Standard Operating Procedure for Cleaning and Decontamination of Cell Culture Areas in Biosimilar Labs

Department	Biosimilars
SOP No.	SOP/BS/047/2025
Supersedes	SOP/BS/047/2022
Page No.	Page 1 of 10
Issue Date	04/05/2025
Effective Date	06/05/2025
Review Date	04/05/2026

1. Purpose

To describe the procedure for routine cleaning and decontamination of cell culture laboratories used in biosimilar development to maintain aseptic processing conditions and prevent microbial or cross-contamination.

2. Scope

This SOP is applicable to all ISO-classified biosimilar laboratories, clean rooms, and associated areas involved in mammalian cell culture processes.

3. Responsibilities

• Housekeeping Staff: Perform scheduled cleaning as per instructions using approved disinfectants.
• Lab Technicians: Ensure work surfaces and biosafety cabinets are disinfected before and after use.
• QA Team: Verify cleaning records and conduct cleanliness inspections.

4. Accountability

The Head of Biosimilar Operations is accountable for ensuring adherence to this cleaning SOP, and maintaining contamination-free culture environments.

5. Procedure

5.1 Cleaning Frequency and Schedule

1. Daily:
   • Floor mopping with disinfectant
   • Wipe workbenches, door handles, switches
2. Weekly:
   • Wall and ceiling wipe-down
   • Clean drains and air vent covers
3. Monthly:
   • Disinfection behind equipment and storage cabinets

5.2 Cleaning Agents and Disinfectants

1. Use approved disinfectants such as:
   • 70% Isopropyl Alcohol (IPA)
   • 1% Sodium Hypochlorite
   • 0.5% Hydrogen Peroxide
2. Rotate disinfectants monthly to avoid resistance.
3. Maintain Disinfectant Preparation and Usage Log (Annexure-1).

5.3 Cleaning Technique

1. Follow unidirectional wiping — top to bottom, clean to dirty.
2. Use sterile lint-free wipes; discard after single use.
3. For floors, use color-coded mop heads specific to area classification.
4. Do not re-use contaminated wipes or mops.

5.4 Biosafety Cabinet Decontamination

1. Before each use:
   • Wipe all surfaces with 70% IPA
   • Allow 10-minute air purge after blower startup
2. Weekly:
   • Clean base tray, sash, and side walls
   • Record in BSC Cleaning Log (Annexure-2)

5.5 Fumigation and Terminal Decontamination

1. Performed quarterly or during contamination incidents.
2. Use fogging with validated agents (e.g., 6% hydrogen peroxide).
3. Document in the Terminal Decontamination Log (Annexure-3).

5.6 Waste Handling During Cleaning

1. Collect used wipes, PPE, and disposables in biohazard bags.
2. Dispose as per biohazard SOP for contaminated materials.
3. Label and segregate infectious waste from general lab trash.

5.7 Documentation

1. Fill cleaning records immediately after completion.
2. Records to be signed by cleaning personnel and verified by lab-in-charge or QA.

6. Abbreviations

• IPA: Isopropyl Alcohol
• BSC: Biosafety Cabinet
• QA: Quality Assurance

7. Documents

1. Disinfectant Preparation and Usage Log (Annexure-1)
2. BSC Cleaning Log (Annexure-2)
3. Terminal Decontamination Log (Annexure-3)

8. References

• WHO TRS 961 – GMP for Biological Products
• Schedule M – Good Manufacturing Practices (India)
• ICH Q9 – Quality Risk Management

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Disinfectant Preparation and Usage Log

Date	Disinfectant	Concentration	Prepared By	Used In
03/05/2025	Hydrogen Peroxide	0.5%	Ajay Verma	CLD Room

Annexure-2: BSC Cleaning Log

Date	Cabinet ID	Surface Cleaned	Cleaned By	Verified By
04/05/2025	BSC-102	Interior, Tray	Sunita Reddy	Vinay Pawar

Annexure-3: Terminal Decontamination Log

Date	Room ID	Agent Used	Method	Performed By
01/04/2025	CLD-1	6% H₂O₂	Fogging	QA Team

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
04/05/2025	2.0	Added fumigation and wall cleaning guidance	Routine SOP Upgrade