FPGEE Questions & Answers
Original / Incorrect
According to Federal standard class 100 clean room is generally defined as:
A. Not more than 100 people working in a room.
B. Not more than 100 particles per cubic ft of 0.5 mcm or larger size.
C. Not more than 100 bacteria per cubic ft of 40 mcm or larger size.
D. Not more than 100 viruses per cubic ft of 40 mcm or larger size.
Answer: A class 100 room is defined as an environment that contains no more than 100 particles per cu ft of 0.5 mcm or larger size. Laminar flow of a HEPA filter should meet the standard for class 100 as defined by Federal standard. A class 10,000 clean room is a conventional clean room so it is less appropriate to carry out aseptic techniques.
Correction
Under USP <797>, ISO Class 5 air cleanliness permits which maximum concentration of airborne particles measuring 0.5 µm or larger?
A. 352 particles per cubic meter of air.
B. 3,520 particles per cubic meter of air.
C. 35,200 particles per cubic meter of air.
D. 352,000 particles per cubic meter of air.
Explanation Answer B: ISO Class 5 permits no more than 3,520 airborne particles measuring 0.5 µm or larger per cubic meter of air. This corresponds approximately to the former Class 100 designation. The classification concerns airborne particles, rather than counts of bacteria or viruses.
Correct answer: B
Corrected Explanation
Replace the outdated “Federal Standard Class 100” terminology with “ISO Class 5” and revise the choices to use particles per cubic meter. The correct answer is B: Not more than 3,520 airborne particles measuring 0.5 µm or larger per cubic meter of air. The original answer B correctly described the former Class 100 designation.
