Document Control
Document ID: IQ-FH-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Installation Qualification Protocol for Sterile Grade Filter Housing
Objective: To verify that the filter housing used for sterilizing-grade filters in the production of ophthalmic products meets specified requirements and is installed correctly.
Scope: This protocol applies to the installation qualification of the filter housing utilized in the production area for sterile eye drops and eye ointments.
Responsibilities:
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Staff: Responsible for ensuring the equipment is maintained and operated according to established procedures.
Prerequisites:
- Completion of the equipment installation.
- Availability of necessary documentation (URS Annex1).
- Training of personnel on equipment operation and safety procedures.
Equipment Description:
The filter housing is designed to hold sterilizing-grade filters used in the production of sterile ophthalmic products. It is critical for ensuring the integrity of the filtration process and must maintain pressure hold seal integrity.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-FH-001 | Verify installation of filter housing according to manufacturer specifications. | Installation matches specifications outlined in URS Annex1. | Installation checklist and photographs. |
| IQ-FH-002 | Conduct pressure hold seal integrity test. | Pressure hold integrity maintained for [insert time frame]. | Test results and log entries. |
Detailed Test Cases:
- Test Case 1: Installation Verification
- Check all connections and fittings for proper installation.
- Ensure all components are secured and free from damage.
- Test Case 2: Pressure Hold Seal Integrity
- Apply pressure as per specifications.
- Monitor and record pressure over the specified duration.
- Document any fluctuations in pressure.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A deviation report should be created, detailing the nature of the deviation, potential impact, and corrective actions taken.
Approvals:
Prepared By: ___________________ Date: __________
Approved By: ___________________ Date: __________