Performance Qualification Protocol for Isolator/RABS in NDDS Filling

Meta Description: This document outlines the Performance Qualification (PQ) protocol for Isolator/RABS used in the filling of NDDS, specifically focusing on liposomes and lipid nanoparticles.

Tags: Equipment Validation, NDDS, Liposomes, Lipid Nanoparticles, Isolator, RABS, Aseptic Barrier

Objective

The objective of this Performance Qualification (PQ) protocol is to validate the Isolator/RABS used in the aseptic filling of NDDS products, ensuring compliance with regulatory requirements and operational standards.

Scope

This protocol applies to the Isolator/RABS used in the production area for the filling of liposomes and lipid nanoparticles. It encompasses all activities related to the validation of the equipment’s performance in maintaining aseptic conditions.

Responsibilities

• Validation Team: Responsible for executing the PQ protocol and documenting results.
• Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
• Production Team: Responsible for providing access to the equipment and supporting the validation activities.

Prerequisites

• Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
• Availability of necessary documentation including URS, Annex 1, and Annex 11.
• Training of personnel on equipment operation and validation processes.

Equipment Description

The Isolator/RABS is designed to provide an aseptic barrier during the filling of NDDS products. It incorporates advanced features for maintaining sterility, including glove integrity monitoring, leak integrity checks, and a validated VHP cycle.

Test Plan

Detailed Test Cases

Test Case 1: Leak Integrity Test

• Procedure: Conduct a leak test using appropriate methods.
• Acceptance Criteria: No leaks detected.
• Evidence: Document results in the test report.

Test Case 2: Glove Integrity Test

• Procedure: Perform glove integrity testing using leak detection methods.
• Acceptance Criteria: All gloves intact.
• Evidence: Document results in the test report.

Test Case 3: VHP Cycle Audit Trail Review

• Procedure: Review the VHP cycle audit trail for compliance.
• Acceptance Criteria: Cycle meets validation parameters.
• Evidence: Document results in the audit trail report.

Deviations

Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed and approved by the Quality Assurance team.

Approvals

All results must be reviewed and approved by the Quality Assurance team prior to the finalization of the PQ protocol.

Data Integrity Checks

• Ensure that all data recorded during testing is time-stamped and attributed to the responsible personnel.
• Regular backups of electronic data should be performed to prevent data loss.
• Audit trails should be maintained for all electronic records associated with the PQ process.