Performance Qualification Protocol for Dynamic Pass Box with HEPA

Meta Description: This document outlines the Performance Qualification protocol for a dynamic pass box with HEPA used for material transfer in solid dosage form manufacturing, ensuring compliance with ISO14644 standards.

Tags: Equipment Validation, Performance Qualification, Solid Dosage Form, Pass Box, HEPA

Objective

The objective of this Performance Qualification (PQ) protocol is to validate the dynamic pass box with HEPA filter to ensure it operates within specified parameters for material transfer in a controlled facility environment.

Scope

This protocol applies to the dynamic pass box utilized for the transfer of materials in the solid dosage form manufacturing area, ensuring compliance with regulatory requirements and operational standards.

Responsibilities

• Validation Team: Responsible for executing the PQ protocol and documenting results.
• Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
• Maintenance Team: Responsible for ensuring equipment is maintained and calibrated prior to testing.

Prerequisites

• Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
• Training of personnel on the operation of the dynamic pass box.
• Availability of all necessary materials and equipment for testing.

Equipment Description

The dynamic pass box is designed for material transfer with an air purge system to maintain a controlled environment. It features HEPA filtration to ensure air quality and integrity during material transfer processes.

Test Plan

Detailed Test Cases

Test Case 1: Airflow HEPA Integrity

Objective: To ensure the airflow and HEPA filter are functioning as intended.

Procedure: Measure airflow rates at specified locations using an anemometer. Perform a HEPA integrity test using a particle counter.

Acceptance Criteria: Airflow must be within the specified range, and HEPA integrity must be intact with no detectable particles.

Test Case 2: Interlocks and Alarms

Objective: To verify that all safety interlocks and alarms are operational.

Procedure: Simulate conditions that trigger alarms and check for proper response from interlocks.

Acceptance Criteria: All interlocks must engage, and alarms must sound or display correctly.

Deviations

Any deviations from the acceptance criteria must be documented and reviewed by the validation team and Quality Assurance for further investigation and corrective actions.

Approvals

Approval of this PQ protocol signifies that all parties agree to the terms and conditions outlined herein and that the testing will proceed as planned.

Validated By: [Name, Title, Date]

Approved By: [Name, Title, Date]