CSPT Critical Point Review: Questions With Analytical
Solutions
Method Suitability Test Correct Answer - Only preformed once, as long
as there are no changes to the drug product that could affect the testing.
Sterility test only detect viable microorganisms present at the time of the test
Correct Answer - true
The 2008 version of the <797> requires that high-risk CSPS be sterility tested
in Correct Answer - Prepared in groups of more than 25 identical
individual dose packages for injection
Exposed longer than 6 hours >8 C or longer than 12 hours at 2 to 8 C before
sterilization
Prepared in multiple-dose vials for administration to multiple patients
What are the steps for membrane filtration sterility test? Correct Answer -
Set up test system
Wet the filter w/designated rinse fluid. Filter = amounts of the CSP through
the sterile tubing into both canisters.
Rinse the CSP from both canisters using the rinse fluid
Pump the media into each canister
Labe canisters w/date and indetifying info then incubate.
Membrane filtration is preferred method of sterility testing (over direct
inoculation) for all the following reasons Correct Answer - Entire
volume of the CSP is filtered so all contamination that may be present is
captured
Membrane filtration is not dependent on concentration of microorganisms
Reduces potential inhibition of growth due to CSP characteristics.
What are the limitations of direct inoculation in sterility testing? Correct
Answer - Characteristics of the product may make media appear turbid.
Can only be used on final CSP volumes of 10ml or less
Lack of sensitivity.
What are the 2 methods of sterility testing described in USP Chapter <71>
Correct Answer - Direct Inoculation
Solutions
Method Suitability Test Correct Answer - Only preformed once, as long
as there are no changes to the drug product that could affect the testing.
Sterility test only detect viable microorganisms present at the time of the test
Correct Answer - true
The 2008 version of the <797> requires that high-risk CSPS be sterility tested
in Correct Answer - Prepared in groups of more than 25 identical
individual dose packages for injection
Exposed longer than 6 hours >8 C or longer than 12 hours at 2 to 8 C before
sterilization
Prepared in multiple-dose vials for administration to multiple patients
What are the steps for membrane filtration sterility test? Correct Answer -
Set up test system
Wet the filter w/designated rinse fluid. Filter = amounts of the CSP through
the sterile tubing into both canisters.
Rinse the CSP from both canisters using the rinse fluid
Pump the media into each canister
Labe canisters w/date and indetifying info then incubate.
Membrane filtration is preferred method of sterility testing (over direct
inoculation) for all the following reasons Correct Answer - Entire
volume of the CSP is filtered so all contamination that may be present is
captured
Membrane filtration is not dependent on concentration of microorganisms
Reduces potential inhibition of growth due to CSP characteristics.
What are the limitations of direct inoculation in sterility testing? Correct
Answer - Characteristics of the product may make media appear turbid.
Can only be used on final CSP volumes of 10ml or less
Lack of sensitivity.
What are the 2 methods of sterility testing described in USP Chapter <71>
Correct Answer - Direct Inoculation
