Standard Operating Procedure for Ensuring Backup Power for Sample Freezers in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/126/2025 |
| Supersedes | SOP/BA-BE/126/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To define the procedure for ensuring uninterrupted power supply to freezers storing biological samples in BA/BE studies by implementing reliable backup systems to prevent sample degradation during power failures.
2. Scope
This SOP applies to all clinical and bioanalytical research facilities involved in BA/BE studies where biological samples are stored in freezers operating at -20°C and -70°C.
3. Responsibilities
- Facility Maintenance Officer: Ensures functioning of backup power systems, including generator and UPS.
- Bioanalytical Staff: Monitors freezer temperature and logs excursions during outages.
- QA Officer: Verifies implementation of backup procedures and reviews logbooks.
- Study Coordinator: Alerts facility team during outages and maintains freezer surveillance.
4. Accountability
The Head of Bioanalytical Facility is accountable for ensuring all critical equipment including sample freezers have uninterrupted power supply backed by validated systems.
5. Procedure
5.1 Backup Power Infrastructure
- All sample freezers shall be connected to an automatic power backup system comprising:
- Online UPS (minimum 2-hour capacity)
- Diesel Generator (DG) set with auto-start within 30 seconds
- Verify electrical connectivity weekly using Annexure-1: Freezer Power Backup Checklist.
5.2 Power Failure Monitoring and Response
- Install power failure alarm systems on all critical freezers.
- In the event of power failure:
- UPS provides immediate backup
- DG set should activate automatically
- Facility team must verify transfer within 1 minute
- Record outage and system switch-over in Annexure-2: Power Failure Incident Log.
5.3 Temperature Monitoring During Power Outage
- Each freezer must be equipped with:
- Digital temperature display
- 24/7 data logger
- Visual/audio alarm system
- Study staff to manually log temperatures at 15-minute intervals during outages using Annexure-3.
5.4 Preventive Maintenance and Testing
- Schedule monthly load testing of:
- UPS battery life
- DG fuel level and startup performance
- Document findings in Annexure-4: Backup System Maintenance Log.
5.5 Escalation and Sample Transfer (If Needed)
- If power backup fails or temperature exceeds acceptable limits:
- Notify QA, PI, and sponsor immediately
- Transfer samples to validated alternate freezer (pre-identified)
- Use validated cool boxes with dry ice for temporary transport
- Log the transfer in Annexure-5: Emergency Sample Relocation Form.
6. Abbreviations
- UPS: Uninterruptible Power Supply
- DG: Diesel Generator
- BA: Bioavailability
- BE: Bioequivalence
- QA: Quality Assurance
- PI: Principal Investigator
7. Documents
- Freezer Power Backup Checklist – Annexure-1
- Power Failure Incident Log – Annexure-2
- Manual Temperature Monitoring Log – Annexure-3
- Backup System Maintenance Log – Annexure-4
- Emergency Sample Relocation Form – Annexure-5
8. References
- ICH E6(R2) – Good Clinical Practice
- 21 CFR Part 58 – GLP for Nonclinical Studies
- WHO Guidelines for Biological Sample Handling
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Freezer Power Backup Checklist
| Date | UPS Test Result | DG Status | Checked By |
|---|---|---|---|
| 15/04/2025 | Pass | Auto-start OK | Ajay Verma |
Annexure-2: Power Failure Incident Log
| Date | Start Time | End Time | Freezers Affected | Remarks |
|---|---|---|---|---|
| 16/04/2025 | 11:32 AM | 11:50 AM | FZ-02, FZ-03 | Backup restored within 2 min |
Annexure-3: Manual Temperature Monitoring Log
| Time | Freezer ID | Temperature (°C) | Recorded By |
|---|---|---|---|
| 11:35 | FZ-02 | -69.2 | Sunita Reddy |
Annexure-4: Backup System Maintenance Log
| Date | UPS Battery Voltage | DG Test Run Status | Maintained By |
|---|---|---|---|
| 10/04/2025 | 24V | Pass | Rajesh Kumar |
Annexure-5: Emergency Sample Relocation Form
| Date | From Freezer | To Freezer | Samples Moved | Moved By |
|---|---|---|---|---|
| 16/04/2025 | FZ-02 | ALT-FZ-01 | 96 | Meena Joshi |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 10/01/2022 | 1.0 | Initial SOP Release | GCP Requirement | QA Head |
| 17/04/2025 | 2.0 | Added UPS/DG testing and sample relocation SOP | Risk Mitigation Enhancement | QA Head |