Unidirectional Flow Stations

Introduction

Unidirectional Airflow Workstations (previously know as laminar flow units LFU's) provide an ultra-clean working environment for numerous applications in pharmaceutical research, manufacture and dispensing, medical device manufacturing, any non-hazardous application that requires ultra-clean air.

Unidirectional airflow workstations are designed to provide and ultra-clean airflow exceeding EU GMP Grade A or ISO Class 5 air quality.

Approach

Our testing is comprehensive and designed to satisfy the requirements of US (FDA), UK (MHRA) and European regulatory authorities.

We measure airflow across the filter face to demonstrate the airflow is uniform across the working area.

We perform integrity testing of the HEPA filters to insure the air quality is not compromised by particles penetrating the filters.

We perform airflow visualisation to demonstrate the airflow is unidirectional and there is no reversal of flow from outside the working area.

We measure particle levels at the working area to demonstrate the air quality meets the required classification.

Detailed validation reports are compiled that contain all of the real-time data generated as well as a concise summary and clear conclusion.

Experience

We are experienced in the qualification of unidirectional airflow workstations ranging from small bench top horizontal units to large scale entire cleanroom installations.

We have experience with many manufactures including Envair, Microflow and Bigneat.

We can help with the generation of User Requirement Specifications (URS), perform Design Qualification (DQ) and Validation Reviews.

We perform Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Re-qualification on clients behalf.