Overall Specifications

• Product Series : PTWS 1230 / PTWS D630 Series High-Throughput Dissolution Testing Systems (USP/EP Tablet Dissolution Testing Instrument)

• Manufacturer : Pharma Test Apparatebau AG (Germany)

• Version Specification : Version 1.1 / 1.0

• Product positioning and application :

  • A 12-vessel high-throughput dissolution tester designed specifically for solid preparations (tablets, capsules, etc.).

  • It adopts a 6+6 dual-row matrix layout , which provides excellent front operating view and convenience for manual sampling.

  • Perfectly suited for high-throughput quality control (QC), R&D prescription screening, and biowaiver comparison tests between original manufacturers and generic drugs.

• Model specifications and dual-drive differences :

  • PTWS 1230 (Standard Model) : 12 mixing stations with single synchronous speed control.

  • PTWS D630 (Dual Drive) : The front 6 seats and the rear 6 seats have independent speed control functions , which can simultaneously compare the dissolution under two different speed conditions.

• Compliance with international regulations and pharmacopoeia :

  • It fully complies with the latest specifications of USP <711/724> , EP <2.9.3/4> , BP , DAB and JP <15> (Japanese Pharmacopoeia) .

  • All key contact components are USP/EP certified and comply with cGMP and GLP requirements.

• Dissolution vessel configuration and capacity :

  • 12 stirring and dissolving positions (6 × 2 double-row design), standard configuration includes 12 individually coded 1,000 mL high-precision borosilicate glass dissolving cups.

  • Two additional heating spare vessels are provided : dedicated to isothermal solvent replenishment or constant temperature preheating of reference standard solutions (total of 14 vessel positions).

  • Optional accessories include a 250 mL MiniVessel set and a dedicated mini oars.

  • Optional UV-resistant, light-shielding amber (brown) dissolution cup, suitable for photosensitive active drugs.

• Stirring system and MonoShaft™ patented quick-release technology :

  • MonoShaft™ Stirring Tool System : Featuring a fixed spindle with quick-release tool connectors, once initially installed and positioned, tool replacement (chamber/blade) does not require recalibrating the immersion depth and height .

  • Each stirring shaft can be manually lifted and positioned individually, making it convenient to add, observe, or sample individual dissolution cups.

  • Mixing speed range: 25 – 250 RPM .

  • Rotational speed accuracy: ±2% (typical value better than <1% ).

  • Stirring shaft wobble: better than 0.2 mm total runout .

  • Supports the full range of MonoShaft™ mixing tools: USP 1 (rotary basket method), USP 2 (paddle method), USP 5 (paddle disc method), USP 6 (rotary cylinder method), Cream Cell, and skin patch tools (all with independent anti-counterfeiting serial numbers).

• Water bath circulation and independent heating and temperature control system :

  • The independent external high-flow-rate circulating heating module features a durable powder-coated stainless steel casing.

  • With advanced internal closed-loop heating technology, no additional control sensors need to be installed inside the water bath , greatly simplifying maintenance and ensuring uniform water flow and precise temperature control.

  • Water bath quick-release connector system: Equipped with a leak-proof self-locking mechanism, tool-free and safe quick release.

  • Temperature control range: 25.0 – 45.0 °C .

  • Temperature control accuracy: ±0.2 °C in the water bath.

  • Safety protection mechanism: Both the inlet and outlet of the heater are equipped with precision temperature sensors and a manually resettable overheat safety fuse protection switch (thermal cutoff switch).

  • It comes standard with an external independent temperature probe, which can monitor the actual medium temperature of each dissolution cup or water bath in real time.

• Highly stable water bath and cup lid positioning mechanism :

  • Water bath drainage optimization design: reinforced drain faucet connectors are repositioned to achieve complete drainage, and the water bath and cover can be completely disassembled for deep cleaning.

  • Durable PVC water bath cover: Features excellent dimensional stability and resistance to solvent corrosion.

  • Three-way snap-fit positioning ring : The dissolution cup is directly and precisely embedded and positioned to ensure excellent concentricity and alignment with the center of the cup.

  • Low-evaporation silicone protective lid : effectively prevents solvent evaporation loss during long-term testing.

• Precision electronic lifting system :

  • The rigid fixed lifting column is equipped with precision bearings to support the machine head.

  • It is driven to rise by an electric linear actuator and assisted by a gas pressure spring for precision counterweight; during descent, it adopts a powerless gravity descent mechanism, which smoothly stops when encountering foreign objects , completely eliminating the risk of the machine head being pinched or damaged in the water bath.

  • It features 16 programmable working height positions for the mixing head (suitable for various types of mixing tools or different height requirements).

  • When equipped with the EPE automatic sampling mechanism, it also supports 16 sampling height position settings (including a dedicated cleaning positioning height).

  • It has an automatic stop function with a safety interlock for lifting the machine head (the agitator will stop automatically immediately when the machine head is moved).

• Touchscreen and user management system :

  • 7-inch high-resolution full-color capacitive touchscreen (1024 × 600 pixels, high-brightness LED backlight).

