Standard Operating Procedure for Storage of Hazardous and Flammable Materials in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/011/2025 |
| Supersedes | SOP/API/011/2022 |
| Page No. | Page 1 of 11 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To define the procedure for safe handling and storage of hazardous and flammable materials used in API manufacturing to minimize risks of fire, explosion, chemical exposure, and ensure compliance with GMP, GHS, and safety regulations.
2. Scope
This SOP applies to all hazardous and flammable chemicals including solvents, acids, bases, and toxic substances received, stored, and handled within the API manufacturing warehouse and production areas.
3. Responsibilities
- Warehouse Staff: Ensure proper labeling, segregation, and safe handling practices are followed.
- Maintenance Team: Maintain fire safety equipment, explosion-proof fixtures, and ventilation systems.
- Safety Officer: Conduct safety audits, training, and ensure regulatory signage and PPE availability.
4. Accountability
The Warehouse and EHS (Environment, Health, Safety) Managers are jointly accountable for ensuring safe storage, training, and monitoring compliance with hazardous material handling procedures.
5. Procedure
5.1 Classification and Identification
- All chemicals shall be classified as per Globally Harmonized System (GHS) and MSDS.
- Examples of hazardous materials:
- Flammable liquids (e.g., Methanol, Acetone)
- Oxidizers (e.g., Hydrogen Peroxide)
- Corrosives (e.g., HCl, NaOH)
- Toxic substances (e.g., Cyanides)
- Affix hazard symbols, UN numbers, and handling instructions on each container.
5.2 Storage Requirements
- Store flammable materials in flameproof rooms or cabinets as per local fire department regulations.
- Segregate incompatible substances based on chemical compatibility chart.
- Store acids, bases, and oxidizers separately in ventilated, corrosion-resistant shelves.
- Ensure storage areas have:
- Explosion-proof electrical fixtures
- Temperature controls
- Secondary spill containment
- Proper exhaust ventilation
5.3 Labeling and Signage
- Every storage area and container must bear:
- Hazard classification (e.g., flammable, corrosive)
- Signal word (e.g., Danger)
- Pictogram and precautionary statement
- Install signage like “No Smoking,” “Flammable Area,” and emergency exit direction boards.
5.4 Inventory and Monitoring
- Maintain updated inventory of hazardous chemicals in the “Hazardous Chemical Register” (Annexure-1).
- Conduct physical verification monthly.
- Perform routine checks for:
- Container integrity
- Label clarity
- Leakage or spillage
- Log temperature and humidity daily for flammable storage areas (Annexure-2).
5.5 Safety Measures and Emergency Equipment
- Provide the following safety infrastructure:
- Fire extinguishers (foam, CO2, dry chemical)
- Eye wash stations
- Emergency shower
- Fire hydrants and smoke detectors
- Train staff on:
- MSDS usage
- Evacuation procedures
- Use of fire extinguishers
- Conduct mock drills every 6 months.
6. Abbreviations
- SOP: Standard Operating Procedure
- MSDS: Material Safety Data Sheet
- GHS: Globally Harmonized System
- EHS: Environment, Health, and Safety
7. Documents
- Hazardous Chemical Register (Annexure-1)
- Temperature and Humidity Log (Annexure-2)
- Hazardous Storage Area Audit Checklist (Annexure-3)
8. References
- OSHA 29 CFR 1910.106 – Flammable Liquids
- ICH Q7 – GMP Guide for APIs
- NFPA Codes and IS 2182: Fire Safety Guidelines
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Designation | Warehouse Executive | EHS Officer | QA Manager |
| Department | API Manufacturing | Environment, Health & Safety | Quality Assurance |
11. Annexures
Annexure-1: Hazardous Chemical Register
| Date | Material | Batch | Storage Location | Classification | Quantity |
|---|---|---|---|---|---|
| 13/04/2025 | Acetone | AC202504 | Flammable Store 1 | Flammable | 100 L |
Annexure-2: Temperature and Humidity Log
| Date | Time | Temp (°C) | Humidity (%) | Checked By |
|---|---|---|---|---|
| 13/04/2025 | 09:00 | 25.1 | 60 |
Annexure-3: Hazardous Storage Area Audit Checklist
| Date | Audit Area | Checklist Item | Status | Corrective Action (if any) |
|---|---|---|---|---|
| 10/04/2025 | Solvent Bay | Fire Extinguisher Validity | OK | — |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP | GMP Safety Compliance | QA Head |
| 13/04/2025 | 2.0 | Integrated GHS and Fire Safety Enhancements | Regulatory Update | QA Head |