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 |