Pharma test PTWS 830 8-vessel
dissolution tester
The Pharma Test PTWS 830 tablet dissolution tester features a classic 8-vessel (4 x 2 double-row) layout, designed specifically for routine analysis in pharmaceutical quality control (QC) and drug research and development (R&D) laboratories, providing a highly stable, accurate, and compliant dissolution testing solution that meets the latest regulations.
I. Fully compliant with international standards such as the United States Pharmacopeia (USP) <711/724>, the European Pharmacopoeia (EP) <2.9.3/4>, the Japanese Pharmacopoeia (JP <15>), and the British Pharmacopoeia (BP), and equipped with 6 test sample tanks and 2 reference standard/blank tanks (can also be set to 8 fully stirred sample tanks).
II. Equipped with patented MonoShaft™ quick-release mixing shaft technology, the main shaft does not need to be disassembled when changing the paddle or basket. It is precisely locked at the standard 25 mm immersion height at the factory and does not require manual calibration, which greatly improves the efficiency of replacement and eliminates human setting errors.
III. It adopts a fully automatic electric lifting head and an external ultra-quiet circulating temperature control system, which effectively isolates vibration interference and ensures that the temperature in the water bath is quickly, uniformly and constant, providing excellent reproducibility and test stability.
IV. Equipped with an intuitive color touchscreen, built-in unlimited user access management, test method storage, and full-featured audit trail, fully compliant with FDA 21 CFR Part 11 and modern data integrity regulations.
Equipment Introduction
Classic 8-Vessel Layout: 4 × 2 Dual-Row Configuration
Configured with 8 dissolution vessel (can be set to 6 sample tanks + 2 blank/standard tanks, or 8 tanks for full sample mixing).
Its compact size makes it ideal for routine quality control (QC) analysis and standard dissolution testing in pharmaceutical research laboratories.
Patented MonoShaft™ Quick-Coupling Stirring Tool System :
Replacing the mixing tool (Paddle, Basket, Paddle-over-Disk, etc.) only requires a quick one-handed replacement of the lower rotor; the entire drive shaft does not need to be disassembled.
After replacement, it automatically and accurately positions itself at the 25 mm (±2 mm) immersion height specified in the pharmacopoeia, without requiring repeated manual calibration, and maintains extremely low axial runout (< 0.2 mm).
Full Compliance with 21 CFR Part 11 and Data Integrity :
Built-in full-featured audit trail, which records operation events, login records, and data before and after method parameter changes in detail.
It supports the creation of unlimited user accounts and multi-level password access control, complying with GMP and regulatory requirements of various countries.
Intuitive Color Touchscreen with Smart Laboratory Management :
High-resolution color touch interface with clear operation logic, and can store an unlimited number of test methods.
It provides sampling time reminders, buzzer alerts, scheduled operations, automatic warm-up wake-up, and OQ/PQ calibration/maintenance cycle reminders.
Motorized Drive Head Lift & External Ultra-Quiet Circulation Heating :
The electric motor drives the lifting head, ensuring smooth and vibration-free lifting.
The external heating circulating water pump module provides water bath temperature control accuracy of ±0.2 °C and effectively eliminates the interference of pump vibration on the sample dissolution process.
Flexible automation options and system upgrade capabilities :
Optional features include an electric automatic sampling manifold (EPE), an automatic dosing system (TM/TMA), and an independent temperature monitoring system (ITM) for each tank.
It can be connected to an automated sampling and collection instrument (such as DSR-M), a piston/peristaltic pump, or an online UV/HPLC system to upgrade to a semi-automatic or fully automated dissolution analysis system.
Product Features
Classic 8 vessel layout
(4 x 2 design)
Also considers standard test comparisons
Patented MonoShaft™ Quick-release mixing shaft system Height adjustment-free
Smart color touch interface; Compliance data integrity management
Overall Specifications
Product Model : PTWS 830 / PTWS 830-2
Manufacturer : Pharma Test Apparatebau AG (Germany)
Version Specification : Version 1.0
Product positioning and configuration :
Compact 8-vessel dissolution tester (4 × 2 matrix arrangement, 8 vessel fully stirred tank).
Designed specifically for testing the solubility and release of oral solid formulations.
Model derivative version: PTWS 830-2 (compatible with 2-liter dissolving vessel, and can also be switched to compatible with 1-liter standard cups).
International regulatory compliance :
It fully complies with the specifications of the United States Pharmacopeia (USP) <711/724>, the European Pharmacopoeia (EP) <2.9.3/4>, the British Pharmacopoeia (BP), the German Pharmacopoeia (DAB), and the Japanese Pharmacopoeia (JP) <15>.
Meets cGMP and GLP standards, and all material contact components are USP/EP certified.
Stirring system and speed control :
Stirring mechanism: It adopts the MonoShaft single-shaft quick-release stirring tool design, with a constant spindle length. After changing the tool head (chamber/blade), there is no need to readjust the immersion height and bottom distance.
Each stirring shaft can be manually lifted independently for easy and quick removal and cleaning of the dissolving cup.
Speed range: 25 – 250 RPM
Speed accuracy: ±2% of set speed (typically better than < 1%)
Runout: The total runout of the stirring shaft throughout its entire stroke is better than 0.2 mm.
Staggered start function: Supports staggered start timing for 8 workstations, facilitating manual sequential sampling.
