Operational Qualification Protocol for Raw Material Sampling Booth

Meta Description: This document outlines the Operational Qualification (OQ) protocol for the Raw Material Sampling Booth used in API manufacturing, ensuring compliance with industry standards.

Tags: Equipment Validation, API Manufacturing, Operational Qualification

Objective

The objective of this Operational Qualification (OQ) protocol is to verify that the Raw Material Sampling Booth operates within specified parameters to ensure the integrity of API raw materials and intermediates during sampling.

Scope

This protocol applies to the Raw Material Sampling Booth located in the Warehouse/Sampling area, used for sampling API raw materials and intermediates. It encompasses all critical parameters as defined in the user requirements specification (URS).

Responsibilities

Validation Team: Responsible for executing the OQ protocol and documenting results.
Quality Assurance: Responsible for reviewing and approving the OQ documentation.
Operations: Responsible for providing access to the equipment and supporting validation activities.

Prerequisites

Completion of Installation Qualification (IQ).
Availability of necessary equipment and materials for testing.
Training of personnel on the operation of the Raw Material Sampling Booth.

Equipment Description

The Raw Material Sampling Booth is a controlled environment system designed for the safe sampling of API raw materials and intermediates. Key features include HEPA filtration, adjustable air velocity, and integrated differential pressure (DP) alarms to ensure proper airflow and contamination control.

Test Plan

Test ID	Procedure	Acceptance	Evidence
OQ-01	Measure air velocity at designated points within the booth.	Air velocity must be within 0.45 m/s to 0.75 m/s.	Calibration certificate and measurement log.
OQ-02	Verify HEPA filter integrity using a particle counter.	HEPA filter must maintain <0.5% penetration at 0.3 micron.	Particle counter results and filter integrity report.
OQ-03	Test differential pressure alarms during operation.	Alarms must activate when DP exceeds specified limits.	Alarm test log and operational report.

Detailed Test Cases

Test Case OQ-01: Air Velocity Measurement

Objective: To ensure that the air velocity within the Raw Material Sampling Booth is maintained within specified limits.

Procedure: Use an anemometer to measure air velocity at multiple points within the booth. Record the measurements.

Acceptance Criteria: Air velocity must be within 0.45 m/s to 0.75 m/s.

Evidence: Measurement log and calibration certificate of the anemometer.

Test Case OQ-02: HEPA Filter Integrity Test

Objective: To confirm that the HEPA filter is functioning correctly and prevents contamination.

Procedure: Utilize a particle counter to assess the HEPA filter integrity at specified locations.

Acceptance Criteria: The HEPA filter must maintain <0.5% penetration at 0.3 micron.

Evidence: Particle counter results and filter integrity report.

Test Case OQ-03: Differential Pressure Alarm Verification

Objective: To ensure that the differential pressure alarms function correctly during operation.

Procedure: Simulate conditions that exceed the differential pressure limits and verify alarm activation.

Acceptance Criteria: Alarms must activate when DP exceeds specified limits.

Evidence: Alarm test log and operational report.

Deviations

Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis will be performed for any critical deviations, and corrective actions will be implemented as necessary.

Approvals

Prepared by: ______________________ Date: ___________

Approved by: ______________________ Date: ___________