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

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

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.

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

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 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.