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

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.

We are conversant with current industry standards and guidelines.

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

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 provide operational resource and assistance with User Requirement Specifications (URS), Design Qualification/Reviews (DQ), Factory Acceptance Testing (FAT), Site Acceptance Tests (SAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Re-qualification and Validation Reviews.