Document Number: IQ-RMSB-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Prepared by: [Your Name]
Approved by: [Approver’s Name]
Installation Qualification Protocol for Raw Material Sampling Booth
Meta Description: This document outlines the Installation Qualification (IQ) protocol for the Raw Material Sampling Booth used in API manufacturing, focusing on critical parameters and acceptance criteria.
Tags: Equipment Validation, API Manufacturing, IQ Protocol, Sampling Booth
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Raw Material Sampling Booth is installed correctly and operates according to specified requirements and standards.
Scope
This protocol applies to the Raw Material Sampling Booth used in the Warehouse/Sampling area for sampling API raw materials and intermediates. It addresses the critical parameters impacting product quality.
Responsibilities
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the IQ protocol.
- Maintenance Team: Responsible for ensuring the equipment is maintained and operational.
Prerequisites
- Completion of equipment installation.
- Availability of necessary tools and materials for testing.
- Training of personnel on the operation of the sampling booth.
Equipment Description
The Raw Material Sampling Booth is designed for the safe and efficient sampling of API raw materials and intermediates. It features HEPA filtration, adjustable air velocity settings, and alarm systems for differential pressure (DP) monitoring.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify air velocity at sampling location. | Air velocity within specified range (0.45 – 0.75 m/s). | Air velocity measurement logs. |
| IQ-02 | Check HEPA filter integrity. | HEPA filter passes integrity test (DOP test results). | Filter integrity test report. |
| IQ-03 | Verify DP alarm functionality. | DP alarms activate at specified thresholds. | Alarm test logs. |
Detailed Test Cases
Test Case IQ-01: Verify Air Velocity
Procedure: Use an anemometer to measure air velocity at the sampling location. Record measurements at various points within the booth.
Acceptance Criteria: Air velocity must be within the range of 0.45 – 0.75 m/s.
Evidence: Documented measurement logs with timestamps and locations.
Test Case IQ-02: Check HEPA Filter Integrity
Procedure: Conduct a DOP test to assess the integrity of the HEPA filter. Follow the standard operating procedure for testing.
Acceptance Criteria: The HEPA filter must pass the integrity test.
Evidence: Integrity test report detailing the results.
Test Case IQ-03: Verify DP Alarm Functionality
Procedure: Simulate conditions to trigger the DP alarm and verify activation at the specified thresholds.
Acceptance Criteria: The DP alarm must activate as per the defined specifications.
Evidence: Logs of alarm tests conducted.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A corrective action plan should be implemented as necessary.
Approvals
Prepared by: ____________________ Date: ___________
Reviewed by: ____________________ Date: ___________
Approved by: ____________________ Date: ___________