Document Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Operational Qualification Protocol for Inline Heater/Heat Exchanger
Objective: To validate the operational performance of the Inline Heater/Heat Exchanger used for heating/cooling bulk solutions in IV Infusions.
Scope: This protocol applies to the Inline Heater/Heat Exchanger located in the Production area, used for direct impact on product quality.
Responsibilities:
- Validation Team: Execution of the OQ protocol and documentation of results.
- Quality Assurance: Review and approval of the OQ protocol and results.
- Production Team: Ensure equipment is operational and maintained.
Prerequisites:
- Installation Qualification (IQ) must be completed and approved.
- All required training for personnel must be completed.
- Equipment must be cleaned and sanitized according to SOP.
Equipment Description:
The Inline Heater/Heat Exchanger is a system designed to heat or cool bulk solutions for IV infusions. It operates by transferring heat through a series of tubes, ensuring efficient temperature control.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001-01 | Verify temperature flow at specified settings. | Temperature within ±2°C of set point. | Temperature log, calibration certificates. |
| OQ-001-02 | Assess heat transfer efficiency. | Heat transfer efficiency ≥90%. | Efficiency calculation report. |
Detailed Test Cases:
Test Case OQ-001-01
Objective: To verify the temperature flow at specified settings.
Procedure: Set the Inline Heater/Heat Exchanger to the specified temperature. Measure the output temperature at designated intervals.
Acceptance Criteria: Temperature must be within ±2°C of the set point.
Evidence: Document temperature readings and calibration certificates.
Test Case OQ-001-02
Objective: To assess the heat transfer efficiency of the system.
Procedure: Measure the input and output temperatures and flow rates to calculate the heat transfer efficiency.
Acceptance Criteria: Heat transfer efficiency must be ≥90%.
Evidence: Provide a report detailing the efficiency calculations.
Deviations: Any deviations from the acceptance criteria must be documented and assessed for impact on product quality.
Approvals:
- Validation Team Lead: ______________________ Date: __________
- Quality Assurance: ______________________ Date: __________