For almost 50 years, parenteral products have been
manufactured
in a "clean room" which is defined as a Class 100
environment.
The clean room typically has one or more gowned operators who
are
trained to generate as little as possible particulate or "viables"
i.e., bacteria, viruses from their presence. A HEPA air system maintains
a Class
100 or a log 3 environment.
The Class 100 can be also stated as a log three reduction
from the Class
of the room before the HEPA system was used. We can assume that
the
room was a Class 100,000, if it is now a Class 100 or a reduction of two
factors of 10. A log change is a change by a factor of ten.
We now have published information that pyrogens (any dead
cell material),
in any amount, can do great harm to an immune compromised (sick)
patient, when the pyrogen is injected along with the medication. This
is because
the body can only assume that the pyrogen is really alive
(otherwise how did it
get into the body), and mobilizes additional immune
forces to deal with the new
invader. The body also raises in temperature
in the body, with a fever to assist
the immune system, hence the Latin
word "Pyro" which means fire or
fever.
So the real goal is zero pyrogens. Pyrogens end up
in an injectable in
several ways. They are generated by the operator who
generates almost
all of the viables in a filling room. They are also generated
by improperly
prepared stoppers, which have pyrogens on the stopper surface. The
vials
are normally subjected to 300º C heat, and the pyrogenic cell material is
actually turned into carbon (ash) and is not a factor.
It is clear that the FDA, in view of the published
information, will be
expecting better than log 3 pyrogen reduction, which is the
standard today.
Huber machines, because of the patented Direct Impact
Clean System,
provide better than a log 4 reduction. In many cases log 5
reduction is
possible with longer cleaning cycles.
This is accomplished with all interior surfaces
electropolished, and many
high impact direct sprays directly impinging on every
square millimeter
of interior machines surfaces. There is no place for pyrogens
or particulate
to "hide."
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