Document Control Number: IQ-CT-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Installation Qualification Protocol for Cooling Tunnel Equipment
Objective: To ensure that the Cooling Tunnel operates according to specified requirements for the cooling of suppositories after molding.
Scope: This protocol applies to the Installation Qualification of the Cooling Tunnel used in the production area for suppositories and implants.
Responsibilities:
- Validation Team: Responsible for execution and documentation of IQ protocol.
- Quality Assurance: Responsible for review and approval of the protocol.
- Production Team: Responsible for providing operational support during the qualification process.
Prerequisites:
- Installation of Cooling Tunnel completed.
- All necessary utilities (electricity, water, etc.) are connected and operational.
- Personnel trained on equipment operation and safety protocols.
Equipment Description:
The Cooling Tunnel is a conveyor system designed to cool suppositories post-molding. It features adjustable cooling temperature, airflow, and time settings, controlled through a PLC system. The equipment is critical for maintaining product quality and compliance with regulatory standards.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| IQ-CT-001 | Verify installation against manufacturer specifications. | All components are installed as per specifications. | Installation checklists, photographs. |
| IQ-CT-002 | Check PLC functionality and audit trail. | PLC logs show no errors and maintain an audit trail. | PLC log reports. |
| IQ-CT-003 | Test cooling temperature settings. | Temperature meets specified limits. | Temperature logs, calibration certificates. |
| IQ-CT-004 | Validate airflow settings. | Airflow meets specified limits. | Airflow measurement reports. |
| IQ-CT-005 | Measure cooling time. | Cooling time is within specified range. | Cooling time logs. |
Detailed Test Cases:
- Test Case 1: Verify installation of all mechanical and electrical components according to manufacturer’s specifications. Document any discrepancies.
- Test Case 2: Ensure PLC is programmed correctly, and the audit trail is functioning without errors. Review logs for compliance.
- Test Case 3: Measure the cooling temperature during operation. Record data and compare against acceptance criteria.
- Test Case 4: Assess airflow rate using calibrated instruments. Document results and ensure compliance with specifications.
- Test Case 5: Monitor cooling time from start to finish. Ensure it falls within the specified range and document results.
Deviations: Any deviations from the acceptance criteria must be documented and reported to the Quality Assurance team for further investigation and resolution.
Approvals:
- ____________________ Validation Team Lead
- ____________________ Quality Assurance Manager
- ____________________ Production Supervisor