Design Qualification Protocol for Sterile Holding Tank in Prefilled Syringes & Cartridges

Objective

The objective of this Design Qualification (DQ) protocol is to verify that the Sterile Holding Tank for prefilled syringes and cartridges meets the specified requirements and is suitable for holding sterile filtered bulk product.

Scope

This protocol applies to the Sterile Holding Tank used in the production area for prefilled syringes and cartridges. The focus is on ensuring product integrity and compliance with relevant standards.

Responsibilities

• Validation Team: Responsible for executing the DQ protocol and documenting results.
• Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
• Operations: Responsible for providing necessary equipment access and support during the validation process.

Prerequisites

• Completion of User Requirements Specification (URS).
• Installation Qualification (IQ) must be completed prior to DQ execution.
• Training of personnel on equipment operation and validation processes.

Equipment Description

The Sterile Holding Tank is designed to hold sterile filtered bulk product prior to filling into prefilled syringes and cartridges. The tank is equipped with a pressure hold vent and PLC audit trail for monitoring and documentation of critical parameters.

Test Plan

Detailed Test Cases

Test Case DQ-01: Verify Pressure Hold Vent Integrity

Procedure: Conduct a pressure hold test for a minimum of 30 minutes. Monitor for any pressure drop.

Acceptance Criteria: Pressure must remain stable within specified limits.

Evidence: Document results in the pressure log.

Test Case DQ-02: Review PLC Audit Trail

Procedure: Access the PLC system and review the audit trail for the last 30 days.

Acceptance Criteria: All critical parameters must be logged and retrievable.

Evidence: Document findings in the PLC audit report.

Deviations

Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. Justifications for deviations must be provided and approved by Quality Assurance.

Approvals

Prepared by: ____________________ Date: ___________

Reviewed by: ____________________ Date: ___________

Approved by: ____________________ Date: ___________

Data Integrity Checks

Ensure that all data logged during the validation process is backed up and securely stored. Regular audits of the PLC data must be conducted to ensure ongoing compliance with data integrity standards.