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| home > pmps > winter 2003 > general considerations for the risk assessment of isolators used for aseptic processes |
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Pharmaceutical Manufacturing and Packing Sourcer
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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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