SOP for Balance Calibration in Pharma industries

To lay down the procedure for Weighing Balance. or sop for operation and calibration of analytical balance. This procedure applies to the QC, Production, Store, and QA Department of XYZ Ltd.

RESPONSIBILITIES

QC Chemists, online QA Supervisors, Mixer Operators, and Storekeepers follow the SOP.

Head – QA & QC, Production and Store for compliance of SOP.

PROCEDURE

General cleaning:

Ensure that the instrument calibration is maintained.

Clean the weighing pan with the help of a brush or dry lint-free cloth.

Ensure the cleanliness of the balance.

Allow the balance to charge up for one hour or more.

Operation for Weighing Balance 

Weighing procedure-For solid & Liquids.

Place paper/container on the weighing pan if required.

Press the tare (T/Z)   key of the balance.

Transfer the required amount of sample to the tared paper/container.

Wait till a stable value appears on the display. The numerical value displayed shall be the weight of the sample taken.

Clean the balance pan after use.

Before cleaning the whole balance, disconnect the balance from the power supply.

Maintain the Logbook as per Annexure III (Logbook for Weighing Balance), format no. XYZ/QC/02/FR03-00

Balance Calibration Procedure 

Calibration Frequency

Daily Calibration, Annexure I (Daily Balance Calibration Format) / Monthly Calibration, Annexure III (Monthly Balance Calibration Format).

SOP For Operation and Calibration of Weighing Balance

Daily Verification

After self-calibration is over display will show 0.0000 g / 0.0 g. Then the balance is  ready for use. (Steps shown above may differ by make and model).

Ensure that the standard weights used are within the validity period of its calibration.

Calibrate the balance using the following standard weights:

For balance (10.0 mg -220.0 gm)

For balance (5.0 gm -1050.0 gm)

100 mg

500 mg

1 gm

10 gm

100 gm

100 mg

500 mg

1 gm

10 gm

100 gm

500 gm


Acceptance criteria 

The observed weight should be within +0.1% of the actual values of standard weights and within the least count of the balance whichever is greater.

Record the observation as Annexure I “Daily Balance Calibration Format”, format no. XYZ/QC/02/FR01-00

Monthly Calibration of Weighing Balance 

Calibrate the balance monthly with the standard weights of 100 mg, 500 mg, 1 gm, 2 gm, 5 gm, 10 gm, 20 gm, 50 m, 100 gm, 500 gm, and 1 Kg individually and record the observations in the monthly balance calibration data sheet.  

 Acceptance criteria

The observed weight should be within +0.1% of the actual values of standard weights and within the least count of the balance whichever is greater.

Record the observations as Annexure-II “Monthly Balance Calibration Format”, format no. XYZ/QC/02/FR02-00

In the case of non-conformance, clean the standard weight with a lint-free cloth and re-weigh, if the problem persists then inform the Head QA/QC for corrective and preventive action. Do not use the balance, until the problem is rectified. Recalibrate the balance after maintenance.

ABBREVIATIONS

SOP:             Standard Operating Procedure

QA:               Quality Assurance

QC:               Quality Control

No.:               Number

gm:               Gram

mg:               Milligram

Kg:               Kilogram

Logbook & Annexure:- Download

BANTI SINGH

Hi I'm Banti Singh, a Chemical Engineer! Welcome all of you to my blog. If you got the information right? Share the information. All of you Thank you

Thanks to visit this site.

Post a Comment (0)
Previous Post Next Post