Document Control
Document ID: IQ-BC-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Installation Qualification Protocol for Class II/III Biosafety Cabinet
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Class II/III Biosafety Cabinet is installed correctly and operates in accordance with the manufacturer’s specifications and regulatory requirements.
Scope
This protocol applies to the installation of the Class II/III Biosafety Cabinet used for aseptic handling of cell lines and cultures in the production area.
Responsibilities
The Quality Assurance (QA) department is responsible for the execution and approval of this protocol. The Facilities and Maintenance team is responsible for the installation and initial setup of the equipment.
Prerequisites
All personnel involved in the installation and qualification process must have completed relevant training on equipment handling and validation protocols.
Equipment Description
The Class II/III Biosafety Cabinet is designed for aseptic handling of cell lines and cultures. It provides HEPA-filtered air to ensure a sterile environment and contains potential biohazards.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Visual inspection of installation | All components installed as per manufacturer’s specifications | Inspection checklist |
| IQ-02 | HEPA filter integrity test | Passes integrity test per ISO14644 Annex 1 | Test report |
| IQ-03 | Airflow measurement | Airflow within specified range | Measurement log |
Detailed Test Cases
Test ID: IQ-01
Procedure: Conduct a visual inspection of the installation to ensure that all components are properly installed.
Acceptance Criteria: All components should be installed according to the manufacturer’s specifications.
Evidence: Complete the inspection checklist and document findings.
Test ID: IQ-02
Procedure: Perform a HEPA filter integrity test using a suitable method (e.g., DOP test).
Acceptance Criteria: The HEPA filter must pass the integrity test as per ISO14644 Annex 1.
Evidence: Provide the test report detailing the results.
Test ID: IQ-03
Procedure: Measure the airflow velocity at the cabinet’s work surface using an anemometer.
Acceptance Criteria: Airflow should be within the specified range outlined in the user manual.
Evidence: Document the measurements in the log.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality and safety.
Approvals
This Installation Qualification protocol must be reviewed and approved by the QA department and relevant stakeholders prior to execution.