Standard Operating Procedure for Disposal of Culture Waste in Biosimilar Manufacturing

Department	Biosimilars
SOP No.	SOP/BS/114/2025
Supersedes	SOP/BS/114/2022
Page No.	Page 1 of 11
Issue Date	04/05/2025
Effective Date	06/05/2025
Review Date	04/05/2026

1. Purpose

To define the procedure for biosafety-compliant collection, inactivation, segregation, and disposal of culture waste generated during upstream biosimilar manufacturing processes.

2. Scope

This SOP applies to the handling and disposal of spent cell cultures, used media, residual biomass, contaminated disposables, and effluent generated from bioreactor operations, shake flasks, and seed expansion vessels in the upstream facility.

3. Responsibilities

• Production Operator: Collect and label culture waste, perform primary inactivation, and record disposal steps.
• Utility/Engineering: Support effluent neutralization systems and hazardous waste line function.
• EHS Officer: Verify safe disposal, biosafety compliance, and environmental documentation.

4. Accountability

The Head of Manufacturing is accountable for ensuring culture waste is disposed of in accordance with biosafety, environmental, and regulatory standards.

5. Procedure

5.1 Waste Identification and Segregation

1. Culture waste is classified as:
   • Liquid waste: spent media, broth, process effluent
   • Solid waste: biomass, filters, tubes, pipettes
2. Use color-coded bins:
   • Red – biohazardous solids
   • Yellow – sharps/contaminated plastic
   • Blue – autoclaved inert waste

5.2 Inactivation of Liquid Waste

1. Use thermal inactivation at 121°C for 30 minutes OR
2. Chemical inactivation using 1% hypochlorite (hold for 1 hour at pH ≥10).
3. Transfer deactivated liquid to ETP line using labeled hoses.

5.3 Handling of Solid Culture Waste

1. Place solid waste in autoclavable biohazard bags and seal tightly.
2. Autoclave at 121°C, 15 psi, 30 minutes in designated autoclave room.
3. Post-autoclave, tag as “Decontaminated – Safe for Disposal”.
4. Transport to central bio-waste collection area in leak-proof bins.

5.4 Disposal Documentation

1. Complete Annexure-1: Culture Waste Disposal Log.
2. For offsite disposal, coordinate with EHS-approved bio-waste contractor.
3. Ensure manifest (Annexure-2) is signed by contractor and retained for audit.

5.5 Emergency Handling

1. If spill occurs, isolate the area immediately.
2. Apply 1% sodium hypochlorite and absorb with sterile wipes.
3. Collect as hazardous waste and record incident in deviation log.

6. Abbreviations

• ETP: Effluent Treatment Plant
• EHS: Environment, Health and Safety
• psi: Pounds per square inch

7. Documents

1. Culture Waste Disposal Log – Annexure-1
2. Bio-Waste Manifest Record – Annexure-2

8. References

• WHO TRS 999 Annex 6 – GMP for Biological Products
• Bio-Medical Waste Management Rules 2016 (India)

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Culture Waste Disposal Log

Date	Type	Volume/Weight	Method	Disposed By	Verified By
04/05/2025	Liquid	150 L	Thermal	Sunita Reddy	Ajay Verma

Annexure-2: Bio-Waste Manifest Record

Date	Bag Count	Contractor Name	Vehicle No.	Signature (Receiver)
04/05/2025	4	CleanMed Services Pvt. Ltd.	MH12BC1234	Authorized Agent

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
04/05/2025	2.0	Expanded disposal tracking and added chemical spill response section	Compliance update