Procedure for Cleaning Heating Jacketed Vessels
| Department | Production/Engineering/Quality Assurance (QA) |
|---|---|
| SOP No. | SOP/Ointment/055 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a standardized method for cleaning heating jacketed vessels used in ointment manufacturing. Proper cleaning ensures the removal of residues, prevents contamination, and maintains compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all personnel involved in the cleaning and maintenance of heating jacketed vessels used in the production of ointments.
3. Responsibilities
- Production Supervisor: Ensures cleaning activities are performed as per SOP guidelines.
- Machine Operator: Prepares the vessel for cleaning and performs initial rinsing.
- Cleaning Personnel: Conducts thorough cleaning and sanitization of the vessel.
- Quality Assurance (QA) Personnel: Inspects and verifies the cleaning effectiveness.
- Engineering Technician: Assists in troubleshooting mechanical issues related to the heating jacket.
4. Accountability
The Production, Engineering, and QA Managers are accountable for ensuring that heating jacketed vessel cleaning follows GMP standards and is properly documented.
5. Procedure
5.1 Pre-Cleaning Preparations
- Ensure the vessel is empty and disconnected from power and steam supply.
- Depressurize the heating jacket system to avoid hazards.
- Wear appropriate Personal Protective Equipment (PPE), including gloves, goggles, and aprons.
- Ensure that all necessary cleaning
materials and equipment are available.
5.2 Initial Rinsing
- Flush the interior of the vessel with purified water to remove loose residues.
- Drain completely before proceeding to detergent cleaning.
5.3 Cleaning Process
5.3.1 Detergent Cleaning
- Prepare a cleaning solution using an approved detergent.
- Circulate the cleaning solution in the vessel for at least 15 minutes.
- Use soft brushes or scrubbing pads to clean the interior surfaces, including the walls and base.
- Ensure that the heating jacket’s external surface is also cleaned.
5.3.2 High-Pressure Rinsing
- Use high-pressure purified water to rinse off detergent residues.
- Ensure complete removal of any detergent traces.
5.3.3 Final Sanitization
- Apply an approved sanitizing agent (e.g., 70% ethanol or peracetic acid solution).
- Allow sufficient contact time (10-15 minutes) for effective disinfection.
- Perform a final rinse with purified water.
5.4 Cleaning the Heating Jacket
- Flush the heating jacket with an appropriate descaling agent if mineral buildup is detected.
- Rinse with purified water to remove any descaling agent residues.
- Ensure all drainage points are clear and free from blockages.
5.5 Drying and Post-Cleaning Inspection
- Allow the vessel to air dry completely in a controlled environment.
- Conduct a visual inspection to ensure no residues remain.
- Perform swab tests to verify microbial cleanliness.
- Record the results in the Cleaning Log.
5.6 Documentation and Approval
- Log all cleaning activities in the Cleaning Record.
- QA personnel must review and approve the cleaning before the next batch.
- Store records for compliance audits.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- PPE – Personal Protective Equipment
7. Documents
- Cleaning Log (Annexure-1)
- Cleaning Validation Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 211 – Current Good Manufacturing Practices
- ICH Q7 Good Manufacturing Practice Guide 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: Cleaning Log
| Date | Vessel ID | Cleaning Solution Used | Sanitization Agent | Verified By |
|---|---|---|---|---|
| 01/02/2025 | HJ-101 | Detergent Solution | 70% Ethanol | QA Officer |
| 02/02/2025 | HJ-102 | Alkaline Cleaner | Peracetic Acid | QA Officer |
Annexure-2: Cleaning Validation Report
| Date | Vessel ID | Swab Test Result | Microbial Limits | Final Status | Approved By |
|---|---|---|---|---|---|
| 01/02/2025 | HJ-101 | Pass | Within Limit | Approved | QA Head |
| 02/02/2025 | HJ-102 | Pass | Within Limit | Approved | QA Head |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |