Procedure for Cleaning Mixing Tanks Post-Manufacturing
| Department | Production/Engineering/Quality Assurance (QA) |
|---|---|
| SOP No. | SOP/Ointment/051 |
| 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 method for cleaning mixing tanks post-manufacturing to prevent cross-contamination, maintain product integrity, and comply with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all personnel involved in cleaning and sanitizing mixing tanks after ointment manufacturing in the production facility.
3. Responsibilities
- Production Supervisor: Ensures that cleaning is performed as per SOP.
- Machine Operator: Performs initial rinsing and preparation for cleaning.
- Cleaning Personnel: Conducts thorough cleaning and sanitation.
- Quality Assurance (QA) Personnel: Verifies cleaning effectiveness and maintains records.
4. Accountability
The Production and QA Managers are accountable for ensuring that cleaning procedures follow GMP standards and are properly documented.
5. Procedure
5.1 Pre-Cleaning Preparations
- Ensure the mixing tank is empty of product residue.
- Disconnect all power sources before cleaning.
- Wear appropriate Personal Protective Equipment (PPE) such as gloves, goggles, and aprons.
5.2 Initial Rinsing
- Flush the mixing tank with purified water to remove visible residues.
- Drain and inspect the interior for remaining product traces.
5.3 Cleaning Process
5.3.1 Detergent Cleaning
- Prepare a cleaning solution using an approved detergent.
- Scrub the tank walls and mixing blades with soft-bristle brushes.
- Circulate the cleaning solution for at least 15 minutes.
5.3.2 High-Pressure Rinsing
- Use high-pressure purified water to rinse the tank thoroughly.
- Ensure no detergent residues remain.
5.3.3 Final Sanitization
- Apply an approved sanitizing agent (e.g., 70% ethanol or peracetic acid solution).
- Allow contact for the recommended dwell time (e.g., 10 minutes).
- Perform a final rinse with purified water.
5.4 Post-Cleaning Inspection
- Check the tank for cleanliness using visual inspection and swab tests.
- Record pH and microbial test results for compliance verification.
- Ensure the tank is completely dry before the next batch.
5.5 Documentation and Approval
- Record all cleaning steps in the Cleaning Log.
- QA must verify and approve the cleaned equipment before reuse.
- Retain cleaning records for audits and compliance checks.
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 | Tank ID | Cleaning Solution Used | Sanitization Agent | Verified By |
|---|---|---|---|---|
| 01/02/2025 | MT-101 | Detergent Solution | 70% Ethanol | QA Officer |
| 02/02/2025 | MT-102 | Alkaline Cleaner | Peracetic Acid | QA Officer |
Annexure-2: Cleaning Validation Report
| Date | Tank ID | Swab Test Result | Microbial Limits | Final Status | Approved By |
|---|---|---|---|---|---|
| 01/02/2025 | MT-101 | Pass | Within Limit | Approved | QA Head |
| 02/02/2025 | MT-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 |