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PTZ AUTO

PTZ AUTO Semi-Automated Tablet Disintegration Testing


PTZ AUTO

PTZ AUTO Semi-Automated Tablet Disintegration Testing

The PTZ AUTO disintegration test instruments are available as single, double, triple and four station systems. They are equipped in full compliance with the current USP [701/2040] and EP [2.9.1/2.9.2.1] Pharmacopoeia.

PTZ AUTO Semi-Automated Tablet Disintegration Testing


Operating Mode

A large 320x240 pixel LCD screen and an alpha-numerical keyboard is used to edit product and test information, such as the disintegration time for each station, bath and media temperature. The total testing time for the station is displayed at the end of a run. Operator intervention to stop a run is also displayed. Print the individual disintegration time of each sample once it was visually detected by simply pressing the corresponding numeric key. All this information can be printed as a test report when a PCL printer is attached to the instruments parallel printer port.


Heating System
The built-in heating system uses a silent circulation pump and a heater to pre-heat the outer water bath over the range of 25.0-45.0˚ C. The actual bath temperature is always displayed and measured by an external manual temperature probe. The overheating protection secures automatic shut-down of the pump and heater in the event that no water flow is detected. A built-in safety system including an overheating detection sensor, a thermo switch and a thermo fuse closes down the heating when temperature exceeds +60˚C or max. 95˚C at the heater.



Cleaning and Maintenance
For easy cleaning and maintenance, the Plexiglas water bath can be easily removed. Fast Tube Couplings connect the tubing to the heating system. The digital controlled stroke mechanism is automatically adjusted to provide the USP / EP specified 30 strokes a minute to each station.

At the end of a test run, each basket is completely removed from the test media by the individual basket lift device. This feature is particularly useful if sustained released products are tested, which may require a medium change during the run.

PTZ32 Software
The PTZ AUTO EZ is equipped with a serial RS-232 interface. The instrument can be connected to a PC and the PTZ32 software (21 CFR part 11 compliant) offers test methods, result filing, batch comparison and graphical information. Export functions to Excel and LIMS (Laboratory Information Management Systems) are available as options.

Upgrade to Fully-Automated Instrument
The PTZ AUTO disintegration test instruments upgradeable to fully-automated PTZ AUTO EZ instruments, which automatically determine independent disintegration data for each test sample using the PT-MKT electronic disintegration baskets. At the end of a test run, a test report can then be printed showing the minimum and maximum disintegration time, statistics as well as bath and media temperature, stroke frequency, and product data for each sample tube and each testing station.



Features
  • Fully USP [701/2040] and EP [2.9.1/Test A and B] compliant
  • Available as 1, 2, 3 and 4 station instruments (PTZ AUTO 1, PTZ AUTO 2, PTZ AUTO 3 and PTZ AUTO 4)
  • GMP compliant stainless steel housing
  • Upgradeable to fully-automated operation
  • Store up to 16 methods with sample and test information


Advantages
  • Select from models with 1, 2, 3 or 4 stations to ideally meet your workload
  • Independent movement of all test stations
  • Automated lift to raise samples out of the medium at the end of a test
  • Automated time log when disintegration is observed
  • Integrated method management system
  • Excellent access to all vessels
  • DQ/QC, IQ and OQ documents included free of charge

Technical Specifications

ParameterSpecifications
DisplayBacklit LCD, 320x240 pixels
Data EntryAlpha-numerical keys and function keys
Testing Stations1, 2, 3 or 4 stations - each independently operateable
Testing TimeProgrammable from 1 second up to 23h, 59m, 59s
Auto Basket LiftRaises samples out of the medium at test end
Security SystemsPassword protection for calibration and validation
OQ InformationProgrammable time sequence information to perform OQ
ThermostatWater bath temperature programmable from 25.0˚ - 45.0˚C, overheating protection
Temperature Accuracy± 0.3˚C
Safety SystemsPressure switch to protect from overheating (no liquid flow - no heating - no pump); Thermo switch and thermo fuse to protect the heating system in case of electronical fault
Stroke Frequency30 per minute
Stroke Accuracy± 1 stroke
Stroke Height55 mm
Stroke Height Accuracy± 1 mm
InterfacesRS-232 serial interface for external control and data transfer
Instrument DimensionsPTZ AUTO 1 approx. 61 x 37 x 54cm (width x depth x height); PTZ AUTO 2 approx. 61 x 37 x 54cm (width x depth x height); PTZ AUTO 3 approx. 76 x 37 x 54cm (width x depth x height); PTZ AUTO 4 approx. 91 x 37 x 54cm (width x depth x height)
Packaging DimensionsPTZ AUTO 1 approx. 80 x 51 x 70cm (width x depth x height); PTZ AUTO 2 approx. 80 x 51 x 70cm (width x depth x height); PTZ AUTO 3 approx. 80 x 51 x 70cm (width x depth x height); PTZ AUTO 4 approx. 107 x 77 x 95cm (width x depth x height)
Net / Gross WeightPTZ AUTO 1 approx. 22 / 30kg; PTZ AUTO 2 approx. 29 / 35kg; PTZ AUTO 3 approx. 35 / 45kg; PTZ AUTO 4 approx. 42 / 108kg;
CertificationAll components certified to USP / EP requirements
CE / EMC CertificationAll CE / EMC Certification provided
ValidationAll IQ & OQ documents included

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



Included in the Standard Supply Scope
  • One six position "A type" disintegration baskets for each testing station
  • One set of six glass tubes for each disintegration basket
  • One set of six disintegration disks for each disintegration basket
  • 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

  • Alternative three position "B type" disintegration baskets for larger samples
  • Upgrade kit for fully-automated operation
  • DIN A4 PCL report printer



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Pharma Test Instruments India Private Limited
Pragathi Nagar, Medchal Dist. Hyderabad - 500090, Telangana. T: +91 40 48591800 E: c.neelam@pharma-test.de




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