Standard Operating Procedure for Collection and Segregation of Used Solvents in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/041/2025 |
| Supersedes | SOP/API/041/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To define a standardized procedure for the collection, segregation, and safe handling of used solvents during API manufacturing operations to prevent cross-contamination, enable solvent recovery, and ensure environmental and regulatory compliance.
2. Scope
This SOP applies to all production processes within the API manufacturing facility where solvents are used and subsequently require collection for recovery, reuse, or disposal.
3. Responsibilities
- Production Operator: Collect and label used solvents as per category and ensure transfer to designated containers.
- Shift Supervisor: Monitor segregation and maintain used solvent records.
- QA Department: Review and verify segregation logs and compliance with the SOP.
- EHS Department: Oversee environmental safety, labeling, and storage requirements.
4. Accountability
The Production Head is accountable for implementation of the procedure. The QA and EHS Heads are responsible for ensuring compliance with GMP and environmental guidelines.
5. Procedure
5.1 Categories of Used Solvents
- Recoverable Solvents: Solvents suitable for recovery and reuse (e.g., Toluene, Acetone, Methanol).
- Non-Recoverable Solvents: Contaminated, mixed, or degraded solvents requiring disposal.
- Aqueous Solvent Waste: Water-containing solvents (e.g., mother liquors) not suitable for recovery.
5.2 Collection Procedure
- Immediately after completion of the process, transfer used solvents from reactors or receivers into dedicated solvent collection tanks or drums.
- Ensure separate collection containers for:
- Each solvent type
- Non-recoverable solvents
- Mixed solvent streams
- Label all containers with:
- “Used Solvent”
- Solvent name and quantity
- Batch number and date
- Maintain records in the “Used Solvent Collection Log” (Annexure-1).
5.3 Segregation and Storage
- Store used solvent drums in a designated area with secondary containment.
- Ensure flammable solvents are stored with proper grounding and fire control measures.
- Do not mix different solvent classes (e.g., chlorinated and non-chlorinated).
- Use color-coded drums or tags for quick identification (e.g., Green – Recoverable, Red – Non-Recoverable).
5.4 Transfer and Recovery Coordination
- Coordinate with the solvent recovery unit or vendor for periodic collection.
- Use closed transfer systems where applicable to avoid vapors and spills.
- Retain solvent transfer acknowledgment copies from recovery/disposal vendor in batch files.
5.5 Safety Precautions
- Use PPE: gloves, goggles, aprons, and antistatic footwear.
- Handle solvents in well-ventilated areas or fume hoods.
- Keep spill kits and fire extinguishers readily accessible.
- Immediately report any spills or leaks to the EHS team.
6. Abbreviations
- SOP: Standard Operating Procedure
- EHS: Environment, Health & Safety
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Used Solvent Collection Log (Annexure-1)
- Solvent Segregation Checklist (Annexure-2)
- Vendor Transfer Log (Annexure-3)
8. References
- ICH Q7 – Good Manufacturing Practice for APIs
- 21 CFR Part 211 – Subpart C (Buildings and Facilities)
- EPA Guidelines for Hazardous Waste Management
- WHO TRS 957 Annex 2 – Waste Disposal
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Used Solvent Collection Log
| Date | Batch No. | Solvent Name | Quantity (L) | Container ID | Category |
|---|---|---|---|---|---|
| 13/04/2025 | API-202505 | Toluene | 95 | DR-0021 | Recoverable |
Annexure-2: Solvent Segregation Checklist
| Solvent Type | Segregated (Y/N) | Color Code | Remarks |
|---|---|---|---|
| Methanol | Y | Green | Properly Tagged |
Annexure-3: Vendor Transfer Log
| Date | Container ID | Solvent | Volume Transferred | Vendor Name | Acknowledged By |
|---|---|---|---|---|---|
| 13/04/2025 | DR-0021 | Toluene | 95 L | GreenSol Pvt. Ltd. |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial Issue | New Process Implementation | QA Head |
| 13/04/2025 | 2.0 | Updated segregation categories and annexures | GMP Compliance | QA Head |