Standard Operating Procedure for Monitoring Temperature during Sterile Filling
| Department | Sterile Injectable Manufacturing |
|---|---|
| SOP No. | SOP/SIM/071/2025 |
| Supersedes | SOP/SIM/071/2022 |
| Page No. | Page 1 of 13 |
| Issue Date | 18/06/2025 |
| Effective Date | 20/06/2025 |
| Review Date | 18/06/2026 |
1. Purpose
This SOP defines the standardized procedure for monitoring temperature during the sterile filling of injectable products to ensure environmental control and prevent microbial contamination.
2. Scope
This procedure is applicable to all Grade A/B cleanroom environments involved in sterile filling operations for vials, ampoules,
and prefilled syringes.
3. Responsibilities
- Production Operator: Ensure proper placement and reading of temperature monitors.
- QA Personnel: Review and verify temperature records.
- Engineering Staff: Maintain calibration and functionality of temperature sensors and devices.
4. Accountability
The Head of Production is accountable for ensuring compliance with temperature monitoring requirements during sterile filling operations.
5. Procedure
5.1 Preparation and Equipment
- Ensure the temperature monitoring system (data loggers, sensors, or SCADA) is calibrated and within the valid calibration period.
- Verify placement of sensors at critical locations including:
- Filling needle zone
- Material transfer point
- Laminar airflow zone
5.2 Monitoring Activities
- Start temperature monitoring 30 minutes before sterile filling begins.
- Record temperature every 15 minutes manually or automatically through a validated monitoring system.
- Acceptable temperature range: 18°C – 25°C unless otherwise defined in batch manufacturing record.
- Log temperatures in Annexure-1: Temperature Monitoring Log.
5.3 Deviations and Out-of-Range Conditions
- If temperature exceeds specified range:
- Stop filling operation immediately.
- Inform QA and Engineering.
- Initiate deviation form as per SOP/QAD/002.
- Document deviation details in Annexure-2: Temperature Deviation Report.
5.4 End-of-Operation Verification
- Continue monitoring for 30 minutes post completion of sterile filling.
- Review entire temperature profile and compare against set limits.
- Attach printed graphs and digital logs to batch record.
5.5 Preventive Actions
- Perform periodic maintenance of HVAC and temperature control systems.
- Train all concerned personnel on importance of temperature control in aseptic operations.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- HVAC: Heating, Ventilation, and Air Conditioning
- SCADA: Supervisory Control and Data Acquisition
7. Documents
- Temperature Monitoring Log – Annexure-1
- Temperature Deviation Report – Annexure-2
8. References
- WHO Annex 6: GMP for Sterile Pharmaceutical Products
- ISO 14644-1: Cleanrooms and Associated Controlled Environments
- 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Production Executive | QA Executive | Head QA |
| Department | Production | Quality Assurance | Quality Assurance |
11. Annexures
Annexure-1: Temperature Monitoring Log
| Date | Time | Temperature (°C) | Location | Operator Name |
|---|---|---|---|---|
| 18/06/2025 | 09:15 | 22.1 | Filling Zone A | Sunita Reddy |
| 18/06/2025 | 09:30 | 22.0 | Filling Zone A | Sunita Reddy |
Annexure-2: Temperature Deviation Report
| Date | Location | Observed Temp (°C) | Action Taken | Reported By |
|---|---|---|---|---|
| 18/06/2025 | Zone B | 26.5 | Filling halted, HVAC adjusted | Rajesh Kumar |
Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial version | New SOP | Head QA |
| 18/06/2025 | 2.0 | Annexures and procedure expanded | Periodic review | Head QA |