Elixir Department: SOP for Cleaning of Transfer Pipelines – V 2.0

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Elixir Department: SOP for Cleaning of Transfer Pipelines – V 2.0

Standard Operating Procedure for Cleaning of Transfer Pipelines in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/162/2025
Supersedes SOP/ELX/162/2022
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 validated and standardized method for the cleaning of product contact transfer pipelines used in elixir manufacturing, ensuring removal of residues and prevention of cross-contamination between batches.

2. Scope

This SOP applies to all stainless steel and flexible transfer pipelines used for transferring bulk elixir from mixing vessels to holding or filling tanks within the Elixir Department.

3. Responsibilities

  • Production Operator:
    • Disassemble and clean pipelines as per instructions.
    • Record cleaning details and observations.
  • Engineering Department:
    • Ensure availability and maintenance of cleaning utilities and tools.
    • Support preventive maintenance of CIP pumps (if used).
  • QA Officer:
    • Perform visual and swab/rinse inspections for cleaning verification.
    • Approve the pipeline for subsequent use based on compliance.
See also  Elixir Department: SOP for Transfer of Final Bulk for Bottling - V 2.0

4. Accountability

The Production Head is accountable for execution of pipeline cleaning. The Engineering Head ensures operational readiness of cleaning equipment. The QA Head is responsible for compliance verification and documentation.

5. Procedure

5.1 Pre-Cleaning Checks

  1. Ensure the pipeline is disconnected from both the source and receiving tanks.
  2. Verify the batch has been completed and documented in the BMR.
  3. Label pipeline as “TO BE CLEANED.”

5.2 Manual Cleaning Procedure

  1. Flush pipeline with purified water to remove residual product.
  2. Prepare 1% v/v detergent solution in a suitable container.
  3. Pass detergent through the pipeline using a cleaning pump or pressure system for 5 minutes.
  4. Brush clean external ports, clamps, and hose connectors using designated tools.
  5. Flush with purified water until rinse water is clear and pH matches purified water.
  6. Drain water completely and dry the pipeline using filtered compressed air or hang to air dry.
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5.3 CIP-Based Cleaning Procedure

  1. Connect inlet and outlet ports of pipeline to CIP loop securely.
  2. Initiate the CIP cycle from control panel:
    • Pre-rinse with purified water – 5 minutes
    • Detergent wash at 45°C – 10 minutes
    • Intermediate rinse – 5 minutes
    • Final rinse with hot purified water – 5 minutes
  3. Monitor flow rate, return pressure, and temperature during the cycle.
  4. After final rinse, dry the pipeline using 0.22 µm filtered compressed air.

5.4 Post-Cleaning Activities

  1. Inspect the pipeline internally using a borescope (if applicable) or visual inspection.
  2. Label the cleaned pipeline with “CLEANED” status tag.
  3. Record cleaning in the Transfer Pipeline Cleaning Logbook (Annexure-1).

5.5 QA Verification

  1. QA to review the logbook and verify cleaning record completion.
  2. Collect swab/rinse samples for validation (based on cleaning validation protocol).
  3. Allow pipeline for next batch only after successful test results.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • CIP: Clean-In-Place
  • QA: Quality Assurance
  • BMR: Batch Manufacturing Record
See also  Elixir Department: SOP for Timer Settings and Logging Parameters - V 2.0

7. Documents

  1. Transfer Pipeline Cleaning Logbook (Annexure-1)
  2. Cleaning Validation Report
  3. Swab and Rinse Test Record

8. References

  • 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
  • WHO TRS 937 – Annex 4: Cleaning Validation
  • ICH Q7 – GMP Guidelines for APIs

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Transfer Pipeline Cleaning Logbook

Date Pipeline ID Cleaning Method Performed By QA Verified Remarks
11/04/2025 TPL-08 CIP Rajesh Kumar Sunita Reddy Cleaned and Approved

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 Included borescope inspection and air drying details Enhanced GMP Compliance QA Head
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