USP 797 UPDATED Exam Questions and
CORRECT Answers
Hazardous Drug - CORRECT ANSWER - Any drug identified by at least one of the
following six criteria:
• Carcinogenicity
• Teratogenicity or developmental toxicity
• Reproductive toxicity in humans
• Organ toxicity at low doses in humans or animals
• Genotoxicity
• New drugs that mimic existing hazardous drugs in structure or toxicity
Air sampling should be done how often? - CORRECT ANSWER - at least every 6 months
What is the cleanest air?
a. ISO 9
b. ISO 5
c. ISO 3
d. ISO 1 - CORRECT ANSWER - d. ISO 1 is cleanest
ISO 9 = normal air
have how much microbial air contamination?
ISO 5
ISO 7
ISO 8+
ISO 9 - CORRECT ANSWER - ISO 5 >1
ISO 7 >10
ISO 8+ >100
,ISO 9 = normal air
PEC cleaning frequency? - CORRECT ANSWER - At the beginning of each shift, before
each batch, not longer than 30 minutes following
the previous surface disinfection when ongoing compounding activities are occurring,
after spills, and when surface contamination is known or suspected
cleaning frequency?
Counters and easily cleanable work surfaces
Floors cleaning - CORRECT ANSWER - Daily
cleaning frequency?
walls
ceilings
storage shelving cleaning - CORRECT ANSWER - monthly
how long should hands be washed before garbing? - CORRECT ANSWER - at least 30
seconds
What is the most common source of sterile product contamination? - CORRECT
ANSWER - hands
Ante-Area - CORRECT ANSWER - An ISO Class 8 or better area where personnel hand
hygiene and garbing procedures, staging of
components, order entry, CSP labeling, and other high-particulate-generating activities are
performed.
Aseptic Processing - CORRECT ANSWER - A mode of processing
pharmaceutical and medical products that involves the separate sterilization of the product and of
the package and the transfer of the product into the container and its closure
, under at least ISO Class 5 conditions.
Beyond-Use Date (BUD) - CORRECT ANSWER - the date or time after which a CSP
shall not be stored or transported.
(BSC)Biological Safety Cabinet - CORRECT ANSWER - 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 (HEPA)-filtered laminar
airflow for product protection, and HEPA-filtered exhausted air for environmental protection.
Buffer Area - CORRECT ANSWER - An area where the primary engineering control
(PEC) is physically located. Activities that occur in this area
include the preparation and staging of components and supplies used when compounding CSPs.
</equal ISO 7
What is a PEC ? - CORRECT ANSWER - Primary engineering control
Clean Room - CORRECT ANSWER - A room in which the concentration of airborne
particles is controlled to meet a specified airborne particulate
cleanliness class.
(CACI)
Compounding Aseptic Containment Isolator - CORRECT ANSWER - A compounding
aseptic isolator (CAI) 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 preparations.
(CAI) Compounding Aseptic Isolator - CORRECT ANSWER - A form of isolator
specifically designed for compounding pharmaceutical ingredients
CORRECT Answers
Hazardous Drug - CORRECT ANSWER - Any drug identified by at least one of the
following six criteria:
• Carcinogenicity
• Teratogenicity or developmental toxicity
• Reproductive toxicity in humans
• Organ toxicity at low doses in humans or animals
• Genotoxicity
• New drugs that mimic existing hazardous drugs in structure or toxicity
Air sampling should be done how often? - CORRECT ANSWER - at least every 6 months
What is the cleanest air?
a. ISO 9
b. ISO 5
c. ISO 3
d. ISO 1 - CORRECT ANSWER - d. ISO 1 is cleanest
ISO 9 = normal air
have how much microbial air contamination?
ISO 5
ISO 7
ISO 8+
ISO 9 - CORRECT ANSWER - ISO 5 >1
ISO 7 >10
ISO 8+ >100
,ISO 9 = normal air
PEC cleaning frequency? - CORRECT ANSWER - At the beginning of each shift, before
each batch, not longer than 30 minutes following
the previous surface disinfection when ongoing compounding activities are occurring,
after spills, and when surface contamination is known or suspected
cleaning frequency?
Counters and easily cleanable work surfaces
Floors cleaning - CORRECT ANSWER - Daily
cleaning frequency?
walls
ceilings
storage shelving cleaning - CORRECT ANSWER - monthly
how long should hands be washed before garbing? - CORRECT ANSWER - at least 30
seconds
What is the most common source of sterile product contamination? - CORRECT
ANSWER - hands
Ante-Area - CORRECT ANSWER - An ISO Class 8 or better area where personnel hand
hygiene and garbing procedures, staging of
components, order entry, CSP labeling, and other high-particulate-generating activities are
performed.
Aseptic Processing - CORRECT ANSWER - A mode of processing
pharmaceutical and medical products that involves the separate sterilization of the product and of
the package and the transfer of the product into the container and its closure
, under at least ISO Class 5 conditions.
Beyond-Use Date (BUD) - CORRECT ANSWER - the date or time after which a CSP
shall not be stored or transported.
(BSC)Biological Safety Cabinet - CORRECT ANSWER - 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 (HEPA)-filtered laminar
airflow for product protection, and HEPA-filtered exhausted air for environmental protection.
Buffer Area - CORRECT ANSWER - An area where the primary engineering control
(PEC) is physically located. Activities that occur in this area
include the preparation and staging of components and supplies used when compounding CSPs.
</equal ISO 7
What is a PEC ? - CORRECT ANSWER - Primary engineering control
Clean Room - CORRECT ANSWER - A room in which the concentration of airborne
particles is controlled to meet a specified airborne particulate
cleanliness class.
(CACI)
Compounding Aseptic Containment Isolator - CORRECT ANSWER - A compounding
aseptic isolator (CAI) 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 preparations.
(CAI) Compounding Aseptic Isolator - CORRECT ANSWER - A form of isolator
specifically designed for compounding pharmaceutical ingredients
