Sterilization is the highest
level of disinfection.
Because tattoo and piercing needles penetrate into normally "sterile"
areas of the body they must be sterile. To maintain sterility
everything that touches that needle before
a procedure must be sterile also.
Sterility is a probability, not an absolute.
Though "Sterilization" is meant to convey an
absolute (the destruction or inactivation of all
microorganisms - either something is sterile or it is not)
A. It cannot be known with whether all
microorganisms
have been killed.
1. We may not
be aware of the existence of some.
2. We may not
actually be culturing for all microorganisms.
B. We cannot prove the existence of a
negative absolute.
Therefore the approach is to employ a "process"
definition.
Sterilization is the process by which living organisms are
removed or killed to the extent that they are no longer detectable
in standard culture media in which they had previously
proliferated. (Block, 4th Edition, Dis. Ster. Pres.)
Both the process and the methods used to test are equally important.
In actuality it is a probability and not an absolute.
Sterility measurement is expressed as a probability.
Sterility is considered achieved when it reaches what
is called a "log of minus 6 of reduction" rather than as an
absolute and is called the "Sterility Assurance Level" (SAL) which
can be quantitatively (in numbers) expressed. Let's see what
this means.
Each log represents a 90% reduction of microbes.
Imagine a glass full of water. Assume for a moment the water
represents the microbes and it equals one million microbes (estimated to be on your
product). We would call this "level 6", or a "Log of 6" (this is what a log of 6
will mean for our example: equals 1
million, the starting point).
If we empty 90% of the water it leaves 10% of the water. Our original one million (1,000,000 microbes - our water) minus 90% is
100,000 microbes left, and since we are reducing we go down the logs, as it were,
and now have a "log of 5" (or, now only 100,000 microbes-90% have been
killed or inactivated).
We proceed to empty 90% of what is left over in the
glass and we get a "log of 4" (100,000 microbes left over,
minus 90% (90,000 microbes),
equals now 10,000 microbes left) and so forth.
If we do this a total of 6 times we have a
"log of 0", which would be one microbe left. If we
now continue and want to empty 90%
of what's left (our 1 microbe) of course we can't empty 90% of just
one microbe.
But we can think of probability like this:
If we had one item we were sterilizing we would at this level have one microbe on
that item. Suppose though there were ten items we were
sterilizing and we did our log reductions up to this point. Since
there is 1 microbe left, we can say we have
one microbe among the ten items after the 6 logs of reduction. This level would be (minus one)
Log of -1, meaning one microbe per 10 items. A
log of reduction to -2 therefore means would mean the same thing as
having one microbe per 100 items, etc. A log of -6 means that only one microbe
might survive on a million items presuming that the original
microbial load was one million microbes or less. This is what is
called a Sterility Assurance Level (SAL) 10-6 = One
microbe per million items. That's it.
This is the level that your sterilizer must produce to be acceptable
as "sterile," a log of (minus) -6.
A log of - 3 is considered suitable for topically applied "sterile"
products. Implantables require a SAL of -6 Log. The level of disinfection-sterilization
varies according to the appropriate use of the item.
Normal saturated steam processing produces one log of reduction
(90% "kill") in about
1 to 2 minutes at 15 Lbs. psi. and 250°F.
"Sterility" under the conditions of saturated steam can be reached in about 12
to 15 minutes.
From this you can see the importance of cleaning to reduce the
original microbial load so that you can be sure of this SAL of
-6. If you started instead with 10 billion microbes ( a
quantity of 1010) you can see that
to reach a probability of 1
in a million items (10-6) will require
a longer cycle per minute time or higher
temperatures. (Sterilization Technology)
To be Assured of your sterility, thorough cleaning is required.
Items should be cleaned, dried and placed into sterilization
pouches. Though air is a source of microbes to possibly contaminate
items after washing and before bagging, even hospital air has been
measured to only an estimated load of 128 microbes per cubic meter, so
air is not of great concern unless you live in areas that have
a heavy soil particle air count. Soils are the predominant source
of spores.
Overkill is a term referring to the additional time a
sterilizer operates beyond the time necessary to reach the kill
level of sterilization. The common reference is the bacterial
spore G. Stearolthermphilus which is used for biological
monitoring of the sterilization process, which is usually in your
spore test strips that you send to the lab for testing. Test
kits normally contain two strips or one ampoule. One is processed by you in the
sterilizer and the other is not. Both are sent back to lab where
they are cultured. Hopefully the processed strip that you sterilized
will not grow and
the unprocessed strip that you did not sterilize will grow.
Normal
sterilization of the BI can usually be achieved in 6 minutes with the rest of
the time considered "overkill." A holding time of 15
to 20 minutes at temperature and pressure is considered adequate
"overkill." It would be un-reasonable to extend this time
without known and good reason. In our non-hospital environment you
can certainly give your clients the greatest confidence that they
will not be in danger.
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