Cleaning, Operation and Calibration of Digital Tablet Tester (Campbell)

In this post Standard Operating Procedure of Cleaning, Operation and Calibration of Digital Tablet Tester (Campbell) in pharmaceuticals is describe.

1.0 OBJECTIVE:

To lay down a procedure for cleaning, operation and calibration of Electronic Tablet Tester (Campbell).

2.0 SCOPE:

This procedure is applicable to the cleaning, operation and calibration of Electronic Tablet Tester (Campbell) in production area.

3.0 RESPONSIBILITY:

Technical Associate : Cleaning and Operation

Officer and Executive : Calibration, Supervision

Head Production : SOP compliance

4.0 DEFINITION (S):

5.0 PROCEDURE:

5.1 CLEANING:

5.1.1 Dedust the tablet platform of apparatus with the help of brush and collect all the powder and

crushed tablet in tablet collecting bowl. And finally dispose the tablets in disposal bin in IPQA.

5.1.2 Clean the apparatus with dry lint free cloth followed by moist lint free cloth.

5.1.3 Cleaning should be done after performing each test.

5.2 MACHINE SETTING:

5.2.1 Switch ON the apparatus, the screen displays

5.2.2

5.2.3 Press the ENTER key, now screen displays

Select ‘C’ and enter the user name, password as per there level (i.e. administrator, supervisor,

operator/user level). To change the password press’P

5.2.4 If Administrator level login, then screen displays main menu.

* In Supervisor level ‘U’ Create User option doesn’t appears.

* And In User/Operator level ‘U’ Create User, ‘R’ Create Recipe,’E’ Edit Recipe,’P’

Report and ‘T’ Setting option doesn’t appears.

5.2.1 Create Recipe

5.2.1.1 To create the recipe press “R” in step no. 5.2.4. The screen displays

Here different recipe can be created. The recipe no. is auto generated.

5.2.1.2 After entering the product name and ID press enter. The screen displays

Select the unit of weight by pressing the “g” for gram & “m” for milligram and press enter the

cursor comes to the NOMINAL WEIGHT i.e. standard weight, enter this weight as per BMR

and press enter.

The cursor comes to “+T1”, this is the upper limit of weight enter this then press enter the cursor

comes to “-T1”, this is the lower limit of weight enter this then press enter the cursor comes to

“+T2” this is the deviated upper limit of weight enter this then press enter the cursor comes to “-

T2”, this is the deviated lower limit of weight then press enter this then press enter.

5.2.1.3 Now the screen displays

Select the unit of width by pressing the “m” for mm & “I” for inches and press enter the cursor

comes to the NOMINAL WIDTH i.e. standard width, enter this width as per BMR and press

enter.

The cursor comes to “+T1”, this is the upper limit of width enter this then press enter the cursor

comes to “-T1”, this is the lower limit of width enter this then press enter the cursor comes to

“+T2” this is the deviated upper limit of width enter this then press enter the cursor comes to “-

T2”, this is the deviated lower limit of width then press enter this then press enter.

5.2.1.4 Now the screen displays

Select the unit of thickness by pressing the “m” for mm & “I” for inches and press enter

the cursor comes to the NOMINAL THICKNESS i.e. standard thickness, enter this

width as per BMR and press enter.

The cursor comes to “+T1”, this is the upper limit of thickness enter this then press enter the

cursor comes to “-T1”, this is the lower limit of thickness enter this then press enter the cursor

comes to “+T2” this is the deviated upper limit of thickness enter this then press enter the cursor

comes to “-T2”, this is the deviated lower limit of thickness then press enter this then press

enter.

5.2.1.5 Now the screen displays

Select the unit of diameter by pressing the “m” for mm & “I” for inches and press enter the cursor comes to the NOMINAL DIAMETER i.e. standard diameter, enter this width as per BMR and press enter.

The cursor comes to “+T1”, this is the upper limit of diameter enter this then press enter the cursor comes to “-T1”, this is the lower limit of diameter enter this then press enter the cursor comes to “+T2” this is the deviated upper limit of diameter enter this then press enter the cursor comes to “-T2”, this is the deviated lower limit of diameter then press enter this then press enter

5.2.1.6 Now the screen displays the hardness parameter.

Select the unit of hardness by pressing the [K]p for Kilopond & [N] for Newton,[S]c for StrongCobb and [U]d user defined press enter the cursor comes to the NOMINAL HARDNESS i.e. standard diameter, enter this width as per BMR and press enter.

The cursor comes to “+T1”, this is the upper limit of hardness enter this then press enter the cursor comes to “-T1”, this is the lower limit of hardness enter this then press enter the cursor comes to “+T2” this is the deviated upper limit of hardness enter this then press enter the cursor comes to “-T2”, this is the deviated lower limit of hardness then press enter this then

press enter.

