Digital Weighing Balance operation, Purpose:
Digital Weighing Balance operation, To lay down the procedure for operation, accuracy check and cleaning of the weighing balances at the Packaging Area.
Digital Weighing Balance operation, Scope:
This SOP is applicable for 820 gm weighing balance for weighing of materials at the Packaging Area of XX Pharmaceuticals Ltd.
Definitions / Abbreviation:
N/A.
Responsibilities:
[][]The Roles and Responsibilities are as follows:\
Operator
[][]To follow the laid down procedure
Executive, Packaging
[][]To monitor and check the cleanliness of area
Manager, Production
[][]To implement this correctly
Head of Quality Assurance
[][]To approve the Document
Annexure:
N/A
Procedure:
Precaution:
[][]Do not pour liquids on the weighing platform.
[][]Do not use solvents to clean the platform.
[][]Ensure balance is clean before use, including its surrounding area.
[][]Check and ensure the due date of calibration before use.
[][]Check and ensure the level indicator of weighing balance is in the middle, if applicable.
[][]Use hand gloves to hold standard weights for function check and calibration.
Daily Performance Check :
[][]Plug in the power cord.
[][]Level the balance using leveling feet so that air bubble is centered within circle of level indicator.
[][]To turn the balance ON, short pressing the → O/T ← key.
[][]Wait a while so that the stability indicator [*] is displayed.
[][]Zero the balance by pressing the → O/T ← key.
[][]Press the 100 mg mass at the centre of the platform and record the value displayed in the daily balance check logbook.
[][]Press the 100 g mass at the centre of the platform and record the value displayed.
[][]Press the 200 g mass at the centre of the platform and record the value displayed.
[][]Print the results by pressing print ( ) button if necessary.
[][]Record the value of those weights in Log Book for Daily Accuracy Check (As per Form No.: SOP/ PRO/004/I).
[][]If any displayed value is out of acceptable limit, label the balance “DO Not Use” and inform the QA Executive for immediate calibration of the balance.
[][]Balance check must be performed every working day before starting operation.
[][]If the factory remains close for the day(s), put the comments in the remarks column against that day(s) at the day of factory resume.
Operation of 820 g Balance of Mettler Toledo :
Empty container for Weighing:
[][]Press the zero button.
[][]Place an empty container on the scale platform.
[][]Press the Tare button.
[][]Fill the container with material to be weighed.
[][]The terminal will display the net weight and the NET cursor will light up. Allow the reading to be stable. Write down the reading.
[][]To clear a tare weight (with the scale in the net weight mode and a tare weight previously entered),press the Clear key (C)
Filled container for Weighing:
[][]Press the zero button.
[][]Place the material to be weighed on the scale platform.
[][]The terminal will display the net weight and the NET cursor will light up. Allow the reading to be stable. Write down the reading.
[][]Follow the Daily Accuracy Check.
Acceptance Criteria:
[][]The observed weights should be within ± 0.1% of the certified standard weights.
[][]If the acceptance criteria are not satisfied, follow the procedure for Handling of out of calibration for instrument & equipment.
Calibration:
[][]Perform the calibration in every six months. Recalibration is required in the following cases :
[][]After any minor service has been done or replacement of parts.
[][]When the software or firmware has been upgraded or changed.
[][]If daily check fails.
Cleaning:
[][]Place the status label ‘TO BE CLEANED’ on the equipment.
[][]Switch off the balance and unplug from the socket.
[][]Remove all objects from the weighing platform of balance.
[][]Lift up and remove the weighing pan in such a way that there is no damage in weighing system.
[][]Clean the pan including underside using a piece of dry cloth. Use wet cloth and finally clean with disinfection solution
[][]Wipe the display, switch board and cables with dry cloth.
[][]Remove ‘TO BE CLEANED’ and affix ‘CLEANED’ label on the equipment after approval from Quality Compliance.
[][]Record the cleaning parameters on the ‘Equipment Log Book’ .
Annexure:
Annexure I Equipment Use Log Book