  • The surface is equipped with a reinforced solid glass protective panel that is resistant to chemical corrosion and scratches.

  • Highly sensitive touch feedback allows for smooth and precise operation even when wearing laboratory latex/nitrile gloves .

  • It features a graphically user-friendly interface, coupled with intuitive animated guidance and clear text instructions.

  • Unlimited user account management : Supports multi-level password and custom permission security management.

  • Unlimited test method storage : Supports flexible access to a vast array of R&D and quality control analysis methods.

• Compliance with regulations and completeness of data :

  • Built-in integrated audit trail , fully compliant with FDA 21 CFR Part 11 regulations.

  • Automatically and completely record all system events and parameter modifications, including detailed information before and after the changes .

  • Supports multi-condition audit tracking filtering: date and time, user, method name, event type, etc.

• Smart experimentation features and automation support :

  • Staggered drug dosing activation function : 12 test stations support staggered drug dosing activation in sequence, which greatly improves the error tolerance and accuracy of manual sampling.

  • Automatic preheating and wake-up function : The heating can be started earlier by preset schedule, reducing the waiting time for laboratory staff.

  • Unlimited test mode : Supports setting full-speed rotation after the test ends to facilitate complete dissolution evaluation.

  • Built-in sampling time countdown prompt, providing clear audio and visual warnings (Optical & Acoustic Signals) .

  • Built-in guided calibration program with periodic OQ/PQ maintenance and validity expiration warning .

• Optional expansion modules from the manufacturer :

  • EPE-1230 Automatic Sampling Manifold System : Automatically drives the stainless steel sampling needle to accurately descend into the dissolution cup at a set time point to take a sample, and automatically rises away from the liquid surface after sampling is completed.

  • ITM-1230 Twelve-Channel Independent vessel Temperature Monitoring System : Automatically measures and records the actual medium temperature of all 12 vessel simultaneously before drug administration and at the time of each sampling.

  • TM-1230 Manual Synchronous Dosing Kit / TMA-1230 Automatic Synchronous Dosing Kit : Enables 12 samples to fall into each dissolution vessel simultaneously at the start of the test.

  • Sampling needle and tubing magnetic cleaning system : Equipped with a dedicated cleaning beaker and magnetic mounting base, it can be directly attached to the bottom of the dosing box, realizing one-click online flushing and waste disposal of the sampling needle and tubing.

• Automated online and connectivity expansion capabilities :

  • Offline automatic sampling :

    • Seamlessly connectable to the DSR-M robotic automated sampling workstation (equipped with a valveless piston pump, supporting online high-precision dilution and automatic isothermal and isochoric solvent replenishment).

    • It can be connected to the PTFC-16SP (or PTFC-2/8SP) automatic liquid collector and paired with the PT-SP syringe pump, allowing direct control from the main unit without the need for external computer software.

  • Online automated spectral analysis :

    • Integrates the J&M TIDAS L dual-beam fiber diode array UV/Vis spectrometer (equipped with a 16-channel automatic cell changer) with WinDiss ARGUS professional dissolution data management software .

  • Smart Lab Network Connection :

    • The PT-Node adapter allows for direct control and reporting output to a network printer via a web browser over a wired network (LAN), or data transmission to a LIMS/external system.

• Transmission and communication interface :

  • CAN-Bus interface : used for remote communication and module expansion in high-speed systems.

  • RS-232 serial port : Connects to a miniature thermal printer or an external serialization device.

  • I/O control ports : used for connecting to external control devices in automation systems (such as DSR-M, PTFC trigger signals).

• External dimensions and weight :

  • Instrument water bath main unit dimensions: approximately 900 × 600 × 750 mm (width × depth × height).

  • Circulating heater module dimensions: approximately 220 × 320 × 220 mm (width × depth × height).

  • Machine net weight / gross weight: approximately 75 kg / 130 kg .

• Electrical and Safety Certifications :

  • The entire machine has passed complete CE marking and EMC electromagnetic compatibility certification .

• Standard Scope of Supply :

  • PTWS 1230 (or PTWS D630) dissolution apparatus main unit and external heating circulation module

  • 1 set (12 pieces) MonoShaft™ stainless steel mixing shafts and USP 2 blades

  • One set (12 individually numbered 1,000 mL borosilicate glass dissolution cups

  • 1 set (2 pieces) of constant temperature replenishment and standard product spare cups

  • 1 set (12 pieces) of dissolution cup positioning rings with a three-way snap-fit mechanism

  • 1 set (12 pieces) of low-evaporation sealing cup lids with silicone liner

  • 1 set (12 balls) of height positioning and correction steel balls

  • 1 set of water bath and dissolution cup external high-precision temperature probe

  • 1 bottle of ALGEX Magenta water bath anti-algae, preservative, and antibacterial agent

  • Complete original manufacturer technical and validation folder:

    • Original manufacturer's Chinese/English operating manual

    • Factory inspection and testing report and certificate of conformity (DQ / QC)

    • Install the validation file (IQ).

    • Operation Qualification (OQ)

    • Instrument maintenance logbook

    • Original manufacturer's certification for materials and dimensions of the dissolving cup and stirring tools.