USP 797 & 825 Overview 2025/2026
Exam Questions and Verified Answers |
Already Graded A+
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
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
Exam Questions and Verified Answers |
Already Graded A+
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
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
