1) SOP for Operating Analytical Balances
2) Purpose
The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for the calibration, operation, and maintenance of analytical balances to ensure accurate and reliable measurements.
3) Scope
This SOP applies to all personnel involved in the use of analytical balances within the pharmaceutical manufacturing and quality control areas.
4) Responsibilities
- Operators are responsible for calibrating, operating, and cleaning analytical balances according to this SOP.
- Supervisors are responsible for overseeing the use of analytical balances and ensuring compliance.
- Quality Assurance (QA) personnel are responsible for verifying that procedures are followed correctly and addressing any deviations.
5) Procedure
- Preparation
- Ensure the analytical balance area is clean and free of contaminants.
- Verify the availability of calibration weights and cleaning materials.
- Check the cleanliness and readiness of the analytical balance.
- Calibration
- Turn on the analytical balance and allow it to warm up as per the manufacturer’s instructions.
- Perform internal calibration if the balance has an internal calibration feature.
- If using external weights, select appropriate calibration weights and place them on the balance.
- Document the calibration process in the calibration logbook.
- Operation
- Place the sample on the balance pan using appropriate tools to avoid contamination.
- Record the weight displayed on the balance.
- Ensure that the balance
is tared to zero before each measurement.
Avoid drafts and vibrations during weighing to ensure accurate measurements.
Document all measurements in the relevant batch record or logbook.
Troubleshooting
Cleaning and Maintenance
- If the balance malfunctions or shows erratic readings, stop using the balance immediately.
- Refer to the manufacturer’s manual for troubleshooting guidelines.
- Document the issue and the corrective actions taken in the maintenance logbook.
- Resume operation once the issue is resolved and the balance is functioning properly.
- Turn off the balance before cleaning.
- Clean the balance pan and surrounding area with a soft brush or lint-free cloth.
- Avoid using solvents or abrasive materials that could damage the balance.
- Document the cleaning process in the cleaning logbook.
- Perform regular maintenance checks and document them in the maintenance logbook.
6) Abbreviations, if any
- SOP: Standard Operating Procedure
- QA: Quality Assurance
7) Documents, if any
- Calibration Logbook
- Cleaning Logbook
- Maintenance Logbook
- Batch Record
8) Reference, if any
- Current Good Manufacturing Practice (cGMP) guidelines
- Manufacturer’s operation and maintenance manual
9) SOP Version
Version 1.0