Electric lifting mechanism and working position :
A high-precision electric lifting column is installed in the center of the machine body.
It has 16 programmable stirring tool working height positions (such as disk screen, transdermal patch tube, etc.).
When used with the EPE automatic sampling system, it provides an additional 16 sampling needle immersion depth positions (including 1 dedicated cleaning position).
Safety protection mechanism: When the instrument head moves up or down, the stirring motor will automatically and safely stop running.
Water bath and temperature control circulation system :
Water bath tank: made of highly transparent acrylic material, equipped with quick-release leak-proof water pipe connectors.
Drainage design: Optimized integrated drain valve structure for more thorough drainage and quick cleaning and disassembly.
Water bath cover: made of high-rigidity anodized aluminum alloy, ensuring dimensional stability and no deformation; the dissolution cup retaining ring is equipped with a three-point bayonet-type quick centering mechanism.
Low evaporation lid: Standard silicone sealing ring low evaporation lid (24-hour evaporation rate < 0.7%).
Independent external heating circulation module: Powder-coated stainless steel shell with a built-in fully independent self-sealing heating circulation system. No additional control sensors need to be installed in the water bath, making maintenance simple.
Temperature control range: 25.0 – 45.0 °C
Temperature control accuracy: ±0.2 °C within the water bath.
Safety protection: The module's inlet and outlet are equipped with multiple internal temperature sensors and a manually reset overheat safety shut-off switch.
External temperature probe: Standard configuration includes 1 set of external temperature probes, which can directly monitor the temperature of the dissolution cup medium or water bath.
User interface and user management :
7-inch high-resolution (1024 × 600 pixels) color LCD capacitive touchscreen.
Protection and Hygiene: The screen surface is covered with a robust glass protective panel, supporting smooth operation while wearing laboratory gloves.
User permission management: Supports the creation of an unlimited number of user accounts, and allows for the assignment of customized access permissions and passwords based on roles.
Method storage capacity: Supports the creation of unlimited test methods.
Scheduled power-on and automatic standby: The heating time can be preset to shorten the waiting time.
Unlimited test mode: Supports programmable long-term dissolution testing.
Audit tracking and data integrity :
It complies with the requirements of the US FDA 21 CFR Part 11 regulations.
It has a built-in complete audit tracking system that fully records all operation events and parameter values before and after modification.
Provides multi-dimensional filtering functions (quick search by date and time, user, test method, and event type).
Automatic expansion function :
EPE-830 Automatic Sampling Manifold System: Automatically lowers the sampling probe into the dissolution cup for precise sampling according to the set schedule.
ITM-830 Real-time Temperature Monitoring System for Each Cup: Automatically measures and records the actual medium temperature of 8 dissolution cups before and after sampling.
TM-830 (manual) / TMA-830 (automatic) dosing kit: ensures that 8 samples are simultaneously added to the dissolution vessel at the start of the test.
Probe and pipeline magnetic cleaning module: Includes a dedicated cleaning beaker and magnetic mounting base, which can be directly attached to the bottom of the dosing box for fully automatic probe backflushing and pipeline cleaning.
Integration of offline sampling and online analysis :
Offline automatic sampling system: can be directly connected to the DSR-M dissolution sampling robot (built-in valveless plunger pump, supporting sample dilution and isothermal and isochoric solvent replenishment), or directly connected to the PTFC-2/8SP syringe pump sample collector (neither of which requires external computer software control).
Online closed-loop optical spectrum analysis system: Supports integration with J&M TIDAS L UV/Vis array spectrometer (8-slot automatic switch), with centralized control and analysis via WinDiss ARGUS professional dissolution software.
Connection interface and data output :
Communication ports: CAN bus interface (remote control), RS-232 serial port (external serial devices), I/O control port (automation system linkage trigger).
Supports Pharma Test PT-Node Smart Network Adapter: Print reports or transmit data directly from the browser to LIMS/external systems via wired local area network (LAN).
Supports outputting GMP test reports from an external micro-printer.
Material and structural specifications :
Machine body and head: The shell is made of powder-coated stainless steel, which is resistant to acid and alkali corrosion and easy to clean daily.
Modular and separate design: significantly saves space on the experimental tabletop.
Electricity requirements :
Power requirements: 100 – 240 VAC, 50/60 Hz
External dimensions and weight :
Water bath unit dimensions: approximately 75 × 45 × 75 cm (width × depth × height)
Heating circulation module dimensions: approximately 22 × 32 × 22 cm (width × depth × height)
Instrument net weight / gross weight: approximately 75 kg / 130 kg
Standard Scope of Supply :
PTWS 830 main unit (including electric lifting column and external heating circulation module)
MonoShaft stainless steel mixing shafts (8 pieces) and USP 2-blade tool heads (8 sets)
Eight 1,000 ml borosilicate glass dissolution cups (each individually numbered)
8 sets of centering rings with bayonet mounts
Low-evaporation cup lids with silicone sealing rings (8 sets)
8 depth calibration balls
External water bath/medium temperature probe (1 piece)
ALGEX Special Antibacterial and Algae-Inhibiting Agent 1 bottle
Complete original manufacturer's certified folder:
Original manufacturer's operating manual
Factory inspection and design certificate
Installation confirmation file
Operation confirmation document
Instrument Maintenance Log
Certificate of Conformity for Dissolution Cup and Stirring Tool