including those used for transfer of components, equipment, and materials.

3. Responsibilities

• Production Operator: Performs daily cleaning and disinfection of pass-through chambers.
• QA Officer: Verifies compliance, conducts checks, and reviews cleaning records.
• Housekeeping Staff: May assist under supervision for non-critical chamber cleaning.

4. Accountability

The Production Head and Quality Assurance Head are accountable for adherence to this SOP.

5. Procedure

5.1 Preparation

1. Gather all required cleaning supplies including sterile wipes, disinfectants (e.g., 70% IPA or sporicidal agents), gloves, and logs.
2. Ensure the chamber is empty and the indicator lights (if any) show “READY” or “NOT IN USE.”
3. Wear sterile gloves and gown before entering the cleanroom zone to avoid contaminating the chamber interior.

5.2 Cleaning Steps

1. Clean the outer surface using lint-free wipes soaked in WFI or disinfectant from top to bottom.
2. Open the external door and clean the inner surfaces—walls, floor, ceiling, corners, and the door—using a unidirectional wiping technique.
3. Close the outer door, wait for interlock to release, and open the cleanroom side door.
4. Repeat the wiping process on the cleanroom side door and adjacent interior surfaces.
5. Use a fresh wipe for each major surface area to prevent cross-contamination.

5.3 Disinfection

1. After cleaning, spray or wipe all internal surfaces with an approved disinfectant.
2. Maintain required contact time as per the manufacturer’s instructions (e.g., 5–10 minutes).
3. Allow surfaces to air dry completely before use.

5.4 Frequency

• Before the start of each production shift.
• Immediately after any spillage or visible contamination.
• At the end of the day or after batch changeover.

5.5 Documentation

1. Record each cleaning activity in the Pass-Through Cleaning Log (Annexure-1).
2. Include date, time, name, cleaning agent used, and signature of the personnel.
3. QA must verify the log at the end of each shift.

5.6 Precautions

• Do not open both doors of the pass-through chamber at the same time.
• Do not use non-approved cleaning agents or cloths.
• Avoid using excessive force that may damage the chamber’s internal lining or gaskets.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• WFI: Water for Injection
• IPA: Isopropyl Alcohol

7. Documents

1. Annexure-1: Pass-Through Cleaning Log
2. Annexure-2: Disinfectant Usage Record
3. Annexure-3: Cleaning Checklist

8. References

• EU GMP Annex 1: Manufacture of Sterile Medicinal Products
• WHO TRS 961 Annex 6
• 21 CFR Part 211 – cGMP 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: Pass-Through Cleaning Log

Date	Time	Cleaning Agent	Cleaned By	Checked By (QA)
23/06/2025	07:00	70% IPA	Ravi Sharma	Sunita Reddy

Annexure-2: Disinfectant Usage Record

Batch No.	Disinfectant	Preparation Date	Expiry Date	Prepared By
D202506A	Hydrogen Peroxide	22/06/2025	23/06/2025	Megha Jain

Annexure-3: Cleaning Checklist

Item	Cleaned	Disinfected	Remarks	Initials
Outer Door	✔	✔	–	RS
Inner Surface	✔	✔	–	RS
Cleanroom Door	✔	✔	–	RS

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Issue	New SOP	Head QA
24/06/2025	2.0	Updated disinfectant procedure and checklist	Annual Review	Head QA