SOP for Use and Calibration of Weighing Balances

Standard Operating Procedure for Use and Calibration of Weighing Balances

1) Purpose

The purpose of this SOP is to provide instructions for the proper use and calibration of weighing balances used for measuring ingredients in nasal formulations. Regular calibration ensures accurate weight measurements for ingredient consistency.

2) Scope

This SOP applies to all personnel responsible for weighing raw materials and conducting balance calibration at [Company Name].

3) Responsibilities

Operators: Responsible for accurately weighing ingredients and ensuring proper calibration of balances before each use.
Quality Assurance (QA): Ensures that weighing procedures and calibration results meet product specifications and regulatory standards.
Maintenance Team: Responsible for maintaining and troubleshooting the balances to ensure accurate functionality.

4) Procedure

4.1 Use of Weighing Balances

4.1.1 Pre-Operation Inspection

Inspect the balance to ensure it is clean, free from debris, and has been calibrated. Check that the surface is level, and the balance is properly zeroed.
Document the pre-operation inspection in the balance log.

4.1.2 Weighing Procedure

Place the empty container or weighing paper on the balance and tare the weight to zero. Ensure that the container is stable and not affected by airflow or vibrations.
Slowly add the material to be weighed. Record the weight once the balance stabilizes. If necessary, perform weighing in smaller increments to avoid errors.
Record the final weight in the Batch Manufacturing Record (BMR). Repeat for all materials to be weighed.

4.2 Calibration of Weighing Balances

4.2.1 Daily Calibration Procedure

Calibrate the balance daily before use by placing certified calibration weights on the balance. Compare the displayed weight with the certified weight.
If the difference exceeds the tolerance specified in the calibration log, recalibrate the balance according to the manufacturer’s instructions. Record the results in the calibration log.

4.2.2 Annual Calibration

Perform annual calibration of the balance using certified weights, following the manufacturer’s calibration procedures. Record the calibration results and ensure the balance meets the specified accuracy.
Document the annual calibration results in the calibration log and submit the balance for QA review.

4.3 Maintenance of Weighing Balances

4.3.1 Routine Maintenance

Clean the weighing balance after each use to avoid contamination. Ensure that all debris is removed from the balance platform and surrounding areas.
Inspect the balance weekly for any signs of malfunction, including unstable readings or display errors. Record all maintenance activities in the maintenance log.

4.3.2 Troubleshooting

If the balance is malfunctioning, contact the maintenance team immediately. Do not use the balance until it has been repaired and recalibrated.
Document any repairs and recalibration in the maintenance log.

5) Abbreviations, if any

BMR: Batch Manufacturing Record
QA: Quality Assurance

6) Documents, if any

Balance Log
Calibration Log
Maintenance Log
Batch Manufacturing Record (BMR)

7) References, if any

Manufacturer’s manual for weighing balances
Internal SOP for cleaning and maintenance

8) SOP Version

Version 1.0

Annexure

1. Calibration Log Template


  
    Date
    Balance ID
    Certified Weight (g)
    Measured Weight (g)
    Difference (g)
    Operator Initials
    QA Approval
  
  
    DD/MM/YYYY
    Balance Name/ID
    Certified Weight
    Measured Weight
    Difference
    Operator Name
    QA Name