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Pharmaceutical Manufacturing and Packing Sourcer
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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.
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
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News and Press Releases |
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New PFA SonicLineŽ ultrasonic flowmeters
Flow measurement with ultrasound fast, precise, free from contamination The new PFA SonicLineŽ ultrasonic flowmeters assure precise measurement and control of chemical consumption and management of chemical stocks with high reliability. SonicLineŽ is also ideally suited for accurate batch and dosing processes with high reproducibility.
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