Standard Operating Procedure for Controlled Storage of Radioactive or Hazardous Raw Materials
| Department | Warehouse / Quality Assurance / Safety |
|---|---|
| SOP No. | SOP/RM/135/2025 |
| Supersedes | SOP/RM/135/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 28/02/2025 |
| Effective Date | 05/03/2025 |
| Review Date | 28/02/2026 |
1. Purpose
This Standard Operating Procedure (SOP) establishes guidelines for the safe and compliant storage of radioactive and hazardous raw materials. It ensures the protection of personnel, property, and the environment while maintaining compliance with regulatory requirements.
2. Scope
This SOP applies to all radioactive and hazardous raw materials received, stored, and handled within the warehouse facilities. It covers materials classified as flammable, corrosive, toxic, carcinogenic, reactive, or radioactive.
3. Responsibilities
- Warehouse Personnel: Ensure proper storage, labeling, and handling of hazardous and radioactive materials.
- Warehouse Manager: Supervise the controlled storage process and ensure compliance with safety and regulatory guidelines.
- Quality Assurance (QA): Verify compliance with Good Manufacturing Practices (GMP) and ensure proper documentation of storage conditions.
- Safety Officer: Ensure safety procedures are followed and proper Personal Protective Equipment (PPE) is used during handling and storage.
- Radiation Safety Officer (RSO): Oversee the storage and handling of radioactive materials and ensure compliance with radiation protection regulations.
4. Accountability
The Warehouse Manager is accountable for ensuring hazardous and radioactive materials are stored safely and in compliance with regulatory guidelines. The QA Manager and Radiation Safety Officer are responsible for verifying adherence to safety protocols and proper documentation.
5. Procedure
5.1 Receiving and Inspection of Hazardous and Radioactive Materials
- Initial Inspection:
- Inspect all incoming hazardous and radioactive materials for leaks, damage, or improper labeling.
- Ensure that containers are intact, sealed, and labeled with the appropriate hazard symbols and handling instructions.
- Verify accompanying documentation, such as the Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), and radiation transport certificates, if applicable.
- Document receipt and inspection in the Hazardous Material Receiving Log (Annexure-1).
- Verification of Documentation:
- Ensure all regulatory documents are in place before accepting materials into storage.
- Record verification in the Documentation Verification Log (Annexure-2).
5.2 Storage Conditions for Hazardous and Radioactive Materials
- Controlled Access Areas:
- Store hazardous and radioactive materials in restricted-access areas with controlled entry, monitored by keycards or biometric access systems.
- Document access permissions in the Access Control Log (Annexure-3).
- Storage Environment:
- Store materials in well-ventilated, temperature-controlled environments, ensuring segregation based on material compatibility (e.g., flammable materials separate from oxidizers).
- For radioactive materials, use lead-shielded storage containers or cabinets, with regular radiation monitoring in place.
- Document storage conditions in the Storage Condition Log (Annexure-4).
5.3 Labeling and Segregation of Hazardous and Radioactive Materials
- Proper Labeling:
- Ensure all hazardous and radioactive materials are labeled with hazard symbols, batch numbers, expiry dates, and storage conditions.
- Radioactive materials should be marked with the trefoil radiation symbol and the words “Caution – Radioactive Material.”
- Record labeling activities in the Labeling Log (Annexure-5).
- Segregation Protocols:
- Segregate incompatible materials, such as acids from bases and flammable materials from oxidizers.
- Ensure radioactive materials are stored separately from non-radioactive materials, with adequate shielding and signage.
- Document segregation protocols in the Segregation Log (Annexure-6).
5.4 Radiation Safety and Monitoring
- Radiation Monitoring Procedures:
- Regularly monitor radiation levels in storage areas using calibrated Geiger counters or dosimeters.
- Ensure that radiation exposure levels do not exceed permissible limits as defined by regulatory authorities.
- Document monitoring results in the Radiation Monitoring Log (Annexure-7).
- Personnel Safety Measures:
- Ensure personnel handling radioactive materials wear dosimeters and appropriate PPE.
- Rotate staff handling radioactive materials to minimize exposure time.
- Document PPE usage and monitoring in the Personnel Safety Log (Annexure-8).
