CSPT Critical Point Questions with all Correct & 100% Verified
Answers |Latest Version |Already Graded A+
1. Method Suitability Test Only preformed once, as long as there are no changes to the
drug product
that could attect the testing.
2. sterility test only sons
de-tect viable
microor-ganisms 6. What are the limita-tions of direct
present at the time inocula-tion in sterility testing?
of the test
3. The 2008 version of
the <797>
requires that high-
risk CSPS be
sterility tested in
4. What are the
steps for
membrane filtra-
tion sterility
test?
5. Membrane
filtration is
preferred method
of sterility testing
(over direct
inoculation) for all
the following rea-
1/
9
, CSPT Critical Point Questions with all Correct & 100% Verified
Answers |Latest Version |Already Graded A+
true 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.
Prepared in groups of more than Entire volume of the CSP is filtered so all contamination that may be
25 identical individual dose present is captured
packages for injection Membrane filtration is not dependent on concentration of
Exposed longer than 6 hours >8 C microorgan-isms
or longer than 12 hours at 2 to 8 C Reduces potential inhibition of growth due to CSP characteristics.
before sterilization
Prepared in multiple-dose vials for
administration to multiple patients Characteristics of the product may make media appear
turbid. Can only be used on final CSP volumes of 10ml
Set up test system or less
Wet the filter w/designated rinse Lack of sensitivity.
fluid. Filter = amounts of the CSP
7.
2/
9
Answers |Latest Version |Already Graded A+
1. Method Suitability Test Only preformed once, as long as there are no changes to the
drug product
that could attect the testing.
2. sterility test only sons
de-tect viable
microor-ganisms 6. What are the limita-tions of direct
present at the time inocula-tion in sterility testing?
of the test
3. The 2008 version of
the <797>
requires that high-
risk CSPS be
sterility tested in
4. What are the
steps for
membrane filtra-
tion sterility
test?
5. Membrane
filtration is
preferred method
of sterility testing
(over direct
inoculation) for all
the following rea-
1/
9
, CSPT Critical Point Questions with all Correct & 100% Verified
Answers |Latest Version |Already Graded A+
true 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.
Prepared in groups of more than Entire volume of the CSP is filtered so all contamination that may be
25 identical individual dose present is captured
packages for injection Membrane filtration is not dependent on concentration of
Exposed longer than 6 hours >8 C microorgan-isms
or longer than 12 hours at 2 to 8 C Reduces potential inhibition of growth due to CSP characteristics.
before sterilization
Prepared in multiple-dose vials for
administration to multiple patients Characteristics of the product may make media appear
turbid. Can only be used on final CSP volumes of 10ml
Set up test system or less
Wet the filter w/designated rinse Lack of sensitivity.
fluid. Filter = amounts of the CSP
7.
2/
9
