Vent Filter (Sterile Gas Filter Assembly) – IQ Protocol

Installation Qualification Protocol for Vent Filter (Sterile Gas Filter Assembly)

Document Number: IQ-001

Version: 1.0

Effective Date: [Insert Date]

Review Date: [Insert Date]

Objective

The objective of this Installation Qualification (IQ) protocol is to verify that the Vent Filter (Sterile Gas Filter Assembly) is installed correctly and operates as intended to maintain sterility in the tank vent for IV infusions.

Scope

This protocol applies to the Installation Qualification of the Vent Filter in the Production area, specifically for IV Infusions (LVP/SVP – Bags/Bottles).

Responsibilities

The Validation Team is responsible for executing this protocol, while the Quality Assurance team will oversee the review and approval process.

Prerequisites

  • Installation of the Vent Filter must be completed prior to executing this protocol.
  • All relevant documentation regarding installation must be available for review.
  • Personnel must be trained on the operation and maintenance of the Vent Filter.

Equipment Description

The Vent Filter (Sterile Gas Filter Assembly) is designed to maintain sterility in tank vents during the production of IV infusions. It operates by filtering out contaminants while allowing gas exchange.

Test Plan

Test ID Procedure Acceptance Criteria Evidence
IQ-01 Perform integrity test at specified pressure. Pressure hold maintained as per URS Annex1. Test report documenting pressure hold results.

Detailed Test Cases

Test Case 1: Integrity Test

Test ID: IQ-01

Objective: To verify that the Vent Filter maintains integrity under specified pressure.

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Procedure:
1. Connect the Vent Filter to the integrity testing apparatus.
2. Apply the specified pressure as per URS Annex1.
3. Monitor the pressure for a defined hold time.

Expected Result: Pressure should remain stable throughout the hold time without any drop.

Deviations

Any deviations from the acceptance criteria must be documented and reviewed. A root cause analysis should be performed to determine the impact on product quality.

Approvals

Prepared by: ________________________ Date: ___________

Reviewed by: ________________________ Date: ___________

Approved by: ________________________ Date: ___________

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