Overall Specifications

• Product Models : PTWS 130D / PTWS 130S / PTWS 130D-2 / PTWS 130S-2

• Manufacturer : Pharma Test Apparatebau AG, Germany

• Version Specification : Version 1.0

• Product positioning and operating principles :

  • A compact 6-station dissolution tester specifically designed for testing the solubility and release rate of solid preparations.

  • The symmetrical layout of 3+3 double rows significantly reduces the space occupied by the laboratory countertop.

  • The machine head is equipped with a central electronic lifting mechanism, which automatically raises upon completion of testing, providing unobstructed sampling and cleaning space.

  • It features a staggered start-up testing function, allowing each workstation to be started sequentially to facilitate precise manual sampling.

  • The agitator automatically stops operating when the drive head moves, ensuring operational safety.

• Compliance with International Pharmacopoeia and Regulatory Standards :

  • It fully complies with the standards and specifications of the United States Pharmacopeia, European Pharmacopeia, British Pharmacopeia, German Pharmacopeia, and Japanese Pharmacopoeia.

  • Built-in audit tracking and user security access management that meet the standards of Section 21, Paragraph 11 of the U.S. Federal Regulations.

  • The fuselage structure and contact materials fully comply with the requirements of Good Laboratory Practice and Good Pharmaceutical Manufacturing Practice.

• Mixing mechanism and drive control technology :

  • Mixing tool frame: It adopts a single-shaft quick-release mixing shaft design, with the main shaft fixed to the machine body, so there is no need to readjust the immersion height after changing the rotor.

  • Workstation configuration: 6 sets of stirring and dissolving cup workstations (3 plus 3 symmetrically arranged)

  • Stirring shaft runout: Total runout over the entire stroke is better than 0.2 mm.

  • Speed control range: 25 to 250 revolutions per minute

  • Speed control accuracy: ±2% of set speed (typically better than 1%)

  • Model drive differences:

    • PTWS 130D: Single-drive motor synchronous control to maintain the same speed at 6 workstations.

    • PTWS 130S: Each of the 6 workstations is equipped with an independent stepper motor, supporting independent speed settings for each of the 6 workstations (designed specifically for R&D and method development).

  • Stirring and immersion position: Built-in central electronic lifting drive, providing 16 programmable working immersion height settings (supporting paddle method, skin-penetrating cylindrical method, etc.)

  • It features a manual, individual stirring shaft lifting function at each workstation for easy loading and unloading of dissolving cups.

• Water bath temperature control and water circulation system :

  • Temperature control unit architecture: The heater and circulating pump are integrated into a single, independent external module, using a corrosion-resistant powder-coated stainless steel casing.

  • Independent temperature control technology: The module integrates a fully enclosed self-sustaining heating control system, eliminating the need for control sensors inside the water bath, making maintenance simple and temperature control precise.

  • Temperature control range: 25.0 to 45.0 °C

  • Water bath temperature control accuracy: better than ±0.2 °C within the water bath.

  • Safety protection mechanism: Both the inlet and outlet of the heater are equipped with internal temperature sensors and resettable thermal shutdown protection switches.

  • External monitoring probe: Standard configuration includes an independent external temperature probe for real-time monitoring of the actual temperature inside the water bath or dissolution vessel.

  • Quick-release interface for water bath: The acrylic water bath is equipped with a quick-release connector system to ensure a safe and leak-proof connection to the external heating module.

  • Water bath structure optimization: The drain valve connection structure has been strengthened and the drain position has been reconfigured. Both the water bath and the top cover can be directly disassembled for thorough cleaning.

  • Robust water bath cover: Made of protective aluminum alloy material, with strong resistance to deformation.

  • Precise positioning of the dissolution cup: The dissolution cup is inserted into the fixing ring fixed to the top cover and precisely centered through the three-way snap-fit positioning ring.

  • Low-evaporation sealing lid: Equipped with a silicone sealing ring, this low-evaporation lid significantly reduces evaporation loss of the test medium over long periods.

• User interface and intelligent control system :

  • Display: 7-inch color capacitive backlit touchscreen LCD (1024 × 600 pixels resolution)

  • Touch sensitivity: Features highly sensitive touch response, allowing for smooth operation even when wearing laboratory gloves.

