1.1 Test Types
The Dissolution Temperature Test Type Package can be used independently or in conjunction with other Dissolution Test Type Packages offered by Prime Technologies. The Dissolution Temperature TTP is used for recording additional temperature readings of Vessels, Baths and/or Probes.
1.2 Set Up Test Type Packages Screen
The Set-Up Test Type Packages screen (shown in Figure below) is used to add, modify and if necessary delete Test Type packages from the database. This screen is invoked by selecting the “Set Up Test Type Packages…” option on the File menu when the System Options and Defaults screen is open.
1.3 Adding New Test Types
To add a new Test Type to your database you must first copy the required library file “Diss_Temp.bpl” into the folder labeled “bin” under the ProCalV5 directory (typically “C:\Program Files\Prime Technologies\ProCal V5\bin”) in Windows Explorer. The “Diss_Temp.bpl” file contains all the information necessary for the Test Type’s automatic and proper setup in ProCalV5. Once the file has been copied into the correct folder you may launch the Set-Up Test Type Packages screen. Once the screen is open you may click the Add New Record button or select “New Record” from the screen’s File menu. This will invoke a browser screen titled Choose New Package File that automatically directs you to the “bin” folder in which all the “.bpl” files reside. Select the required file “Diss_Temp.bpl” and click the Open button or double-click the file name.
Once the correct file has been selected you will be returned to the new Test Type record which will already be set up for you. In this instance you can save the record, making it available for application to all types of item master records in the system (i.e. Instruments, Loops, Systems, Test Instruments, in addition to any PM records that may require a Calibration). Once a Test Type has been saved to the database, as long as it is marked as “Active”, it will be available for selection on the Test Type field’s drop-down list on the Calibration Points tab in all screens where that tab exists.
Although you will have no ability to change the Test Type’s Calibration requirements, you do have the ability to make some customizations to it in terms of field label changes and also giving users the ability to edit target setpoints and such when entering Calibrations using that Test Type. Please reference section 8 of the User Manual for information on modifying Test Type Packages once they have been imported into the database.
1.4 Distributing Test Types
Test Types only need to be installed in the System Option and Defaults screen once, but for all Client, Administrator, or Mobile Workstations, the “Diss_Temp.bpl” file must be present in the “bin” directory one level down from the ProCal V5 installation directory.
2.1 Entering Item Records Using the Dissolution Temperature Test Type Package
When creating a new master record that uses the Dissolution Temperature Test Type, the Test Type must be applied to the record through the Calibration Points tab on the master record screen. Once a new group has been added to the record, click the Test Type drop-down list and select “Dissolution – Temperature” from the available Test Types.
Once the Test Type has been selected, the inputs will change according to the settings defined by the library file. As shown in the Figure above, the remaining fields are: Input Type, Input Resolution, and Input Tolerance. These fields will have the same parameters and settings as a Group that has no Test Type Package defined.
The Show Group Options (as shown in Figure 3) shows three additional fields: Displayed-Set Tolerance, Measured-Displayed Tolerance (both are a manual decimal entry) and Test Performed (a Yes or No dropdown list). The values entered here will be available for review during calibration. If when setting up the Test Type you set the “Restrict Editing” for one or all three fields, then upon Calibration entry the technician will not be able to edit those fields.
The Displayed-Set Tolerance and Measured-Displayed Tolerance is where the tolerance levels will be set. The Test Performed field contains a drop-down list value with “Yes” or “No” values. Once the values are entered, save the record.
3.1 Entering Calibration Records
Once a Test Point Group has been created for a master item record that uses the Dissolution Temperature Test Type, a Calibration record can be created, and data can be entered on the Test Results tab on the Calibration screen. It should be noted that the required inputs must be entered on the master item record as detailed above.
On the Dissolution Temperature Test screen (Figure below) the column for Set Point Used? will default to “Yes”. This field can be changed to “No” if applicable. The column for Point Type will default to “Vessel”. This can also be changed to either “Bath” or “Probe”. The columns for Set Point Value and Unit will have the values from the Master record. As the values are entered and you tab off, the Results column will update. Once the values are entered, select the Apply button to Apply your results. At any time, you can select the Reset button to reset back to the default values.
3.2 Pass/Fail Logic
Values entered on the main Test Results tab for this Group will have no bearing on the Pass/Fail logic in ProCalV5. Some examples of entered values can be seen in Figure 6. If a row has a Fail result for either the Displayed or Measured columns, the result will show in red (the defined Spec Limit Exceeded color) indicating that that row Fails. Both the Displayed and the Measured results must be in tolerance for the row to Pass. (See row 5 in the Figure below)
If on the Test Results tab, the Test Performed field is set to “No” this Group will not set any “Fail” flags.
Please note that this Test Type has no “As Found” column, so no “As Found” Compliance Reports, “As Found” Notifications or any “As Found” warnings will be generated.