Here’s a comprehensive and structured report on the rules and regulations for solvent storage in Indian pharmaceutical industries, governed by PESO (Petroleum and Explosives Safety Organization) and other relevant authorities. This is suitable for publishing on your blog.
📘 Solvent Storage Guidelines in Indian Pharmaceutical Industries
🔰 Section 1: Regulatory Authorities & Legal Framework
1.1 Governing Bodies
- PESO: Regulates petroleum and explosive substances under the Petroleum Act, 1934 and Petroleum Rules, 2002.
- MoEFCC: Oversees hazardous chemical storage under the Environment Protection Act, 1986 and MSIHC Rules, 1989.
- BIS: Provides fire safety codes like IS 3594:1991.
- DGFSCDHG: Issues the National Building Code (NBC) Part IV – Fire & Life Safety.
1.2 Key Acts & Rules
- Petroleum Rules, 2002 – PESO[1]
- MSIHC Rules, 1989 – MoEFCC[2]
- IS 3594:1991 – BIS Fire Safety Code[3]
- National Building Code – Fire & Life Safety[4]
- Chemical Industry Laws Overview[5]
🧪 Section 2: Classification & Quantity Limits of Solvents
2.1 Classification by Flash Point (Petroleum Rules, 2002)
- Class A: Flash point < 23°C (e.g., acetone, ethanol)
- Class B: 23°C ≤ Flash point < 65°C (e.g., kerosene)
- Class C: 65°C ≤ Flash point < 93°C (e.g., furnace oil)
2.2 Storage Limits Without License
- Class A: Up to 30 litres (non-sale use)
- Class B: Up to 2,500 litres (non-bulk)
- Class C: Up to 45,000 litres (bulk)[6]
For quantities exceeding these limits, a PESO license is mandatory.
🏭 Section 3: Storage Conditions & Infrastructure Requirements
3.1 Storage Area Design
- Must be well-ventilated, flameproof, and isolated from ignition sources.
- Flammable solvents must be stored in dedicated solvent rooms under lock and key.
- Use drum transfer trolleys; avoid rolling drums on the floor.
3.2 Fire Safety Measures
- Hydrants & Sprinklers: Mandatory for bulk storage areas.
- Smoke Detectors: Required in enclosed solvent rooms.
- Flameproof Electricals: All equipment must be explosion-proof.
- NBC Part IV mandates fire exits, alarms, and extinguishers.[4]
3.3 Containment & Spillage Control
- Secondary containment (bund walls or trays) must be provided.
- Spill kits and absorbents should be readily available.
- Logbooks must record all dispensing and handling activities.[7]
📋 Section 4: SOP for Solvent Handling in Pharma
Refer to the Pharmainform SOP[7] for detailed procedures:
4.1 Receipt
- Verify COA, vendor approval, expiry date.
- Clean drums with lint-free cloth.
- Quarantine and QC sampling.
4.2 Issuance
- Dispense in ventilated areas with PPE.
- Use calibrated weighing balances.
- Label containers with batch and quantity.
4.3 Storage
- Segregate released and rejected drums.
- Maintain flameproof environment.
4.4 Handling
- Avoid dropping drums.
- Use PPE and flameproof tools.
🛡️ Section 5: Compliance & Licensing
5.1 PESO Licensing Forms
- Form XV: Bulk storage license.
- Form XVI: Non-bulk storage exceeding limits.
- Form XIV: Storage for pump outfit.
- PESO SOP & Licensing Guide[6]
5.2 MSIHC Compliance
- Identify Major Accident Hazards (MAH).
- Submit site notification and safety reports.
- Maintain threshold quantity records.[2]
🔗 Section 6: Useful Resources & Downloads
| Document | Link |
|---|---|
| Petroleum Rules, 2002 | Download PDF[1] |
| PESO SOP for Licensing | Download PDF[6] |
| MSIHC Rules, 1989 | Download PDF[2] |
| NBC Fire Safety Guidelines | View Online[4] |
| SOP for Solvent Handling | Pharmainform SOP[7] |
Would you like me to format this into a downloadable PDF or HTML version for your blog?
References
[1] MINISTRY OF PETROLEMUM & NATURAL GAS Notification – PESO
[2] MANUFACTURE, STORAGE AND IMPORT OF HAZARDOUS CHEMICAL RULES, 1989
[3] IS 3594 (1991): Code of practice for fire safety of industrial …
[4] National Building Code Of India (Fire and Life safety)
[5] Laws and Regulations that govern the Chemical Process Industry in India
[7] SOP For Receipt, Issuance, Storage & Handling Of Solvents