Procedure for Cleaning Pipes and Valves in Equipment
| Department | Production/Engineering/Quality Assurance (QA) |
|---|---|
| SOP No. | SOP/Ointment/057 |
| 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 define a standardized process for cleaning pipes and valves in equipment used for ointment manufacturing. Proper cleaning prevents cross-contamination, maintains process efficiency, and ensures compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all personnel involved in the cleaning and maintenance of pipes and valves in ointment manufacturing equipment.
3. Responsibilities
- Production Supervisor: Ensures that cleaning activities are performed as per SOP.
- Machine Operator: Prepares pipes and valves for cleaning.
- Cleaning Personnel: Performs cleaning and sanitization of pipes and valves.
- Quality Assurance (QA) Personnel: Inspects and verifies cleaning effectiveness.
- Engineering Technician: Assists with valve and pipe disassembly and troubleshooting if required.
4. Accountability
The Production, Engineering, and QA Managers are accountable for ensuring that cleaning of pipes and valves follows GMP standards and is properly documented.
5. Procedure
5.1 Pre-Cleaning Preparations
- Ensure the equipment is turned off and disconnected from power and pressure sources.
- Depressurize and drain any residual materials from the pipes and valves.
- Wear appropriate Personal Protective Equipment (PPE), including gloves, goggles, and aprons.
- Ensure that
all required cleaning agents, brushes, and sanitizers are available.
5.2 Disassembling Pipes and Valves
- Refer to the equipment manual for proper disassembly instructions.
- Remove pipes, connectors, and valves carefully, ensuring no damage.
- Inspect components for signs of clogging, scaling, or residue buildup.
5.3 Cleaning Process
5.3.1 Initial Rinsing
- Flush pipes and valves with purified water to remove loose residues.
- Drain completely before proceeding to detergent cleaning.
5.3.2 Detergent Cleaning
- Prepare a cleaning solution using an approved detergent.
- Circulate the cleaning solution through the pipes and valves for at least 20 minutes.
- Use pipe brushes to scrub internal surfaces of pipes and valve seats.
- Ensure all components are thoroughly cleaned.
5.3.3 High-Pressure Rinsing
- Use high-pressure purified water to rinse off detergent residues.
- Repeat rinsing until all traces of detergent are removed.
5.3.4 Final Sanitization
- Prepare a sanitizing solution (e.g., 70% ethanol or peracetic acid solution).
- Circulate the solution through the pipes and valves for at least 15 minutes.
- Drain and allow parts to dry completely before reassembly.
5.4 Drying and Reassembly
- Allow cleaned components to air dry in a controlled environment.
- Reassemble pipes and valves according to the equipment manual.
- Ensure all seals and gaskets are properly positioned.
5.5 Post-Cleaning Inspection
- Conduct a visual inspection to ensure no residues remain.
- Perform swab tests for microbial verification.
- 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 cleaned pipes and valves before use.
- Retain cleaning records for audits and compliance verification.
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 | Pipe/Valve ID | Cleaning Solution Used | Sanitization Agent | Verified By |
|---|---|---|---|---|
| 01/02/2025 | PV-101 | Detergent Solution | 70% Ethanol | QA Officer |
| 02/02/2025 | PV-102 | Alkaline Cleaner | Peracetic Acid | QA Officer |
Annexure-2: Cleaning Validation Report
| Date | Pipe/Valve ID | Swab Test Result | Microbial Limits | Final Status | Approved By |
|---|---|---|---|---|---|
| 01/02/2025 | PV-101 | Pass | Within Limit | Approved | QA Head |
| 02/02/2025 | PV-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 |