5.2.1.7 After feeding all the 5 parameters i.e. weight, width, thickess, diameter, and hardness the screen displays the main menu as in step no. 5.2.4.

5.2.2 Edit Recipe

5.2.2.1Press ‘E’ in main menu (5.2.4), the “Edit Recipe Menu’ comes

Enter the recipe no (i.e. already added) what to be edit

5.2.2.2 Now follow the step 5.2.1.1 to 5.2.1.7, in these steps EDIT RECIPE will be come on top of screen instead of NEW RECIPE.

5.2.3 View Recipe

5.2.3.1 Press “V” in main menu (5.2.4), here the loaded recipe parameters can be viewed.

5.2.4 Clock / Reset Test No./Company Name/Printer Setting

5.2.4.1 To set the Clock / Reset Test No./Company Name/Printer press “T” in main menu (step 5.2.4).

5.2.4.2 After pressing “T” in main menu the new screen displays

5.2.4.3 To set the TIME & DATE press “C” . Here the options comes to edit date,month,year,hours and minutes.

5.2.4.4 To reset the TEST SERIES No press “R”.

5.2.4.5 To change the company name press “N” and enter the company name.

5.2.4.6 To set the printer press “P” the option comes, Press “D” for Dot Matrix and “I” for Ink Jet/laser printer.

5.3 MACHINE OPERATION

5.3.1 To start the operation press “S” in the main menu (step 5.2.4).

5.3.2 The 2 option comes on screen “P” and “C”.

Press “P” if want the print out of previous performed test.

Press “C” if do not want the print out of previous performed test.

5.3.3 The screen displays

The test no comes automatically with increment with last test.

Load the recipe no regarding the test tablet.

5.3.4 After loading the recipe no the BATCH NO displays. Enter the batch no and press enter the

screen displays.

5.3.5

Here Put the total numbers of tablets to be tested, for “Valid Sample/”For Weight”/”For Weight”/ “For Thickness”/ “For Diameter”/ “For Hardness”.

5.3.6 After feeding above parameters press enter key,the screen displays

For “Auto Mode” press “A” key and for ” Manual Mode” press “M” key.

* In auto mode tests can conducted one by one automatically till test set test are not over. As we select the auto mode the system ask for delay time (sec.) i.e. delay time each test parameter measurment. After entering delay time the system ask to enter

the Back-Off Dstance,as we enter the Back -Off distance the system adjust the jaw position for specified jaw distance [2-15mm]. * And in manual mode before every test unit the “Enter” to be pressed. As we select

the manual mode the system ask to enter the Back-Off Dstance,as we enter the Back -Off distance the system adjust the jaw position for specified jaw distance [2-15mm].

5.3.7 Now put the tablet smple to be tested horizontally for measure width,diameter and hardness. And vertically to measure thickness.

5.4 CALIBRATION OF HARDNESS

5.4.1 To start the calibration press “C” in the main menu (step 5.2.4).

5.4.2 The screen displays

5.4.3 Press “Q” and message prompt on screen “DO YOU WANT TO CALIBRATION FOR

HARDNESS?” Press “ENTER” key to continue.

5.4.4 Message prompt on screen to remove the load cell assembly cover by sliding it out.

5.4.5 Now remove the load cell from holder by removing allen bolt by using allen key.

5.4.6 Take out the load cell and affix it into the groove of load cell holder in vertical position. (Ensure the cables while taking out the load cell). Press “ENTER” key to continue.

5.4.7 Now affix the weight holder on the load cell.

5.4.8 When the message displays on “PUT 5 Kg WEIGHT ON PAN” then place 5 kg certified weight on the pan genteelly. And then press “ENTER” key.

5.4.9 The calibration is over and message displays on screen “CALIBRATION FOR 5 Kg WEIGHT

CALIBRATION DONE SUCESSFULLY”. And press “ENTER” key.

5.4.10 The message displays

Select the due date calibration period by selecting option 1,2 and 3. And pree “ENTER” key.

5.4.11 The “CLIBRATIN DATE” and “CALIBRATION DUE DATE” will display and press “ENTER” key. The calibration report get printed automatically. (If printer is attached)

5.5 VARIFICATION OF HARDNESS

5.5.1 Follow the step no. 5.4.1 to 5.4.2. And press “L” for hardness verification.

5.5.2 The message prompt on screen

Press “ENTER” key to continue.

5.5.3 Follow the step no 5.4.4 to 5.4.7.

5.5.4 The message prompt on screen “VARIFICATION FOR ZERO REFERENCE” “PUT KNOWN WEIGHT ON THE PAN” then put the known weight rather then used for calibration (1- 50 kg) and press “ENTER” key to continue.

5.5.4 The message displays on screen