Design Qualification Protocol for Grade A/B/C/D Cleanrooms
Document Control
Document Number: DQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed by: [Insert Name]
Approval Date: [Insert Date]
Objective
The objective of this Design Qualification (DQ) Protocol is to ensure that the Grade A/B/C/D Cleanrooms are designed and constructed to meet the requirements for aseptic processing in a classified environment.
Scope
This protocol covers the qualification of the Grade A/B/C/D Cleanrooms used for sterile injectables and aseptic processing within the facility. It applies to all engineering and operational aspects of the cleanroom environment.
Responsibilities
The following personnel are responsible for the execution and approval of this protocol:
- Validation Team: Execute the DQ protocol and document results.
- Engineering Team: Provide technical support and documentation.
- Quality Assurance: Review and approve the DQ protocol and results.
Prerequisites
All necessary engineering drawings, specifications, and user requirement specifications (URS) must be available and approved prior to executing this protocol.
Equipment Description
The Grade A/B/C/D Cleanrooms are designed to maintain specific environmental conditions necessary for aseptic processing. Key features include:
- ISO Class Recovery
- Air Changes per Hour (ACH)
- Differential Pressure (DP)
- Temperature (Temp)
- Relative Humidity (RH)
- Airflow Visualization (Smoke Tests)
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | ISO Class Recovery Test | Meets ISO 14644 requirements | Test Report |
| DQ-02 | ACH Measurement | Minimum 20 ACH | Test Report |
| DQ-03 | DP Measurement | Positive pressure maintained | Test Report |
| DQ-04 | Temperature Measurement | 20-25°C | Test Report |
| DQ-05 | RH Measurement | 30-60% RH | Test Report |
| DQ-06 | Airflow Visualization | No turbulence | Test Report |
Detailed Test Cases
Test Case DQ-01: Perform ISO Class Recovery Test.
Procedure: Conduct recovery testing in the cleanroom after a disturbance.
Acceptance Criteria: Must meet ISO 14644 standards for class recovery.
Evidence: Documented test results and observations.
Test Case DQ-02: Measure ACH.
Procedure: Measure airflow to ensure a minimum of 20 ACH.
Acceptance Criteria: Should maintain at least 20 ACH.
Evidence: Recorded measurements and calculations.
Test Case DQ-03: Measure DP.
Procedure: Monitor differential pressure across the cleanroom.
Acceptance Criteria: Positive pressure must be maintained.
Evidence: Pressure gauge readings.
Test Case DQ-04: Measure Temperature.
Procedure: Monitor temperature within the cleanroom.
Acceptance Criteria: Temperature should be maintained between 20-25°C.
Evidence: Temperature logs.
Test Case DQ-05: Measure RH.
Procedure: Monitor relative humidity levels.
Acceptance Criteria: Should be maintained between 30-60% RH.
Evidence: Humidity logs.
Test Case DQ-06: Conduct Airflow Visualization.
Procedure: Perform smoke tests to visualize airflow.
Acceptance Criteria: No turbulence observed.
Evidence: Video or photographic documentation.
Deviations
Any deviations from the acceptance criteria must be documented and justified in a deviation report. Corrective actions must be implemented and verified.
Approvals
This protocol must be approved by the following personnel:
- Validation Manager: ____________________ Date: ___________
- Quality Assurance: ____________________ Date: ___________
- Engineering Lead: ____________________ Date: ___________