Microbiological
Safety Cabinets
Introduction
Microbiological safety cabinets (MSC) are categorised into 3 types.
Class I, II and III.
Class I cabinets incorporate an open front aperture where manipulations
can be carried out. Air is drawn through the aperture to provide
operator protection and is filtered through two HEPA filters before
exhausting.
Class II cabinets incorporate an inflow at the aperture in the
same manor as a class I, but also incorporate a laminar downflow
to provide product protection.
Class III safety cabinets have total separation from the operator.
The cabinet consists of a sealed chamber where manipulations are
carried out using gauntlet gloves sealed to the chamber. The cabinet
is also maintained at a negative pressure to provide further protection.
Approach
The validation of microbiological safety cabinets including filter
integrity testing, particulate monitoring and airflow checks.
We measure the airflows within the cabinet in accordance with
the relevant standards.
We perform integrity testing of the HEPA filters to insure the
containment of any microbiological hazard.
We perform pressure decay tests (class III safety cabinets) to
ensure the safety cabinet carcass is integral.
We perform K.I. discus tests to prove operator protection at the
aperture of class I and II safety cabinets.
We perform airflow visualisation to demonstrate there are no still
air areas within the safety cabinet and the inflow around the front
aperture (class I and II cabinets) is not turbulent and allowing
reversal of flow.
We measure particle levels at the working area to demonstrate
the air quality meets the required classification.
Our testing is comprehensive and designed to satisfy the requirements
of US (FDA), UK (MHRA) and European regulatory authorities.
Experience
PEV staff are experienced in the validation of MSC's. We understand
the requirement of the relevant standards and guidelines for all
MSC types.
We are experienced in the validation of many manufactures of safety
cabinets including Envair, Microflow, ACE and CAMR.
We are able to assist in the qualification of all types of safety
cabinets. We can provide operational resources and assistance with
the generation of User Requirement Specifications (URS), Fatctory
acceptance test (FAT), site acceptance test (SAT), Installation Qualification
(IQ), Operational Qualification (OQ) and Performance Qualification
(PQ).
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