SOP Guide for Pharma

Elixir Department: SOP for CIP System Operation – V 2.0

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Elixir Department: SOP for CIP System Operation – V 2.0

Standard Operating Procedure for CIP System Operation in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/133/2025
Supersedes SOP/ELX/133/2022
Page No. Page 1 of 10
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To define the standard procedure for the operation of the Clean-in-Place (CIP) system used in the Elixir Department to ensure effective and validated cleaning of internal product contact surfaces of tanks, pipelines, and associated equipment.

2. Scope

This SOP is applicable to all automated and semi-automated CIP systems used for cleaning manufacturing and holding tanks, transfer lines, and filling equipment used in elixir production.

3. Responsibilities

  • Production Operator:
    • Perform CIP operations as per approved cycle parameters.
    • Record process parameters and verify cleaning completion.
  • Engineering Department:
    • Maintain CIP system performance and perform periodic validation.
  • QA Officer:
    • Review CIP logs and verify cleaning effectiveness through swab/rinse testing.
See also  Elixir Department: SOP for Use of Controlled Atmosphere During Mixing - V 2.0

4. Accountability

The Production Head is accountable for ensuring proper cleaning is performed using the CIP system. The Engineering Head is accountable for the system’s calibration and maintenance.

5. Procedure

5.1 Pre-CIP Checks

  1. Verify that the system is labeled “READY FOR CLEANING.”
  2. Ensure the supply of utilities such as water, compressed air, and cleaning agents (alkaline/acidic).
  3. Confirm connection of CIP return and delivery lines to the appropriate tanks and pipelines.
  4. Check that drain valves are properly closed and flow paths are correctly aligned.

5.2 CIP Cycle Parameters

  1. Typical CIP cycle includes:
    • Pre-rinse with purified water: 5–10 minutes
    • Detergent wash (e.g., 1–2% NaOH solution): 15–20 minutes at 60–80°C
    • Intermediate rinse with purified water: 5–10 minutes
    • Acid wash (e.g., 0.5% nitric acid): 10 minutes (if applicable)
    • Final rinse with purified water until rinse water pH is neutral
  2. Adjust duration and temperature as per equipment type and validation report.
See also  Elixir Department: SOP for Shelf-Life Testing Protocol - V 2.0

5.3 CIP Operation

  1. Start the CIP control panel and select the appropriate cleaning recipe.
  2. Monitor and log parameters such as temperature, flow rate, pressure, and conductivity.
  3. Ensure no leakage or overflow occurs during cleaning.
  4. On completion of the cycle, verify that rinse water is clear and pH is within 6.5–7.5.

5.4 Post-CIP Activities

  1. Drain any remaining cleaning solution from the tank and pipelines.
  2. Disconnect the CIP lines and store them as per standard storage SOP.
  3. Inspect the cleaned equipment visually for absence of residues.
  4. Affix the “CLEANED” status label after successful QA clearance.
  5. Record all observations in the CIP Log (Annexure-1).

5.5 Safety and Precautions

  1. Wear appropriate PPE including apron, gloves, face shield, and safety shoes.
  2. Handle cleaning agents with caution—refer to respective SDS for safe handling.
  3. Ensure drains are not blocked to avoid flooding.
  4. Never open tanks or valves under pressure during the cycle.

See also  Elixir Department: SOP for Digital Weighing Balance Usage - V 2.0

6. Abbreviations

  • SOP: Standard Operating Procedure
  • CIP: Clean-in-Place
  • QA: Quality Assurance
  • SDS: Safety Data Sheet

7. Documents

  1. CIP Log (Annexure-1)
  2. CIP Cycle Printout/Report (if PLC-based)
  3. Cleaning Validation Protocol/Report

8. References

  • 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
  • WHO TRS 986 – GMP Cleaning Practices
  • 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: CIP Log

Date Equipment ID Cycle Type Detergent Used Final Rinse pH Operator QA Verified
11/04/2025 MIX-303 Standard 1.5% NaOH 7.1 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 detailed parameters and buffer instructions Process Optimization QA Head
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