Document Control
Document Number: IQ-DB-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Reviewer Name]
Approval Date: [Insert Approval Date]
Installation Qualification Protocol for Dispensing Booth in API Manufacturing
Meta Description: This document outlines the Installation Qualification (IQ) protocol for the Dispensing Booth used in API manufacturing, focusing on critical parameters and acceptance criteria.
Objective
The objective of this protocol is to verify that the Dispensing Booth is installed according to specifications and is functioning as intended for weighing API raw materials.
Scope
This Installation Qualification applies to the Dispensing Booth used in the API manufacturing area, specifically for the weighing of raw materials that have a direct impact on product quality.
Responsibilities
The Validation Team is responsible for executing this protocol, documenting results, and ensuring compliance with applicable standards and regulations.
Prerequisites
All installation activities must be completed, and the Dispensing Booth must be cleaned and sanitized before beginning the IQ protocol.
Equipment Description
The Dispensing Booth is designed to provide a controlled environment for the accurate weighing of API raw materials. Key features include HEPA filtration, controlled air velocity, and integrated alarm systems for differential pressure monitoring.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify air velocity at the booth’s entry points. | Air velocity must be within the specified range as per URS. | Calibration report and measurement logs. |
| IQ-02 | Check HEPA filter integrity. | HEPA filter must pass integrity testing. | Test results and certificates. |
| IQ-03 | Test differential pressure alarms. | Alarms must activate at specified DP thresholds. | Alarm test logs. |
Detailed Test Cases
Test Case: IQ-01
Objective: To verify that the air velocity is within the specified range.
Procedure: Measure air velocity at designated entry points using an anemometer.
Acceptance Criteria: Air velocity must be between [insert range] m/s.
Evidence: Calibration report and measurement logs.
Test Case: IQ-02
Objective: To ensure HEPA filter integrity.
Procedure: Conduct a HEPA integrity test using [insert method].
Acceptance Criteria: The filter must show no leaks or breaches.
Evidence: Test results and certificates.
Test Case: IQ-03
Objective: To verify the functionality of differential pressure alarms.
Procedure: Simulate conditions to trigger alarms and verify activation.
Acceptance Criteria: Alarms must activate at specified DP thresholds.
Evidence: Alarm test logs.
Deviations
Any deviations from this protocol must be documented and justified. Approval from the Validation Manager is required for any changes to the acceptance criteria.
Approvals
Prepared By: [Insert Name]
Approved By: [Insert Name]
Date: [Insert Date]