- GALENIC INSTRUMENTS
- DISSOLUTION TESTING
- OVERVIEW ALL PRODUCTS
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 [2.9.1/220.127.116.11] Pharmacopoeia.
PTZ AUTO Semi-Automated Tablet Disintegration Testing
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.
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.
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.
|Display||Backlit LCD, 320x240 pixels|
|Data Entry||Alpha-numerical keys and function keys|
|Testing Stations||1, 2, 3 or 4 stations - each independently operateable|
|Testing Time||Programmable from 1 second up to 23h, 59m, 59s|
|Auto Basket Lift||Raises samples out of the medium at test end|
|Security Systems||Password protection for calibration and validation|
|OQ Information||Programmable time sequence information to perform OQ|
|Thermostat||Water bath temperature programmable from 25.0˚ - 45.0˚C, overheating protection|
|Temperature Accuracy||± 0.3˚C|
|Safety Systems||Pressure 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 Frequency||30 per minute|
|Stroke Accuracy||± 1 stroke|
|Stroke Height||55 mm|
|Stroke Height Accuracy||± 1 mm|
|Interfaces||RS-232 serial interface for external control and data transfer|
|Instrument Dimensions||PTZ 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 Dimensions||PTZ 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 Weight||PTZ AUTO 1 approx. 22 / 30kg; PTZ AUTO 2 approx. 29 / 35kg; PTZ AUTO 3 approx. 35 / 45kg; PTZ AUTO 4 approx. 42 / 108kg;|
|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.