Document Control:
Version: 1.0
Date: 2023-10-01
Prepared by: [Your Name]
Reviewed by: [Reviewer Name]
Approved by: [Approver Name]
Performance Qualification Protocol for Sampling Booth in Solid Dosage Form Production
Meta Description: This document outlines the Performance Qualification protocol for Sampling Booths in Solid Dosage Form production, focusing on critical parameters and compliance.
Objective
The objective of this protocol is to validate the performance of the Sampling Booth (Downflow/RLAF) in the production area for raw material sampling under containment, ensuring compliance with critical parameters.
Scope
This protocol applies to the Sampling Booth utilized in the production and sampling of raw materials for solid dosage forms. It encompasses the performance qualification of the system to ensure it meets the defined acceptance criteria.
Responsibilities
The following personnel are responsible for the execution and oversight of this protocol:
- Validation Team: Conducts the qualification tests and documents the results.
- Quality Assurance: Reviews and approves the protocol and results.
- Production Team: Provides access to the equipment and necessary resources.
Prerequisites
Before executing this protocol, the following prerequisites must be met:
- Equipment must be installed and operational.
- Personnel must be trained on the use of the Sampling Booth.
- All relevant SOPs must be reviewed and available.
Equipment Description
The Sampling Booth (Downflow/RLAF) is designed for the safe sampling of raw materials under containment. Key features include:
- HEPA filtration for air cleanliness.
- Downflow design to minimize contamination risk.
- Integrated alarm systems for differential pressure monitoring.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| TP-001 | Measure air velocity at designated points | Air velocity must be within specified range | Velocity test report |
| TP-002 | HEPA filter integrity test | HEPA filter must pass integrity test | HEPA integrity test report |
| TP-003 | Verify differential pressure alarm functionality | DP alarms must activate within specified limits | Alarm test report |
Detailed Test Cases
Test Case 1: Air Velocity Measurement
Objective: To ensure the air velocity in the Sampling Booth is within the specified range.
Procedure: Use an anemometer to measure air velocity at the intake and exhaust points. Record values and compare to acceptance criteria.
Acceptance Criteria: Air velocity must be between 0.5 to 1.0 m/s.
Evidence: Documented measurements in the test report.
Test Case 2: HEPA Integrity Test
Objective: To confirm the integrity of the HEPA filter.
Procedure: Conduct a DOP test to assess HEPA filter integrity.
Acceptance Criteria: No leakage detected.
Evidence: HEPA integrity test report.
Test Case 3: Differential Pressure Alarm Functionality
Objective: To verify the functionality of the differential pressure alarm system.
Procedure: Simulate a condition that would trigger the alarm and confirm activation.
Acceptance Criteria: Alarm must activate within specified limits.
Evidence: Alarm test report.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A deviation report must be filed and approved by Quality Assurance.
Approvals
This protocol must be approved by the following personnel:
- Validation Team Lead: ______________________
- Quality Assurance Manager: ______________________
- Production Manager: ______________________