Standard Operating Procedure for Disposal of Biohazardous Cell Culture Waste in Biosimilar Labs

Department	Biosimilars
SOP No.	SOP/BS/048/2025
Supersedes	SOP/BS/048/2022
Page No.	Page 1 of 10
Issue Date	04/05/2025
Effective Date	06/05/2025
Review Date	04/05/2026

1. Purpose

To define the standardized procedure for the safe handling, segregation, treatment, and disposal of biohazardous waste generated during biosimilar cell culture operations in compliance with applicable biosafety and biomedical waste regulations.

2. Scope

This SOP applies to all personnel involved in the generation and handling of biohazardous waste including used cell culture materials, contaminated disposables, PPE, and biological fluids in biosimilar R&D laboratories.

3. Responsibilities

• Lab Technicians: Segregate and label biohazard waste at point of generation and ensure timely disposal.
• Housekeeping Personnel: Transport biohazard waste to designated collection points following protocol.
• QA Department: Verify compliance through audit and maintain disposal documentation.

4. Accountability

The Biosafety Officer is accountable for ensuring that biohazardous waste is disposed of as per Biomedical Waste Management Rules, 2016, and institutional biosafety guidelines.

5. Procedure

5.1 Classification of Biohazardous Waste

1. Biohazard waste in biosimilar labs includes:
   • Used cell culture flasks, plates, and tubes
   • Contaminated pipettes, tips, gloves, gowns, and masks
   • Biological fluids and spent media
   • Sharps (e.g., syringes, broken glass)

5.2 Segregation and Labeling

1. Use color-coded containers as per Biomedical Waste Rules:
   • Yellow bag: Infectious solids, PPE
   • Red bag: Contaminated plastic disposables
   • Blue container: Glassware
   • White container: Sharps
2. Affix biohazard symbol and waste identification labels.

5.3 Decontamination Before Disposal

1. Liquid waste (e.g., media, wash buffers) must be decontaminated by:
   • Autoclaving at 121°C for 30 min
   • Disinfection with 1% sodium hypochlorite (contact time: 30 min)
2. Solid waste to be autoclaved before transfer to disposal area.

5.4 Waste Collection and Transport

1. Housekeeping staff to collect sealed bags/containers twice daily.
2. Transport using dedicated, labeled trolleys to central biohazard storage area.
3. Do not store unautoclaved infectious waste for more than 24 hours.

5.5 Final Disposal

1. Coordinate with CPCB-approved biomedical waste disposal vendor.
2. Sharps to be mutilated/disinfected and disposed in puncture-proof containers.
3. Record pickup in Biohazard Waste Disposal Register (Annexure-1).

5.6 Emergency Spill Management

1. Isolate the area and wear PPE.
2. Cover spill with absorbent material soaked in 1% hypochlorite.
3. Wait 30 minutes, collect waste, and autoclave before disposal.
4. Record incident in Spill Incident Log (Annexure-2).

5.7 Documentation and Audit

1. Maintain daily disposal logs and vendor handover receipts.
2. QA to audit records monthly and verify log completeness.

6. Abbreviations

• PPE: Personal Protective Equipment
• CPCB: Central Pollution Control Board
• QA: Quality Assurance

7. Documents

1. Biohazard Waste Disposal Register (Annexure-1)
2. Spill Incident Log (Annexure-2)
3. Autoclave Record Log (Annexure-3)

8. References

• Biomedical Waste Management Rules, 2016 (India)
• WHO Biosafety Manual, 4th Edition
• GMP Guidelines – Cleaning & Waste Disposal

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Biohazard Waste Disposal Register

Date	Type of Waste	Qty (kg)	Autoclaved	Disposed By	Vendor Receipt ID
03/05/2025	Contaminated Plastics	5.2	Yes	Ajay Verma	BMW-1023

Annexure-2: Spill Incident Log

Date	Area	Material Spilled	Action Taken	Reported By
01/05/2025	CLD-1	Spent Media	Neutralized with bleach, autoclaved	Sunita Reddy

Annexure-3: Autoclave Record Log

Date	Batch ID	Temp (°C)	Time (min)	Operator
03/05/2025	AUTO-0345	121	30	Vinay Pawar

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
04/05/2025	2.0	Added emergency spill handling and audit trail requirements	Regulatory alignment