Method Parameters

Under construction

For creating a method the following parameters must be defined on the panels.

Parameters for manual method

Parameters

Description

General tab

Properties:

- Product name

Product Name will appear in the method start panel later.

- Description view

Audit information such as Created at and Modified at are generated upon saving the method.

Tester Setup tab

The Tester Setup panel is for defining the following parameters related to the 708-DS Dissolution bath, used during the test.

Temperatures:

- Vessel Temperature

Media temperature measured by the vessel probes within the vessels.

- Bath Temperature

Temperature of the water in the water bath.

- Temperature Tolerance

The +/- value in which the temperature reading are deemed valid.

Rotation:

- Spindle Speed

Speed in which the spindles rotate.

- Spindel Speed Tolerance

The desired speed fluctuation limit +/-. If the RPM goes over or under the set speed by the amount of this tolerance, an error is recorded as part of the results.

- Rotation Start Delay

Time(s) after the 708-DS drive head has been lowered, before the spindles start to rotate.

Media:

- Media Type

Name of the media being used in the experiment.

- Media Volume

Volume of the media used in the experiment. This is used to calculate the height at which the 708-DS manifold samples.

- Media Volume Tolerance

The +/- value in which the media volume is deemed valid.

Final Spin:

Final spin is a good diagnostic tool used to forcibly break apart any undissolved API. This is often used as a confirmatory check to ensure that the dissolution run shows a complete dissolution profile.

- Enable Final Spin

Check this box to enable final spin.

- Final Spin Speed

Speed in which the spindles rotate.

- Final Spin Duration

The duration of the final spin.

Options:

- Cannula filter type

Enter the details of the cannula filter used.

Sampling Parameters tab

Options:

- Sample Volume

Sample volume in milliliters.

- Media Replacement

- Enable Media Replacement

Check the box to enable media replacement in the method.

Staggered Start:

- Enable staggered start

Check this box to enable staggered start.

- Initial Delay

Enter the time Apparatus rotation will be paused prior to the addition of the first sample.

- Interval Delay

Enter the time between samples.

Lead Times:

- Alarm lead time

Enter the time prior to a time point at which an alarm will sound.

Prefill Volume = 1.0 mL

# of Timepoints = 3 + Final Spin = 4 total

Fill each dissolution vessel with 900 + (1.0 * 4) = 904 mL

Timetable tab

Clicking on to add row, will present a drop-down menu of options.

Sample

Media change

Spindle Speed

Clicking on one of the menu options will add timepoints as defined in the General Settings.

To delete a row, highlight the row and click the icon to delete the selected timepoint.

General Settings:

- Timepoint

Enter a value to determine when the timepoint event is to occur.

- Increment Time

Enter a value to determine how often the time Timepoint event is to occur.

- Number of Increments

The number of times the timepoint is to occur.

- Auto-calculate Media Volume

This allows the software to automatically calculate the media volume remaining in the vessel. This is helpful during longer runs as it can allow the 708-DS manifold to adjust for any drop in volume.

- Enable Days

Changes the timepoint format to include days.

Sample Timepoint:

These options allow the user to change the speed or media volume to the desired amounts during the method run.

Media Change Timepoint:

- Media Addition

Triggers the addition of media at the given timepoint.

- Full Media Change

Triggers a full media change, to be completed by the analyst.

- Sample at timepoint

Check this box to collect a sample at the media change timepoint.

- Spindle Speed

Sets the spindle speed (in RPM) for the media change timepoint.

- Media Volume

Sets the Media Volume, this is important to set if the volume has changed at this timepoint.

- Media Type

Enter information on the media being used during the media change timepoint.

Parameters for 708-DS/850-DS

Parameters

Description

General tab

Properties:

- Product name

Product Name will appear in the method start panel later.

- Description view

Audit information such as Created at and Modified at are generated upon saving the method.

Tester Setup tab

The Tester Setup panel is for defining the following parameters related to the 708-DS Dissolution bath, used during the test.

Temperatures:

- Vessel Temperature

Media temperature measured by the vessel probes within the vessels.

- Bath Temperature

Temperature of the water in the water bath.

- Temperature Tolerance

The +/- value in which the temperature reading are deemed valid.

Rotation:

- Spindle Speed

Speed in which the spindles rotate.

- Spindel Speed Tolerance

The desired speed fluctuation limit +/-. If the RPM goes over or under the set speed by the amount of this tolerance, an error is recorded as part of the results.

- Rotation Start Delay

Time(s) after the 708-DS drive head has been lowered, before the spindles start to rotate.

Media:

- Media Type

Name of the media being used in the experiment.

- Media Volume

Volume of the media used in the experiment. This is used to calculate the height at which the 708-DS manifold samples.

- Media Volume Tolerance

The +/- value in which the media volume is deemed valid.

Final Spin:

Final spin is a good diagnostic tool used to forcibly break apart any undissolved API. This is often used as a confirmatory check to ensure that the dissolution run shows a complete dissolution profile.

- Enable Final Spin

Check this box to enable final spin.

- Final Spin Speed

Speed in which the spindles rotate.

- Final Spin Tolerance

The desired speed fluctuation limit +/-. If the RPM goes over or under the set speed by the amount of this tolerance, an error is recorded as part of the results.

