1.0 OBJECTIVE
To set up a procedure to operate the CITDAS software.
2.0 SCOPE
This procedure is applicable for operation of CITDAS software in Quality Control Department of (Company Name).
3.0 RESPONSIBILITY
3.1 QC Officer/Analyst shall be responsible to carry out the activity as per procedure.
3.2 Overall responsibility for training, implementation & follow-up with the QC Manager or his/her nominee.
4.0 ACCOUNTABILITY
4.1 Head of Quality.
5.0 PRECAUTIONS
5.1 Before operate the software, ensure proper training.
6.0 PROCEDURE
6.1 Double click on CITDAS icon to open the software.
6.2 CITDAS has two different mood of operation. Operator mood and Maintenance mood. It always start up with operator mood. Current mood will be displayed at the bottom left hand side of the screen.
6.3 Enter New Data
6.3.1 In the main window there are three options. From them select ‘Enter New Data’ and then press ok.
6.3.2 Device selection menu will appear. Select desire device, e.g. Cascade Impector (CI).
6.3.3 A new window will appear with few empty cells. The entire cell has to fill with appropriate information. The cells are of the free from type and hence can contain any alphanumeric information that may be of benefit to the operator. Additional information can also be entered into the other information field. Use ‘Tab’ key or mouse to move between cells.
6.3.4 After filling all the cells, press ‘Next’ button at the bottom of the window.
6.3.5 Deposition data screen will appear which allows entry of data up to 12 different analyses. This is also possible to select number of analyses within 12.
6.3.6 Enter data into the relevant cell using ‘Tab’ key or mouse to move between cells. The following data should be entered into the respective cells.
Dose No: Which doses were sampled from the inhaler.
Actuator: The drug deposition on the actuator.
Sample device stage and filter: The drug deposition measured in the respective stages of the ACI.
Flow Rate: The operating flow rate of the ACI
Doses of device: The number of doses sampled from the device.
Delivered Doses: The delivered dose of the test inhaler as determined during the testing for uniformity of delivered dose.
Unit Mass: Unit mass can be selected either mg or µg.
Preseparator: If preseparator is used select ‘show’ from the preseparator option, otherwise select ‘Hide’.
6.3.7 Fine particle dose can be defined by size or stage grouping. Select the ‘Group’ option to define up to five groups.
6.4 Access Stored Data
6.4.1 In the main window there are three options. From them select ‘Access Stored Data’ and then press ok. After that data has been retrieve from its storage area.
6.4.2 If that file’s access has been protected with a password, enter password as requested before clicking OK.
6.4.3 When a file is open, then it can be edited following the procedure of section 6.3.3 to 6.3.7.
6.5 Result Summery
6.5.1 After completion of all data entry in the screen of ‘Deposition data’ clicking ‘Next’ result summery page will appear with summery result as well as with graph.
6.5.2 Graph can be enlarged for view by double clicking the left mouse button over the graph.
6.6 Saving Data Files
6.6.1 Data files may be saved on the any of the three data entry screen. This is achieved by selecting the save option.
6.6.2 Use the browser facilities to select the required destination folder.
6.6.3 To save files with password protection select the save as option, click the ‘save file with password protection’ box, enter a password, confirm the password, and click OK.
6.6.4 When a file has been successfully saved the message ‘File Saved’ will appear at the bottom left hand side of the screen.
6.7 Report Printing
6.7.1 Data can be printed using the print option on Result Summery window.
6.8 Exporting Data
6.8.1 If required, input and output data can be exported to comma separated file and opened using programs such as Microsoft Excel and Word. To do this, open the file required to export data form, and select the export option on the ‘Result summery’ screen. At the prompt screen, enter an appropriate file name and path for the export file.
6.9 Exit Program
6.9.1 Select the ‘Exit Program’ option to exit CITDAS.