The daily verification of a weighing balance is a critical step to ensure its accuracy and reliability in pharmaceutical and laboratory settings. This Standard Operating Procedure (SOP) outlines the procedure for daily verification of a weighing balance:
Title: Standard Operating Procedure for Daily Verification of Weighing Balance
Objective: To establish a procedure for the daily verification of weighing balances to ensure accuracy and reliability in measurements.
Scope: This SOP applies to all weighing balances used in the pharmaceutical manufacturing process at [Company Name].
Responsibilities:
- Quality Control (QC) Department: Responsible for performing daily verifications and maintaining verification records.
- Production Personnel: Responsible for using the verified balances for weighing operations.
- Maintenance Department: Responsible for addressing any issues identified during daily verifications.
Equipment and Materials:
- Weighing balances to be verified
- Calibrated standard weights (traceable to national or international standards)
- Anti-static brush
- Clean, lint-free cloths
- Verification logbook
- SOP for Daily Verification of Weighing Balance
- Personal Protective Equipment (PPE), including lab coats, gloves, and safety goggles
Procedure:
1. Pre-Verification Preparations:
a. Ensure that the balance to be verified is clean and free from any residue or contaminants.
b. Confirm that the balance is properly installed on a stable, level surface.
c. Verify that the balance is in a controlled environment with minimal air disturbances.
2. Safety Precautions:
a. Put on the appropriate PPE, including lab coats, gloves, and safety goggles.
b. Ensure that the area is free from any potential hazards.
3. Zero Verification:
a. Turn on the balance and allow it to warm up as per the manufacturer&39;s recommendations.
b. Place an anti-static brush near the balance to remove any electrostatic charges.
c. Perform a zero verification by pressing the "Tare" or "Zero" button on the balance, ensuring that there is no load on the pan.
4. Verification Process:
a. Place the calibrated standard weights on the balance pan one by one, starting with the smallest weight.
b. Record the displayed weight for each standard weight in the verification logbook.
c. Ensure that the balance stabilizes before recording each measurement.
d. Repeat this process for all standard weights, including the largest weight.
5. Calculation of Verification Data:
a. Calculate the difference between the displayed weight and the known weight for each standard.
b. Calculate the average difference and standard deviation for the recorded measurements.
6. Verification Acceptance Criteria:
a. Compare the average difference with the allowable tolerance specified in the balance&39;s verification certificate or as per regulatory requirements.
b. If the average difference is within the acceptable tolerance, the balance is considered verified for the day.
7. Verification Sticker:
a. Attach a verification sticker to the balance indicating the date of verification, the technician&39;s name, and the next verification due date.
8. Documentation:
a. Record all verification data, including the standard weights used, in the verification logbook.
9. Post-Verification Maintenance:
a. Ensure that the balance is clean and free from any residue.
b. Store the calibrated weights properly to maintain their accuracy.
10. Verification Frequency:
a. Perform the daily verification of the balance before its first use each day.
11. Out-of-Tolerance Handling:
a. If the balance is found to be out of tolerance during verification, take it out of service immediately and notify the appropriate personnel for repair or adjustment.
12. Training:
a. Ensure that all personnel involved in the verification process are adequately trained on this SOP.
13. Archiving:
a. Maintain verification records in accordance with regulatory requirements and company policies.
14. Audit and Review:
a. Periodically review and audit the verification process to ensure compliance and accuracy.
15. Disposal:
a. Dispose of expired or damaged weights and balances according to company procedures and environmental regulations.
This SOP provides a general framework for daily verification of weighing balances in a pharmaceutical setting. Ensure that it is adapted to your specific equipment and regulatory requirements. Always follow the manufacturer&39;s instructions for your weighing balances and adhere to any relevant regulatory guidelines in your region.