5.5 Spill and Emergency Response Procedures
- Spill Prevention:
- Ensure all containers are securely closed and stored in spill-containment trays or cabinets.
- Inspect storage areas regularly for signs of leaks or spills.
- Document inspections in the Spill Prevention Log (Annexure-9).
- Emergency Spill Response:
- In the event of a spill, immediately evacuate the area, contain the spill if safe to do so, and notify the Safety Officer and RSO.
- Use appropriate spill kits and follow emergency response protocols outlined in the MSDS or radiation safety manual.
- Document spill incidents and corrective actions in the Spill Incident Log (Annexure-10).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- PPE: Personal Protective Equipment
- RSO: Radiation Safety Officer
- MSDS: Material Safety Data Sheet
7. Documents
- Hazardous Material Receiving Log (Annexure-1)
- Documentation Verification Log (Annexure-2)
- Access Control Log (Annexure-3)
- Storage Condition Log (Annexure-4)
- Labeling Log (Annexure-5)
- Segregation Log (Annexure-6)
- Radiation Monitoring Log (Annexure-7)
- Personnel Safety Log (Annexure-8)
- Spill Prevention Log (Annexure-9)
- Spill Incident Log (Annexure-10)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- WHO GMP Guidelines
- International Atomic Energy Agency (IAEA) Radiation Safety Standards
- OSHA Hazardous Materials Handling Standards
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Hazardous Material Receiving Log
| Date | Material Name | Batch Number | Condition at Receipt | Inspected By |
|---|---|---|---|---|
| 28/02/2025 | Radioactive Isotope A | Batch9876 | No Damage | Ravi Kumar |
Annexure-2: Documentation Verification Log
| Date | Material Name | Document Verified | Verified By |
|---|---|---|---|
| 28/02/2025 | Radioactive Isotope A | COA, MSDS, Radiation Transport Certificate | Sunita Sharma |
Annexure-3: Access Control Log
| Date | Personnel Name | Access Time | Exit Time | Authorized By |
|---|---|---|---|---|
| 28/02/2025 | Amit Joshi | 10:00 AM | 10:45 AM | Priya Singh |
Annexure-4: Storage Condition Log
| Date | Material Name | Temperature (°C) | Humidity (%) | Storage Area |
|---|---|---|---|---|
| 28/02/2025 | Radioactive Isotope A | 22 | 45 | Radioactive Storage Room 1 |
Annexure-5: Labeling Log
| Date | Material Name | Label Applied | Applied By |
|---|---|---|---|
| 28/02/2025 | Radioactive Isotope A | Radioactive Symbol with Handling Instructions | Neha Verma |
Annexure-6: Segregation Log
| Date | Material Name | Segregation Type | Location | Segregated By |
|---|---|---|---|---|
| 28/02/2025 | Corrosive Chemical B | Separated from Flammable Materials | Hazardous Material Zone B | Ravi Kumar |
Annexure-7: Radiation Monitoring Log
| Date | Material Name | Radiation Level (µSv/h) | Monitoring Device Used | Monitored By |
|---|---|---|---|---|
| 28/02/2025 | Radioactive Isotope A | 0.5 | Geiger Counter Model X123 | Rajeev Menon |
Annexure-8: Personnel Safety Log
| Date | Personnel Name | PPE Used | Dosimeter Reading (µSv) | Verified By |
|---|---|---|---|---|
| 28/02/2025 | Amit Joshi | Lead Apron, Gloves, Goggles | 0.3 | Priya Singh |
Annexure-9: Spill Prevention Log
| Date | Inspection Area | Findings | Corrective Actions | Inspected By |
|---|---|---|---|---|
| 28/02/2025 | Radioactive Storage Room 1 | No leaks found | N/A | Ravi Kumar |
Annexure-10: Spill Incident Log
| Date | Material Name | Spill Description | Corrective Action Taken | Reported By |
|---|---|---|---|---|
| 28/02/2025 | Corrosive Chemical B | Minor leak detected in container seal | Container replaced, spill area cleaned with neutralizing agent | Sunita Sharma |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 28/02/2025 | 2.0 | Updated Procedures for Radioactive Material Storage | Compliance with Updated Regulatory Guidelines | QA Head |