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MP421 > PHARMACEUTICAL MICROBIOLOGY > Flashcards

PHARMACEUTICAL MICROBIOLOGY Flashcards

1
Q

types of infective agents

A
  • prions
  • viruses/viroids
  • bacteria (unicellular, prokaryotic cells) - eubacteria
  • fungi (eukaryotic cells)
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2
Q

prion

A

misfolded protein that can interact with a normal protein molecule causing the normal protein to undergo a conformation change so that is too becomes a prion and ceases its normal function

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3
Q

prions and sterilisation agents

A

prions are extremely resistant to conventional sterilising agents, and need to be eliminated from the pharmaceuticals supply chain ‘at source’

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4
Q

viruses

A
  • no cellular structure but are particles composed of nucleic acid surrounded by proteins and sometimes a lipid envelope with associated glycoproteins
  • incapable of independent replication (must infect other organism to reproduce)
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5
Q

viroids

A

similar to viruses but infect plants

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6
Q

2 main classifications of biological cells

A

prokaryotes
eukaryotes

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7
Q

crucial difference between prokaryotes and eukaryotes

A

eukaryotes bacteria possess a true cell nucleus where the chromosomes are separated from the cytoplasm by nuclear membrane, where as prokaryotic cells have no nucleus and normally possess a single chromosome

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8
Q

groups of bacteria

A
  • archaea
  • eubacteria (stained gram + or -)
  • aerobic/anaerobic bacteria
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9
Q

fungi

A
  • eukaryotes
  • non photosynthetic plants
  • found as yeast
  • moulds with mycelium or filaments
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10
Q

saprophyte

A

live on dead material

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11
Q

parasite

A

live in a host

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12
Q

pathogenic

A

live in, and damage, a host

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13
Q

opportunistic pathogen

A

where the organism takes advantage of an opportunity not normally available, such as a weakened immune system

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14
Q

resistance in bacterial ‘spores’

A

spores are more resistant than normal cells to chemical agents and high temperatures

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15
Q

sterile products

A

where you break a barrier, or treat a sensitive membrane (drug products, medical devices, others like surgical gloves etc.)

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16
Q

sterilisation in the pharmaceutical supply chain

A

the design of the product needs to be sterile, such that is stays that way for the rest of the supply chain

17
Q

sterilisation methods

A
  • heat (dry - oven)
  • heat (steam/wet - autoclave)
  • radiation (gamma rays/high energy electrons)
  • gases (ethylene oxide, hydrogen peroxide, formaldehyde)
  • filtration
18
Q

sterilisation

A

the process of removing or eradicating all the microorganisms in a drug product

19
Q

sterilisation by moist heat (steam or autoclaving)

A
  • kills micro-organisms by transfer of heat energy of saturated steam
  • 121 degrees Celsius, 30 apsi, for >15 min
  • temp/pressure, steam quality, atmospheric gases critical
  • cycle and load validation
20
Q

sterilisation by dry heat

A
  • kills micro-organisms by oxidation
  • 160 degrees celsius for 2 hours, 170 for 1 hour
  • depyrogenation at 220 degrees for >4 hours
21
Q

sterilisation by filtration

A
  • removes micro-organisms using filters with 0.2 micrometer pore sizes
  • ‘capsule filters’: often using 2 in sequence for redundancy
  • filters are tested by ‘bubble point’ after use for integrity
22
Q

minimum contamination level of a sterile product

A

< 1x10^6

23
Q

sterility testing

A

filtration
- drug solution filtered through two 0.2mcm membranes to retain bacteria and broth added

direct inoculation
- sample of drug solution added directly to broth

24
Q

pyrogen

A
  • cell wall components (liposaccaharide) from Gram negative bacteria are exogenous pyrogens and cause high temp fevers
  • viable bacteria are not needed
  • the bacterial liposaccharides activate an immune cascade which include endogenous pyrogens
25
Q

what is a biopharmaceutical?

A
  • also known as biological medicinal product
  • any pharmaceutical drug product manufactured in, extracted from, or semi-synthesised from biological sources
26
Q

examples of biopharmaceuticals

A

vaccines
blood/blood components
allergenics
somatic cells
gene therapies
tissues

27
Q

advantages of biopharmaceuticals

A
  • high specificity
  • reduced side effects
  • difficult to reproduce/copy, protecting manufacturers
28
Q

biological v small molecules challenges

A
  • complex production process
  • costs (of setup)
  • cost to patients
  • cold supply chains (tertiary structures)
  • public concerns over source materials
  • IV products (sterile, need trained staff)
29
Q

depyrogenation

A
  • removes/destroys pyrogens
  • most prevalent pyrogen: bacterial endotoxins found in the outer cell walls of gram-negative bacteria

MP421 (12 decks)

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