Document Control:
Document Number: DQ-BC-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Design Qualification Protocol for Biosafety Cabinet in Biologics Upstream Processing
Meta Description: This document outlines the Design Qualification Protocol for the Biosafety Cabinet used in aseptic handling of cell lines and cultures in Biologics Upstream Processing.
Tags: Equipment Validation, Design Qualification, Biosafety Cabinet, Biologics, Upstream Processing
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Biosafety Cabinet (Class II/III) is designed and installed in compliance with the specified requirements for aseptic handling of cell lines and cultures.
Scope
This protocol applies to the validation of the Biosafety Cabinet used in the Production/Cell Culture area for biologics manufacturing processes.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Production Personnel: Responsible for operating the Biosafety Cabinet and adhering to established procedures.
Prerequisites
- Completion of the User Requirements Specification (URS).
- Installation of the Biosafety Cabinet as per manufacturer specifications.
- Training of personnel on the operation of the Biosafety Cabinet.
Equipment Description
The Biosafety Cabinet (Class II/III) is designed for aseptic handling of cell lines and cultures, providing a sterile environment and protecting both the user and the product from contamination.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-BC-001 | Verify HEPA filter integrity | Passes integrity test as per ISO14644 Annex1 | Test report |
| DQ-BC-002 | Assess airflow patterns | Airflow meets specified parameters | Flow visualization report |
| DQ-BC-003 | Check containment levels | Containment is within acceptable limits | Containment test report |
Detailed Test Cases
Test Case 1: HEPA Filter Integrity
- Procedure: Perform a DOP test to verify HEPA filter integrity.
- Expected Result: Filter passes the integrity test.
- Actual Result: [To be filled during testing]
Test Case 2: Airflow Patterns
- Procedure: Use smoke visualization to assess airflow patterns.
- Expected Result: Airflow patterns are as per design specifications.
- Actual Result: [To be filled during testing]
Test Case 3: Containment Levels
- Procedure: Measure containment levels using appropriate methods.
- Expected Result: Containment levels are within acceptable limits.
- Actual Result: [To be filled during testing]
Deviations
Any deviations from the acceptance criteria must be documented and reviewed by the Quality Assurance department for further investigation and resolution.
Approvals
Approved by: ____________________ Date: _____________
Reviewed by: ____________________ Date: _____________