WorksheetsPyrogen Testing
Total questions: 8
Worksheet time: 5mins
A sterile product is always a non-pyrogenic product.
True
False
Endotoxin is a lipopolysaccharide from the outer membrane of gram-positive bacteria.
True
False
Which of the following approaches can reduce the presence of pyrogenic substances in a product? (you may choose more than 1 answer)
Rinsing the container with Water for Injection
Autoclaving the product
Ultrafiltration of the solution
Heating the product in the presence of hydrogen peroxide and pressure
Why are rabbits being used in the pyrogen testing?
They are cute
They have similar physiological response to pyrogen as human
They digest pyrogen in a similar way as human
They are easier to handle compared to rats
Only pharmaceutical product in solution form can be tested using rabbit in pyrogen testing.
True
False
LAL test involves detection of bacterial endotoxin using amoebocyte lysate from cowshoe crab.
True
False
Which of the following methods are listed in the BP in LAL Test? (you may choose more than 1 answer)
Rabbit method
Gel-clot method
Chromogenic method
Microscopic method
Which of the following statements is/are TRUE regarding pyrogen testing?
(you may choose more than 1 answer)
LAL Test can detect much lower endotoxin level than Rabbit Test
Repeated testing using LAL Test can cause endotoxin tolerance
Rabbit Test is more expensive than LAL Test and requires training of the animals
Rabbit Test can be done relatively quicker than LAL Test
