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.
5. Procedure
5.1 Pre-Cleaning Checks
- Ensure that the vessel is empty and production is complete.
- Affix “To Be Cleaned” label on the vessel.
- Disconnect all power supplies and mechanical connections before cleaning.
5.2 Cleaning Steps
- Remove residual material using rubber scrapers or lint-free wipes.
- Rinse the vessel with purified water to remove loose material.
- Prepare cleaning solution using 1% non-ionic detergent and scrub the interior surface with nylon brush.
- Pay special attention to corners, joints, and pressure ports.
- Rinse thoroughly with purified water until no traces of detergent are observed (test via pH).
- For final rinse, use Water for Injection (WFI) if product requires aseptic conditions.
- Dry the vessel using filtered compressed air or allow to dry under laminar airflow.
5.3 Cleaning of External Surfaces
- Clean outer surfaces with lint-free cloth soaked in 70% IPA.
- 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
- Fill out Cleaning Record Sheet (Annexure-1) with date, time, method, and initials.
- Record any deviation in Annexure-2 and inform QA.
- Retain completed records in batch manufacturing file.
6. Abbreviations
- IPA: Isopropyl Alcohol
- WFI: Water for Injection
- QA: Quality Assurance
7. Documents
- Cleaning Record Sheet – Annexure-1
- Cleaning Deviation Log – Annexure-2
- Swab Sampling Template – Annexure-3
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 |