Design Qualification Protocol for Vent Filter in IV Infusions

This document outlines the Design Qualification (DQ) protocol for the Vent Filter (Sterile Gas Filter Assembly) used in the production of IV infusions.

Objective: To ensure that the Vent Filter maintains sterility in the tank vent, thus ensuring product integrity and compliance with regulatory standards.

Scope: This protocol applies to the Vent Filter used in the production area for IV infusions (LVP/SVP – Bags/Bottles).

Responsibilities:

• Validation Team: Responsible for executing the DQ protocol and documenting results.
• Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
• Production Team: Responsible for ensuring the Vent Filter is installed and maintained according to specifications.

Prerequisites:

• Completion of User Requirements Specification (URS).
• Installation of the Vent Filter in the production area.
• Training of personnel on the operation of the Vent Filter.

Equipment Description:

The Vent Filter (Sterile Gas Filter Assembly) is designed to maintain sterility in the tank vent during the production of IV infusions. The criticality of this equipment is rated as critical due to its direct impact on product sterility.

Detailed Test Cases:

• Test Case ID: DQ-001-01
• Description: Perform integrity test on the Vent Filter.
• Procedure: Apply specified pressure to the filter and monitor for any pressure drop over a defined period.
• Acceptance Criteria: No pressure drop observed during the test duration.
• Expected Outcome: Confirmation of filter integrity.

Deviations:

Any deviations from the protocol must be documented and approved by the Quality Assurance team.

Approvals:

• ____________________ (Validation Team Lead)
• ____________________ (Quality Assurance)
• ____________________ (Production Manager)