Operational Qualification Protocol for Vent Filter in IV Infusion Systems

Objective: To validate the operational performance of the Vent Filter (Sterile Gas Filter Assembly) used in IV Infusions, ensuring it maintains sterility in the tank vent.

Scope: This protocol applies to the Vent Filter utilized in the Production area for both Large Volume Parenterals (LVP) and Small Volume Parenterals (SVP) in bags and bottles.

Responsibilities:

• Validation Team: Execute and document all testing activities.
• Quality Assurance: Review and approve the protocol and results.
• Production Team: Ensure proper operation of the Vent Filter during the qualification process.

Prerequisites:
Ensure that the Vent Filter is installed and operational as per the manufacturer’s specifications. All personnel involved in the qualification process must be trained on the equipment and procedures.

Equipment Description:
The Vent Filter (Sterile Gas Filter Assembly) is designed to maintain sterility in the tank vent of IV infusion systems, ensuring that no contaminants enter the product during the production process. It is critical for maintaining product integrity and safety.

Detailed Test Cases

Test Case ID: OQ-001-01

Test Description: Conduct an integrity test on the Vent Filter.

Procedure:
1. Connect the Vent Filter to the testing apparatus.
2. Apply the specified pressure as per URS Annex1.
3. Monitor the pressure for a designated hold time.
4. Record any pressure drop during the hold time.

Acceptance Criteria: The pressure must remain stable without any drop below the threshold specified in URS Annex1.

Evidence: Documented pressure readings and test results in the validation report.

Deviations

Any deviations from the protocol must be documented and reviewed by the Quality Assurance team. A deviation report should be generated, outlining the nature of the deviation, its impact, and corrective actions taken.

Approvals

This protocol requires approval from the Validation Manager and Quality Assurance prior to execution.