that undergo cleaning and require swab testing prior to reuse.

3. Responsibilities

• QA Executive: Responsible for overseeing swab sampling and result interpretation.
• Microbiology Analyst: Responsible for TOC and microbial limit analysis.
• Production Chemist: Ensures readiness of equipment post-cleaning for swab collection.

4. Accountability

Head – QA and Head – Manufacturing shall ensure strict implementation of this SOP.

5. Procedure

5.1 Preparation

1. Ensure cleaning activity has been completed and documented in the equipment logbook.
2. Gather swab testing kit: pre-sterilized swabs, labeled sample tubes, and TOC compliant solvent.
3. Label the sample tubes clearly with equipment ID, date, time, and sample point.

5.2 Swab Collection

1. Use sterile gloves while handling the swab and do not touch the swabbing surface.
2. Moisten the swab with TOC-grade water before sampling.
3. Rub the swab over a defined surface area (typically 25 cm²) in a pattern of horizontal, vertical, and diagonal strokes.
4. Collect swabs from the following surfaces:
   • Inner tank wall
   • Tank bottom
   • Agitator blades
   • Transfer pipeline
   • Manhole lid (internal)
5. Place the swab into the labeled tube and seal it immediately.

5.3 Sample Submission

1. Submit swab samples to the Quality Control laboratory within 2 hours of collection.
2. Ensure chain-of-custody documentation is completed.

5.4 Analysis

1. Perform TOC analysis for chemical residue detection.
2. If applicable, perform microbial testing to detect bioburden post-cleaning.
3. Compare results to acceptance limits based on cleaning validation data.

5.5 Acceptance Criteria

• TOC < 2.0 µg/cm² for chemical residues.
• Microbial count < 10 CFU/swab.

5.6 Documentation and Release

1. Document all results in the swab testing register.
2. QA to review test reports and authorize reuse of equipment.

6. Abbreviations

• TOC: Total Organic Carbon
• CFU: Colony Forming Units
• QA: Quality Assurance
• GMP: Good Manufacturing Practices

7. Documents

1. Swab Sampling Logbook – Annexure-1
2. TOC and Microbial Test Report Format – Annexure-2

8. References

• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• Schedule M: Cleaning Procedures
• Internal Cleaning Validation Protocol

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: Swab Sampling Logbook

Date	Equipment ID	Sample Point	Swab ID	Collector	Remarks

Annexure-2: TOC and Microbial Test Report

Sample ID	TOC (µg/cm²)	CFU Count	Acceptance Limit	Pass/Fail	QA Sign
			<2.0 µg/cm², <10 CFU

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2022	1.0	Initial version	New SOP	QA Head
02/06/2025	2.0	Added microbial testing and updated TOC limits	Compliance update	QA Head