Document Control:
Document Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Operational Qualification Protocol for Shaking Incubator in Cell Culture Growth
Objective: To validate the operational performance of the Shaking Incubator used for cell culture growth in the production area, ensuring compliance with URS Annex11.
Scope: This protocol applies to the Shaking Incubator utilized in upstream processing for biologics production. It covers the validation of critical parameters including temperature, RPM, and uniformity.
Responsibilities:
- Validation Team: Execute the protocol and document results.
- Quality Assurance: Review and approve the protocol and final report.
- Production Team: Provide access to the equipment and assist in the execution of the tests.
Prerequisites:
- Shaking Incubator installed and operational.
- Standard Operating Procedures (SOPs) for equipment use in place.
- Training completed for personnel involved in the qualification.
Equipment Description: The Shaking Incubator is designed for optimal cell culture growth through controlled shaking and temperature settings. It is equipped with PLC logs for monitoring operational parameters.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify temperature uniformity across the chamber. | ±2°C from set point. | Temperature mapping report. |
| OQ-02 | Check RPM uniformity during operation. | ±10% of set RPM. | RPM log data. |
| OQ-03 | Review PLC logs for operational consistency. | No critical alarms or failures. | PLC log report. |
Detailed Test Cases:
- Test Case OQ-01: Conduct temperature mapping using calibrated thermocouples. Record temperatures at various points within the incubator to assess uniformity.
- Test Case OQ-02: Use a calibrated tachometer to measure RPM at multiple points. Ensure readings fall within acceptance criteria.
- Test Case OQ-03: Extract PLC logs for the past 30 days. Review for any deviations or alarms that may indicate operational issues.
Deviations: Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A corrective action plan should be developed as necessary.
Approvals:
- Validation Team Lead: ____________________ Date: ___________
- Quality Assurance: ____________________ Date: ___________
Data Integrity Checks:
- Ensure all data entered into the system is timestamped and attributed to the responsible individual.
- Perform periodic audits of PLC logs to verify data accuracy and completeness.
- Implement backup procedures for critical data to prevent loss.