Performance Qualification Protocol for Media Preparation Vessel in Biologics Production

Objective

The objective of this Performance Qualification (PQ) protocol is to ensure that the Media Preparation Vessel operates within defined parameters to produce sterile growth media for recombinant products, specifically monoclonal antibodies (mAbs).

Scope

This protocol applies to the Performance Qualification of the Jacketed Stainless Steel Media Preparation Vessel used in the production of biologics, specifically vaccines and recombinant products.

Responsibilities

The following personnel are responsible for executing this protocol:

• Validation Team: Responsible for the execution and documentation of the PQ activities.
• Quality Assurance: Responsible for reviewing and approving the protocol and results.
• Operations: Responsible for ensuring the equipment is maintained and operated according to the protocol.

Prerequisites

• Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
• Training of personnel on the operation of the Media Preparation Vessel.
• Availability of all necessary materials and equipment required for testing.

Equipment Description

The Media Preparation Vessel is a Jacketed Stainless Steel unit designed for the preparation of sterile growth media. It is equipped with temperature control, stirring capabilities, and appropriate connections for sterile transfer.

Test Plan

Detailed Test Cases

Test Case PQ-001: Verify Temperature Control Functionality

Procedure: Set the temperature to 37°C and monitor the temperature over a period of 30 minutes.

Acceptance Criteria: The temperature must remain within ±2°C of the set point.

Evidence: Document temperature readings at 5-minute intervals.

Test Case PQ-002: Check Stirring Speed Accuracy

Procedure: Set the stirring speed to 200 RPM and verify with a calibrated tachometer.

Acceptance Criteria: Stirring speed must be within ±10% of the set point.

Evidence: Document tachometer readings and calibration certificate.

Test Case PQ-003: Perform Sterility Test of Prepared Media

Procedure: Prepare media and incubate samples for 14 days at 30°C.

Acceptance Criteria: No microbial growth should be observed in any sample.

Evidence: Document sterility test results and observations.

Deviations

Any deviations from this protocol must be documented and justified. Deviations must be reviewed and approved by Quality Assurance before proceeding with the test.

Approvals

This protocol must be approved by the following personnel:

• Validation Manager: ______________________
• Quality Assurance Manager: ______________________
• Operations Manager: ______________________

Data Integrity Checks

Data integrity checks will include:

• Verification of data entry accuracy during temperature and stirring speed monitoring.
• Regular audits of data logs to ensure compliance with acceptance criteria.
• Use of electronic signatures for all documented evidence.