Operational Qualification Protocol for Media Preparation Vessel in Biologics Production

Objective: To validate the operational performance of the Media Preparation Vessel used for the preparation of sterile growth media in the production of recombinant mAbs.

Scope: This protocol applies to the Media Preparation Vessel (Jacketed SS) utilized in the production of biologics, specifically vaccines, focusing on the critical parameters impacting the production process.

Responsibilities:

• Quality Assurance: Ensure compliance with validation requirements.
• Validation Team: Execute the OQ protocol and document results.
• Operations: Provide access to the equipment and necessary support.

Prerequisites:

• Completion of Installation Qualification (IQ).
• Availability of all necessary documentation and standard operating procedures.
• Training of personnel on the use of the Media Preparation Vessel.

Equipment Description:

The Media Preparation Vessel is a jacketed stainless steel tank designed for the preparation of sterile growth media. It includes integrated heating and cooling systems to maintain optimal temperature conditions during media preparation.

Detailed Test Cases:

• Test Case OQ-1: Set the temperature to the desired set point and monitor for stability over a 30-minute period.
• Test Case OQ-2: Simulate a pressure drop and observe the system’s response to restore pressure to the set point.
• Test Case OQ-3: Prepare a batch of media and incubate samples to assess sterility.

Deviations:

Any deviations from the acceptance criteria will be documented and assessed for impact on the validation process. A corrective action plan will be developed if necessary.

Approvals:

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Validation Team Lead

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Quality Assurance Manager

Data Integrity Checks:

• Regular audits of temperature and pressure logs.
• Verification of calibration status for all measurement instruments.
• Documentation of all media preparation activities and results.