Standard Operating Procedure for Using Weighing Balance

1) Purpose

The purpose of this SOP is to describe the procedure for operating and maintaining the weighing balance used in the manufacturing of otic dosage forms to ensure accurate and reliable measurements.

2) Scope

This SOP applies to all personnel involved in the operation and maintenance of the weighing balance in the pharmaceutical manufacturing facility.

3) Responsibilities

Operators: Responsible for correctly operating the weighing balance according to this SOP.
Quality Control (QC) Personnel: Responsible for performing calibration and verification of the weighing balance.
Maintenance Personnel: Responsible for maintaining the weighing balance in proper working condition.

4) Procedure

4.1 Operation
4.1.1 Preparation
4.1.1.1 Ensure the weighing balance is on a stable, vibration-free surface.
4.1.1.2 Clean the weighing pan and surrounding area with a lint-free cloth.
4.1.1.3 Verify that the weighing balance is properly calibrated.

4.1.2 Weighing Procedure
4.1.2.1 Turn on the weighing balance and allow it to warm up if required.
4.1.2.2 Place a clean, dry container on the weighing pan.
4.1.2.3 Tare the balance to zero.
4.1.2.4 Add the sample to the container until the desired weight is achieved.
4.1.2.5 Record the weight displayed on the balance.

4.2 Calibration
4.2.1 Daily Calibration
4.2.1.1 Perform a daily calibration check using standard weights before beginning any weighing activities.
4.2.1.2 Record the calibration results in the calibration log.

4.2.2 Monthly Calibration
4.2.2.1 Perform a full calibration of the weighing balance monthly using certified calibration weights.
4.2.2.2 Document the calibration results and any adjustments made.

4.3 Maintenance
4.3.1 Routine Maintenance
4.3.1.1 Clean the weighing balance regularly to prevent buildup of debris.
4.3.1.2 Inspect the balance for any signs of damage or wear.

4.3.2 Troubleshooting
4.3.2.1 If the balance displays error messages, refer to the manufacturer’s manual for troubleshooting steps.
4.3.2.2 Contact maintenance personnel if the issue cannot be resolved.

5) Abbreviations, if any

QC: Quality Control
SOP: Standard Operating Procedure

6) Documents, if any

Calibration log
Maintenance log

7) Reference, if any

Manufacturer’s manual for the weighing balance
Regulatory guidelines for equipment calibration and maintenance

8) SOP Version

Version 1.0