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. |