Standard Operating Procedure for Using Analytical Balance
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the analytical balance in the pharmaceutical manufacturing of otic dosage forms to ensure accurate and precise weighing of materials.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of analytical balances in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the analytical balance as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the calibration and accuracy of the balance.
Maintenance Personnel: Responsible for maintaining the analytical balance in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the analytical balance for cleanliness and integrity before use.
4.1.1.2 Ensure that the balance is properly leveled and stable.
4.1.1.3 Check that the calibration is up-to-date and the balance is functioning correctly.
4.1.2 Preparation
4.1.2.1 Clean the weighing pan and surrounding area with a suitable solvent.
4.1.2.2 Turn on the balance and allow it to warm up for the manufacturer’s recommended time.
4.1.2.3 Perform an internal calibration if the balance is equipped with this feature.
4.2 Operation
4.2.1 Weighing Procedure
4.2.1.1 Tare the balance by pressing the tare button to set the display to zero.
4.2.1.2 Place the container or material to be weighed on the center of the weighing pan.
4.2.1.3 Record the weight once the reading stabilizes.
4.2.1.4 If multiple weights are needed, repeat the taring and weighing steps as required.
4.2.2 Safety Precautions
4.2.2.1 Wear appropriate personal protective equipment (PPE) when handling hazardous materials.
4.2.2.2 Avoid placing heavy or wet items on the balance to prevent damage.
4.2.2.3 Follow all safety protocols to prevent contamination or accidents.
4.3 Post-operation
4.3.1 Shutdown Procedure
4.3.1.1 Remove all materials from the weighing pan.
4.3.1.2 Turn off the analytical balance.
4.3.1.3 Clean the weighing pan and surrounding area with a suitable solvent.
4.3.2 Cleaning and Maintenance
4.3.2.1 Regularly clean the balance and its components to maintain accuracy.
4.3.2.2 Inspect the balance for any signs of wear or damage and repair or replace components as necessary.
4.3.2.3 Perform routine calibration checks and document the results.
4.3.2.4 Document all cleaning and maintenance activities in the analytical balance log.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
PPE: Personal Protective Equipment
6) Documents, if any
Analytical balance log
Calibration records
7) Reference, if any
Manufacturer’s manual for the analytical balance
Pharmacopeial guidelines for weighing procedures in pharmaceutical manufacturing
8) SOP Version
Version 1.0