USP 797 2025/2026 Exam Questions and
Answers 100% Guaranteed Success |
Already Rated A+
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
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
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
3
COPYRIGHT©JOSHCLAY 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE. PRIVACY
STATEMENT. ALL RIGHTS RESERVED
, 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.
(BSC)Biological Safety Cabinet - 🧠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.
Answers 100% Guaranteed Success |
Already Rated A+
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
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
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
3
COPYRIGHT©JOSHCLAY 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE. PRIVACY
STATEMENT. ALL RIGHTS RESERVED
, 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.
(BSC)Biological Safety Cabinet - 🧠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.
