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8 Flashcards

1
Q

sterility assurance level

A

1 in 10 power 6 probability of a viable microorganism (non sterility)

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2
Q

sterility is required for

A

preps for irrigation, opthalmic preps and parenteral preps

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3
Q

bioburden in manufacturing steps must be

A

minimised before sterilisation

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4
Q

what are examples of pyrogens

A

endotoxins which are lipopolysaccharides produced by g neg bacteria eg e coli

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5
Q

inactivation factor

A

degree to which biological indicator is reduced by sterilising treatment

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6
Q

overkill approach

A

12 log reduction in the biological indicator (microorganism) through the sterilising process

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7
Q

SAL

A

indicates the probability of one viable microorganism in certain no of drug products usually 10 power 6

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8
Q

suitability test

A

validity of sterility test: spike test with known quantities of microorganisms. incubate for 3-5 days and compare turbidity. if test sample has same tubidity as positive control –> not sterile

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9
Q

2 types of sterility tests

A

membrane filtration and direct inoculation.

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10
Q

main source of contamination

A

people. use a isolator

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11
Q

growth promotion test

A

validation of sterility test. used to confirm that rage culture media can support the growth of less than 10 viable microorganisms if it cannot, it fails. A portion also tested for sterility and if not sterile the test fails

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12
Q

endotoxin test

A

LAL limulus amoebacyte lysate test. clotting of blood indicated presence of endotoxins

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13
Q

endotoxins lead to release of

A

cytokines and interleukins

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14
Q

endotoxin limit conc formula

A

elc= K/M
M Is max recommended dose (kg/h)
K is max endotoxins dose usually 5

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15
Q

max valid dilution

A

mvd = ELC/ method sensitivity
use lowest dilution you can get

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16
Q

sterile biologic drugs are manufactured by sterile filtration followed by

A

aseptic filling and processing

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17
Q

how to reduce bio burden

A

use aseptic handling techniques everywhere possible
reduce microbial load prior to and on sterile filter with pre filters
increase effective filter surface area by using larger single filter or multiple filters in series
limit batch vol to be sterile filtered
test integrity of sterilising filters pre and post use

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18
Q

D value

A

time required for sterilisation process to achieve a 90% reduction in microbial population (one log reduction)

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19
Q

issues with sub visible/ visible particles

A

adverse rections eg mechanical obstruction with lung as a target
injection site reactions eg phlebitis

20
Q

test for sub visible particles

A

light obscuration particle count test
microscopic particle count test

21
Q

requirement for light obscuration .. test

A

(only for sub visible particles) should not exceed 6000 per container more than 10 micrometers and 600 greater than 25 micrometers

22
Q

microscopic particle test should be

A

free of visible particles
same as light obscuration test for sub visible particles

23
Q

6 types of sterilisation methods

A

dry heat, moist heat, lyophilisation, aseptic filtration, nitrous/ethylene oxide/h2o2 fog, gamma radiation

24
Q

aseptic process simulation

A

validating an aseptic process to simulate the process the product itself will undergo

25
Q

aseptic filtration filter size

A

0.22 micrometers

26
Q

aseptic filtration description
what is not removed

A

sterile filtrate is produced.
pyrogens and bacteria and mould are removed but viruses and mycoplasma not removed so heat treatments needed.

27
Q

lyophilisation aka __
describe process

A

freeze drying.
water is removed from a product after it is frozen and placed in vacuum, allowing the ice to change from solid to vapour directly

28
Q

7 steps of lyophilisation process

A
  • dissolve drug and excipients in suitable solvent, usually water for injection
  • sterilise bulk solution by passing though a 0.22 micron BACTERIA RETENTIVE filter
  • filling into individual sterile containers and partially stoppering the containers under aseptic conditions
  • transporting the containers to lyophiliser and loading under aseptic conditions
  • freezing solution by placing partially stoppered containers on cooled shelves in free drying chamber
  • applying vacuum to chamber er and heating shelves to evaporate water
  • complete stoppering of vials by hydraulic or screw rod mechanisms installed in lyophilisers
29
Q

3 processes in lyophilisation

A

freezing, primary drying (sublimation), secondary drying (description to remove most water)

30
Q

which medium to use for aseptic process simulation for powder

A

for aerobic bacteria, fungi and yeast - soybean casein digest medium
for aerobic bacteria = fluid thioglicollate medium
for yeast - sabouraud dextrose agar

31
Q

when is a sterile powder needed

A

when drug is unstable in liquid form

32
Q

sterile powder must be reconstituted with____ before administration

A

sterile diluent

33
Q

6 components of injections

A

vehicle, antimicrobial agent, tonicity adjuster, dispersing agent and surfactant, buffer, antioxidant

34
Q

7 examples of dispersing agents (prevent agglomeration and promote solubilisation)

A

lecithin
carboxymethylcellulose
methyl cellulose
acacia
gelatin
Tween 80
Pluronic F68

35
Q

preservatives for injections - 9

A

thimerosal
parabens
BAK
phenyl mercuric nitrate
phenol
chlorocresol
benzethonium chloride
benzyl alcohol
chlorbutanol

36
Q

small vol IV bags - piggy backs vs continuous preps

A

small vol is administered over short time at specific intervals (less than 250ml)
continuous preps are either large vol or drips

37
Q

what sterilisation is necessary for IV bags

A

terminal

38
Q

what do multi dose vials usually contain

A

preservatives
can retain sterility after puncture

39
Q

are epidurals preservative free?

A

yes as they can cause paralysis

40
Q

what does irrigation usually contain

A

must be sterile, usually w gentamicin

41
Q

how long does albumin last once opened

A

4h

42
Q

plasma protein fraction dosing

A

single dose IV administration

43
Q

immunoglobulin notes

A

must be sterile and lyophilised
must be recostitued before administration

44
Q

how are opthlamics manufactured

A

aseptic filtration technique

45
Q

which is performed first suitability test or growth promotion test

A

growth promotion test to see if medium can support the selected strain and no other strains. then do suitability test and check for sample sterility

dsv (6 decks)

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