Standard Operating Procedure for Monitoring CO₂ Levels in Incubators in Biosimilar Labs
| Department | Biosimilars |
|---|---|
| SOP No. | SOP/BS/045/2025 |
| Supersedes | SOP/BS/045/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 04/05/2025 |
| Effective Date | 06/05/2025 |
| Review Date | 04/05/2026 |
1. Purpose
To outline the routine procedure for monitoring and verifying carbon dioxide (CO₂) concentrations in cell culture incubators used in biosimilar development, ensuring optimal atmospheric conditions for cell growth and viability.
2. Scope
This SOP applies to all CO₂ incubators used in biosimilar R&D laboratories and cell line development areas where mammalian cells are cultured for biosimilar product development.
3. Responsibilities
- Lab Technician: Conducts routine monitoring and records readings.
- Engineering/Maintenance Staff: Performs calibration and adjustment of CO₂ sensors if deviations are detected.
- QA Personnel: Reviews CO₂ monitoring records and verifies compliance.
4. Accountability
The Head of Biosimilar Manufacturing is accountable for ensuring the accuracy of CO₂ levels in all incubators used for critical cell culture operations.
5. Procedure
5.1 Monitoring Frequency and Instruments
- Monitor CO₂ levels in each incubator:
- Daily visual check of digital CO₂ display
- Weekly verification using a calibrated external CO₂ analyzer
- Ensure external analyzer is traceable and within calibration validity.
5.2 Daily Monitoring
- Record displayed CO₂ percentage in the Incubator CO₂ Log (Annexure-1).
- Expected range: 5.0% ± 0.2%
- If out of range, inform Engineering immediately and initiate deviation form.
5.3 Weekly Verification Using External Analyzer
- Place analyzer probe inside the incubator’s sample port or chamber.
- Allow reading to stabilize for 3–5 minutes.
- Record external analyzer reading and compare with incubator display.
- If deviation exceeds ±0.2%, initiate CO₂ calibration.
5.4 CO₂ Level Adjustment
- Adjust incubator CO₂ setpoint through the control panel following manufacturer’s guidelines.
- Re-verify after 15 minutes to confirm stabilization.
- Document adjustment in the CO₂ Correction Log (Annexure-2).
5.5 Gas Cylinder Management
- Ensure CO₂ gas cylinders are replaced before depletion (<20%).
- Record gas change in the CO₂ Gas Supply Log (Annexure-3).
5.6 Troubleshooting and Deviation Management
- Common issues:
- Blocked gas inlet
- Sensor drift or fault
- Leak in CO₂ tubing
- Raise deviation report for any unresolved discrepancies and isolate incubator if required.
6. Abbreviations
- CO₂: Carbon Dioxide
- OOT: Out of Tolerance
- QA: Quality Assurance
7. Documents
- Incubator CO₂ Log (Annexure-1)
- CO₂ Correction Log (Annexure-2)
- CO₂ Gas Supply Log (Annexure-3)
8. References
- WHO TRS 1010 – GMP Equipment Guidelines
- Manufacturer Manual for CO₂ Incubator (Model Specific)
- ICH Q9 – Quality Risk Management
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Incubator CO₂ Log
| Date | Incubator ID | CO₂ Display (%) | Remarks | Initials |
|---|---|---|---|---|
| 04/05/2025 | INC-CO2-01 | 5.1 | Within limit | AV |
Annexure-2: CO₂ Correction Log
| Date | Incubator ID | Observed Value (%) | Corrected To (%) | Adjusted By |
|---|---|---|---|---|
| 03/05/2025 | INC-CO2-02 | 4.7 | 5.0 | Vinay Pawar |
Annexure-3: CO₂ Gas Supply Log
| Date | Cylinder ID | Replaced By | Remaining Pressure | Remarks |
|---|---|---|---|---|
| 02/05/2025 | CO2-2025-17 | Sunita Reddy | 18% | New cylinder installed |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 04/05/2025 | 2.0 | Included weekly analyzer verification and cylinder tracking | Enhanced Monitoring |