Document Control Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Operational Qualification Protocol for Vent Filter Assembly
Objective: To validate the operational qualification of the Vent Filter Assembly used in the production of nasal and otic products, ensuring the maintenance of sterility in the holding vessel.
Scope: This protocol applies to the Vent Filter Assembly utilized in the production area for both sterile and non-sterile nasal and otic products.
Responsibilities:
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the OQ results.
- Production Team: Responsible for operating the Vent Filter Assembly during the qualification process.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Training of personnel on the operation of the Vent Filter Assembly.
- Availability of necessary materials and equipment for testing.
Equipment Description:
The Vent Filter Assembly is designed to maintain the sterility of the holding vessel during the production of nasal and otic products. It features a high-efficiency particulate air (HEPA) filter and is critical for ensuring product integrity.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Perform integrity pressure hold test. | Maintain pressure for 30 minutes without drop. | Pressure log and observation report. |
Detailed Test Cases:
- Integrity Pressure Hold Test:
- Set up the Vent Filter Assembly as per the operational guidelines.
- Connect pressure gauge to the assembly.
- Apply the required pressure and maintain for 30 minutes.
- Document any pressure drops during the test period.
Deviations:
Any deviations from the acceptance criteria must be documented with a detailed explanation and corrective actions proposed.
Approvals:
______________________________
Validation Team Lead
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Quality Assurance Representative