Document ID: IQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Installation Qualification Protocol for Shaking Incubator in Biologics Upstream Processing
Objective: To establish the installation qualification (IQ) of the Shaking Incubator used for cell culture growth in biologics upstream processing.
Scope: This protocol applies to the installation qualification of the Shaking Incubator in the Production/Cell Culture area, impacting product quality directly.
Responsibilities:
- Validation Team: Conduct and document the IQ process.
- Quality Assurance: Review and approve the IQ protocol and results.
- Maintenance Team: Ensure the equipment is installed per specifications.
Prerequisites:
- Completion of equipment installation.
- Availability of relevant documentation (URS, equipment manuals).
- Personnel trained on equipment operation and validation processes.
Equipment Description:
The Shaking Incubator is designed for cell culture growth, providing controlled temperature and shaking conditions to maintain optimal growth environments for biological materials.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation according to manufacturer specifications. | All installation steps completed as per manufacturer guidelines. | Installation checklist signed off. |
| IQ-02 | Check temperature uniformity. | Temperature variation within ±1°C across the incubator. | Temperature mapping report. |
| IQ-03 | Verify RPM uniformity. | RPM variation within ±5% of set point. | RPM test report. |
| IQ-04 | Review PLC logs for operational consistency. | All PLC logs indicate compliance with operational parameters. | PLC log summary report. |
Detailed Test Cases:
- Test ID: IQ-01
- Procedure: Inspect the physical setup of the Shaking Incubator.
- Acceptance: All components installed as per specification.
- Evidence: Installation checklist.
- Test ID: IQ-02
- Procedure: Conduct temperature mapping using calibrated thermocouples.
- Acceptance: Temperature variation within specified limits.
- Evidence: Temperature mapping report.
- Test ID: IQ-03
- Procedure: Measure RPM at various points using a calibrated tachometer.
- Acceptance: RPM variation within specified limits.
- Evidence: RPM measurement report.
- Test ID: IQ-04
- Procedure: Review PLC logs for consistency in operation.
- Acceptance: All logs show compliance.
- Evidence: PLC log summary.
Deviations:
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed and implemented as necessary.
Approvals:
All results must be reviewed and approved by the Quality Assurance team before proceeding to the next validation phase.
Data Integrity Checks:
- Verification of data entry into the CSV files against physical measurements.
- Audit trails for any changes made to PLC logs.
- Regular calibration checks of measurement devices used during testing.