SOP Guide for Pharma

Creams: SOP for Cleaning and Calibrating Dispensing Scales – V 2.0

Auditor

Creams: SOP for Cleaning and Calibrating Dispensing Scales – V 2.0

Standard Operating Procedure for Cleaning and Calibrating Dispensing Scales

Department Creams
SOP No. SOP/CRM/006/2025
Supersedes SOP/CRM/006/2022
Page No. Page 1 of 5
Issue Date 25/03/2025
Effective Date 30/03/2025
Review Date 25/03/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the cleaning and calibration of dispensing scales used in the formulation of creams. This ensures that the dispensing scales are accurate, reliable, and free from contamination, maintaining product consistency and compliance with GMP standards.

2. Scope

This SOP applies to all dispensing scales used for weighing raw materials and excipients in the production of creams within the Creams Department. It covers procedures for routine cleaning, maintenance, and calibration of dispensing scales to ensure their proper functioning.

3. Responsibilities

4. Accountability

The Head of Creams Manufacturing is responsible for ensuring that the cleaning and calibration of dispensing scales are conducted in compliance with this SOP. The QA Manager is ultimately accountable for overseeing the entire process and ensuring that all actions are documented and compliant with regulatory guidelines.

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5. Procedure

5.1 Cleaning of Dispensing Scales

  1. After each use, ensure that the dispensing scale is turned off and unplugged (if applicable) before starting the cleaning process to prevent accidents.
  2. Wipe the scale platform with a lint-free cloth to remove any loose powder, residues, or material from previous weighing.
  3. Clean the scale platform with a mild detergent solution or disinfectant, ensuring that no cleaning solution drips into the scale mechanism. Use a damp cloth or sponge to clean the surface, and ensure that the scale is completely dry before use.
  4. If any material has spilled into the scale’s weighing mechanism, carefully disassemble the scale (if possible) and clean the components with appropriate solvents or cleaning agents as per the manufacturer’s recommendations.
  5. Inspect the scale for any signs of wear, damage, or malfunction during cleaning. Report any issues to the maintenance team for further inspection and repair.

5.2 Calibration of Dispensing Scales

  1. Calibration must be performed on the dispensing scales at regular intervals, as outlined by the manufacturer’s guidelines and internal SOPs. Calibration should also be conducted if the scale shows any signs of malfunction or after significant usage.
  2. Use certified calibration weights that are traceable to national or international standards. Ensure that the calibration weights are within the capacity range of the scale being calibrated.
  3. Before calibration, ensure that the scale is placed on a flat, stable surface free from vibrations or air drafts. Check that the scale is level using the built-in level indicator (if available).
  4. To calibrate, follow the scale’s manual for the specific calibration process. This typically involves zeroing the scale, then placing the calibration weight on the platform and adjusting the scale to match the known weight.
  5. Document all calibration results, including the date, time, calibration weights used, and the technician who performed the calibration. If the scale does not pass the calibration check, initiate corrective actions, which may include recalibration or maintenance.
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5.3 Frequency of Cleaning and Calibration

  1. The dispensing scales should be cleaned after every use to maintain accuracy and prevent contamination.
  2. Calibration should be performed:
    • Annually, as a routine measure.
    • After any significant repairs or malfunctions.
    • After any changes in the type of materials being dispensed.
  3. QC should perform periodic checks on the dispensing scales to ensure they remain within acceptable accuracy limits. These checks should be documented.

5.4 Documentation and Record-Keeping

  1. All cleaning and calibration activities must be documented in the Equipment Maintenance Log. The log should include:
    • Scale ID and location
    • Date and time of cleaning/calibration
    • Technician’s name
    • Cleaning agent used (if applicable)
    • Calibration weights used and their traceability
    • Calibration results (including any adjustments made)
  2. The QA team will periodically review the Equipment Maintenance Log to ensure compliance with this SOP and to verify that cleaning and calibration procedures are being followed correctly.

5.5 Troubleshooting

  1. If the dispensing scale fails the calibration test, perform the following actions:
    • Check for any external factors, such as uneven surfaces or unstable conditions, that may affect the scale’s performance.
    • Ensure the scale is clean and free from material buildup or contamination that may affect accuracy.
    • If the issue persists, contact the maintenance team for further inspection and repair.
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5.6 Final Review and Approval

  1. The QA team will periodically review the records for cleaning and calibration activities to ensure compliance with this SOP. Any discrepancies or issues must be addressed immediately and documented for corrective action.
  2. Once all procedures are verified, the dispensing scale will be approved for continued use in the cream manufacturing process.

6. Abbreviations

7. Documents

  1. Equipment Maintenance Log (Annexure-1)
  2. Calibration Certificate (Annexure-2)

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Equipment Maintenance Log

Scale ID Location Cleaning Date Calibration Date Technician Calibration Results
Scale 001 Room A 25/03/2025 25/03/2025 John Doe Passed

Annexure-2: Calibration Certificate

Scale ID Calibration Weight Calibration Date Technician Results
Scale 001 500g 25/03/2025 John Doe Passed

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/03/2024 1.0 Initial Version New SOP Creation QA Head
01/03/2025 2.0 Format Revision and Updates Standardization of Document QA Head
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