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July 1999

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Subject:
From:
Scott Sutton <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Thu, 15 Jul 1999 13:54:24 -0500
Content-Type:
text/plain
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text/plain (173 lines)
Warren,

I thoroughly enjoyed your message.  With your indulgance, I would present a
small contribution of my own -


        Alien/Inspector II: The Return


After several days spent touring manufacturing facilities on Mars and the
moons of Jupiter, the inspector has had a chance to review the initial
discussion and returns with some questions.


The Alien/Inspector:
"Surely everyone at USP cannot be blind to the facts, how is it that the
situation exists where improper media are used for recovery?"
"Well, the problem is that no one can agree on how to change it"
"How hard can it be?  Just change it."
"You see, if you propose a change, then a stand of trees in Oregon dies to
provide the paper used by Corporate Regulatory Representatives, consultants,
and VPs of contract laboratories to protest the intent, wording, and impact
of the changes.  They all have better ways to improve the test, but few of
them are compatible.  The only thing they agree on is that the current
method is hopelessly flawed."

The Alien/Inspector thinks for a moment, then asks:
"How about the government?  In your system of splitting the regulatory
authority between two bodies, a civilian and a governmental, surely the
other body can help."
"Well yes, the government has got a different method, a method widely held
to be superior to the USP method.  It is described in a manual called BAM."
"So this procedure uses better media than TSA and SDA?"
"Well, it uses Potato Dextrose Agar rather than SDA.  PDA is superior
because it isn't even slightly selective for fungi. BAM also refers to TSA
as M124 which sounds a lot more scientific."
"Have they different incubation temperatures?"
"Well, no."

These admissions result in another pause in the conversation.

The Alien/Inspector pushes on, although now a bit more cautiously:
"I've heard of something called 'ICH Harmonization' where the flawed USP
procedures are abandoned for the superior European procedures."
"Yes, it is an established fact that anything in Europe is better than
anything in the USP."
"Excellent, then we can rely on the ICH to correct this situation.  What
media do the scientifically superior Europeans use?"
"TSA and SDA, although they call them Medium B and Medium C which makes the
technique superior."
"Do they use different incubation temperatures?"
"Well, no."
"Do they have different limits for 'total' arerobic count?"
"Well, no.  But they don't have a separate specification for fungi!"

Now the Alien/Inspector is a bit agitated.
"So you are telling me that this procedure that will not recover all
organisms, and must be changed, is used by all organizations on this world,
with only minor modifications of specifications?"
"Yes, but that doesn't make it right.  We must maintain pressure to develop
a better method that is scientifically justified.  While we are doing this,
we must also make sure that any new method will not result in greater number
of product failures, as we know that products on the market are safe."

This is too much for our space-faring hero, who retreats to his spacecraft.
As he re-enters his craft, he is seen shaking his head, wondering how the
poor people of this world will find a way out of their conflicting needs and
expectations.

Enjoy,

Scott Sutton

-----Original Message-----
From: Casey, Warren M [mailto:[log in to unmask]]
Sent: Thursday, July 15, 1999 10:28 AM
To: [log in to unmask]
Subject: [PMFLIST] A little light reading


I took some time during lunch yesterday to write a little commentary on
Methods and Specs.  I figured I would submit it for your amusement.

Is There Fungus Among Us?  If so, How Do We Count It?  A Commentary on the
Not So Sensible World of Microbiological Nomenclature and Methodology  used
in the USP .

Suppose an alien (or FDA inspector) were to walk into your lab and ask you
to explain the rationale behind the MLT procedure you are using and the
associated numerical specifications (I will only discuss numerical
specifications in this essay due to the massive deforestation/bandwith clog
that would result from a discussion of "objectionable organisms").

The Alien/Inspector begins:
"I see you have a specification for Total Aerobic Microbial Count, TAMC, of
No More Than 100 CFU/g.   Tell me, how is this number calculated"
You Reply, with a high degree of confidence, "Well, we put a small amount of
product in a rich agar media called TSA, and then we incubate it at 32C for
2 days"
"And all microorganims on your planet will form colonies under these
conditions?"
"Well, no.  But it will pick up most of the fungi and bacteria that we think
are important to our industry"
"So it's really not a "total" aerobic count, it's more of a "the majority of
significant organisms" count?
"Correct"
"And this numerical limit of 100 cfu/g, I assume this number was derived
from data collected from numerous scientific studies"
"Well, no.  It was derived from some guys who guessed it may be a good
number. But there are almost no reported cases of people getting sick from
contaminated pharmaceutical products, so the specification must be good."
"I see" says the so Alien, and continues with  "And tell me about this
Fungal Count specification,  how do you determine the number of fungi in a
sample"
"We use special media called SDA to determine the number of yeast and molds
in our samples and we incubate the samples at 24C for 5 days instead of 32 C
for 2 days"
"Ahhhh, and this SDA was specifically designed to enumerate fungi?"
"Well, no.  It was actually developed as a highly selective media for the
qualitative  recovery of fungi from samples which were heavily contaminated
with bacteria."
"And your samples are heavily contaminated with bacteria?"
"Well, no.  But if they were......"
"So why are you using a qualitative recovery media to generate quantitative
data?"
"Because, um..."
"Hmmmm, well,  I assume that 24C is the optimum growth temperature for
fungi?"
"Well, no. C albicans and A. niger, the organisms we use to validate all of
our methods, grow much better on TSA than SDA and their optimum growth
temperature is closer to 37C.  Actually most medically important fungi have
an optimum growth temp close to 37C,  because this is close the body
temperature of us humans"
Confused, the Alien/Inspector continues, "I noticed that your Total Yeast
and Mold Count was derived directly from SDA plate counts"
"Yep, straight out of good ol' USP<51>"
"Will bacteria also grow on SDA"
"Sure, some of those little guys grow great on SDA at 24 C"
"So you could be counting bacteria and calling them fungi?"
"Yeah, but...."
"I also notice that the fungal specification is half the numerical value of
the Total Aerobic Microbial count"
"Yep, those fungi can be nasty little bugs"
"Nastier than bacteria"
"Well, no"
"More infective than Bacteria?"
"Well, no."
"More detrimental to the product than bacteria?"
"Well, no"
"Then why the lower spec?"
"Well, just because....."  does this Alien guy not understand anything!!

So the Alien/Inspector hops back into her spaceship, still wondering whether
or not she has encountered an intelligent life-form. You retire back to your
lab, thankful that the alien/inspector did not ask why you were testing for
Salmonella species in a product -type that would never support the growth of
these organisms, or why you use R2A media to recover waterborne /stressed
organisms, but TSA to recover organisms from your products (where most of
the contamination will probably come from water).

Regards,

Warren


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