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sterile products

Chapter 2

The area in which the compounding will take place is referred to as the clean room
The mandatory requirements and related suggestions appear in good professional guidelines such as those provided by the? America Society of Health Systems Pharmacists(ASHP)
4 key factors contribute to the preparation of high quality sterile products *facilities * environmental control * components *operators
The area that is to be set up for compounding should have limited ____________________ and airflow______________ traffic and unrestricted
considerations for the clean room should include at least these 8 items *laminar airflow hood*provide proper storage for drugs and supplies*temperature*light*moisture*sanitation*ventilation *security
room located outside the clean room, where gowning and handwashing take place, also no drinks/food/low particulate anteroom
what 3 things are highly regulated for a clean room *air quality *temperature *humidity
Federal Standard 209D clean room air quality standards *class 10,000 no more than 10,000 particulates larger than 0.5 micron in any given cubic foot of air
Federal Standard 209D clean room air quality standards *class 1000 no more than 1000 particulates larger than 0.5 micron in any cubic foot of air
Federal Standard 209D clean room air quality standards *class 100 no more than 100 particulates larger than 0.5 micron in any given cubic foot of air
how many doors does a clean room have 1
what is a positive pressure room when the door is open, the air flows out of the room
usp 797 criteria for proper set up of aseptic preparations help evaluate these 8 areas *facility design*microbial contamination risk levels*personal training and evaluation*clean room atmosphere*proper dress*quality assurance*validation*monitoring
what are the 2 types of air flow hoods? *Laminar Airflow Hood(LAH) **Biological Safety Cabinet(BSC)
What are the 2 functions of the air flow hood *to filter bacteria and other particulate matter from the air *to maintain a constant airflow out of the hood to prevent entry of any of the contaminants
RE: LAH where is the prefilter located ?? front
RE: LAH when should the prefilter be changed monthly
RE: LAH the HEPA filter removes particles that are what size 2 microns and larger
how many times should a HEPA filter be tested for efficiency Every 6 months
which air flow hood has 4 sides and a 8 to 12 inch opening in the front/also a sliding glass window in the front BSC Biological Safety Cabinet
in this air flow hood the HEPA filter filters the air to 0.3 micron BSC
a thorough cleaning of the hood should be done at least every ____ hrs or when it gets dirty 8
Created by: Rx14phx



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