Pyrogen Testing

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