Document Control
Document ID: IQ-THF-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Installation Qualification Protocol for Terminal HEPA Filters
Meta Description: This document outlines the Installation Qualification (IQ) Protocol for Terminal HEPA Filters used in sterile environments, ensuring compliance with ISO14644 Annex 1.
Tags: Equipment Validation, Sterile, HEPA Filters, Installation Qualification, Aseptic, Engineering
Objective
The objective of this protocol is to verify that the Terminal HEPA Filters are installed correctly and meet the specified requirements for HEPA filtration in Grade A/B environments.
Scope
This protocol applies to the Installation Qualification of Terminal HEPA Filters used in sterile (injectables/aseptic) manufacturing areas within the Engineering department.
Responsibilities
The Engineering team is responsible for the execution of this protocol, while the Quality Assurance team will oversee compliance and documentation.
Prerequisites
- Completion of equipment installation.
- Availability of necessary testing equipment.
- Personnel trained in validation protocols.
Equipment Description
The Terminal HEPA Filters are designed to provide high-efficiency particulate air (HEPA) filtration for Grade A/B environments, ensuring the removal of airborne particulates.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| IQ-THF-01 | Integrity leak test | No leaks detected | Test report |
| IQ-THF-02 | Airflow face velocity measurement | Within specified range | Measurement log |
Detailed Test Cases
Test Case 1: Integrity Leak Test
Procedure: Conduct an integrity leak test on the HEPA filters using a suitable method (e.g., DOP test). Record the results.
Acceptance Criteria: No leaks detected.
Evidence: Documented test report with results and observations.
Test Case 2: Airflow Face Velocity Measurement
Procedure: Measure the airflow face velocity at multiple points across the HEPA filter surface using a calibrated anemometer.
Acceptance Criteria: Airflow face velocity must be within the range specified in ISO14644 Annex 1.
Evidence: Measurement log with recorded values and calibration certificates.
Deviations
Any deviations from the acceptance criteria must be documented and reviewed by the Quality Assurance team. Justification for deviations must be provided.
Approvals
Approved by: [Insert Name], [Insert Title]
Date: [Insert Date]
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