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Pharmaceutical Manufacturing and Packing Sourcer

Containment by Airflow for Highly Potent Materials

This article was prepared in response to a common question posed by manufacturing facilities, 'Can we process highly potent materials (above 50 microgram/m3) using containment by airflow devices, such as downflow booths?' The simple answer to this is 'yes', but it is not a recommended best practice for a number of reasons. This question is normally asked because the manufacturing facility wants to avoid the use of isolation technology due to:

Perceived high capital cost
Restrictions placed with respect to the operator's ability
to interface with the target operation
Space requirements

This article discusses the reasons why using containment by airflow devices is not best practice for high potency products and puts forward the case for closed processing of these materials using isolation technology.

Containment By Airflow

Containment by airflow systems provide operator protection by moving air at high velocity across the area where the required material is being handled. The premise here is that any airborne contamination is captured by the airflow and eventually captured in filter media. By their nature containment by airflow devices are open systems - that is, there is no physical barrier between the hazardous material and the operator.

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By Hari Floura, President of Operations for Applied Containment Engineering Inc. Hari Floura is the President of Operations for Applied Containment Engineering Inc. Since obtaining his degree in Industrial Design Engineering in 1988, Hari has worked exclusively in the field of containment technology within the pharmaceutical industry.
Prior to the inauguration of Applied Containment Engineering Inc. in July 2001, Hari held positions with Parsons Inc, Kvaerner Process, Total Process Containment Ltd, Process Containment Technology Ltd and Extract Technology Ltd. During this time he has been responsible for R&D, conceptual/detail design, project management, assembly, installation and validation for a number of successful containment projects.
Hari has also provided consultancy to many major pharmaceutical companies with respect to their containment guidelines, and facility and containment system designs. He is also a member and regular presenter at the International Society of Pharmaceutical Engineers, and sits on the Standardized Measurement of Equipment Particulate Airborne Concentration (SMEPAC) Committee.

Hari Floura
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