Elixir Department: SOP for Cleaning of Mixing Vessels Post-Batch – V 2.0

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Elixir Department: SOP for Cleaning of Mixing Vessels Post-Batch – V 2.0

Standard Operating Procedure for Cleaning of Mixing Vessels Post-Batch in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/161/2025
Supersedes SOP/ELX/161/2022
Page No. Page 1 of 10
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To establish a standardized procedure for the thorough cleaning of mixing vessels after completion of each elixir batch to ensure removal of residues, prevent cross-contamination, and maintain GMP compliance.

2. Scope

This SOP is applicable to all types of mixing vessels used in the Elixir Department, including fixed and mobile tanks with or without CIP systems, following the completion of batch manufacturing.

3. Responsibilities

  • Production Operator:
    • Perform cleaning activities as per the defined procedure.
    • Record cleaning parameters and observations.
  • Engineering Department:
    • Ensure cleaning utilities such as purified water, hot water, and cleaning agents are available.
    • Maintain functionality of CIP systems and validate effectiveness.
  • QA Officer:
    • Verify cleaning effectiveness via swab/rinse sampling and approve vessels for next use.
See also  Elixir Department: SOP for Operation of Recirculation Loops - V 2.0

4. Accountability

The Production Head is accountable for executing cleaning operations. The Engineering Head ensures system maintenance. QA Head is responsible for compliance verification and

cleaning validation.

5. Procedure

5.1 Pre-Cleaning Preparation

  1. Ensure batch documentation is completed and vessel is labeled as “TO BE CLEANED.”
  2. Disconnect all utility lines (e.g., product transfer, heating jackets).
  3. Wear appropriate PPE including gloves, apron, face shield, and safety shoes.

5.2 Manual Cleaning Process

  1. Drain residual product through bottom outlet into a designated waste container.
  2. Flush the vessel twice using purified water.
  3. Prepare 1% v/v non-ionic detergent solution and fill up to 10% of vessel capacity.
  4. Scrub the internal surfaces using a long-handled brush, focusing on corners and agitator blades.
  5. Drain and rinse the vessel twice with purified water until rinse water is clear and pH-neutral.
  6. Perform final rinse using hot purified water (60–80°C) if applicable.
See also  Elixir Department: SOP for Pressure Relief Valve Operation - V 2.0

5.3 Cleaning Using CIP System (if equipped)

  1. Connect the CIP supply and return hoses securely to the vessel.
  2. Initiate the CIP cycle from HMI or control panel.
  3. Cycle steps include:
    • Pre-rinse with purified water for 5 minutes
    • Detergent wash with 1% solution at 45°C for 10 minutes
    • Intermediate rinse with purified water for 5 minutes
    • Final rinse with hot purified water for 5 minutes
  4. Monitor CIP parameters such as flow rate, pressure, and temperature throughout.

5.4 Post-Cleaning Activities

  1. Visually inspect the vessel for cleanliness, spots, or residues.
  2. Dry the vessel using compressed air filtered through 0.22 µm filter or clean lint-free cloths.
  3. Label the tank as “CLEANED” with cleaning date and operator name.
  4. Record cleaning data in the Cleaning Logbook (Annexure-1).

5.5 QA Verification

  1. QA shall perform swab or rinse sampling as per cleaning validation protocol.
  2. Verify absence of product residue, detergent, or microbial contamination.
  3. Approve the vessel for the next use only after passing test results.
See also  Elixir Department: SOP for CIP System Operation - V 2.0

6. Abbreviations

  • SOP: Standard Operating Procedure
  • CIP: Clean-In-Place
  • PPE: Personal Protective Equipment
  • QA: Quality Assurance

7. Documents

  1. Cleaning Logbook (Annexure-1)
  2. Swab/Rinse Test Report
  3. Cleaning Validation Protocol

8. References

  • 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
  • WHO TRS 937 – Annex 4: Cleaning Validation
  • ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cleaning Logbook

Date Tank ID Batch No. Cleaning Method Performed By QA Verified Remarks
11/04/2025 MXR-ELX-05 ELX-2025-038 CIP Rajesh Kumar Sunita Reddy Passed

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Release New SOP QA Head
11/04/2025 2.0 Added hot water rinse and final drying instructions Improved Compliance QA Head
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