MPharm Master of Pharmacy Pharmaceutical Microbiology and Biotechnology 1

Question 1

Which sterilization method is most appropriate for heat-labile pharmaceutical products such as protein biologics?

Accepted Answer

Filtration through 0.22 µm membrane filters

Answer

Membrane filtration through 0.22 µm filters physically removes bacteria and fungi without exposing heat-labile biologics to damaging temperatures or radiation.

Question 2

What does the Bioburden test measure in pharmaceutical microbiology?

Accepted Answer

The total number of viable microorganisms present in or on a product before sterilization

Answer

Bioburden testing quantifies the microbial population on a product before final sterilization, which is essential for validating the sterilization process.

Question 3

Which organism is used as the biological indicator for validating steam sterilization (autoclaving) processes?

Accepted Answer

Geobacillus stearothermophilus spores

Answer

Geobacillus stearothermophilus spores are the most heat-resistant organisms and are used as the standard biological indicator for moist heat (autoclave) sterilization validation.

Question 4

In aseptic manufacturing of injectable products, what is the purpose of the Media Fill (Process Simulation) test?

Accepted Answer

To simulate aseptic filling using sterile culture media to validate the process against contamination risk

Answer

A Media Fill test uses growth-promoting culture media instead of drug product to challenge aseptic process integrity; incubated units must show no microbial growth.

Question 5

The limulus amebocyte lysate (LAL) test is used in pharmaceutical testing to detect:

Accepted Answer

Bacterial endotoxins (pyrogens) from Gram-negative bacteria

Answer

The LAL test detects bacterial endotoxins (lipopolysaccharides from Gram-negative bacteria) in parenteral products; endotoxins cause fever and septic shock in patients.

MPharm Master of Pharmacy Practice Test

MPharm Master of Pharmacy Practice Test

MPharm Master of Pharmacy Pharmaceutical Microbiology and Biotechnology 1