Clean Room Environments

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Importance Of Cleanroom Procedures
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The importance of cleanroom cleanliness cannot be
understated. Cleanrooms must adhere to a strict
standard and are rated according to their level
of cleanliness. If cleanrooms do not maintain
their cleanliness standard, the consequences
could be quite serious.
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Recently, a pharmacy in Tennessee had tragic
results when cleanliness procedures where not
adhered to. Cleanrooms are measured by the ISO
standard which limits the amount of particulates
that can be in an air sample of the cleanroom.
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There are various levels within the ISO standard
and they are ranged based on what types of
processes are being conducted in the room. Rooms
that work in sterile compounding or compounding
pharmaceuticals are held to an additional
standard .
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Several people received routine steroid
injections in which the steroids had been
produced in a Tennessee cleanroom facility.
Unfortunately, many of these patients developed
abscesses due to fungus and bacteria which had
contaminated the steroids. Although this
situation is tragic, it could have been
significantly worse.
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The FDA advises that all cleanrooms follow
written procedures. Cleanrooms can vary greatly
in size, and in order to keep these rooms running
up to standard, procedures must be followed.
Surfaces need to be cleaned, floors need to be
mopped and equipment may need maintenance or
cleaning.
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There are also additional procedures for wearing
the proper clothing and how to correctly enter
and exit the cleanroom. A report regarding this
Tennessee cleanroom showed some horrifying
findings. In addition to product splatters and
spiders, the FDA's findings also showed that the
cleanroom wasn't following written procedures.
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Furthermore, the FDA's report showed many
surfaces within the room were stained and not
cleaned using the appropriate materials. Worst of
all a lyophilisation machine was leaking oil from
the motor, and a paper towel was simply placed
underneath to absorb the oil.
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All of these factors from not cleaning properly
to not following a written procedure had terrible
consequences. Other instances of contaminated
materials from a singapore based facility led to
the sickness of hundreds and the death of over a
dozen people. Following written procedures to
maintain cleanliness is of the utmost importance.
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In conclusion, cleanrooms are controlled
environments that have a strict set of protocol
for cleanliness. Understanding that if these
protocols are not followed in the cleanroom,
drastic consequences could follow. Remember to
always follow procedures to keep your cleanroom
operating at the appropriate level.
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