ABSTRACT
The preparation of sterile products often requires that
firms utilize aseptic processing, as there are many formu-
lations where terminal sterilization using either steam or
radiation is incompatible with the formulation. The
inherent and largely unavoidable risks associated with
the use of aseptic processing are widely recognized;
regulators and practitioners across the globe acknowl-
edge that aseptic processing should only be used where
lethal treatments are not possible. A lethal process
directed at final containers is always preferable to one
that relies on the uncertain exclusion of microorganisms
as a final product is assembled from a number of
previously sterilized materials. As aseptic processing
ordinarily requires activities be performed by personnel,
there is the additional concern for introduction of human
borne microbial contamination. The regulatory prefer-
ence for terminal sterilization has been formalized by
both FDA and EMEA (1-3). Regrettably, while the expec-
tation and intent is that terminal sterilization will be
utilized wherever possible, there are a variety of materials
where aseptic processing is currently the only possible
means for preparation, i.e., sterile bulk antibiotics, freeze
dried formulations, most but not all biological products,
and materials without sufficient moisture content
(a minimum of approximately 10%). For the production
of these types of products, aseptic processing is the only
current methodology available.
