Design Qualification Protocol for Sterile Filtration Skid

Meta Description: This document outlines the Design Qualification Protocol for the Sterile Filtration Skid used in the production of prefilled syringes and cartridges, ensuring compliance with regulatory standards.

Tags: Equipment Validation, Design Qualification, Sterile Filtration, Prefilled Syringes, Quality Assurance

Objective

The objective of this Design Qualification (DQ) protocol is to establish documented evidence that the Sterile Filtration Skid is designed and installed in accordance with the specified requirements to ensure its suitability for its intended use in the production of prefilled syringes and cartridges.

Scope

This protocol applies to the Sterile Filtration Skid utilized in the production area for filtering sterile bulk solutions, focusing on ensuring that the equipment meets critical quality and regulatory standards.

Responsibilities

• Validation Team: Responsible for executing the DQ protocol and documenting results.
• Quality Assurance: Responsible for reviewing and approving the DQ protocol and associated documentation.
• Engineering: Responsible for ensuring the equipment is installed and operational according to specifications.

Prerequisites

• Completion of User Requirement Specification (URS).
• Installation of Sterile Filtration Skid.
• Training of personnel on equipment use and validation processes.

Equipment Description

The Sterile Filtration Skid is a system designed for the filtration of sterile bulk solutions. It includes components such as filtration units, pumps, and monitoring systems to ensure the integrity and sterility of the filtered product.

Test Plan

Detailed Test Cases

Test Case T1: Flow Rate Test

Procedure: Measure the flow rate of the sterile solution through the filtration skid under operational conditions.

Acceptance Criteria: Flow rate must be within the defined range as specified in the URS.

Evidence: Documented flow rate measurements with timestamps.

Test Case T2: DP Integrity Test

Procedure: Perform a differential pressure integrity test on the filtration units.

Acceptance Criteria: The integrity test must pass with no leaks detected.

Evidence: Integrity test results recorded in the validation log.

Test Case T3: Audit Trail Review

Procedure: Review the audit trail logs generated by the system for any discrepancies or errors.

Acceptance Criteria: Audit trail must show no discrepancies or errors during operation.

Evidence: Signed audit trail review documentation.

Deviations

Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed to address any identified issues.

Approvals

All sections of this protocol must be reviewed and approved by the designated personnel from the Validation Team and Quality Assurance.