- Rotation Start Delay

Time (s) after the 708-DS drive head has been lowered, before the spindles start to rotate.

Sampling Parameters tab

Pump Parameters:

- Syringe Speed

The speed at which the syringe will draw. If a customer is experiencing foaming in the syringe due to the media or API in use, reducing the syringe speed may counter some of the foaming observed.

- Aspiration Dwell Time

Sets the time (in seconds) that the syringe pauses after pulling in liquid prior to dispensing. This setting may need to be increased to maintain volume accuracy for certain types of dissolution media.

Options:

- Sample Volume

Sample volume in milliliters.

- Prime Volume

Use this option to set the amount of drawn medium necessary to fill the sampling lines of the entire system.

- Purge Volume

Use this option to set a purge volume in milliliters that ensures all stranded medium is properly expelled.

- Waste Drop Volume

The drop volume is an amount of sample that is dispensed through the sampling station needles prior to dispensing samples into the collection tubes to ensure the needles are purged completely from the previous timepoint.

- Enable Dual Sample

Enable dual sample to dispense a sample into two consecutive rows at a single timepoint.

- Enable Initial Sample

Enable initial sample to dispense a sample prior to the addition of the API into the vessels.

Media Replacement:

- Enable Media Replacement

Check the box to enable media replacement in the method.

- Full

Check this box to enable full media replacement in the method.

- Defined

Check this box to enable a defined media replacement. Enter the volume of this defined media replacement in the box.

Prefill:

Prefill is used to dispense a volume (in mL) of media into sample tray for each timepoint in the method (including final spin) prior to the method start. The volume can be delivered from either the vessel or via media replacement, dependent on the option selected. Vessels should be filled with an appropriate volume to account for the Prefill volume as needed.

For example:

Vessel Volume = 900 mL

Prefill Volume = 1.0 mL

# of Timepoints = 3 + Final Spin = 4 total

Fill each dissolution vessel with 900 + (1.0 * 4) = 904 mL

Sampling Parameters tab

Pump Parameters:

- Syringe Speed

The speed at which the syringe will draw. If a customer is experiencing foaming in the syringe due to the media or API in use, reducing the syringe speed may counter some of the foaming observed.

- Aspiration Dwell Time

Sets the time (in seconds) that the syringe pauses after pulling in liquid prior to dispensing. This setting may need to be increased to maintain volume accuracy for certain types of dissolution media.

Options:

- Sample Volume

Sample volume in milliliters.

- Prime Volume

Use this option to set the amount of drawn medium necessary to fill the sampling lines of the entire system.

- Purge Volume

Use this option to set a purge volume in milliliters that ensures all stranded medium is properly expelled.

- Waste Drop Volume

The drop volume is an amount of sample that is dispensed through the sampling station needles prior to dispensing samples into the collection tubes to ensure the needles are purged completely from the previous timepoint.

- Enable Dual Sample

Enable dual sample to dispense a sample into two consecutive rows at a single timepoint.

- Enable Initial Sample

Enable initial sample to dispense a sample prior to the addition of the API into the vessels.

Media Replacement:

- Enable Media Replacement

Check the box to enable media replacement in the method.

- Full

Check this box to enable full media replacement in the method.

- Defined

Check this box to enable a defined media replacement. Enter the volume of this defined media replacement in the box.

Prefill:

Prefill is used to dispense a volume (in mL) of media into sample tray for each timepoint in the method (including final spin) prior to the method start. The volume can be delivered from either the vessel or via media replacement, dependent on the option selected. Vessels should be filled with an appropriate volume to account for the Prefill volume as needed.

For example:

Vessel Volume = 900 mL

Prefill Volume = 1.0 mL

# of Timepoints = 3 + Final Spin = 4 total

Fill each dissolution vessel with 900 + (1.0 * 4) = 904 mL

Timetable Tab

Clicking on to add row, will present a drop-down menu of options.

Sample

Media change

Spindle Speed

Media top-up

Clicking on one of the menu options will add timepoints as defined in the General Settings.

To delete a row, highlight the row and click the icon to delete the selected timepoint.

General Settings:

- Timepoint

Enter a value to determine when the timepoint event is to occur.

- Increment Time

Enter a value to determine how often the time Timepoint event is to occur.

- Number of Increments

The number of times the timepoint is to occur.

- Auto-calculate Media Volume

This allows the software to automatically calculate the media volume remaining in the vessel. This is helpful during longer runs as it can allow the 708-DS manifold to adjust for any drop in volume.

- Enable Days

Changes the timepoint format to include days.

Sample Timepoint:

These options allow the user to change the speed or media volume to the desired amounts during the method run.

Media Change Timepoint:

- Media Addition

Triggers the addition of media at the given timepoint.

- Full Media Change

Triggers a full media change, to be completed by the analyst.

- Sample at timepoint

Check this box to collect a sample at the media change timepoint.

- Spindle Speed

Sets the spindle speed (in RPM) for the media change timepoint.

- Media Volume

Sets the Media Volume, this is important to set if the volume has changed at this timepoint.

- Media Type

Enter information on the media being used during the media change timepoint.

Media Top-up Timepoint :

- Top-up Volume

The defined volume (mL) is dispensed into the vessels using the media replacement media to maintain media volume. Where evaporation over long dissolution tests needs to be replaced.