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The medicine > sterilisation processing > Flashcards

sterilisation processing Flashcards

1
Q

which sterilisation processing is the most reliable

A

producing under clean conditions not aseptic

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2
Q

give 3 examples of contaminants in he drug development process

A

raw materials, water, manufacturing environment

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3
Q

give an example of a source of gram positive bacteria

A

soil

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4
Q

give an example of a source of gram negative bacteria

A

water

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5
Q

give an example of a source of yeasts and moulds

A

plants

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6
Q

D value =

A

time taken at certain temp to reduce the population by 90%

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7
Q

Z value =

A

temo change required to produce a 90% reduction in D value

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8
Q

what is the value for sterility assurance level

A

10^-6

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9
Q

4 factors D value can be influenced by

A

spore forming bacteria have higher resistance and higher d value
the bacterial species
the nutrient environment
production dose

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10
Q

do you need documentary evidence for process validation

A

yes

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11
Q

what is the purpose of biological indicators

A

to asses the microbial lethality of a sterilisation process

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12
Q

advantages of using BIs to asses sterilisation process

A

stable

high resistance to sterilising agents

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13
Q

what BI is used for filtration

A

brevundimonas diminuta

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14
Q

what BI is used for moist heat

A

bacillus stearothermophilus

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15
Q

what BI is used for dry heat

A

bacillus subtilus

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16
Q

what BI is used for irrigation

A

Bacillus pumilus

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17
Q

what BI is used for EtO

A

bacillus subtilus

18
Q

give the 4 ways filtration works by

A

irregular shape
simultaneous arrival
blocked pore
surface interactions

19
Q

what test validates filtration

A

bubble point pressure test and BI

20
Q

describe the differences between depth filters and screen filters

A

d-non fixed pore size s-uniform pore size
d- inertial impaction s- direct interception
d- high retentive capacity s- easily blocked
d- robust s- fragile
d- cheap s- expensive
d- no sterility s- sterility

21
Q

what types of products may use dry heat sterilisation

A

dry powders, oil preparations, glassware and instruments

22
Q

which is the longest section of the dry heat process

A

cooling

23
Q

during dry heat sterilisation, which section does sterilising occur

A

exposure

24
Q

what is the most common temperatures and time for dry heat sterilisation

A

160 for 120min

170 for. 60 min

25
Q

how is heat transferred in moist heat sterilisation

A

latent heat of vaporisation

26
Q

in autoclave operation where are the thermocouples situated and why

A

in the drain as it is the coolest place

27
Q

what are the 5 stages of autoclave operation

A

air removal, replace with steam under pressure to remove endospores
heating
sterilisation/holding period - 121-124 15 mins 15 psi
cooling
drying

28
Q

what Is the master temp record

A

specific for one type of load

29
Q

what are the disadvantages in compendial cycles

A

SAL overkill
problems of product degradation
economically wasteful
expensive

30
Q

what are the advantages of F0 value

A

allows lethalities to be compared
can be used for heat liable products
greater flexibility for heat sterilisation

31
Q

what items is EtO sterilisation used for

A

disposable items, medical devices

32
Q

what are the three stages of EtO sterilisation

A

pre conditioning
steriliser
aeration

33
Q

what are the disadvantages of EtO sterilisation

A

toxic residues, operator safety

34
Q

3 things to consider when selecting agent

A

not hazardous process
no toxic residues in product
microbial effectievers

35
Q

what is the test of sterility

A

on devices exposed to a fraction of specified sterilisation process via direct immersion or indirect elution

36
Q

how to reduce false positives with the test of sterility

A

trai personelle
environmentally controlled area
sterilize test equipment and materials

37
Q

what can be the causes of false negative with test of sterility

A

presence of a cidal substance

intervals between treatment and testing

38
Q

what is the test for sterility

A

testing for absence of microorganisms and frequency of contamination

39
Q

disadvantages of the test fro sterility

A

imprecise as it assumes sample represents the whole batch

40
Q

what is pyrogen testing and what test do you use & describe

A

detecting endotoxins via LAL test which looks for a clotting reaction after 1h 37 degrees and inverted

41
Q

depylrogenation conditions

A

dry heat at 250 degrees for 45 mins

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