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pht 100 c103

chapter 10 part 3

the cdc is the center for disease control
the cdc gives guidelines & recommendations to control infections
the cdc's major focus is preventing infections within hospitals
the cdc updates and publishes preventive guidelines
hand hygiene is most important
hand hygiene gets practiced 40% of the time
flu shots are effective by 70-90%
every year, flu shots are administered to 40% of healthcare workers
in 2004, the usp developed enforceable requirements for sterile preparation compounds
in 2008 sterile preparation compounds requirements were updated and approved
the usp chpt. 797 focuses on sterility & stability
compounding sterile preparations are done outside of the pharmaceutical manufacturer's facility like hospitals/compounding pharm]s
the usp chpt. 797 has guidelines for the csp developed by the u.s. pharmacopeia
the csp is the compounding sterile preparation
compounding sterile standards are more stringent
the usp chpt. 797 uses iso classification system for defining particulate matter amount allowed in room air
the iso is the internat'l organization for standardization
the buffer area is for component & supply storage and is for changing/washing
the hepa filter in the direct sterile compounding area gives iso class 5 air quality
hepa is the High Efficiency Particulate Air filter
ante area air quality should be at iso class 7 or 8
buffer area air quality should be at iso class no more than 7
the staging area outside of the compounding work benches should have an air quality of iso class 5
Created by: wildap



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