MPharm Master of Pharmacy Pharmaceutical Microbiology and Biotechnology

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

Autoclaving at 121°C

Answer

Dry heat at 170°C

Answer

Gamma irradiation at 25 kGy

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

The number of endotoxins per unit of product

Answer

The minimum inhibitory concentration of a preservative

Answer

The sterility assurance level of a manufacturing environment

Question 3

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

Accepted Answer

Geobacillus stearothermophilus spores

Answer

Bacillus atrophaeus spores

Answer

Staphylococcus aureus

Answer

Clostridium sporogenes

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

To determine drug potency after manufacturing

Answer

To test the chemical compatibility of the container-closure system

Answer

To measure particulate matter in the final product

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

Mycoplasma contamination in bioreactors

Answer

Viral contamination in blood products

Answer

Fungal biofilm formation

Question 6

Which growth medium is used for the detection of Salmonella species in pharmaceutical raw materials per USP standards?

Accepted Answer

Rappaport Vassiliadis Soya Peptone (RVS) Broth with selective plating

Answer

Tryptic Soy Broth

Answer

Nutrient Broth

Answer

Buffered Peptone Water alone