PTWS 120D

The flexible dissolution bath for constrained bench space requirements.

PTWS 120D

6-Station Tablet Dissolution Testing Instrument

The PTWS 120D is a 6 position, single drive compact tablet dissolution testing instrument for solid dosage forms as described in USP chapter <711/724> and EP section<2.9.3/4> as well as the DAB and Japanese Pharmacopeia section <15>.

PTWS 120D dissolution tester features and external pump and heating module to prevent any vibration transfer to the testing vessel.
The MonoShaft™ stirring tools make immersion depth re-qualification after tool change unnecessary.

PTWS 120D dissolution tester features and external pump and heating module to prevent any vibration transfer to the testing vessel.

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User Interface

In keeping with our cutting edge design, a large color, touch screen allows control of the various mechanical features of the instrument such as the tool stirring speed, lift drive and heater. The instrument control is menu driven using a resistive touch screen and selection wheel technology.

Visual signals on the display inform the user of the status of critical instrument parameters, e.g. bath target temperature not reached. Access to the instrument can be password controlled if required. If certain operational parameters form a regular feature of the daily routine, then these can be incorporated into a test method for faster set up.

These parameters can be tool speed, target bath temperature, sampling time points and so on. The test method memory capacity is almost limitless. As soon as the test is started, a screen saver can be activated with the most important information displayed in large script so that this information remains visible even at time when the operator is not standing directly in front of the instrument.

Stirring Tools

The PTWS 120D uses the Pharma Test MonoShaft™ design. Tools consist of the main shaft plus interchangeable tool heads (adapters). The main shaft remains in place in the instrument regardless of the tool head being used.

The clearance of each tool from the vessel base will always be correct once the main tool shaft has been installed and qualified with any one of the tool sets once. Each stirrer can be raised by hand into a convenient position for easy vessel removal or insertion.

Vessel Centering System

The PTWS 120D features a rigid and precise three-point individual centering system for each dissolution vessel (picture shows view from below). The vessels are held in position by three adjustable noses and are inserted into the instrument support framework.

The access points for sampling as well as the openings for the tools are contained in an auxiliary, low evaporation, vessel cover. Each USP Borosilicate glass vessel has a batch code on top of the flange for easy visibility and positioned placement inside the water bath cover.

Look on the head of the PTWS 120D with its lift mechanism

Look on the head of the PTWS 120D with its lift mechanism

Lift Mechanism

The upper drive is motorized and electronically controlled it offers eight programmable positions: an upper cleaning and instrument qualification position and lower working positions are programmable depending on the type of stirring tool used.

The upper position offers ideal access to the stirring tools and vessels for a change of tools and cleaning steps between the dissolution tests. The motorized drive head lifting mechanism is positioned in a way so that the tool shafts are always kept parallel and at a 90° angle to the vessel walls when in the working position.

Heating System

The heating system is contained in a separate stainless steel housing. The connections between the heater and the bath are made by “quick connect fittings” for easy connection and disconnection. Water is pumped through the system using a powerful, yet quiet, circulation pump.

The pump itself is spring mounted (to limit vibration transmission) and the flow-through heater is protected from overloading (overheating in case of control electronics failure) via a thermal fuse as well as a thermo switch for added security. With service and maintenance in mind, access to the compact pump and heater section is easily achieved without having to move the main body of the instrument.
Easy access for manual sampling

Easy access for manual sampling

Vacuum-Moulded Water Bath

The vacuum molded water bath can easily be removed from the support frame for cleaning purposes. The water bath contains a water diffuser for faster heating and to ensure that heated water is evenly distributed throughout the whole bath. The bath is double walled to reduce the heat transfer to the outer environment saving internal heating and external cooling.

Space Requirements

A key point in today’s crowded labs is the footprint of the PTWS 120D. The space saving design of the PTWS 120D offers the user the choice between a 2×3 or a 3×2 configuration with a minimal space requirement of just 45cm by 65cm (width by depth). The display module can be mounted either of two positions on the drive head of the PTWS 120D instrument.

Features

  • Automated temperature check and log at all sampling times
  • Fully USP <711/724> and EP <2.9.3/4> compliant
  • 6 stirred positons, excellent access to all vessels
  • Store a practically unlimited number of different test descriptions (methods) on SD card
  • CS 3-point individual vessel centering system
  • Centrally located electronic lift drive
  • Staggered start capability
  • Options – PT-RP8 report printer
  • Interfaces – RS-232 to connect report printer, I/O port for remote control in offline automated applications

Technical Data

Parameter Specification
Display 6″, 320×240 pixel color LCD, illuminated
Data Entry Resistive touch screen, functional touch keys
Acoustic Signal Programmable acoustic signal for operator information
Timer Programmable sampling times, wake-up and sleeping mode, operation time information and timer count-down mode
Stirrer Position 8 programmable stirrer immersion positions (paddle over disk, transdermal cylinder etc.)
Testing Method Programming Unlimited number of different test descriptions can be stored on SD card
User Access Control Multiple level access control, CFR compliant
OQ, PQ control Programmable time periods to remind on QO or PQ testing
Printer External PT-RP80 report printer using long-life printer paper
Number of Stirred Vessels 6 (3 by 2 or 2 by 3 arrangement)
Standard Vessels 1 liter USP/EP Borosilicate glass vessel, each individually coded
Vessel Covers Ultra-low evaporation design (< 0.7% within 24h)
Stirring Speed Control 25 – 250 RPM
Speed Accuracy ±2% of set speed, typically < 1%
Stirrer Shaft Wobble Better than 0.2 mm total run out
System Tools MonoShaft™ stirrer design, USP/EP apparatus 1, 2, 5, 6 tool adapter, cream cell, transdermal patch tools, each tool and vessel individually coded
Heating System Pump for water circulation and 1500W heater for fast heating up (230/240V units only)
Heater Range 25 – 45°C
Heater Accuracy ± 0.2°C inside the water bath
Heat Up Process Energy saving, programmable “wake up” heater function and “sleep mode”
Water Circulation Water circulated from external heating system through special diffuser inside the water bath
Vibration Elimination External heating system, spring loaded pump assembly
Calibration Built-in calibration procedures for speed, temperature control, OQ/PQ interval programmable including alarm indicator
Bench Space Requirement 45 x 65 cm (2 by 4) or 65 x 45 cm (4 by 2)
Certification All components certified to USP / EP requirements
CE / EMC Certification All CE / EMC Certification provided
Validation All IQ & OQ documents included

We reserve the right to make technical changes without any prior notice.

Included in the Standard Scope of Supply

  • Eco saving double walled vacuum molded water bath
  • One set of stainless steel paddles
  • One set of batch coded 1000ml Borosilicate glass vessels
  • One set of depth adjustment balls
  • One bottle of ALGEX water preservative
  • Comprehensive documentation folder including:
    • User manual
    • DQ/QC instrument compliance test certificate
    • IQ documentation
    • OQ documentation
    • Instrument logbook
    • Compliance certificates for vessels and stirring tools

Options

  • Direct control of peripheral instruments via I/O port such as PTFC-2/8 fraction collector or DSR-M Sampling Robot
  • 2 liter vessel version (can also be used with 1 liter vessels)
  • 250 ml Mini Vessel set incl. mini paddle stirrers
  • Amber colored vessels for UV sensitive test materials
  • Full range of MonoShaft™ stirring tools available
  • Full range of certified validation tools available
  • PT-RP80 serial report printer

PT-RP80 Report Printer

Use the PT-RP80 serial report printer to print out the runtime report of the PTWS 120D.

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