USP 797 & 825 Overview Exam 2025
Questions and Answers
United State Pharmacopeia (USP) - ANSWER✔✔-Non-profit, scientific, independent
public health organization developed by a unique process of public involvement
FDA - ANSWER✔✔-Food and Drug Administration; approves USP standards
USP General Chapters - ANSWER✔✔-Intended to help protect and improve the health
of people by facilitating access to high quality, safe, and beneficial medicines
USP 797 - ANSWER✔✔-Compounded Sterile Preparations (CSP) rules & regulations for
clean room, compounding room, and ante room
USP 825 - ANSWER✔✔-General Chapter for Radiopharmaceuticals - Preparation,
Compounding, Dispensing, and Repackaging
ISO Class 8 - ANSWER✔✔-ISO classification for 100,000 particles per cubic foot in the
Ante-area
ISO Class 5 - ANSWER✔✔-ISO classification for laminar airflow hood with a maximum
of one particle per cubic foot
COPYRIGHT © 2025 ALL RIGHTS RESERVED
, ISO Class 7 - ANSWER✔✔-ISO classification for Buffer Area with a maximum of 10,000
particles per cubic foot
ISO Class 3 - ANSWER✔✔-ISO classification equivalent to the former Class 1, allowing
a maximum of one particle per cubic foot
ISO Class 5 Environment - ANSWER✔✔-Environment for compounding of sterile
preparations with single-dose containers usable up to 6 hours after needle puncture
ISO Class 7 Environment - ANSWER✔✔-Buffer Area environment with ISO Class 7
cleanliness level
ISO Class 8 Environment - ANSWER✔✔-Anteroom environment with ISO Class 8
cleanliness level
Low-Risk Level CSPs - ANSWER✔✔-Compounded with aseptic manipulations within
ISO class 5 quality air using only sterile ingredients
Medium-Risk Level CSPs - ANSWER✔✔-Include all low-risk conditions plus complex
aseptic manipulations or multiple doses of sterile products
High-Risk Level CSPs - ANSWER✔✔-Include all low and medium-risk conditions plus
non-sterile ingredients or devices, or exposure to air quality inferior to ISO class 5
Media-Fill Testing - ANSWER✔✔-Annual testing for personnel compounding low or
medium-risk products to simulate challenging conditions
COPYRIGHT © 2025 ALL RIGHTS RESERVED
Questions and Answers
United State Pharmacopeia (USP) - ANSWER✔✔-Non-profit, scientific, independent
public health organization developed by a unique process of public involvement
FDA - ANSWER✔✔-Food and Drug Administration; approves USP standards
USP General Chapters - ANSWER✔✔-Intended to help protect and improve the health
of people by facilitating access to high quality, safe, and beneficial medicines
USP 797 - ANSWER✔✔-Compounded Sterile Preparations (CSP) rules & regulations for
clean room, compounding room, and ante room
USP 825 - ANSWER✔✔-General Chapter for Radiopharmaceuticals - Preparation,
Compounding, Dispensing, and Repackaging
ISO Class 8 - ANSWER✔✔-ISO classification for 100,000 particles per cubic foot in the
Ante-area
ISO Class 5 - ANSWER✔✔-ISO classification for laminar airflow hood with a maximum
of one particle per cubic foot
COPYRIGHT © 2025 ALL RIGHTS RESERVED
, ISO Class 7 - ANSWER✔✔-ISO classification for Buffer Area with a maximum of 10,000
particles per cubic foot
ISO Class 3 - ANSWER✔✔-ISO classification equivalent to the former Class 1, allowing
a maximum of one particle per cubic foot
ISO Class 5 Environment - ANSWER✔✔-Environment for compounding of sterile
preparations with single-dose containers usable up to 6 hours after needle puncture
ISO Class 7 Environment - ANSWER✔✔-Buffer Area environment with ISO Class 7
cleanliness level
ISO Class 8 Environment - ANSWER✔✔-Anteroom environment with ISO Class 8
cleanliness level
Low-Risk Level CSPs - ANSWER✔✔-Compounded with aseptic manipulations within
ISO class 5 quality air using only sterile ingredients
Medium-Risk Level CSPs - ANSWER✔✔-Include all low-risk conditions plus complex
aseptic manipulations or multiple doses of sterile products
High-Risk Level CSPs - ANSWER✔✔-Include all low and medium-risk conditions plus
non-sterile ingredients or devices, or exposure to air quality inferior to ISO class 5
Media-Fill Testing - ANSWER✔✔-Annual testing for personnel compounding low or
medium-risk products to simulate challenging conditions
COPYRIGHT © 2025 ALL RIGHTS RESERVED
