Standard Operating Procedure for Cleaning of Sampling Booth and Tools in Gel Manufacturing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/137/2025 |
| Supersedes | SOP/GM/137/2022 |
| 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 standardized procedure for cleaning and sanitizing the sampling booth and associated tools used during the sampling of raw materials in gel manufacturing to ensure cleanliness and avoid cross-contamination.
2. Scope
This SOP
applies to all sampling booths and sampling tools used for collecting raw material samples in the Gel Manufacturing department.
3. Responsibilities
- Production Operator: Carries out the cleaning of sampling booths and tools.
- QA Executive: Verifies and records cleanliness status before and after sampling activities.
- Engineering Staff: Provides maintenance and calibration support for cleaning equipment.
4. Accountability
Head – Manufacturing
5. Procedure
5.1 General Requirements
- Ensure cleaning is performed before and after each sampling activity or as per shift schedule.
- Use only approved cleaning agents and validated sanitizing solutions.
5.2 Cleaning of Sampling Booth
- Switch off the airflow and lights before cleaning.
- Remove visible dust using a clean dry lint-free cloth.
- Wipe internal surfaces using 70% IPA solution in a unidirectional motion.
- Dry the surfaces using a sterile dry wipe.
- Clean pre-filters using a vacuum cleaner on a weekly basis or as per maintenance schedule.
5.3 Cleaning of Sampling Tools
- Use stainless steel or single-use plastic tools only.
- Rinse stainless steel tools with purified water followed by detergent cleaning.
- Follow with rinsing using purified water and final rinse with Water for Injection (WFI).
- Dry the tools in a designated drying area or in a hot air oven at 60–70°C for 1 hour.
- Store cleaned tools in labeled, covered trays or cabinets.
5.4 Sanitization Procedure
- Spray sanitizing solution (70% IPA or Quat-based) on booth surfaces and allow contact time of at least 5 minutes.
- Do not wipe off unless visibly wet after contact time.
5.5 Cleaning Verification
- Inspect cleaned surfaces visually for residue, stains, or foreign matter.
- Record the activity in the cleaning logbook.
- QA to inspect and sign off cleaning checklist prior to next sampling activity.
6. Abbreviations
- IPA: Isopropyl Alcohol
- WFI: Water for Injection
- QA: Quality Assurance
- cGMP: Current Good Manufacturing Practices
7. Documents
- Sampling Booth Cleaning Log – Annexure-1
- Tool Cleaning Checklist – Annexure-2
- Cleaning Agent Usage Record – Annexure-3
8. References
- WHO TRS 986 Annex 2: GMP for Pharmaceutical Products
- Schedule M: Good Manufacturing Practices
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: Sampling Booth Cleaning Log
| Date | Time | Performed By | Checked By | Remarks |
|---|---|---|---|---|
Annexure-2: Tool Cleaning Checklist
| Tool Name | Cleaned (Y/N) | Sanitized (Y/N) | Drying Method | Performed By | Date |
|---|---|---|---|---|---|
Annexure-3: Cleaning Agent Usage Record
| Agent Name | Lot No. | Preparation Date | Used On | By Whom |
|---|---|---|---|---|
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 18/04/2022 | 1.0 | Initial Issue | New SOP | QA Head |
| 09/06/2025 | 2.0 | Incorporated new cleaning tools and revised drying steps | Annual Review | QA Head |