UPDATED CSP Risk Categories

Question 1

preparation environment of an immediate-use CSP

Answer 1

uncontrolled

Question 2

preparation environment of a Category 1 CSP

Answer 2

ISO 5 PEC in an SCA

Question 3

preparation environment of a Category 2 CSP

Answer 3

ISO 5 PEC in a cleanroom

Question 4

preparation environment of a Category 3 CSP

Answer 4

ISO 5 PEC in a cleanroom + additional requirements (including sterility testing, more frequent environmental monitoring, etc.)

-> lower contamination risk, allowing for a longer BUD