Installation Qualification Protocol for Sterile Filtration Skid in IV Infusions

This document outlines the Installation Qualification (IQ) protocol for the Sterile Filtration Skid used in the production of IV infusions.

Objective

The objective of this protocol is to ensure that the Sterile Filtration Skid is installed correctly and functions as intended, meeting all specified requirements for sterilizing filtration before fill.

Scope

This protocol applies to the Installation Qualification of the Sterile Filtration Skid used for LVP/SVP in the production area. It encompasses all relevant equipment and processes involved in the sterilizing filtration of IV infusion products.

Responsibilities

The following roles are responsible for the execution and approval of this protocol:

• Validation Engineer: Responsible for protocol execution and documentation.
• Quality Assurance: Responsible for review and approval of the protocol.
• Production Manager: Responsible for ensuring that the equipment is available and operational for testing.

Prerequisites

Prior to executing this protocol, the following must be completed:

• Installation of the Sterile Filtration Skid.
• Completion of the User Requirement Specification (URS).
• Training of personnel on equipment operation.

Equipment Description

The Sterile Filtration Skid is designed for the sterilizing filtration of LVP/SVP IV infusion products. It features:

• Flow DP integrity monitoring
• Integration with audit trail systems
• Critical parameters for validation

Test Plan

Detailed Test Cases

Test Case: IQ-001

Procedure: Inspect all components of the Sterile Filtration Skid to ensure proper installation.

Acceptance Criteria: All components must match the installation checklist.

Evidence: Completed and signed installation checklist.

Test Case: IQ-002

Procedure: Measure the flow rate and differential pressure during operation.

Acceptance Criteria: Flow rate must be within the specified range; differential pressure must remain stable.

Evidence: Recorded flow rate and DP measurements.

Test Case: IQ-003

Procedure: Review the audit trail for any discrepancies or anomalies.

Acceptance Criteria: No discrepancies in audit trail logs.

Evidence: Audit trail report showing integrity.

Deviations

Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A corrective action plan should be established if necessary.

Approvals

This protocol requires approval from the following individuals:

• Validation Engineer: ______________________
• Quality Assurance: ______________________
• Production Manager: ______________________