ANSWERS 2026 FINAL PAPER EXAM Q&A
STUDY GUIDE WITH VERIFIED SOLUTIONS
◉ Pharmacopeial specifications consists of each of the following
except:
Volume of nitrogenous liquids
Sterility tests
Microbial limits
Uniformity of dosage units
There are pharmacopeial specifications for all the other choices.
Answer: Volume of nitrogenous liquids
◉ What instrument is used to actively sample the air in a
biomanufacturing suite for microorganisms?
Centrifugal Air sampler
Biological indicator strips
Laser particle counter
Hamster wheel
, High Efficiency Particulate Air (HEPA) sampler. Answer: Centrifugal
Air sampler
◉ "In the video on sterilization of BSCs, for sterility testing of a 4-ft
BSC, what was not done to the settling plates?"
Place plates upright in the incubator
"Write date, start and end times on petri dishes"
Wipe petri dishes with 70% ethanol prior to putting in BSC
Use 4 settling plates for a 4 ft BSC
Leave settling plates uncovered for 30 min in the BSC. Answer: Place
plates upright in the incubator
◉ "Endotoxins are lipopolysaccharides found on the outer
membrane of Gram negative, but not in Gram positive bacteria. What
is not used to test for the presence of endotoxins in drug products?"
Hybridization assay
Rabbit Pyrogen Test
LAL gel clot assay
Chromogenic LAL Assay
Pyrogene
Recombinant Factor C assay. Answer: Hybridization assay