Document Control Number: IQ-GLR-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Signature: ___________________
Installation Qualification Protocol for Glass Lined Reactor (GLR)
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Glass Lined Reactor (GLR) is installed according to the manufacturer’s specifications and is suitable for its intended use in chemical synthesis reactions.
Scope
This protocol applies to the Installation Qualification of the Glass Lined Reactor (GLR) used in the API manufacturing area for chemical synthesis and purification processes.
Responsibilities
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Engineering: Responsible for installation and technical support.
- Quality Assurance: Responsible for review and approval of the IQ documentation.
Prerequisites
- Installation of the Glass Lined Reactor must be completed.
- All relevant documentation (URS, specifications) must be available.
- Personnel must be trained on the use of the GLR.
Equipment Description
The Glass Lined Reactor (GLR) is designed for chemical synthesis reactions with the following key features:
- Temperature control
- Pressure monitoring
- Agitation capabilities
- Reaction control via PLC
- Audit trail for compliance
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation against manufacturer specifications. | All components installed as per specifications. | Installation checklist signed and dated. |
| IQ-02 | Check utility connections (water, electricity, gas). | All connections are secure and leak-free. | Utility connection report. |
| IQ-03 | Test temperature calibration. | Temperature readings within ±2°C of set point. | Calibration records. |
| IQ-04 | Test pressure calibration. | Pressure readings within ±5% of set point. | Calibration records. |
| IQ-05 | Verify agitation functionality. | Agitation speed within specified range. | Agitation test report. |
| IQ-06 | Check PLC functionality and audit trail. | PLC logs show proper operation and data integrity. | PLC audit trail report. |
Detailed Test Cases
Test Case IQ-01: Verify installation against manufacturer specifications.
- Procedure: Inspect all components visually and compare with installation drawings.
- Expected Result: All components are installed correctly.
Test Case IQ-02: Check utility connections.
- Procedure: Inspect all utility connections for leaks and secure fittings.
- Expected Result: No leaks detected.
Test Case IQ-03: Test temperature calibration.
- Procedure: Set temperature and compare readings with calibrated thermometer.
- Expected Result: Readings match within ±2°C.
Test Case IQ-04: Test pressure calibration.
- Procedure: Set pressure and compare readings with calibrated gauge.
- Expected Result: Readings match within ±5%.
Test Case IQ-05: Verify agitation functionality.
- Procedure: Start agitation and measure speed with tachometer.
- Expected Result: Speed is within specified range.
Test Case IQ-06: Check PLC functionality and audit trail.
- Procedure: Review PLC logs for accuracy and completeness.
- Expected Result: Logs show proper operation.
Deviations
Any deviations from this protocol must be documented and approved by Quality Assurance. A deviation report must be generated if acceptance criteria are not met.
Approvals
Approved by: ___________________
Date: ___________________