Semi-Automated Tablet Disintegration Testing
Semi-Automated Tablet Disintegration Testing
The PTZ AUTO disintegration test instruments are available as single, double, triple and four station systems. Each disintegration basket can be operated independently. They are equipped in full compliance with the current USP <701/2040> and EP <2.9.1/18.104.22.168> Pharmacopoeia.
PTZ AUTO 4 Semi-Automated Tablet Disintegration Testing Instrument
A large LCD screen and an alpha-numerical keyboard are used to edit product and test information, such as the target disintegration time for each station and the bath and media temperatures. Up to 16 different testing methods can be filed in the instrument’s memory. A test screen shows the run time information once a disintegration test is started. The individual disintegration time of each sample once it was visually detected can be easily logged by pressing the corresponding numeric key. The total testing time for the station is displayed at the end of a run. A result report including the individual disintegration times can be printed by connecting a PCL printer to the instrument.
The instruments are supplied with a complete PT-MKT electronic disintegration test basket for each testing position. Each basket is used to test six samples and includes six glass tubes and six disks. For larger samples of up to 30mm diameter we offer the PT-MKT33 basket (“B”-type according to USP <2040> and EP <22.214.171.124>). This basket is used to test three samples and is equipped with three tubes and disks only.
To enable the automated detection of the final disintegration time of each individual sample, the basket bottom sieves are split. A small metal ring is injected into the disks during manufacturing. This ring closes a contact between the two sieve halves once the sample has disintegrated. Each disk can be used in any of the testing positions. There is no need to always place them into the same tube or even basket. There is also no need to use different designs or tools to test different tablet shapes. The complete basket design including sieve and disks is in full compliance with the current USP and EP pharmacopoeias. The specific weight of the disks is kept in full compliance too.
Sustained Release Testing
At the end of a test run, each basket is completely raised out of the test media by the individual basket lifting system. This feature is particularly useful if sustained released products are tested, which may require a medium change during the test run.
Heating System and Mechanical Features
The built-in heating system of the PTZ AUTO EZ instrument uses a silent circulation pump and a heater to pre-heat the outer water and keep the temperature within a tight tolerance. The actual bath temperature is displayed at all times and measured by an external movable temperature probe inside the water bath. The overheating protection system includes a pressure gauge to monitor the pump flow, a thermo switch and thermo fuse to cut the power supply in case of an electronical fault.
This secures automatic shutdown of the pump and heater in the event that no water flow is detected or the electronical control system fails. A built-in digital safety sensor placed at the end of the heating coil shuts down the heating when temperature exceeds +60° C max. 95°C at the heater.
The PTZ AUTO 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.
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.
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.
- 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
- 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
|Display||LED backlit LCD, 320x240 pixels, 9" diagonal, approx. 90x120mm|
|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.
Included in the Standard Scope of Supply
- 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
- Alternative three position “B type” disintegration baskets for larger samples
- Upgrade kit for fully-automated operation
- DIN A4 PCL report printer