all material and personnel airlocks present in sterile production areas, including Grade A/B zones within the facility.

3. Responsibilities

• Production Operator: Executes the sanitization procedure as per the approved protocol.
• QA Officer: Reviews cleaning records and ensures compliance with SOP.
• Engineering: Assists in resolving any issues with HVAC or ventilation systems related to airlocks.

4. Accountability

Head of Production is accountable for effective execution and documentation of airlock sanitization activities. QA Head is responsible for verification and compliance assurance.

5. Procedure

5.1 General Guidelines

1. Sanitization shall be performed at the start of each shift and whenever the area is suspected to be contaminated.
2. Use only validated disinfectants approved for cleanroom use (e.g., 70% IPA, sporicidal agents).
3. Maintain adequate stock of sanitized mops, wipes, and sprayers in the cleaning station.

5.2 Preparation

1. Wear sterile gloves, gown, and face mask before entering airlock for cleaning.
2. Ensure the area is clear of any materials or personnel before starting sanitization.
3. Check disinfectant expiry and lot number before use; record in Annexure-2.

5.3 Sanitization Steps

1. Wipe ceiling of airlock using pre-saturated mop in unidirectional motion.
2. Wipe side walls starting from top and working downward in vertical strokes.
3. Disinfect floor area in overlapping ‘S’ motion starting from the farthest corner to exit door.
4. Focus on high-touch points including door handles, intercoms, and pass box interfaces.
5. Spray disinfectant mist throughout the airlock and allow contact time (min. 5 minutes).

5.4 Frequency of Sanitization

• Every shift (once every 8 hours).
• Before and after product changeover.
• After any maintenance or material spills.

5.5 Special Notes

• Do not use expired or non-approved disinfectants.
• Change mop heads after each use to prevent microbial carryover.
• Report any damage or uncleanable area to engineering for corrective action.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• IPA: Isopropyl Alcohol
• HVAC: Heating, Ventilation and Air Conditioning

7. Documents

1. Airlock Cleaning Log – Annexure-1
2. Disinfectant Usage Log – Annexure-2
3. Sanitization Checklist – Annexure-3

8. References

• WHO TRS 961 Annex 6 – GMP for Sterile Pharmaceutical Products
• EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
• 21 CFR Part 211 – Good Manufacturing Practice for Finished Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Airlock Cleaning Log

Date	Shift	Cleaned By	Verified By
17/06/2025	Morning	Rajesh Kumar	Priya Mehta

Annexure-2: Disinfectant Usage Log

Date	Disinfectant Name	Lot No.	Expiry	Used By
17/06/2025	70% IPA	IPA2304	12/2025	Sunil Patil

Annexure-3: Sanitization Checklist

Area	Sanitized	Remarks	QA Signature
Ceiling	Yes	Clean	Anita Sharma
Walls	Yes	No issues	Anita Sharma
Floor	Yes	Dry and residue-free	Anita Sharma

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial release	New SOP	QA Head
18/06/2025	2.0	Updated frequency and added disinfectant log	Annual Review	QA Head