Document Control Number: IQ-HEPA-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Installation Qualification Protocol for HEPA Integrity Test System
This document outlines the Installation Qualification (IQ) protocol for the HEPA Integrity Test System used in sterile (injectables/aseptic) environments to ensure the equipment’s proper installation and functionality.
Objective: To verify that the HEPA Integrity Test System is installed correctly and operates as intended according to specified criteria.
Scope: This protocol applies to the HEPA Integrity Test System (Photometer + Aerosol Generator) located in the Engineering area and is intended for use in testing HEPA filter integrity for sterile applications.
Responsibilities:
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Engineering Team: Responsible for equipment installation and maintenance.
- Quality Assurance: Responsible for final review and approval of the IQ documentation.
Prerequisites:
- Completion of equipment installation according to manufacturer specifications.
- Availability of necessary tools and materials for testing.
- Training of personnel on equipment operation and safety protocols.
Equipment Description:
The HEPA Integrity Test System consists of a photometer and aerosol generator designed to assess the integrity of HEPA filters used in sterile environments. This system evaluates the aerosol concentration scan method to determine pass/fail criteria in accordance with ISO14644 standards.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| IQ-HEPA-001 | Perform aerosol concentration scan using the photometer. | Aerosol concentration meets pass/fail criteria as per ISO14644. | Recorded data from the photometer. |
| IQ-HEPA-002 | Verify calibration of the aerosol generator. | Calibration within specified limits. | Calibration certificate. |
Detailed Test Cases:
- Test Case 1: Verify installation of the photometer and aerosol generator.
- Test Case 2: Conduct aerosol concentration scan and document results.
- Test Case 3: Confirm calibration of the aerosol generator is within limits.
Deviations:
Any deviations from the acceptance criteria must be documented and investigated. Corrective actions should be implemented as necessary.
Approvals:
__________________________ Validation Team Lead
__________________________ Engineering Manager
__________________________ Quality Assurance Manager