Chapter 24 Standards of Sterile Products (TECH) Q&A (1 OF 7) Sample Questions

1. According to Federal standards, class 100 clean room is generally defined as:
  1. A. Not more than 100 people working in a room
  2. B. Not more than 100 particles per cubic ft. of 0.5 micron or larger size.
  3. C. Not more than 100 bacteria per cubic ft. of more mm or larger size
  4. D. Not more than 100 viruses per cubic ft. of 40 mcm or larger size
Answer
Ans: B
Tips: A class 100 clean room is defined as an environment that contains no more than 100 particles per cu. Ft. of 0.5 micron 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.