Exam 3

The following organization establishes clean room environment international standards
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The following organization establishes clean room environment international standards
ISO
Clean room contamination control is performed with the following (select all that apply)
Limiting the number of trained personnel occupying the space.
Filtering the volume of the air entering the clean room
Regularly monitoring equipment
Which of the following cleanroom classification allows for the least particles and CFUs?
Class A (ISO 5)
Out-of-Specification results when the sample does not meet the accepted established criteria.
True
The most common source of contamination is personnel
True
Which of the following is NOT a type of environmental monitoring?
Chemical
Which of the following laminar flow hood provides filtered air that moves from behind the work area toward the operator?
Horizontal flow hood
ISO 5 environments allow up to 10 CFUs
False (<1)
Which of the following testing is performed to ensure the sterility of the product is met?
Microbiology based testing
Objectionable organisms do not cause illness but are still not allowed in the final product
False
Which of the following is NOT and example of physical environmental monitoring?Viable air samplingViable Monitoring quantifies the microbial load in the airTrueSurface sampling includes all areas which the product comes in contact withTrueWhich of the following is NOT included in the testing of functionality of the product's delivery system?Visible particlesIdeal growth medium temperature, gas composition, and time are all needed to allow the growth of microbes on an agar plateTrueEnvironmental Monitoring is a direct measure of batch sterilityFalse