Standard Operating Procedure for Verifying Cleaning of Equipment in Gel Manufacturing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/178/2025 |
| Supersedes | SOP/GM/178/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 09/06/2025 |
| Effective Date | 11/06/2025 |
| Review Date | 09/06/2027 |
1. Purpose
To establish a systematic and validated process for verifying the cleanliness of gel manufacturing equipment post-cleaning, ensuring that the equipment is free from product residue, cleaning agents, and microbial contaminants.
2. Scope
This procedure applies to all gel manufacturing equipment including vessels, mixers, transfer lines, and filling machines used in the manufacturing facility.
3. Responsibilities
- Production Staff: Perform initial visual inspection of cleaned equipment.
- QA Executive: Perform swab and rinse sample collection, and approve equipment for next use.
- QC Analyst: Analyze swab/rinse samples for residues and
contaminants.
Engineering: Ensure cleaning systems are functional and calibrated.
4. Accountability
The Head – Manufacturing is accountable for ensuring compliance with cleaning verification practices.
5. Procedure
5.1 Visual Inspection
- Inspect all product contact surfaces after cleaning for:
- No visible residue or staining.
- No signs of previous batch remnants.
- No water droplets or standing liquids.
- Document findings in the Cleaning Verification Logbook (Annexure-1).
5.2 Swab Sampling Procedure
- Use pre-validated swab sticks and wet with suitable solvent (e.g., WFI or 70% IPA).
- Identify worst-case sampling points: corners, valves, impellers, discharge outlets.
- Swab 25 cm2 surface area using a defined horizontal and vertical stroke.
- Place swabs in labeled test tubes and transfer to QC.
5.3 Rinse Sampling
- Collect final rinse from equipment directly into a sterile, labeled container.
- Analyze for:
- Conductivity
- TOC (Total Organic Carbon)
- Microbial contamination (if required)
5.4 Sample Analysis
- QC to perform quantitative analysis of:
- Residue (API or excipient traces)
- Detergent or cleaning agent (as per cleaning validation protocol)
- Bioburden if specified
- Compare results with acceptance limits defined in cleaning validation protocol.
5.5 Approval and Documentation
- QA reviews visual inspection and analytical results.
- Upon satisfactory outcome, approve equipment for production use by signing Equipment Cleaning Tag (Annexure-2).
6. Abbreviations
- QA: Quality Assurance
- QC: Quality Control
- WFI: Water for Injection
- TOC: Total Organic Carbon
7. Documents
- Cleaning Verification Logbook – Annexure-1
- Equipment Cleaning Tag – Annexure-2
- Swab Sampling Template – Annexure-3
- Rinse Sample Analysis Report – Annexure-4
8. References
- WHO TRS 986 – Annex 7: Cleaning Validation
- SOP/GM/105/2025 – Cleaning Procedure for Equipment
- ICH Q7: Good Manufacturing Practice Guide
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Production Chemist | QA Executive | Head – Manufacturing |
| Department | Gel Manufacturing | Quality Assurance | Manufacturing |
11. Annexures
Annexure-1: Cleaning Verification Logbook
| Date | Equipment ID | Area Inspected | Inspector | Remarks |
|---|---|---|---|---|
Annexure-2: Equipment Cleaning Tag
| Equipment ID | Cleaned On | Inspected By | QC Sample ID | QA Approval |
|---|---|---|---|---|
Annexure-3: Swab Sampling Template
| Sample ID | Equipment | Location | Surface Area (cm²) | Sampler |
|---|---|---|---|---|
Annexure-4: Rinse Sample Analysis Report
| Sample ID | Conductivity | TOC (ppm) | Bioburden (CFU/mL) | Analyst |
|---|---|---|---|---|
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 10/04/2022 | 1.0 | Initial issue | New SOP | QA Head |
| 09/06/2025 | 2.0 | Updated with separate swab and rinse verification sections | GMP Compliance | QA Head |