Elixir Department: SOP for Detergent Solution Preparation for Cleaning – V 2.0

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Elixir Department: SOP for Detergent Solution Preparation for Cleaning – V 2.0

Standard Operating Procedure for Preparation of Detergent Solution for Cleaning in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/167/2025
Supersedes SOP/ELX/167/2022
Page No. Page 1 of 10
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To provide a standardized procedure for the preparation of detergent solutions used for cleaning equipment and product-contact surfaces in the Elixir Department, ensuring correct concentration, labeling, and usage.

2. Scope

This SOP applies to the preparation of all types of cleaning detergent solutions (alkaline, neutral, enzymatic, non-ionic) used in manual and CIP cleaning processes of manufacturing vessels, pipelines, transfer equipment, and utensils.

3. Responsibilities

  • Production Operator:
    • Prepare detergent solutions as per this SOP.
    • Ensure proper labeling and usage within the validity period.
  • Engineering Department:
    • Provide cleaned preparation tanks, calibrated measuring tools, and utilities.
  • QA Department:
    • Verify preparation records and approve detergent solution for use.
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4. Accountability

The Production Head is accountable for ensuring correct preparation. QA Head is responsible for verification and GMP compliance. The Engineering Head ensures the availability of calibrated equipment.

5. Procedure

5.1 General Instructions

  1. Use only approved detergent as per the cleaning validation master list.
  2. Check expiry date and intactness of container seal before use.
  3. Perform preparation in the designated area under supervision.

5.2 Preparation Steps

  1. Wear PPE including gloves, goggles, and apron.
  2. Clean and rinse the preparation container with purified water.
  3. Measure the required volume of purified water and pour it into the tank.
  4. Using a calibrated measuring cylinder, add the required quantity of detergent (example: 1% solution = 1 L detergent in 99 L purified water).
  5. Stir gently using a sanitized stirrer or agitator until fully dissolved (typically 5–10 minutes).
  6. Label the solution container with:
    • “DETERGENT SOLUTION”
    • Name of detergent
    • Concentration
    • Date and time of preparation
    • Prepared by and checked by
    • Use Before Date (typically 24–48 hours)
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5.3 Storage and Usage

  1. Store detergent solution in a clean, covered, labeled container.
  2. Avoid exposure to direct sunlight or excessive heat.
  3. Use only for the intended cleaning purpose as per the approved cleaning SOPs.
  4. Discard any unused solution after its expiry or end of the day (unless stability data supports extended use).

5.4 Documentation

  1. Record preparation details in the Detergent Solution Preparation Logbook (Annexure-1).
  2. Include batch number of detergent, concentration, date, time, and signature of personnel.
  3. QA to verify and sign before first use in a shift.

6. Abbreviations

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

7. Documents

  1. Detergent Solution Preparation Logbook (Annexure-1)
  2. Detergent Material Safety Data Sheet (MSDS)
  3. Cleaning Validation Master List
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8. References

  • 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
  • WHO TRS 986 Annex 4 – Cleaning Validation
  • 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: Detergent Solution Preparation Logbook

Date Detergent Name Batch No. Concentration Volume Prepared Prepared By QA Verified Use Before
11/04/2025 Neutral Detergent ND-02 ND022504 1% 50 L Rajesh Kumar Sunita Reddy 12/04/2025

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 sanitization of prep container and labeling requirements Audit Observation QA Head
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