Document Control
Document ID: IQ-ISOLATOR-NDDS-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Installation Qualification Protocol for Isolator/RABS in NDDS Filling
Meta Description: This Installation Qualification (IQ) Protocol outlines the requirements and procedures for validating the Isolator/RABS used in NDDS filling processes, ensuring compliance with industry standards.
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Isolator/RABS equipment used in NDDS filling meets the specified requirements and is suitable for its intended use in aseptic barrier applications.
Scope
This protocol applies to the Installation Qualification of the Isolator/RABS equipment utilized in the production area for the filling of liposomes and lipid nanoparticles (LNP) under aseptic conditions.
Responsibilities
- Validation Team: Responsible for the execution and documentation of the IQ protocol.
- Quality Assurance: Responsible for reviewing and approving the IQ documentation.
- Engineering: Responsible for ensuring the equipment is installed according to manufacturer specifications.
Prerequisites
- Equipment must be installed as per manufacturer’s guidelines.
- All utilities must be operational and verified.
- Personnel must be trained on the operation of the equipment.
Equipment Description
The Isolator/RABS is designed to provide an aseptic barrier for the filling process of NDDS products, ensuring product integrity and operator safety. Key features include:
- Leak integrity monitoring
- Glove integrity assessment
- VHP (Vaporized Hydrogen Peroxide) cycle audit trail
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Leak Integrity Test | No leaks detected | Test report |
| IQ-02 | Glove Integrity Test | No breaches detected | Test report |
| IQ-03 | VHP Cycle Audit Trail Review | Complete and accurate audit trail | Audit trail log |
Detailed Test Cases
Test Case: Leak Integrity Test
Objective: To ensure the Isolator/RABS maintains a leak-proof environment.
Procedure: Conduct a pressure decay test following the manufacturer’s guidelines.
Acceptance Criteria: No leaks detected during the test.
Evidence: Documented test results and any observations.
Test Case: Glove Integrity Test
Objective: To verify that the gloves provide an intact barrier for aseptic operations.
Procedure: Perform a glove integrity test using a suitable method.
Acceptance Criteria: No breaches detected during testing.
Evidence: Documented test results and any observations.
Test Case: VHP Cycle Audit Trail Review
Objective: To confirm that VHP cycles are logged accurately.
Procedure: Review the VHP cycle audit trail for completeness and accuracy.
Acceptance Criteria: The audit trail must be complete and show all cycles performed.
Evidence: Printed audit trail log.
Deviations
Any deviations from the protocol must be documented and justified. A deviation report should be submitted for review and approval.
Approvals
This Installation Qualification Protocol must be approved by the Quality Assurance and Validation teams prior to execution.