Pharmaceutical Microbiology and Biotechnology Flashcards
6 cards from real MPharm Master of Pharmacy practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Pharmaceutical Microbiology and Biotechnology flashcards as text
Which sterilization method is most appropriate for heat-labile pharmaceutical products such as protein biologics?
Answer: Filtration through 0.22 µm membrane filters
Membrane filtration through 0.22 µm filters physically removes bacteria and fungi without exposing heat-labile biologics to damaging temperatures or radiation.
What does the Bioburden test measure in pharmaceutical microbiology?
Answer: The total number of viable microorganisms present in or on a product before sterilization
Bioburden testing quantifies the microbial population on a product before final sterilization, which is essential for validating the sterilization process.
Which organism is used as the biological indicator for validating steam sterilization (autoclaving) processes?
Answer: Geobacillus stearothermophilus spores
Geobacillus stearothermophilus spores are the most heat-resistant organisms and are used as the standard biological indicator for moist heat (autoclave) sterilization validation.
In aseptic manufacturing of injectable products, what is the purpose of the Media Fill (Process Simulation) test?
Answer: To simulate aseptic filling using sterile culture media to validate the process against contamination risk
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.
The limulus amebocyte lysate (LAL) test is used in pharmaceutical testing to detect:
Answer: Bacterial endotoxins (pyrogens) from Gram-negative bacteria
The LAL test detects bacterial endotoxins (lipopolysaccharides from Gram-negative bacteria) in parenteral products; endotoxins cause fever and septic shock in patients.
Which growth medium is used for the detection of Salmonella species in pharmaceutical raw materials per USP standards?
Answer: Rappaport Vassiliadis Soya Peptone (RVS) Broth with selective plating
Rappaport Vassiliadis Soya Peptone Broth is a selective enrichment broth that suppresses other flora while allowing Salmonella growth, followed by plating on selective agar.