Biomedical Engineering Reference
In-Depth Information
rapid microbiological methods only provide nondefinitive information sooner
rather than later. Sampling can never prove the absence of something. The
placement of one system higher in the continuum relates solely to the system
features that have moved personnel away from critical activities. With isolators,
that separation is near absolute, a situation that can only be attained in aseptic
processing systems operating without personnel.
9.3 RISK ASSESSMENT
The advances in aseptic processing technology as well as the various continuums
were not derived using any formal risk assessment methodology. As humans, we
evaluate risk daily in our personal lives, and almost never invoke any sophisti-
cated means for doing so. Choosing whether to carry an umbrella on a cloudy
day, eat sushi for lunch, or stop when the light turns yellow are choices relative
to risk we make more or less intuitively, and sometimes almost instantaneously.
The technological advances described previously were made without formal con-
sideration of risk in aseptic processing, most likely because defined methods for
doing so did not yet exist.
While risks and human assessment of them have existed for millennia, the
use of formalized methods is a much more recent development. The first of
these is failure mode effects analysis (FMEA), which was originally developed
for the US military in the late 1940s. The evaluation keys to FMEA are esti-
mates of severity, occurrence, and detection; these are multiplied to determine
a risk priority number [20]. Inherent in its application is the ability to iden-
tify the rating given in each category. Numerous other formal risk assessment
tools have been developed including HAACP, HAZOP, FTA, and others. Each
of these has been applied with success within the healthcare industry for various
applications—process reliability, bioreactor contamination, process safety, etc.
The use of risk assessment for aseptic processing is newer still.
The Food and Drug Administration essentially reinvented its role as a
regulator and radically altered its vision of expectations in “Pharmaceutical
CGMPs for the 21st Century—A Risk-Based Approach [21].” This document
essentially challenged the pharmaceutical industry to rethink its approaches
and attitudes with respect to pharmaceutical quality. Among the fundamental
precepts were the following ones.
• “Encourage the early adoption of new technological advances by the phar-
maceutical industry.
• Facilitate industry application of modern quality management techniques,
including implementation of quality systems approaches, to all aspects of
pharmaceutical production and quality assurance.
• Encourage implementation of risk-based approaches that focus both industry
and Agency attention on critical areas.
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