Direct Impact Cleaning




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 300 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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Last modified on Thursday, July 28, 2011
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2007 HUBER