Performance Qualification Protocol for the Filter Integrity Tester

Objective

The objective of this Performance Qualification (PQ) protocol is to verify the integrity of filters used in prefilled syringes and cartridges by utilizing the Filter Integrity Tester. This ensures compliance with regulatory standards and product safety.

Scope

This PQ protocol applies to the Filter Integrity Tester utilized in the Production and Quality Control (QC) areas for verifying filter integrity of prefilled syringes and cartridges. The protocol is applicable to all relevant product batches.

Responsibilities

The responsibilities for executing this PQ protocol are as follows:

• Validation Team: Overall execution and documentation of the PQ protocol.
• Quality Assurance: Review and approval of the protocol and results.
• Production Staff: Execution of the filter integrity tests as per the protocol.

Prerequisites

Before initiating the PQ, the following prerequisites must be met:

• Calibration of the Filter Integrity Tester is up-to-date.
• All relevant personnel have received training on the equipment and protocol.
• Standard Operating Procedures (SOPs) related to filter integrity testing are in place and accessible.

Equipment Description

The Filter Integrity Tester is an instrument designed to verify the integrity of filters used in prefilled syringes and cartridges. It employs a bubble point diffusion method to assess filter performance and ensure product safety.

Test Plan

Detailed Test Cases

Test Case 1: Bubble Point Diffusion Audit Trail

• Step 1: Set up the Filter Integrity Tester as per SOP.
• Step 2: Initiate the bubble point diffusion test.
• Step 3: Record the results and verify against acceptance criteria.
• Step 4: Ensure audit trail logs are complete and accessible.

Deviations

Any deviations from the acceptance criteria must be documented and investigated. The following actions should be taken:

• Identify the root cause of the deviation.
• Implement corrective actions and retest if necessary.
• Document all findings in the deviation report.

Approvals

This protocol requires approval from the following personnel:

• Validation Manager: [Insert Name]
• Quality Assurance Manager: [Insert Name]

Data Integrity Checks

As CSV is required, the following data integrity checks will be implemented:

• Ensure audit trail logs are automatically generated and retained.
• Verify that all test results are time-stamped and linked to the operator’s ID.
• Conduct periodic reviews of logs for completeness and accuracy.