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USP 797 Sterile Compounding Cleanroom FAQ
Tips and Techniques to Maintaining Cleanroom Sterility
florida cleanroom systems 088    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.

   In addition, the steep price of product rejects and recalls makes it difficult  to ensure high product yields.

   Microorganisms 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.

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   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 compounding operations.

   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.

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shadow    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.

   Temperature and 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 solutions.

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   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:

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Should we use hardwall or softwall construction for our USP-797 sterile compounding cleanroom.

 Both 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.

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Can we use our existing air handling system to control temperature and relative humidity in our USP-797 sterile compounding cleanroom?

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.

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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.   

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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.

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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 beginning construction.

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 pdf downloads 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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