SOP Guide for Pharma

Gel Manufacturing: SOP for Cleaning of Pressure Vessels Used in Gel Processing – V 2.0

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Gel Manufacturing: SOP for Cleaning of Pressure Vessels Used in Gel Processing – V 2.0

Standard Operating Procedure for Cleaning of Pressure Vessels Used in Gel Processing

Department Gel Manufacturing
SOP No. SOP/GM/148/2025
Supersedes SOP/GM/148/2022
Page No. Page 1 of 10
Issue Date 09/06/2025
Effective Date 11/06/2025
Review Date 09/06/2027

1. Purpose

To describe the procedure for cleaning of pressure vessels used in the gel manufacturing process to maintain hygiene and avoid cross-contamination.

2. Scope

This procedure applies to all pressure vessels used for holding, mixing, and transferring gel-based products within the Gel Manufacturing area.

3. Responsibilities

  • Production Operator: Performs cleaning as per instructions.
  • Production Supervisor: Verifies the cleaning activity.
  • QA Executive: Performs line clearance post-cleaning and reviews records.

4. Accountability

Head – Manufacturing Department is accountable for ensuring that all cleaning operations are performed and documented

in compliance with this SOP.
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5. Procedure

5.1 Pre-Cleaning Checks

  1. Ensure that the vessel is empty and production is complete.
  2. Affix “To Be Cleaned” label on the vessel.
  3. Disconnect all power supplies and mechanical connections before cleaning.

5.2 Cleaning Steps

  1. Remove residual material using rubber scrapers or lint-free wipes.
  2. Rinse the vessel with purified water to remove loose material.
  3. Prepare cleaning solution using 1% non-ionic detergent and scrub the interior surface with nylon brush.
  4. Pay special attention to corners, joints, and pressure ports.
  5. Rinse thoroughly with purified water until no traces of detergent are observed (test via pH).
  6. For final rinse, use Water for Injection (WFI) if product requires aseptic conditions.
  7. Dry the vessel using filtered compressed air or allow to dry under laminar airflow.
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5.3 Cleaning of External Surfaces

  1. Clean outer surfaces with lint-free cloth soaked in 70% IPA.
  2. Ensure control panels and indicator ports are dry.

5.4 Cleaning Validation and Frequency

  • Carry out visual inspection and swab sampling once per cleaning validation protocol.
  • Routine cleaning to be performed:
    • After every batch (product changeover)
    • Once daily during campaign use
    • After idle time of more than 72 hours

5.5 Documentation

  1. Fill out Cleaning Record Sheet (Annexure-1) with date, time, method, and initials.
  2. Record any deviation in Annexure-2 and inform QA.
  3. Retain completed records in batch manufacturing file.

6. Abbreviations

  • IPA: Isopropyl Alcohol
  • WFI: Water for Injection
  • QA: Quality Assurance

7. Documents

  1. Cleaning Record Sheet – Annexure-1
  2. Cleaning Deviation Log – Annexure-2
  3. Swab Sampling Template – Annexure-3
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8. References

  • WHO TRS 961 Annex 4: GMP for Pharmaceutical Products
  • EU GMP Part I Chapter 5: Production
  • Internal Cleaning Validation Protocol

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation Jr. Production Chemist QA Executive Head – Manufacturing
Department Gel Manufacturing Quality Assurance Manufacturing

11. Annexures

Annexure-1: Cleaning Record Sheet

Date Vessel ID Cleaning Method Performed By Verified By

Annexure-2: Cleaning Deviation Log

Date Deviation Observed Corrective Action Remarks

Annexure-3: Swab Sampling Template

Location Swab Area (cm²) Result (CFU) Analyst Remarks

Revision History

Revision Date Revision No. Change Description Reason Approved By
08/05/2022 1.0 Initial version New SOP QA Head
09/06/2025 2.0 Added WFI rinse and cleaning validation steps Annual update QA Head
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