Document Control
Document ID: IQ-GLR-001
Version: 1.0
Date: 2023-10-06
Prepared by: Validation Team
Approved by: Quality Assurance
Installation Qualification Protocol for Glass-Lined Reactor in API Manufacturing
Meta Description: This document outlines the Installation Qualification protocol for the Glass-Lined Reactor used in API manufacturing for chemical synthesis.
Tags: Equipment Validation, Installation Qualification, API Manufacturing, Glass-Lined Reactor
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Glass-Lined Reactor (GLR) is installed correctly and operates according to the specified requirements for chemical synthesis reactions.
Scope
This protocol applies to the Installation Qualification of the Glass-Lined Reactor used in the production area for API manufacturing processes.
Responsibilities
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the IQ protocol and results.
- Operations Team: Responsible for providing access to the equipment and necessary information.
Prerequisites
- Completion of Equipment Installation.
- Availability of relevant documentation including User Requirement Specification (URS), Annex 11, and Annex 15.
- Training of personnel involved in the validation process.
Equipment Description
The Glass-Lined Reactor (GLR) is designed for chemical synthesis reactions, providing a controlled environment for the production of active pharmaceutical ingredients (APIs). The reactor features capabilities for temperature control, pressure management, and agitation, critical for maintaining reaction conditions.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation of GLR components. | All components installed as per design specifications. | Installation checklist signed off. |
| IQ-02 | Check temperature calibration. | Temperature readings within ±1°C of set point. | Calibration certificate and logs. |
| IQ-03 | Validate pressure settings. | Pressure readings within specified limits. | Pressure test results. |
| IQ-04 | Test agitation RPM. | Agitation RPM within operational range. | Agitation log report. |
| IQ-05 | Review PLC logs for consistency. | Logs show expected operational parameters. | PLC log report. |
Detailed Test Cases
Test Case IQ-01: Verify Installation of GLR Components
Procedure: Inspect all components of the Glass-Lined Reactor to ensure they are installed according to the design specifications.
Acceptance Criteria: All components must be installed as per design specifications.
Evidence: Installation checklist signed off by responsible personnel.
Test Case IQ-02: Check Temperature Calibration
Procedure: Measure temperature using calibrated thermocouples.
Acceptance Criteria: Temperature readings must be within ±1°C of the set point.
Evidence: Calibration certificate and temperature logs.
Test Case IQ-03: Validate Pressure Settings
Procedure: Conduct a pressure test on the reactor system.
Acceptance Criteria: Pressure readings must be within specified limits.
Evidence: Documented pressure test results.
Test Case IQ-04: Test Agitation RPM
Procedure: Measure the RPM of the agitation system during operation.
Acceptance Criteria: Agitation RPM must be within the operational range specified in the URS.
Evidence: Agitation log report.
Test Case IQ-05: Review PLC Logs for Consistency
Procedure: Analyze PLC logs for operational consistency.
Acceptance Criteria: PLC logs must reflect expected operational parameters without discrepancies.
Evidence: PLC log report.
Deviations
Any deviations from the acceptance criteria must be documented and reviewed. A corrective action plan should be developed and approved by the Quality Assurance team.
Approvals
Prepared by: ___________________________ Date: _______________
Approved by: ___________________________ Date: _______________