PTWS 820D

The compact, 8 station tablet dissolution testing instrument.

PTWS 820D

USP/EP Tablet Dissolution Testing Instrument

The PTWS 820D is an 8 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 820D is an 8 position dissolution bath controlled by a color touch screen

PTWS 820D is an 8 position dissolution bath controlled by a color touch screen

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.

User Interface

User Interface

Stirring Tools

The PTWS 820D uses the Pharma Test MonoShaft™ design. The 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. PTWS 820D is capable to perform a staggered start for each of the eight positions

Vessel Centering System

The PTWS 820D 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.

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 electronically driven lift mechanism is located centrally above the water bath. This ensures that the whole lift drive 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.

 

PTWS 820D includes an automated head lift with programmable positions
A tablet drop magazine is available as an option
The MonoShaft™ design allows changing of the tools without re-qualifying the immersion depth
The tubing connections for the sampling system are arranged on the instrument's backside
The EPE automated sampling manifold is driven into the test vessels at programmable intervals

PTWS 820D includes an automated head lift with programmable positions

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Features

  • Fully USP <711/724> and EP <2.9.3/4> compliant
  • 8 stirred positions in a 4 + 4 arrangement
  • Centrally located motorized lift drive to raise and lower the drive head
  • Individually coded Borosilicate vessels
  • File up a nearly unlimited number of different test descriptions (methods)
  • Instrument suitability check prior to start of a test run
  • Staggered start capability
  • Vessel low evaporation sealing covers
  • Removable water bath for easy cleaning
  • Drainage tap to empty the bath
  • Method management and user administration with access control
  • Optical and acoustic signals to inform about sampling intervals, timer count down function
  • Traffic light optical information on display shows the instrument status by different colors (green = ready to use, yellow = preparing to use, red = error encountered)
  • OQ, PQ interval warning with programmable interval
  • Interfaces: USB port for remote control of the PTWS 820D, RS-232 port to connect a serial PT-RP80 report printer, printing date/time, sampling time information, selected sampling position, used stirring tools, media temperature, operator name etc., I/O port for remote control of external instruments in automated applications, like DSR-M, Pumps and PTFC-2/8

Advantages

  • Modular design to minimize bench space requirements
  • 3-point individual vessel centering system
  • Excellent access to all vessels
  • Screen saver functionality offers most important information at a glance (stirrer speed, bath temperature, time to next sampling interval, elapsed time, media temperature etc.)
  • Wake up functionality to start heating at a pre-programmed time
  • Ultra-fast heating system due to newly designed heat exchanger
  • MonoShaft™ system to avoid re-adjustment of immersion depth
  • Staggered stirrer start feature for convenient manual sampling
  • Water diffuser for even temperature distribution
  • Spring loaded pump assembly to eliminate vibration transfer
  • Extraordinary safety features for pump and heating system, flow control, digital temperature control, Thermo switch, Thermo fuse
  • Auto stirrer stop when instrument head is moved
  • Excellent stirrer shaft verticality inside the vessels due to central position of lift columns and drive head assembly
  • Easy removal of the water bath from of the frame work for cleaning and maintenance work
  • DQ/QC, IQ and OQ documents included free of charge

Technical Specifications

Parameter Specification
Display 6”, 320×240 pixel color LCD, illuminated
Data Entry Resistive touch screen
Acoustic Signal Acoustic signal for operator information at programmable intervals
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 Descriptions Unlimited number of different test descriptions can be stored on SD card
User Access Control Multiple level access control
OQ, PQ control Programmable time periods to remind on QO or PQ testing
Printer External PT-RP80 report printer
Number of Stirred Vessels 8 (4 by 2 or 2 by 4 arrangement)
Standard Vessels 1 liter USP/EP Borosilicate glass vessel, each individually coded
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 1400W heater for fast heating up
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 75 cm (2 by 4) or 75 x 45 cm (4 by 2)
Packaging Dimensions
Certification All components certified to USP / EP requirements
CE / EMC Certification All CE / EMC Certification provided

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

Included in the Standard Scope of Supply

  • One set of stainless steel paddles
  • One set of 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

Downloads

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
  • EPE-820 motorized sampling system
  • ITM-820 media temperature monitoring system
  • TM-820 manual tablet drop magazine
  • TMA-820 automated tablet drop magazine
  • 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 120S.

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