Document Control:
Version: 1.0
Date: [Insert Date]
Prepared by: [Insert Name]
Reviewed by: [Insert Name]
Approved by: [Insert Name]
Installation Qualification Protocol for Bottle Unscrambler
Objective: To establish and document the Installation Qualification (IQ) for the Bottle Unscrambler used in the packaging area for solid dosage forms, ensuring compliance with user requirements and regulatory standards.
Scope: This protocol applies to the installation and qualification of the Bottle Unscrambler in the Packaging/Primary area, focusing on its use for bottle feeding and orientation.
Responsibilities:
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Ensures compliance with regulatory requirements and reviews the IQ documentation.
- Maintenance Team: Assists in equipment installation and troubleshooting during the qualification process.
Prerequisites:
- All installation materials and equipment are available.
- Personnel are trained on equipment operation and safety procedures.
- Applicable standard operating procedures (SOPs) are reviewed and available.
Equipment Description:
The Bottle Unscrambler is designed to feed and orient bottles into the packaging line. It operates with speed jam sensors and interlocks to ensure safe and efficient operation.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation of the Bottle Unscrambler in the designated area. | Equipment is installed as per manufacturer specifications. | Installation checklist completed. |
| IQ-02 | Check electrical connections and ensure proper power supply. | Power supply is stable and meets specifications. | Electrical inspection report. |
| IQ-03 | Test speed jam sensors and interlocks. | All sensors and interlocks function correctly. | Sensor test results. |
Detailed Test Cases:
Test Case IQ-01:
- Procedure: Confirm the Bottle Unscrambler is positioned correctly.
- Acceptance Criteria: Equipment is aligned and secured as per specifications.
- Evidence: Photographic documentation and signed installation checklist.
Test Case IQ-02:
- Procedure: Measure voltage and current at the power supply.
- Acceptance Criteria: Voltage and current readings are within specified limits.
- Evidence: Electrical measurement logs.
Test Case IQ-03:
- Procedure: Simulate a jam and verify sensor response.
- Acceptance Criteria: Sensor triggers and interlock activates as intended.
- Evidence: Test report detailing sensor performance.
Deviations: Any deviations from the protocol must be documented and justified in a deviation report.
Approvals:
- [Insert Name], Validation Team Lead
- [Insert Name], Quality Assurance Manager