Standard Operating Procedure for Swab Sampling for Cleaning Validation in Elixir Manufacturing

Department	Elixir Department
SOP No.	SOP/ELX/174/2025
Supersedes	SOP/ELX/174/2022
Page No.	Page 1 of 10
Issue Date	11/04/2025
Effective Date	15/04/2025
Review Date	11/04/2026

1. Purpose

To establish a standardized procedure for performing swab sampling for cleaning validation in the Elixir Department to verify the absence of product residues, cleaning agents, and microbial contamination on product-contact surfaces.

2. Scope

This SOP applies to all cleaned equipment, utensils, and contact surfaces used in elixir manufacturing where swab sampling is required as part of cleaning validation or verification process.

3. Responsibilities

• QA Personnel:
  • Perform swab sampling after cleaning and prior to equipment reuse.
  • Ensure sampling is performed in accordance with the validation protocol.
• QC Personnel:
  • Analyze swab samples for chemical, microbiological, or detergent residues.
• Production Department:
  • Ensure equipment remains in “Hold” status until approved for reuse.

4. Accountability

The QA Head is accountable for sampling integrity and documentation. The QC Head ensures timely testing and accurate reporting. The Production Head ensures cleaning is completed before sampling.

5. Procedure

5.1 Sampling Material and Area Selection

1. Use sterile, pre-moistened swabs (with purified water or neutralizing agent as per protocol).
2. Select worst-case and difficult-to-clean locations for sampling such as:
   • Tank corners
   • Outlet valves
   • Agitator shafts
   • Gasket grooves
3. Use a template of 10 cm × 10 cm (100 cm²) or as specified to define the swab area.

5.2 Swabbing Technique

1. Wipe the defined area horizontally using one side of the swab.
2. Flip the swab and wipe vertically on the same area.
3. Repeat for a second location using a new sterile swab if multiple samples are needed.
4. Place the swab in a labeled sterile container (e.g., test tube with transport medium or dry vial).

5.3 Labeling and Transportation

1. Label each container with:
   • Sample ID
   • Date and time
   • Equipment name/ID
   • Swab location
   • Cleaned by / Swabbed by
2. Transport the samples to QC lab within 30 minutes. If delayed, store at 2–8°C (for microbiological analysis).

5.4 Testing and Results

1. QC will analyze swabs for:
   • API or excipient residues (e.g., via HPLC, UV)
   • Detergent residues (e.g., via TOC, conductivity)
   • Microbial load (TVC and objectionable organisms)
2. Compare results with acceptance limits defined in cleaning validation protocols.
3. Document results and share with QA for equipment release decision.

5.5 Documentation

1. Record swab sample details in the Swab Sampling Logbook (Annexure-1).
2. QC to document results in the Cleaning Validation Test Report.
3. QA to issue clearance or request re-cleaning if results exceed limits.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• TOC: Total Organic Carbon
• TVC: Total Viable Count

7. Documents

1. Swab Sampling Logbook (Annexure-1)
2. Cleaning Validation Protocol
3. Cleaning Validation Test Report

8. References

• 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
• ICH Q7 – GMP for APIs
• WHO TRS 937 – Annex 4: Cleaning Validation

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Swab Sampling Logbook

Date	Equipment ID	Swab Location	Sample ID	Swabbed By	Sent to QC	QC Result	QA Decision
11/04/2025	MXR-ELX-11	Bottom Valve	SS-ELX-20250411-01	Rajesh Kumar	Yes	Compliant	Approved

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Release	New SOP	QA Head
11/04/2025	2.0	Aligned with updated validation protocol and added TOC/microbial scope	Audit Compliance	QA Head