Document Control:
Document ID: PQ-OSD-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Performance Qualification Protocol for Air Shower System
Meta Description: This document outlines the Performance Qualification (PQ) protocol for the Air Shower system used in solid dosage form manufacturing, ensuring compliance with acceptance criteria.
Tags: Equipment Validation, Performance Qualification, Air Shower, Solid Dosage Form
Objective
The objective of this Performance Qualification (PQ) protocol is to validate the Air Shower system used for personnel de-dusting before entry into the manufacturing area, ensuring it meets the specified acceptance criteria.
Scope
This protocol applies to the Air Shower system located in the facility, focusing on its operation and effectiveness in personnel de-dusting processes prior to entry into controlled environments.
Responsibilities
- Validation Team: Responsible for executing the protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Facilities Management: Responsible for maintaining the Air Shower system.
Prerequisites
All personnel involved in the execution of this protocol must have completed the necessary training on equipment operation and validation processes.
Equipment Description
The Air Shower system is designed to remove particulate contamination from personnel before they enter controlled environments. It operates using high-velocity air jets to dislodge dust and other contaminants from clothing and skin.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| TP-01 | Measure air velocity at designated points. | Air velocity must be within specified range (e.g., 20-25 m/s). | Calibration report, measurement logs. |
| TP-02 | Verify cycle time of the air shower. | Cycle time must not exceed 30 seconds. | Timing logs, operational records. |
| TP-03 | Check interlocks functionality during operation. | All interlocks must function correctly without failure. | Test results, operational logs. |
Detailed Test Cases
Test Case 1: Air Velocity Measurement
Objective: To ensure the air velocity is within the specified range.
Procedure: Use an anemometer to measure air velocity at three designated points within the Air Shower.
Acceptance Criteria: Air velocity must be between 20-25 m/s.
Expected Result: Measurements fall within the acceptable range.
Test Case 2: Cycle Time Verification
Objective: To confirm that the air shower cycle time does not exceed the maximum limit.
Procedure: Start the air shower and record the time taken for one complete cycle.
Acceptance Criteria: Cycle time must not exceed 30 seconds.
Expected Result: Cycle time is recorded as less than or equal to 30 seconds.
Test Case 3: Interlocks Functionality Check
Objective: To verify that all interlocks function correctly.
Procedure: Engage each interlock and confirm the air shower operates only when all conditions are met.
Acceptance Criteria: All interlocks must function correctly without failure.
Expected Result: All interlocks are operational as intended.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed and implemented as necessary.
Approvals
Prepared By: [Name, Title]
Reviewed By: [Name, Title]
Approved By: [Name, Title]