Standard Operating Procedure for Cleaning Equipment in Explosion-Proof Areas in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/182/2025 |
| Supersedes | SOP/ELX/182/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To define the safe and compliant procedure for cleaning equipment located in explosion-proof (hazardous) areas within the Elixir Manufacturing Department, particularly where flammable solvents and vapors are handled.
2. Scope
This SOP applies to all production equipment, tanks, valves, and associated components present in classified explosion-proof areas (Zone 1 and Zone 2) of the Elixir Department, especially where alcohol-based or volatile ingredients are processed.
3. Responsibilities
- Production Operator:
- Carry out cleaning using flame-proof tools and approved techniques.
- Engineering Department:
- Ensure all electrical and utility systems in the zone comply with explosion-proof standards.
- EHS & QA Personnel:
- Review and verify adherence to safety measures and cleaning compliance.
4. Accountability
The Production Head is accountable for ensuring compliance with cleaning in hazardous areas. The QA Head is responsible for cleaning verification. The EHS Officer ensures adherence to safety protocols.
5. Procedure
5.1 General Safety Precautions
- Obtain cleaning clearance from EHS before entering the zone.
- Ensure area is well ventilated and free of vapor accumulation.
- Use only flame-proof lighting, electrical connections, and non-sparking tools.
- Prohibit smoking, welding, or use of mobile phones inside the area.
5.2 PPE Requirements
- Antistatic overalls
- Flame-retardant gloves
- Anti-static footwear
- Face shield and safety goggles
5.3 Cleaning Materials and Tools
- Approved non-sparking brushes and scrapers
- Lint-free cloths
- Detergent solution (non-flammable)
- 70% IPA or other approved alcohols (used with caution and in small volumes)
5.4 Cleaning Procedure
- Switch off all equipment and disconnect from power where safe and allowed.
- Wipe external surfaces with detergent and water using lint-free cloth.
- Use non-sparking brushes for residue on flanges and corners.
- For interior parts:
- Use minimum volume of 70% IPA only where validated and allowed.
- Wipe off residual IPA using dry cloth. Allow air drying in ventilated zone.
- Do not spray IPA or solvent directly onto equipment or electrical panels.
- Document time of entry and exit from zone in the hazardous area access register.
5.5 Post-Cleaning Checks
- Inspect cleaned equipment visually for residues, dust, or product remains.
- QA to sign off cleaning completion checklist (Annexure-1).
- Report any signs of leakage, vapor release, or loose connections to Engineering.
5.6 Documentation
- Record all cleaning activity in the Explosion-Proof Area Cleaning Logbook (Annexure-2).
- Note safety observations in EHS Checklist (Annexure-3) and retain records as per retention policy.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- EHS: Environment, Health and Safety
- IPA: Isopropyl Alcohol
7. Documents
- Explosion-Proof Area Cleaning Logbook (Annexure-2)
- Cleaning Verification Checklist (Annexure-1)
- EHS Safety Checklist (Annexure-3)
8. References
- National Building Code – Hazardous Area Classification
- 21 CFR Part 211.67 – Cleaning and Maintenance
- WHO TRS 957 Annex 5 – GMP for Hazardous Pharmaceutical Manufacturing
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Cleaning Verification Checklist
| Equipment ID | Date | Area Cleaned | Visually Clean | QA Verified By | Remarks |
|---|---|---|---|---|---|
| MXR-ELX-05 | 11/04/2025 | Tank Outer Surface | Yes | Sunita Reddy | Approved |
Annexure-2: Cleaning Logbook
| Date | Operator Name | Equipment Cleaned | Cleaning Agent Used | Time In | Time Out | QA Verified |
|---|---|---|---|---|---|---|
| 11/04/2025 | Rajesh Kumar | Alcohol Transfer Line | 1% Neutraclean | 09:30 | 10:15 | Yes |
Annexure-3: EHS Safety Checklist
| Date | Area | Ventilation OK | Flameproof Tools Used | Spark Risk Observed | EHS Verified |
|---|---|---|---|---|---|
| 11/04/2025 | Zone 1 – Solvent Room | Yes | Yes | No | Neha Patil |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Added EHS safety checklist and solvent handling cautions | Compliance Update | QA Head |