Fully Automated Tablet Disintegration Testing

The fully automated PTZ AUTO EZ instruments are available as single, double, triple and four station models

The instruments automatically detect the individual disintegration times of tablets and other solid dosage forms. Each automated disintegration basket can be operated independently and includes a temperature sensor. They are equipped in full compliance with the USP<701/2040> and EP<2.9.1/2.9.1.2> pharmacopoeia requirements.

Features

• Fully USP <701/2040> and EP <2.9.1/Test A and B> compliant
• Available as 1, 2, 3 and 4 station instruments
• GMP compliant stainless steel housing
• Equipped for fully-automated operation
• Store up to 16 methods with sample and test information

Advantages

• Fully automated detection of individual disintegration end point times
• 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
• Integrated method management system
• Excellent access to all vessels
• DQ/QC, IQ and OQ documents included free of charge

Operating Mode

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 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 <2.9.1.2>). 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.

MKT Baskets

The electronic disintegration baskets PT-MKT or PT-MKT33 are equipped with a temperature sensor to monitor the actual media temperature inside the glass beaker during operation. The disintegration time of each individual tablet within the basket is automatically detected. The total time is recorded and displayed. The printed report shows the individual disintegration time of each sample, minimum and maximum time, as well as mean value and standard deviation of all 6 or 3 samples.

The report includes the system information of bath and media temperature with no need of any external computer or software. Simply connect any suitable PCL printer to the parallel printer port of the PTZ AUTO EZ to receive your result report.

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.

 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.

Cleaning and Maintenance

For easy cleaning and maintenance, the Plexiglas water bath can be removed quickly. 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.