USP 797 Sterile Compounding Cleanroom FAQ
Tips and Techniques to Maintaining Cleanroom Sterility
Failure to maintain strict cleanroom cleanliness and sterility in ISO Class
7 and ISO Class 5 USP-797 sterile compounding cleanrooms can adversely harm
patients, promote product rejects and recalls, and if contaminated
with microorganisms, ensure low product yields.
addition, the steep price of product rejects and recalls makes it difficult
to ensure high product yields.
introduced into a cleanroom environment need only three things to grow:
moisture, food and temperature – all of which exist in a cleanroom.
Consequently, all incoming air, water, chemicals, and materials must be
filtered or sterilized to meet high standards of purity and microbiological
control, so as not to contaminate processes or products in production.
USP-797 cleanroom environments must be able to maintain both
viable and non viable counts to remain operationally effective for the
processes that are preformed within the cleanroom environment. Strict
regulatory compliances insist on the cleanroom and process operators
maintaining sterile environmental conditions while preforming sterile
Sterile cleanroom environments
offer the most stringent construction and operational cleanroom environments
with appropriate design and construction serving to present a physical
cleanroom enclosure capable of being sterilized and maintained to the United
States Pharmacopeial Conventions USP-797 cleanroom regulatory compliances.
Surface areas, gasketing, and final finishes must be able to withstand daily
sanitizing with cleanroom chemical solutions without degradation of surface
materials. Prudent sterile construction requires hardwall design with
minimal joints, gap tolerances, or leakage to prevent microbial buildup,
particulate intrusion or any other possible contamination of the cleanroom
interior finish surfaces.
USP-797 air supply, airflow, air changes, and adequate differential
pressurization of the primary cleanroom and change room must operate to
mitigate any intrusion of microbial contamination or particulate matter to
assure a sterile compliant product.
relative humidity, if not controlled to safe levels, will result in
microbial growth and bioburden left deposited throughout the cleanroom
environment. Microbial growth, rust particulates, and corrosion of interior
surfaces from excess relative humidity will ultimately find way into sterile
HEPA filtrations modules, one of the primary levels of defense
against cleanroom particulate intrusion, must be assisted with appropriate
design, placement, and operation by vigorous cleaning and decontamination
protocols for operators and the sterile cleanroom environment. Failure of
one link of the sterility chain results in contamination of all operations.
USP-797 Cleanroom Construction FAQs:
Should we use hardwall or softwall construction
for our USP-797 sterile compounding cleanroom.
systems will provide ISO Class particulate cleanliness levels per USP-797
compliance levels. That is where the similarities end. Cleanroom particulate
levels are only one third of the final equation to maintaining sterility.
All cleanroom surfaces including gaps, joints, surface finishes, and
textures must be accepatable to employing common cGMP sterilization
techniques. Vinyl's, Velcro closures, and gaps between loose panels will
ultimately harbor cleanroom bioburden due to finish porosity and gap
tolerances inherent in their design, composition and construction. They also
deliver minimal if any particulate intrusion or differential pressure
control well below most compliance requirements.
Can we use our existing air handling system to
control temperature and relative humidity in our USP-797 sterile compounding
Commercial air handling units,
typically lacking in any mold mitigation or maintenance cleaning services
have mold growing on the backside of the evaporator coil, in the drain
pan and line, and in the plenum. They are not specially designed to
deliver the airflows, air changes, or sterile operation required for ultra
high sterility cleanroom operations. They are notorious breeders of mold,
funguses, and other contaminants you do not want injected into a USP-797
sterile compounding environment. HEPA filtration modules stop only 99.99% of
particulate at 0.3 microns. The list of possible cleanroom contaminates with
particulate sizes below 0.3 microns is too numerous to fully list.
Maintaining the sterility of the air supply starts with the sterile
cleanroom air handling system, not the HEPA filtration modules.
Can we locate our sterile compounding cleanroom
next to our restrooms and break room to save on plumbing cost?
Cleanrooms utilized for USP-797 sterile processing should not be
located next to existing restroom, break room, kitchen or other facilities
in you building that may host a abundance of bioburden, cleaning chemicals,
or other contamination sources, typically the cost savings on plumbing is
minimal while the risk exposure to bateria contamination is maximum. Any
sinks, sanitary piping, or sink operators should be of a style and material
approved for sterile applications.
We have an 8' ceiling height in our pharmacy and would like to install a
USP-797 compliant compounding area. Is 8' provide enough overall clearance.
No, the clearances required for code
compliances, sterile cleaning of cleanroom process equipment, and utility
systems all typically require a minimum of 10' if installed correctly.
Several clients have requested forms of horizontal flow cleanrooms but
the airflow patterns disperse airborne particulates and contaminants far
differently than vertical flow cleanrooms in our opinion would not be
suitable for sterile processing applications.
Are building permits required for the installation
of USP-797 compliant modular cleanrooms in our pharmacy?
In our home state of Florida, yes, nationwide codes vary due to the
interpretation by local building officials for modular construction. If in
doubt you show consult with your local building department officials before
proceeding with the purchase of any nodular style cleanroom system or
Can we submit for
and pull our own required building permits for the construction or
installation of our cleanroom systems.
In Florida there is a permit by owner process, see the posted download
available on our
page for Florida Builder Owner Permits. Nationwide requirements vary and you
should consult with your local building department officials before assuming
this type of construction or installation.
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