Elixir Department: SOP for Cleaning Between Product Changeover – V 2.0

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Elixir Department: SOP for Cleaning Between Product Changeover – V 2.0

Standard Operating Procedure for Cleaning Between Product Changeover in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/169/2025
Supersedes SOP/ELX/169/2022
Page No. Page 1 of 11
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To establish a validated and standardized cleaning procedure to be followed between manufacturing of two different products in the Elixir Department, in order to prevent cross-contamination and ensure regulatory compliance.

2. Scope

This SOP applies to all equipment, utensils, contact surfaces, and processing areas used for elixir manufacturing that are shared across multiple products and require cleaning during product changeover.

3. Responsibilities

  • Production Operator:
    • Carry out cleaning activities as per this SOP and document the same.
  • QA Officer:
    • Verify cleaning and perform swab/rinse sampling as applicable.
    • Approve equipment for next product use.
  • Engineering Department:
    • Provide maintenance support and ensure cleaning tools and utilities are functional.
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4. Accountability

The Production Head is accountable for cleaning execution and compliance. The QA Head is responsible for final verification and release of equipment post-cleaning. The Engineering Head ensures readiness of cleaning utilities and tools.

5. Procedure

5.1 Evaluation Before Cleaning

  1. Refer to the product changeover matrix or cleaning classification chart to determine the type of cleaning required (Type A – Similar product, Type B – Different product, Type C – Potent/Allergenic product).
  2. Identify all equipment and accessories used in the previous product.
  3. Ensure batch records and product status labels are updated before initiating cleaning.

5.2 Cleaning Process

  1. Perform dry cleaning to remove gross residues (scraping, brushing).
  2. Follow with wet cleaning using approved detergent solution (1% neutral or validated cleaning agent).
  3. For CIP systems:
    • Run standard cycle with pre-rinse, detergent wash, intermediate rinse, and final rinse.
  4. For manual cleaning:
    • Scrub interior and exterior surfaces with lint-free cloths or soft brushes.
    • Pay attention to blind spots, gaskets, and joints.
  5. Rinse thoroughly with purified water until pH of rinse water matches PW and no foam is observed.
  6. Use hot purified water if applicable for enhanced cleaning efficiency.
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5.3 Inspection and Verification

  1. Perform visual inspection under adequate lighting to ensure “visibly clean” status.
  2. Collect swab/rinse samples from defined locations (minimum 3 per equipment).
  3. Submit samples to QC for:
    • Residue check (UV/vis, HPLC, or TOC)
    • Microbial analysis (TVC and pathogens)
  4. Equipment shall be labeled as “CLEANED – PENDING APPROVAL” until QA review is completed.

5.4 Approval and Release

  1. QA shall review swab/rinse test results against predefined limits.
  2. Upon satisfactory results, QA shall approve equipment for the next batch and sign off in the logbook.
  3. Update the cleaning status label to “CLEANED – READY FOR USE.”

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • CIP: Clean-In-Place
  • TOC: Total Organic Carbon
  • TVC: Total Viable Count
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7. Documents

  1. Product Changeover Cleaning Logbook (Annexure-1)
  2. Swab/Rinse Sample Report
  3. Cleaning Verification Checklist

8. References

  • 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
  • ICH Q7 – GMP for APIs
  • WHO TRS 986 Annex 4 – Cleaning Validation

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Product Changeover Cleaning Logbook

Date Previous Product Next Product Equipment ID Cleaning Type Performed By QA Verified Remarks
11/04/2025 Elixir-A Elixir-B MXR-ELX-08 Type B Rajesh Kumar Sunita Reddy Approved

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 Added cleaning classification and sampling strategy GMP Enhancement QA Head
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