharmacopoeia, Chinese Pharmacopoeia, U.S. Food and Drug Administration, and American Society for Testing and Materials.
The system software and data processes strictly comply with Section 21, Paragraph 11 of the U.S. Federal Regulations regarding electronic records and electronic signatures.
The entire machine has passed European conformity certification and electromagnetic compatibility testing standards.
Specifications of the 14-cup dissolution tester (PTWS 1420) :
Dissolution tank configuration: A symmetrical layout of 7 x 2 rows, front and back, with a total of 14 stirred dissolution cup stations, plus two unstirred preheating cup stations, for a total of 16 cup positions.
Automatic lifting system: The instrument head is equipped with a fully automatic electric lifting mechanism.
Pharmacopeia method compatibility: Equipped with an automated sampling manifold system, fully supporting USP Methods I (basket method), II (oar method), V (oar disc method), and VI (rotary drum method).
Sampling and filtration mechanism: Employs a 316 medical-grade stainless steel sampling tube, which can be equipped with an in-line filter membrane to completely prevent undissolved drug particles from entering the spectrophotometer flow cell.
Integrated dosing and cleaning: Standard configuration includes a dosing tank and a built-in magnetic mounting bracket for pipeline cleaning mechanisms.
Specifications of the diode array UV-Vis spectrophotometer (TIDAS L 570) :
Detection technology: Diode array full-spectrum synchronous detection technology, with no moving spectroscopic optical elements, possessing extremely high optical stability, reproducibility, and shock resistance.
Spectral scanning speed: Ultra-fast multi-channel full-spectral acquisition, completing continuous detection of fourteen cuvettes in just about fifteen seconds.
Wavelength range: 190 to 1100 nanometers
Spectral resolution: less than or equal to 2 nanometers
Built-in composite light source: 35-watt high-stability deuterium lamp and 7.5-watt tungsten halogen lamp
Sample tray and fiber expansion: Equipped with a 14-channel automatic flow cuvette changing mechanism, and additionally includes two dedicated optical channels for fiber probes and complete optical components.
Optical signal transmission: Sun-resistant fiber optic cables are used to connect the light source and detector, ensuring stable and uninterrupted signal transmission.
Intelligent dual-monitor interface:
Main screen: Built-in industrial-grade computer system, equipped with a large-size, high-resolution color touchscreen.
Smart Nameplate: Equipped with an independent e-paper display screen, it can still clearly display the laboratory asset number, instrument serial number, previous calibration date, and next calibration due date even when the device is off.
Multi-channel peristaltic pump specifications (IPC 16) :
Number of channels: Sixteen independent flow path channels
Operating speed: 2.5 to 50 revolutions per minute, steplessly adjustable.
Circulation mode: Closed-loop circulation transport, automatically stops circulation at the set sampling time point and performs static absorbance or full spectrum scanning.
Piping and high-precision flow cuvette system :
Connection piping: The entire system uses chemically inert PTFE tubing and wear-resistant pump tubing, with color markings for easy flow path identification and does not absorb active pharmaceutical ingredients.
Flow cuvettes: Beam path length tolerance better than ±0.005 cm, offering a variety of beam path options from 0.1 to 10 mm. For high-concentration samples, the beam path can be directly shortened to replace cumbersome dilution procedures.
Dissolution control and data analysis software (WinDiss ARGUS and TIDASDAQ3) :
Automated program control: Fully automated and precise scheduling and sampling, cuvette measurement, real-time temperature recording, and dissolution percentage calculation.
Data integrity and security: Built-in relational database technology, featuring multi-level role and access control, audit tracking, automatic backup, and tamper-proof functionality.
Turbidity and light scattering correction: Supports second-wavelength absorbance subtraction and second-order derivative spectral calculations to eliminate sample turbidity and particle scattering interference.
Simultaneous multi-component analysis: Supports importing multivariate analysis models for independent analysis of each component of complex compound drugs.
Flexible workflow: Built-in intuitive wizard guidance, combining the standardization of routine quality control inspections with the flexibility of R&D formulation screening.
External dimensions and weight specifications :
Overall system dimensions: approximately 2200 × 1000 × 1000 mm (length × width × height)
System packaging and shipping dimensions: approximately 1370 × 780 × 870 mm (length × width × height)
Machine net weight and gross weight: Approximately 120 kg
Standard equipment list :
PTWS 1420 Fourteen-Cup Solubility Tester Main Unit
TM-1420 Manual Dispensing Tray Module
EPE-1420 Automatic Lifting Sampling Manifold System
Pipe cleaning and cleaning kit with magnetic mounting base
One set of stainless steel stirring paddles
One set of 1000 ml high-purity borosilicate glass dissolution cups with original manufacturer's batch number markings.
A set of depth calibration positioning balls for mixing tools
One bottle of water bath antibacterial protectant
TIDAS L 570 Diode Array Ultraviolet-Vis Spectrophotometer Main Unit (including built-in industrial computer, touch screen and electronic paper smart nameplate)
Fourteen-station automatic flow cuvette changing mechanism and two sets of optical fiber channel components
IPC 16 Multichannel Peristaltic Pump
Full set of color-coded PTFE chemical-resistant piping
TIDASDAQ3 Spectrophotometer Control Software
WinDiss ARGUS Dissolution Test Data Management and Analysis Software Suite
Complete original manufacturer technical and validation document folder (containing operating manual, DQ/QC factory inspection certificate, IQ installation validation document, OQ operation validation document, instrument history logbook, and original manufacturer compliance certificates for dissolving cups and stirring tools)
Optional equipment items :
ITM-1420 Individual Dissolution Vessel Independent Temperature Real-Time Monitoring System
TMA-1420 Motor-Driven Fully Automated Synchronous Drug Delivery Mechanism
PT-RP80 Dedicated Sequence Data Reporting Printer
2-liter large-capacity dissolving cup and stirring assembly
250 ml microdissolution cup set with dedicated micro stirrer
UV-resistant, dark-colored, light-shielding dissolution cup
Full range of quick-release single-shaft mixing tools (rotary basket, shaft and related accessories)
Original manufacturer certified complete set of mechanical calibration and verification tools
Continuous flow cuvettes with various optical paths (0.1 to 10 mm)