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
- Culture waste is classified as:
- Liquid waste: spent media, broth, process effluent
- Solid waste: biomass, filters, tubes, pipettes
- Use color-coded bins:
- Red – biohazardous solids
- Yellow – sharps/contaminated plastic
- Blue – autoclaved inert waste
5.2 Inactivation of Liquid Waste
- Use thermal inactivation at 121°C for 30 minutes OR
- Chemical inactivation using 1% hypochlorite (hold for 1 hour at pH ≥10).
- Transfer deactivated liquid to ETP line using labeled hoses.
5.3 Handling of Solid Culture Waste
- Place solid waste in autoclavable biohazard bags and seal tightly.
- Autoclave at 121°C, 15 psi, 30 minutes in designated autoclave room.
- Post-autoclave, tag as “Decontaminated – Safe for Disposal”.
- Transport to central bio-waste collection area in leak-proof bins.
5.4 Disposal Documentation
- Complete Annexure-1: Culture Waste Disposal Log.
- For offsite disposal, coordinate with EHS-approved bio-waste contractor.
- Ensure manifest (Annexure-2) is signed by contractor and retained for audit.
5.5 Emergency Handling
- If spill occurs, isolate the area immediately.
- Apply 1% sodium hypochlorite and absorb with sterile wipes.
- 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
- Culture Waste Disposal Log – Annexure-1
- 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 |