Standard Operating Procedure for Use and Maintenance of Biosafety Cabinets in Biosimilar Labs

Department	Biosimilars
SOP No.	SOP/BS/046/2025
Supersedes	SOP/BS/046/2022
Page No.	Page 1 of 11
Issue Date	04/05/2025
Effective Date	06/05/2025
Review Date	04/05/2026

1. Purpose

To establish standardized procedures for the safe use, routine cleaning, and maintenance of biosafety cabinets (BSCs) used in biosimilar R&D and manufacturing areas, ensuring aseptic processing and operator protection from biological hazards.

2. Scope

This SOP applies to all Class II biosafety cabinets installed in biosimilar cell culture rooms and processing labs where open handling of biological material occurs.

3. Responsibilities

• Lab Personnel: Operate the cabinet as per procedure, perform routine cleaning, and record usage.
• Engineering/Maintenance: Conduct preventive maintenance and HEPA filter checks.
• QA Team: Monitor compliance, review logs, and verify BSC certifications.

4. Accountability

The Head of Biosimilar Laboratory Operations is accountable for ensuring the operational integrity, safety, and performance verification of all biosafety cabinets.

5. Procedure

5.1 Startup Procedure

1. Ensure the sash is positioned at the indicated working height (usually 8–10 inches).
2. Switch ON the cabinet blower and allow airflow stabilization for 5–10 minutes before use.
3. Wipe internal surfaces with 70% IPA.
4. Place only necessary materials inside, arranged to minimize airflow disruption.

5.2 Aseptic Technique During Use

1. Perform all manipulations at least 4 inches inside the front grille.
2. Minimize rapid hand movements that could disrupt laminar airflow.
3. Do not block rear or front grills with equipment or arms.
4. Avoid using open flames; use flameless alternatives.

5.3 Routine Cleaning

1. Clean work surface with 70% IPA before and after each session.
2. Wipe side walls and sash inside surface daily.
3. Use sterile lint-free wipes for cleaning to avoid particle shedding.

5.4 Weekly Deep Cleaning

1. Disassemble removable trays and wipe below work surface.
2. Sanitize drain pan if accessible.
3. Record in the BSC Weekly Cleaning Log (Annexure-1).

5.5 Preventive Maintenance

1. Schedule quarterly preventive maintenance to include:
   • Inspection of blower and electrical connections
   • HEPA filter pressure differential check
   • Fan and light function tests
2. Record maintenance in the BSC Maintenance Log (Annexure-2).

5.6 Certification and Filter Integrity

1. Perform annual certification by qualified vendor, including:
   • Airflow velocity testing
   • HEPA filter leak test
   • Noise and vibration assessment
2. Maintain certificate in QA-controlled BSC File.

5.7 Shutdown Procedure

1. Remove all materials and waste.
2. Wipe down surfaces with disinfectant followed by 70% IPA.
3. Keep blower ON for 5 minutes before switching OFF.

6. Abbreviations

• BSC: Biosafety Cabinet
• IPA: Isopropyl Alcohol
• HEPA: High-Efficiency Particulate Air

7. Documents

1. BSC Weekly Cleaning Log (Annexure-1)
2. BSC Maintenance Log (Annexure-2)
3. Annual Certification Report (Annexure-3)

8. References

• WHO Biosafety Manual, 4th Edition
• EN12469 – Biotechnology: Performance criteria for microbiological safety cabinets
• Manufacturer Guidelines for Specific BSC Model

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: BSC Weekly Cleaning Log

Date	Cabinet ID	Area Cleaned	Performed By	Verified By
04/05/2025	BSC-01	Interior & Drain Pan	Ajay Verma	Sunita Reddy

Annexure-2: BSC Maintenance Log

Date	Cabinet ID	Maintenance Activity	Performed By	Remarks
03/05/2025	BSC-01	Filter Pressure Check	Vinay Pawar	Normal

Annexure-3: Annual Certification Report Summary

Cabinet ID	Certified On	Certified By	Next Due	Certificate Ref
BSC-01	01/04/2025	BIOCERT SERVICES	01/04/2026	BC-2415

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
04/05/2025	2.0	Integrated HEPA testing and preventive maintenance logs	Audit Compliance