  • User access control: Supports the creation of an unlimited number of user accounts, with password protection and multi-level access permissions.

  • Inspection Method Management: Supports storing an unlimited number of inspection methods.

  • Audit tracking system: Completely records all instrument operation events and comparative information before and after value changes, supporting multi-condition filtering by date and time, user, method, and event type.

  • Smart scheduling and timer: Features programmable scheduled power-on preheating to reduce waiting time, sleep energy-saving mode, sampling time reminder, and countdown timer.

  • Audible and visual alert function: The sampling interval has a programmable audible and visual alert signal.

  • Special testing procedures: Supports programmable infinite dissolution testing procedures

  • Calibration validation management: Built-in calibration guidance program with automatic reminders for the expiration of operational and performance validation cycles.

• Automated integration and peripheral expansion capabilities :

  • Offline automated sampling: Supports direct connection to the DSR-M automated sampling robot (equipped with valveless piston pump for high-precision sampling, online dilution, and automatic media replenishment) or the PTFC-2/8SP syringe pump sample collector, allowing for controlled operation without the need for external computer software.

  • Online continuous spectral monitoring: Supports connection to the J&M TIDAS L UV-Vis array spectrometer equipped with an 8-station automatic slot changer, and uses WinDiss ARGUS proprietary software to control and construct an online closed-loop continuous monitoring system.

  • Networked data transmission: Supports PT-Node smart network adapters, enabling direct browser printing or connection to the laboratory information management system via wired LAN.

• Communication interface and technical parameters :

  • CAN communication port (used for remote control)

  • RS-232 serial communication port (for connecting peripheral serial devices)

  • Digital-to-analog I/O ports (used in automation systems to directly trigger and connect external devices)

• Standard Scope of Supply :

  • PTWS 130 Dissolution Tester Main Unit and External Heating Circulation Module

  • 6 sets of single-shaft quick-release stainless steel mixing shafts and United States Pharmacopeia (USP) No. 2 paddles

  • Six individually coded 1000 ml borosilicate glass dissolving cups

  • 6 sets of three-way snap-fit dissolution cup positioning rings

  • 6 sets of low-evaporation cup lids with silicone sealing rings

  • 6 standard depth adjustment and correction balls

  • One set of water bath and dissolution cup with external temperature monitoring probes

  • 1 bottle of ALGEX Magenta water bath antibacterial preservative

  • Complete original manufacturer validation file folder, containing operating manuals, design and quality conformity test reports and certificates, installation validation documents, operation validation documents, instrument history logbook, and original manufacturer conformity certificates for dissolving cups and stirring tools.

• Product model derivative specifications :

  • PTWS 130D: Standard 6-station synchronous speed model (suitable for 1-liter dissolving cup)

  • PTWS 130S: 6-station independent stepper motor speed control model (suitable for 1-liter dissolving cup)

  • PTWS 130D-2: 2-liter large-capacity dissolving cup synchronous speed model (also compatible with 1-liter dissolving cups)

  • PTWS 130S-2: 2-liter large-capacity dissolving cup with independent speed control

• Optional accessories and expansion modules :

  • A full range of single-shaft quick-release mixing tools: USP and European Pharmacopeia Method 1 rotary basket, Method 2 paddle, Method 5 paddle disc, Method 6 rotary cylinder adapter, ointment cup, and special tools for skin grafting (each tool set has an independent code).

  • Brown, light-proof dissolution cup (with individual coding, specifically designed for the inspection of light-sensitive materials)

  • 250 ml microdissolution cup set (including dedicated microstirring paddle)

  • External ticket thermal printer

  • PT-Node Smart LAN Adapter

  • Original manufacturer certified complete set of physical testing and validation tools

• Airframe specifications and environmental requirements :

  • Water bath unit dimensions: approximately 75 × 45 × 75 cm (width × depth × height)

  • External heating module dimensions: approximately 22 × 32 × 22 cm (width × depth × height)

  • Total instrument weight: Approximately 75 kg net weight, approximately 130 kg gross weight.

• Validation and Certification :

  • All key and contact components fully comply with the standards and certifications of the United States Pharmacopeia and the European Pharmacopeia.

  • Possesses complete safety standards and electromagnetic compatibility certifications

  • Standard configuration includes complete original factory installation and operation confirmation documents.