Operational Qualification Protocol for High Pressure Reactor / Hydrogenator

Objective: To ensure that the High Pressure Reactor / Hydrogenator operates within specified limits and meets the operational requirements for hydrogenation reactions in API manufacturing.

Scope: This protocol applies to the Operational Qualification of the High Pressure Reactor / Hydrogenator used in the production area for hydrogenation reactions impacting product quality directly.

Responsibilities:

• Validation Team: Responsible for executing the OQ protocol and documenting results.
• Quality Assurance: Responsible for reviewing and approving the OQ protocol and results.
• Production Team: Responsible for operating the equipment during testing.

Prerequisites:

• Completion of Installation Qualification (IQ) for the High Pressure Reactor / Hydrogenator.
• Availability of necessary documentation including User Requirement Specifications (URS), Annex 11, and Annex 15.
• Training of personnel on the operation of the equipment.

Equipment Description:

The High Pressure Reactor / Hydrogenator is designed for conducting hydrogenation reactions under controlled pressure and temperature conditions. Key features include:

• Pressure control system
• Temperature monitoring and control
• Agitation control
• Hydrogen flow measurement
• Audit trail logs for operational data

Detailed Test Cases:

Test Case OQ-01: Verify the pressure settings and controls.

• Procedure: Set the reactor to the desired pressure and monitor for stability over a 30-minute period.
• Acceptance Criteria: Pressure must remain within specified limits (10-200 bar).
• Evidence: Documented pressure log data.

Test Case OQ-02: Verify the temperature settings and controls.

• Procedure: Set the reactor to the desired temperature and monitor for stability over a 30-minute period.
• Acceptance Criteria: Temperature must remain within specified limits (20-150°C).
• Evidence: Documented temperature log data.

Test Case OQ-03: Verify agitation speed and control.

• Procedure: Set the reactor to the desired agitation speed and monitor for stability over a 30-minute period.
• Acceptance Criteria: Agitation must meet specified RPM range.
• Evidence: Documented agitation log data.

Test Case OQ-04: Verify hydrogen flow rate.

• Procedure: Set the reactor to the desired hydrogen flow rate and monitor for stability over a 30-minute period.
• Acceptance Criteria: Hydrogen flow must remain within specified limits.
• Evidence: Documented flow rate log data.

Test Case OQ-05: Verify audit trail logs.

• Procedure: Review audit trail logs for completeness and accuracy.
• Acceptance Criteria: All operational data must be logged accurately.
• Evidence: Documented audit trail report.

Deviations: Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. Corrective actions must be implemented as necessary.