USP 797 Exam 2025 Questions and
Answers
Hazardous Drug - 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? - ANSWER✔✔-at least every 6 months
What is the cleanest air?
a. ISO 9
b. ISO 5
c. ISO 3
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,d. ISO 1 - ANSWER✔✔-d. ISO 1 is cleanest
ISO 9 = normal air
have how much microbial air contamination?
ISO 5
ISO 7
ISO 8+
ISO 9 - ANSWER✔✔-ISO 5 >1
ISO 7 >10
ISO 8+ >100
ISO 9 = normal air
PEC cleaning frequency? - 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 - ANSWER✔✔-Daily
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, cleaning frequency?
walls
ceilings
storage shelving cleaning - ANSWER✔✔-monthly
how long should hands be washed before garbing? - ANSWER✔✔-at least 30 seconds
What is the most common source of sterile product contamination? - ANSWER✔✔-
hands
Ante-Area - 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 - 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) - ANSWER✔✔-the date or time after which a CSP shall not be
stored or transported.
COPYRIGHT © 2025 ALL RIGHTS RESERVED
Answers
Hazardous Drug - 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? - ANSWER✔✔-at least every 6 months
What is the cleanest air?
a. ISO 9
b. ISO 5
c. ISO 3
COPYRIGHT © 2025 ALL RIGHTS RESERVED
,d. ISO 1 - ANSWER✔✔-d. ISO 1 is cleanest
ISO 9 = normal air
have how much microbial air contamination?
ISO 5
ISO 7
ISO 8+
ISO 9 - ANSWER✔✔-ISO 5 >1
ISO 7 >10
ISO 8+ >100
ISO 9 = normal air
PEC cleaning frequency? - 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 - ANSWER✔✔-Daily
COPYRIGHT © 2025 ALL RIGHTS RESERVED
, cleaning frequency?
walls
ceilings
storage shelving cleaning - ANSWER✔✔-monthly
how long should hands be washed before garbing? - ANSWER✔✔-at least 30 seconds
What is the most common source of sterile product contamination? - ANSWER✔✔-
hands
Ante-Area - 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 - 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) - ANSWER✔✔-the date or time after which a CSP shall not be
stored or transported.
COPYRIGHT © 2025 ALL RIGHTS RESERVED
