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PR3151 CA1 > IC5 > Flashcards

IC5 Flashcards

1
Q

what are pyrogens

A

substances that induce fever when injected into mammals

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2
Q

what are the types of pyrogens

A

1) LPS from gram -ve bacteria
2) microbial substances: basically the microorganisms
3) non microbial: rubber, microscopic plastic, metal compound in elastomer

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3
Q

types of animal based pyrogen test - rabbit pyrogen test (RPT) - general

A
  • measure rise in rabbit temp after IV injection of tested product
  • qualitative
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4
Q

types of animal based pyrogen test - rabbit pyrogen test (RPT) - disadvantages

A

1) low sensitivity
2) development of pyrogen tolerance after repeated injection
3) stress from rabbit when performing assay
4) POOR RABBITS

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5
Q

types of animal based pyrogen test - bacterial endotoxin test (BET) or limulus amoebocyte lysate (LAL) test

A
  • horseshoe crab
  • high sensitivity (quantification)
  • can’t test for non endotoxin pyrogens
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6
Q

types of in vitro pyrogen test - monocyte activation test (MAT) - how it works

A

IF PYROGEN PRESENT:
monocyte activated -> produce inflamamtory molecule & cytokines for febrile reaction -> detect cytokines using ELISA for specific antibodies & enzymatic colour reaction

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7
Q

types of in vitro pyrogen test - recombinant factor C (rFC)

A
  • factor C react w endotoxin + marker = quantifiable, fluorescent end product
  • similar to BET/LAL but no horseshoe crab blood
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8
Q

types of culture media used for sterility testing

A

1) fluid thioglycolate medium (FTM)
- anaerobic & some aerobic bacteria

2) soybean casein digest medium (SCDM)
- fungi & aerobic bacteria

3) sabouraud dextrose agar (SDA)
- yeast

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9
Q

how many days are samples incubated for in culture medium and why so long

A

14 days, not every bacteria grow at the same rate

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10
Q

types of sterility testing methods - j list down all

A

1) membrane filtration
2) direct inoculation
3) direct transfer
4) product flush

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11
Q

membrane filtration sterility testing - process

A

passed through 0.45 micrometer membrane in filtration canister & culture medium added for incubation

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12
Q

membrane filtration sterility testing - sensitivity

A

HIGH
- whole sample passed through single filter

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13
Q

membrane filtration sterility testing - advantages

A

can wash away components that cause turbidity/inhibit growth (abx, preservative)

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14
Q

membrane filtration sterility testing - most probable number (MPN)

A

estimate viable numbers of bacteria in sample by inoculating broth in 10-fold dilutions based on principle of extinction dilution

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15
Q

direct inoculation sterility testing - process

A

small vol of sample removed aseptically from sample -> inoculated directly into suitable vol of growth medium -> incubation

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16
Q

direct inoculation sterility testing - sensitivity

A

LOW
- only small vol inoculated into culture medium

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17
Q

direct inoculation sterility testing - disadvnatages

A

if sample cloudy/turbid after inoculation: tough to detect turbidity from microbial growth at end of incubation period

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18
Q

direct inoculation sterility testing - testing sterility of antimicrobial product

A

need to neutralise first so microorganism can growth

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19
Q

direct transfer sterility testing - what is it used for

A

medical device

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20
Q

direct transfer sterility testing - how does it work

A

device in direct contact w test media during incubation -> microorganism in/on device grow & proliferate

21
Q

product flush sterility testing - what is it used for

A

medical devices w hollow tubes where fluid pathway is labelled as sterile

22
Q

product flush sterility testing - how does it work

A

product lumen flushed w rinsing fluid -> elute membrane filtered -> placed in suitable media for incubation

23
Q

what are the disadvantages of sterility testing methods

A

1) lengthy process
2) sample size problems
3) costly

24
Q

list of all the sterilisation methods

A

1) moist heat
2) dry heat
3) chemical

  • ethylene oxide
  • peracetic acid
  • gas plasma

4) gamma radiation
5) ozone

25
moist heat sterilisation - process
expose each item to direct steam contact at required temperature & pressure for specified time
26
moist heat sterilisation - MOA
destroy microorganism by irreversible coagulation & denaturation of enzymes & structural proteins
27
moist heat sterilisation - parameters
1) steam 2) pressure (for high temp) 3) high temperature (121 - 132 deg celc)
28
moist heat sterilisation - D-value
- time to reduce surviving population by 90% or 1logD - used for direct comparison of microorganism heat resistance.,...dfdsfsdf
29
moist heat sterilisation - F-concept
- equivalent time that monitored object is exposed to desired temperature - basically from turning on the machine to when object reach sterilisation temperature
30
dry heat sterilisation - what is it used on
1) materials damaged by moist heat 2) materials impenetrable to moist heat (powder, petroleum, sharp instrument)
31
dry heat sterilisation - advantages
1) easier to operate & maintain 2) slow rate of heat penetration
32
dry heat sterilisation - types
1) static-air type - slower in heating (longer time to reach sterilising temp) - less uniform in temperature control throughout chamber 2) forced-air type - circulate heated air throughout chamber = rapid transfer of energy from air to instrument
33
dry heat sterilisation - parameters
> 220 deg celc
34
chemical sterilisation - ethylene oxide (ETO) - how it works
alkylating agent, attack protein, nucleic acid, other compounds
35
chemical sterilisation - ethylene oxide (ETO) - advantages
- works on several materials - well tolerated - residue eliminated w proper aeration
36
chemical sterilisation - ethylene oxide (ETO) - limitations
- flammable & explosive - lots of side effects - carcinogenic
37
chemical sterilisation - paracetic acid - how it works
highly biocidal oxidiser that still works in organic soil
38
chemical sterilisation - paracetic acid - uses
endoscopic tube
39
chemical sterilisation - paracetic acid - parameters for inactivation of different types of microorganism dfjskdjfkasj IDK IF IMPT
1) gram pos, gram -ve, fungi, yeast - < 5 mins at < 100ppm 2) presence of organic matter - 200-500 ppm 3) virus 12-2250 ppm 4) bacterial spore 15s-30s, 500-10k ppm
40
chemical sterilisation - gas plasma - production
deep vacuum -> radio freq/microwave energy -> excite gas molecules -> produce charged particles (free radicals) within plasma field -> interact w essential cell component -> disurpt microorganism metabolism
41
chemical sterilisation - gas plasma - parameters
1) deep vacuum 2) 37-44 deg celc 3) 75 mins
42
chemical sterilisation - gas plasma - MOA
h2o2 inactivate broad range of microorganism from surfaces as well
43
chemical sterilisation - gas plasma - advantages
- by products non toxic (X need aeration) - sterilised material handled safety
44
gamma radiation - parameters
MAN I REALLY DK IF THIS IS IMPORTANT DJHFAKJSD - cobalt 60, cesium 137, electron accelerator - low temperature
45
gamma radiation - general
1) low penetration, high dose rate 2) used for medical product & packaging material
46
gamma radiation - limitations
deleterious effect on patient care equipment - induced oxidation in polyethylene - delamination/cracking in polyethylene knee bearings
47
ozone - production
O2 oxidised -> 2 monoatomic molecules (O) -> collide w O2 -> ozone (O3)
48
advantages of ozone
- powerful oxidant that destroy microorganism - compatible w wide range of materials
49
disadvantages of ozone
highly unstable

PR3151 CA1 (5 decks)

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