SOP Guide for Pharma

Elixir Department: SOP for High Pressure Cleaning Systems – V 2.0

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Elixir Department: SOP for High Pressure Cleaning Systems – V 2.0

Standard Operating Procedure for High Pressure Cleaning Systems in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/179/2025
Supersedes SOP/ELX/179/2022
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 standardized procedure for the operation and use of high pressure cleaning systems for cleaning of equipment surfaces, floors, hard-to-reach areas, and utility components in the Elixir Department.

2. Scope

This SOP is applicable to all high pressure cleaning units and accessories used for cleaning stainless steel tanks, external equipment surfaces, product-contact and non-contact areas in the Elixir Manufacturing Department.

3. Responsibilities

  • Production Operator:
    • Operate the high pressure cleaning system following this SOP.
    • Ensure the system is cleaned, maintained, and stored safely after use.
  • Engineering Department:
    • Ensure functionality and periodic preventive maintenance of the high pressure cleaning unit.
  • QA Officer:
    • Verify cleaning activities and ensure compliance with cleaning effectiveness and documentation.
See also  Elixir Department: SOP for Preparation and Addition of Sugar Syrup - V 2.0

4. Accountability

The Production Head is accountable for the execution of high pressure cleaning. The QA Head ensures compliance verification. The Engineering Head ensures equipment readiness and safety.

5. Procedure

5.1 System Description

  1. High pressure cleaning system includes:
    • Pump unit (≥100 bar)
    • Hose with lance and adjustable nozzle
    • Detergent injection option (if applicable)

5.2 Pre-Cleaning Checklist

  1. Inspect the hose, nozzles, and connectors for damage.
  2. Check availability of purified water or approved water supply line.
  3. Ensure the floor drain is operational before cleaning.
  4. Wear proper PPE: goggles, face shield, waterproof apron, gloves, and safety boots.

5.3 Cleaning Procedure

  1. Connect the high pressure unit to the purified water source.
  2. Switch on the power and prime the pump until a steady jet is obtained.
  3. Start cleaning from top to bottom to avoid re-soiling cleaned areas.
  4. Use the adjustable nozzle to:
    • Widen spray for broad surface areas
    • Narrow the stream for stubborn deposits or hard-to-reach zones
  5. For detergent-supported systems:
    • Inject 1% approved cleaning agent and allow contact for 5 minutes.
    • Rinse thoroughly with high pressure purified water until foam is eliminated.
  6. Avoid spraying directly at electrical panels, sensors, or delicate connections.
See also  Elixir Department: SOP for Maintaining Volume Adjustments - V 2.0

5.4 Post-Cleaning and Shutdown

  1. Turn off the system and disconnect the water line.
  2. Drain residual water from hoses and pump using the pressure release valve.
  3. Wipe external surfaces of the unit and coil hoses properly.
  4. Store the equipment in the designated cleaning equipment area.

5.5 Cleaning Frequency

  1. Use after every batch involving highly viscous or sticky materials.
  2. At the end of each production shift, if bulk spillage has occurred.
  3. Mandatory use once per week for external tank cleaning in campaign production.

5.6 Documentation

  1. Enter cleaning activity in the High Pressure Cleaning Logbook (Annexure-1).
  2. QA to review and verify effectiveness and frequency of cleaning.

See also  Elixir Department: SOP for Cleaning of Weighing Balance After Dispensing - V 2.0

6. Abbreviations

  • SOP: Standard Operating Procedure
  • PPE: Personal Protective Equipment
  • QA: Quality Assurance

7. Documents

  1. High Pressure Cleaning Logbook (Annexure-1)
  2. Equipment Maintenance Checklist

8. References

  • 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
  • WHO GMP Guidelines for Pharmaceutical Production Facilities
  • ICH Q7 – Good Manufacturing Practices for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: High Pressure Cleaning Logbook

Date Equipment/Area Cleaned Operator Name Cleaning Agent Used QA Verified Remarks
11/04/2025 Tank Exterior – MXR-ELX-10 Rajesh Kumar 1% Neutraclean Sunita Reddy Visibly Clean

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 nozzle operation and detergent circulation procedure Process Optimization QA Head
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