1.1 Test Types

ProCalV5 allows for the addition of different “Test Types” to the database that may be applied to any item master record whose required calibration does not fit perfectly into the typical ProCal template. Test types may be used to provide specific testing in addition to or instead of a standard calibration with target set points and as found/as left readings.  Examples of some calibration test types that ProCalV5 normally could not accommodate efficiently are extreme values, linearity and standard deviation tests.

1.2 Set Up Test Type Packages Screen

The Set-Up Test Type Packages screen (shown 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 “DissolutionChemTemp.bpl” into the folder labeled “bin” under the ProCalV5 directory (typically “C:\Program Files\Prime Technologies\ProCal V5\bin”) in Windows Explorer. The “DissolutionChemTemp.bpl” file contains all the information necessary for the test type’s automatic and proper setup in ProCal.  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 “DissolutionChemTemp.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 set points and such when entering calibrations using that test type.

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 “DissolutionChemTemp.bpl” file must be present in the “bin” directory one level down from the ProCalV5 installation directory.

Section 2

2.1 Entering Item Records Using the Dissolution Chemistry Test Type Package

When creating a new master record that uses the Dissolution Chemistry 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 Chemistry from the available test types, as shown in the figure below:

Once the test type has been selected, the inputs will change according to the settings defined by the library file. This test type package allows for a step-by-step way of capturing the necessary readings to get to the eventual comparison of a “% Dissolved” value for each vessel, compared to a minimum and maximum % Dissolved based on a UPS Lot number.

With exception of the Group Name, all group and grid fields will be eliminated. There are additional fields that can be accessed by clicking the Show Group Options button on the right side of the screen. This interface is shown in below.

The inputs are as follows:

• Max Pred Std. Absorbtivity – Maximum prednisone standard absorbtivity.
• Max Sal Std. Absorbtivity – Maximum salicylic acid standard absorbtivity.
• Media Temp Resolution – A resolution list for the media temperature readings during the Dissolution phase of the test.
• Min Pred Std. Absorbtivity – Minimum prednisone standard absorbtivity.
• Min Sal Std. Absorbtivity – Minimum salicylic acid standard absorbtivity.
• Number of Vessels to Test – Number of vessels on the bath to test for all of the chemistry portions, usually 7.
• Prednisone Cell Path Length – Required cell path for the prednisone portion. (For Standard Absorbtivity)
• Prednisone Target Max Wavelength – Target max wavelength for prednisone in “nm”, typically 244.
• Salicylic Acid Cell Path Length – Required cell path for the salicylic acid portion. (For Standard Absorbtivity)
• Salicylic Acid Target Max Wavelength – Target max wavelength for salicylic acid in “nm”, typically 296
• Sample Absorbance Resolution – A resolution list for the measured sample absorbance values.
• Standard Precision Resolution – A resolution list for the Standard Precision calculated values during the Standard Precision phase of the test.
• Standard Precision Tolerance – The +/- % of the initial Standard Absorbance value that all subsequent absorbance readings must be within.
• Tablet Weight Resolution – A resolution list for the measured tablet weights for each vessel.
• Test Performed – List contents: “Yes” “No”; If No is selected, no failure fields will be set regardless of other data entered.

The available input options on the Calibration Points tab while the Group Options are hidden have mostly been removed from the Test Point Group. The Input Specifications, Accuracy, and Description dialogue boxes remain standard and the “Calculate” and “Restore Defaults” buttons retain their standard functionality.

Section 3

3.1 Entering Calibration Records

Once a Test Point Group has been created for a master item record that uses the Dissolution Chemistry Test Type, a calibration record can be created, and data can be entered on the Test Results tab on the Calibrations screen. It should be noted that the required inputs must be entered on the master item record as detailed above. See figure below:

The Calibration screen above allows you to change values from the master record in the Additional Test Type Inputs (if settings allow). All values will be entered on the Dissolution Chemical Test Input Wizard screen accessible by selecting the Enter Data button. See Figure below:

3.2 Setup Screen

The Setup screen is split for entry for either Prednisone and/or Salicylic Acid for this test. The options are the same for both:

• Skip Data Entry – When selected, data can still be entered but the values will not be used for the Pass/Fail logic in ProCal
• Enter/Edit As Found – When selected, values can be entered and the Pass/Fail logic will be used to determine As Found OOT.
• Enter/Edit As Left – When selected, values can be entered and the Pass/Fail logic will be used to determine As Left OOT.
• As Left Same as As Found - Values can be entered and the Pass/Fail logic will be used to determine As Found OOT. As Left will be the same as the As Found.
• View As Found/As Left Summary – Gives the user a view to the summary of the test.

3.3 Media Preparation

(Figure above)

              Prednisone

              Salicylic Acid

• Volume Prepared – How many Liters
• Weight of Sodium Hydroxide – How many grams
• Weight of Sodium Phosphate – How many grams
• pH – pH reading
• Confirm pH – Checkbox to confirm the reading
• Dissolution media deaerated – Check box to confirm the media is deaerated

3.4 Standard Preparation

(Figure above)

              Prednisone & Salicylic Acid

• USP Standard Lot – Open text field to enter a Lot number or Reference number
• Confirm Reference Standard has been dried – Checkbox
• Standard Weight – Enter weight
• Volume of ethanol – Enter volume
• Standard dilution – Enter dilution (Prednisone only)
• Standard Concentration – Auto-calculated

3.5 Dissolution

(Figure above)

              Prednisone & Salicylic Acid

• Verify Height – Checkbox
• Verify vessels are centered – Checkbox
• Record Media Temperature – Enter a Beginning and an End temperature
• Confirm temp of vessels – Checkbox
• Record Speed – Enter RPM

3.6 Absorbance Measurements

(Figure above)

              Prednisone

Salicylic Acid