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
- 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
- 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
- Affix biohazard symbol and waste identification labels.
5.3 Decontamination Before Disposal
- 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)
- Solid waste to be autoclaved before transfer to disposal area.
5.4 Waste Collection and Transport
- Housekeeping staff to collect sealed bags/containers twice daily.
- Transport using dedicated, labeled trolleys to central biohazard storage area.
- Do not store unautoclaved infectious waste for more than 24 hours.
5.5 Final Disposal
- Coordinate with CPCB-approved biomedical waste disposal vendor.
- Sharps to be mutilated/disinfected and disposed in puncture-proof containers.
- Record pickup in Biohazard Waste Disposal Register (Annexure-1).
5.6 Emergency Spill Management
- Isolate the area and wear PPE.
- Cover spill with absorbent material soaked in 1% hypochlorite.
- Wait 30 minutes, collect waste, and autoclave before disposal.
- Record incident in Spill Incident Log (Annexure-2).
5.7 Documentation and Audit
- Maintain daily disposal logs and vendor handover receipts.
- 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
- Biohazard Waste Disposal Register (Annexure-1)
- Spill Incident Log (Annexure-2)
- 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 |