suppository penetration test assembly

Features

• Fully EP <2.9.22.1> Apparatus A compliant
• Test six samples at the same time
• Connect to any PTZ-S, DIST-3, PTZ AUTO 1-4 or PTZ AUTO 1EZ – 4EZ instrument
• Supply scope includes water bath and tubing connection to heating system of disintegration testing instrument

Advantages

• Fully automated detection of suppository softening time (with PTZ AUTO EZ only)
• Round, clear-view waterbath for excellent visibility of all samples
• Multi-purpose system: the disintegration testing instrument can still be used for regular tablet disintegration tests
• IQ/OQ documents included free of charge

Automated Operation

When using the SPT-6 together with any PTZ AUTO EZ tablet disintegration testing instrument the softening time can be detected and reported fully automatically. The SPT-6 test assembly with its six testing positions and its water bath is placed into any testing position of the PTZ AUTO EZ instrument and is connected to the automated time detection electronics by cable. Select the corresponding test procedure from the menu of the PTZ AUTO EZ to operate the SPT-6. Fill 10ml of water into each of the glass tubes. Heat the water bath to 36.5 ± 0.5°C and place one suppository into each tube once the target temperature has been reached. Now put the test rod onto the sample. The time is now controlled. As soon as the test rod touches the glass tube bottom the softening time is recorded. Once all six samples are melted the individual softening time is displayed as well as the statistics. Use a printer connected to the PTZ AUTO EZ to get a printed report.

Manual Operation

The manual operation of the SPT-6 is similar to the procedure described above with the following exceptions: When used with any PTZ AUTO tablet disintegration test instrument, the operator simply presses the number key corresponding to the position of the sample which has melted (where the test rod has touched the glass tube bottom) to log the softening time. As soon as the times for all six samples are recorded, the individual times will be displayed and the statistics are calculated. Connect a printer to the PTZ AUTO to get a printed report.

If the SPT-6 is used with a PTZ-S tablet disintegration test instrument, the operator has to visually determine the softening time and record it manually (for example by using a certified stop watch) and then calculate any statistic he might require.

Installing and Removing SPT-6

The supply scope of the SPT-6 Suppository Penetration Test assembly includes a round Plexiglas water bath with tubing connectors to attach the bath to the heating system of the Pharma Test tablet disintegration tester. SPT-6 can be installed and removed quickly, so that the tablet disintegration tester can again be used for the testing of tablets within just a few moments.

Included in the Standard Scope of Supply

• Glass tube for SPT-6 (part. no. 392-0010)
• Test rod for SPT-6 (part. no. 392-0011)
• Plexiglas water bath, without cover and tubing (part. no. 101-0215)
• Control thermometer 1HN11 -10/+50°C, not calibrated (part. no. 105-0801)
• Supporting shaft (part. no. 392-0100)