SOP Guide for Pharma

Elixir Department: SOP for Addition of Volatile Solvents Under Fume Hood – V 2.0

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Elixir Department: SOP for Addition of Volatile Solvents Under Fume Hood – V 2.0

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.
See also  Elixir Department: SOP for Transfer of Materials to Quarantine Area Post Dispensing - V 2.0

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

  1. Check that the fume hood is functioning and airflow velocity is within specifications.
  2. Ensure the fume hood is labeled “CLEANED” and “READY FOR USE.”
  3. Confirm area clearance from QA and complete line clearance checklist.
  4. Bring the required solvent container(s) as mentioned in the BMR.

5.2 Personal Protective Equipment

  1. Wear the following PPE:
    • Safety goggles
    • Gloves resistant to solvent
    • Solvent mask (if applicable)
    • Lab coat and antistatic footwear

5.3 Solvent Addition Procedure

  1. Open the solvent container under the fume hood slowly to minimize vapour escape.
  2. Measure the solvent using a calibrated container or balance as per BMR quantity.
  3. Transfer solvent carefully into the batch vessel using a funnel or transfer pipe while maintaining airflow inside the hood.
  4. Close the solvent container immediately after use and return it to the designated storage area.
  5. Clean and wipe the working area after addition is completed.
See also  Elixir Department: SOP for Use of Validated Cleaning Detergents - V 2.0

5.4 Post-Addition Activities

  1. Ensure that all solvent residues are cleaned and neutralized using approved cleaning agent (if applicable).
  2. Turn off the fume hood only after QA approval.
  3. Document the addition activity in the Solvent Addition Log (Annexure-1).
  4. Report any spills or deviations immediately to the supervisor.

5.5 Safety Measures

  1. Do not use open flame or spark-producing devices near the fume hood.
  2. Ensure that the fume hood sash is at the recommended height (usually 18 inches).
  3. 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
See also  Elixir Department: SOP for Verification of Test Results - V 2.0

7. Documents

  1. Solvent Addition Log (Annexure-1)
  2. Line Clearance Checklist
  3. 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
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