Elixir Department: SOP for Disinfection of Product Contact Surfaces – V 2.0

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Elixir Department: SOP for Disinfection of Product Contact Surfaces – V 2.0

Standard Operating Procedure for Disinfection of Product Contact Surfaces in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/164/2025
Supersedes SOP/ELX/164/2022
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 compliant procedure for the disinfection of product contact surfaces in elixir manufacturing to prevent microbial contamination and ensure product safety.

2. Scope

This SOP applies to all stainless steel product contact surfaces including mixing vessels, transfer lines, filling heads, storage tanks, and accessories that come into direct contact with the elixir during manufacturing and packaging processes.

3. Responsibilities

  • Production Operator:
    • Perform disinfection as per procedure and record details.
    • Use approved disinfectants within their validity and label status.
  • Engineering Department:
    • Ensure compatibility of disinfectants with product contact surfaces and assist with equipment isolation.
  • QA Officer:
    • Verify disinfection activities and approve readiness for manufacturing.
See also  Elixir Department: SOP for Calibration of Dispensing Balances - V 2.0

4. Accountability

The Production Head is accountable for execution. QA Head ensures effectiveness and documentation. The Engineering Head supports in troubleshooting or repair during disinfection activities.

5. Procedure

5.1 Pre-Disinfection Checks

  1. Ensure cleaning is completed and surfaces are free from visible residue.
  2. Inspect that cleaning logs are signed and verified.
  3. Check disinfectant label for name, concentration, preparation date, and expiry.

5.2 Selection and Preparation of Disinfectant

  1. Use approved disinfectants such as:
    • IPA 70% (Isopropyl Alcohol)
    • Hydrogen Peroxide 6% (for periodic disinfection)
    • Peracetic Acid-Based Solution (if validated)
  2. Disinfectants shall be prepared fresh daily (if not pre-approved with longer shelf-life) and labeled appropriately.
  3. Use disinfectants in rotation as per the rotation plan maintained by QA.

5.3 Disinfection Procedure

  1. Apply disinfectant using one of the following methods:
    • Wipe method – using sterile lint-free cloths soaked in disinfectant
    • Spray method – via spray bottles for smaller pipelines and fittings
    • CIP-based disinfection – if validated and available for tanks/pipes
  2. Ensure full wet contact for at least 10 minutes (contact time may vary per disinfectant SOP).
  3. Do not rinse the surface post-disinfection unless specifically required (e.g., for acidic disinfectants).
  4. Allow surfaces to air dry in cleanroom environment or dry with sterile air if required.
See also  Elixir Department: SOP for Preventive Maintenance of Filling Machines - V 2.0

5.4 Post-Disinfection Activities

  1. Label surfaces as “DISINFECTED” with date and time.
  2. Record activity in Disinfection Logbook (Annexure-1).
  3. QA to perform visual verification and sampling as applicable.

5.5 Frequency of Disinfection

  1. Before use of any cleaned product contact equipment if more than 24 hours have elapsed since cleaning.
  2. After cleaning and prior to start of batch processing.
  3. Between two different products or batches with microbial sensitivity.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • CIP: Clean-In-Place
  • IPA: Isopropyl Alcohol

7. Documents

  1. Disinfection Logbook (Annexure-1)
  2. Disinfectant Preparation Record
  3. Swab/Rinse Test Report
See also  Elixir Department: SOP for Maintaining Volume Adjustments - V 2.0

8. References

  • 21 CFR Part 211 – Equipment Cleaning and Maintenance
  • WHO TRS 961 Annex 6 – Disinfection in Pharmaceutical Manufacturing
  • ICH Q9 – Quality Risk Management

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Disinfection Logbook

Date Surface/Equipment ID Disinfectant Used Method Contact Time Performed By QA Verified
11/04/2025 MXR-ELX-06 IPA 70% Wipe 10 min Rajesh Kumar Sunita Reddy

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 disinfectant rotation and contact time standardization Regulatory Update QA Head
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