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General Considerations for the Risk Assessment of Isolators used for Aseptic Processes

This article examines the risks associated with the operation of isolators used for aseptic processing activities (aseptic filling and sterility testing) and focuses on risks from microbial and particulate contamination. However some of the preventative measures may be applicable to other forms of contamination.

In exploring the subject of risk assessment, it should be noted that different types of isolators are prone to different contamination risks. Therefore, the risks for isolators used for clinical pharmacy, sterility testing, aseptic filling and so on all differ. The definition of an isolator taken in this article is a device (1):

Provided with microbially retentive filtered air (and which does not exchange any other air with the surrounding environment)
That has a decontamination cycle (for the isolator itself and for material entering)
That has a means for material transfer and/or connection to another isolator
Where no human part directly enters the isolator

All isolators are at risk from contamination. Although isolators are superior in many ways to cleanrooms, the approach of regulators, such as the FDA, is:

"Barrier isolators cannot prevent contamination caused by GMP deficiencies such as poor aseptic procedures and inadequate training of... operators". (2)


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By Tim Sandle, Microbiologist at Bio Products Laboratory (BPL)

Tim Sandle is the company Microbiologist at Bio Products Laboratory (BPL). BPL is the manufacturing unit of the National Blood Authority, a special health authority within the NHS. Prior to his current role Tim has worked on a number of different microbiological projects within the blood service including developments in the testing of endotoxins and pyrogens for protein-based products; establishing the environmental monitoring regime in the pharmaceutical factory and validating a sterility testing isolator system. Tim has had articles published relating to pharmaceutical microbiology, including LAL testing; operation of isolators; cleanrooms; environmental monitoring and pharmaceutical microbiological testing.

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Tim Sandle
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