Standard Operating Procedure for Addition of Volatile Solvents Under Fume Hood in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/114/2025 |
| Supersedes | SOP/ELX/114/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To outline the safe handling and controlled addition procedure of volatile solvents under a fume hood during elixir manufacturing, ensuring personnel safety and preventing product contamination or solvent loss.
2. Scope
This SOP is applicable to all volatile solvents such as ethanol, methanol, isopropyl alcohol, and other similar excipients used in elixir formulations that are handled under local exhaust ventilation (fume hoods) in the Elixir Department.
3. Responsibilities
- Production Operator:
- Prepare materials and carry out solvent addition as per BMR under fume hood.
- Wear appropriate PPE and follow safety protocols.
- Production Supervisor:
- Verify solvent quantity and monitor addition process.
- Ensure line clearance and documentation completion.
- QA Officer:
- Verify fume hood performance, cleanliness, and approve area before use.
4. Accountability
The Head of Production is accountable for ensuring that solvent addition under the fume hood is executed as per
this SOP with documented verification.
5. Procedure
5.1 Pre-Addition Preparation
- Check that the fume hood is functioning and airflow velocity is within specifications.
- Ensure the fume hood is labeled “CLEANED” and “READY FOR USE.”
- Confirm area clearance from QA and complete line clearance checklist.
- Bring the required solvent container(s) as mentioned in the BMR.
5.2 Personal Protective Equipment
- Wear the following PPE:
- Safety goggles
- Gloves resistant to solvent
- Solvent mask (if applicable)
- Lab coat and antistatic footwear
5.3 Solvent Addition Procedure
- Open the solvent container under the fume hood slowly to minimize vapour escape.
- Measure the solvent using a calibrated container or balance as per BMR quantity.
- Transfer solvent carefully into the batch vessel using a funnel or transfer pipe while maintaining airflow inside the hood.
- Close the solvent container immediately after use and return it to the designated storage area.
- Clean and wipe the working area after addition is completed.
5.4 Post-Addition Activities
- Ensure that all solvent residues are cleaned and neutralized using approved cleaning agent (if applicable).
- Turn off the fume hood only after QA approval.
- Document the addition activity in the Solvent Addition Log (Annexure-1).
- Report any spills or deviations immediately to the supervisor.
5.5 Safety Measures
- Do not use open flame or spark-producing devices near the fume hood.
- Ensure that the fume hood sash is at the recommended height (usually 18 inches).
- Do not overcrowd the hood with containers or tools that block airflow.
6. Abbreviations
- SOP: Standard Operating Procedure
- PPE: Personal Protective Equipment
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
7. Documents
- Solvent Addition Log (Annexure-1)
- Line Clearance Checklist
- Batch Manufacturing Record (BMR)
8. References
- 21 CFR Part 211.113 – Control of Hazardous Materials
- WHO TRS 986 – GMP Guidelines
- Material Safety Data Sheets (MSDS) for Volatile Solvents
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Solvent Addition Log
| Date | Batch No. | Solvent Name | Quantity Added | Added By | Verified By | Remarks |
|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-1049 | Ethanol | 5.0 L | Rajesh Kumar | Sunita Reddy | Handled under fume hood |
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 | Expanded safety and labeling steps | Process Safety Enhancement | QA Head |