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