EXAM UPDATED ACTUAL EXAM COMPLETE QUESTIONS
WITH DETAILED VERIFIED ANSWERS (100% CORRECT
ANSWERS) /ALREADY GRADED A+
Ante area (anteroom)
Ans: An ISO class 8 or better air quality where personnel perform hand hygiene, and garbing
procedures, staging of components, order entry, compounded sterile preparation labeling and
other high particulate-generating activities
Qiz Aseptic technique
Ans: The methods used to manipulate manufacturer-supplied sterile products so that they
remain sterile as compounded sterile preparations
Qiz Biological safety cabinet (BSC)
Ans: A primary engineering control device that is a ventilated cabinet for CSPs, personnel,
product, and environmental protection having an open front with inward airflow for personnel
protection, downward high-efficiency particulate air-filtered laminar airflow for product
protection, and HEPA-filtered exhausted air for environmental protection
Qiz Buffer area
,Ans: The area where the primary engineering control is physically located. Activities that occur
in this area include the preparation and staging of components and supplies used when
compounding CSPs
Qiz Clean room
Ans: A clean room in which the concentration of airborne particles is controlled to meet a
specified airborne particulate cleanliness class. Microorganisms in the environments are
monitored so that a microbial level for air, surface, and personnel gear are not exceeded for a
specified cleanliness class
Qiz Cold storage conditions
Ans: 2-8 degrees Celsius; 36-46 degrees Fahrenheit
Qiz Components
Ans: The individual ingredients, containers, and closures that are used to compound sterile
preparations
Qiz Compounded Sterile Preparation
Ans: A dose or doses of medication that are prescribed for a patient(s) that must be prepared
for administration and is sterile
Qiz Compounding Aseptic Containment Isolator
, Ans: A primary engineering control that is designed to provide worker protection from
exposure to undesirable levels of airborne drug throughout the compounding and material
transfer processes and to provide an aseptic environment for compounding sterile preparation
Qiz Compounding Aseptic Isolator
Ans: A primary engineering control that is a form of isolator specifically designed for
compounding pharmaceutical ingredients or preparations
Qiz Critical site
Ans: a location that includes any component or fluid pathway surfaces or openings exposed and
at risk of direct contact with air, moisture, or touch contamination
Qiz Direct Compounding Area
Ans: A critical area within the ISO class 5 engineering control where critical sites are exposed to
unidirectional HEPA-filtered air, also known as first air
Qiz First air
Ans: the air exiting the HEPA filter in a unidirectional air stream that is essentially particle free
Qiz Garb