Standard Operating Procedure for Cleaning of Weighing Balance After Dispensing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/016/2025 |
| Supersedes | SOP/ELX/016/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To establish a systematic and validated procedure for cleaning the weighing balance used in the dispensing room after each use to prevent cross-contamination, ensure operational accuracy, and maintain compliance with GMP standards.
2. Scope
This SOP applies to all analytical and precision balances used in the dispensing area of the Elixir Department for weighing raw materials during batch preparation.
3. Responsibilities
- Dispensing Operator:
- Perform cleaning of the weighing balance immediately after use.
- Ensure no residual material remains on or around the balance.
- Warehouse Supervisor:
- Verify completion of cleaning and log entry.
- QA Officer:
- Perform periodic audits and approve cleaning status for sensitive products.
4. Accountability
The Head of Warehouse and the Head of Quality Assurance are accountable for ensuring balance cleaning procedures are followed, recorded, and verified consistently.
5. Procedure
5.1 Pre-Cleaning
Checks
- Ensure the balance is switched off and disconnected from power (if portable).
- Remove all material containers, trays, and beakers used during weighing.
- Wear disposable gloves and mask during the cleaning activity.
5.2 Dry Cleaning
- Use a soft, clean, dry brush or tissue to remove any loose powder or particles from:
- Weighing pan
- Balance chamber walls
- Surrounding balance platform
- Use a lint-free cloth to wipe all external surfaces gently.
5.3 Wet Cleaning
- Wipe the weighing pan and outer surface using a lint-free cloth moistened with 70% IPA.
- For sticky residues or sensitive spills:
- Use a cloth dampened with purified water followed by 70% IPA.
- Do not allow any liquid to enter internal components or display panel.
- Allow the cleaned parts to air dry or wipe with a dry lint-free cloth.
5.4 Post-Cleaning Activity
- Reconnect the balance to the power supply (if applicable).
- Check functionality by placing a calibrated standard weight and ensure reading accuracy.
- Label the equipment with “Cleaned” status label, mentioning:
- Date of cleaning
- Cleaned by
- Verified by
- Record cleaning details in the Balance Cleaning Log (Annexure-1).
5.5 Frequency of Cleaning
- After every use or batch-wise dispensing.
- At the end of the day (daily cleaning).
- Before use with a new product or material.
5.6 Precautions
- Do not apply excessive force while cleaning weighing pans or sensitive parts.
- Do not spray or pour cleaning agents directly onto the balance.
- Always follow the manufacturer’s instructions for balance cleaning and maintenance.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- IPA: Isopropyl Alcohol
- GMP: Good Manufacturing Practices
7. Documents
- Balance Cleaning Log (Annexure-1)
8. References
- 21 CFR Part 211 – Subpart D: Equipment Cleaning and Maintenance
- WHO GMP – Equipment Hygiene Guidelines
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Balance Cleaning Log
| Date | Balance ID | Material Used | Cleaned By | Verified By | Remarks |
|---|---|---|---|---|---|
| 13/04/2025 | WB-01 | Sorbitol | Rajesh Kumar | Sunita Reddy | Cleaned and Ready |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 10/01/2022 | 1.0 | Initial Release | New SOP | QA Head |
| 13/04/2025 | 2.0 | Added functional check and balance log entry | Audit Recommendation | QA Head |