sterilisation processing

Question 1

which sterilisation processing is the most reliable

Answer 1

producing under clean conditions not aseptic

Question 2

give 3 examples of contaminants in he drug development process

Answer 2

raw materials, water, manufacturing environment

Question 3

give an example of a source of gram positive bacteria

Answer 3

soil

Question 4

give an example of a source of gram negative bacteria

Answer 4

water

Question 5

give an example of a source of yeasts and moulds

Answer 5

plants

Question 6

D value =

Answer 6

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

Question 7

Z value =

Answer 7

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

Question 8

what is the value for sterility assurance level

Answer 8

10^-6

Question 9

4 factors D value can be influenced by

Answer 9

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

Question 10

do you need documentary evidence for process validation

Answer 10

yes

Question 11

what is the purpose of biological indicators

Answer 11

to asses the microbial lethality of a sterilisation process

Question 12

advantages of using BIs to asses sterilisation process

Answer 12

stable

high resistance to sterilising agents

Question 13

what BI is used for filtration

Answer 13

brevundimonas diminuta

Question 14

what BI is used for moist heat

Answer 14

bacillus stearothermophilus

Question 15

what BI is used for dry heat

Answer 15

bacillus subtilus

Question 16

what BI is used for irrigation

Answer 16

Bacillus pumilus

Question 17

what BI is used for EtO

Answer 17

bacillus subtilus

Question 18

give the 4 ways filtration works by

Answer 18

irregular shape
simultaneous arrival
blocked pore
surface interactions

Question 19

what test validates filtration

Answer 19

bubble point pressure test and BI

Question 20

describe the differences between depth filters and screen filters

Answer 20

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

Question 21

what types of products may use dry heat sterilisation

Answer 21

dry powders, oil preparations, glassware and instruments

Question 22

which is the longest section of the dry heat process

Answer 22

cooling

Question 23

during dry heat sterilisation, which section does sterilising occur

Answer 23

exposure

Question 24

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

Answer 24

160 for 120min

170 for. 60 min

Question 25

how is heat transferred in moist heat sterilisation

Answer 25

latent heat of vaporisation

Question 26

in autoclave operation where are the thermocouples situated and why

Answer 26

in the drain as it is the coolest place

Question 27

what are the 5 stages of autoclave operation

Answer 27

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

Question 28

what Is the master temp record

Answer 28

specific for one type of load

Question 29

what are the disadvantages in compendial cycles

Answer 29

SAL overkill problems of product degradation economically wasteful expensive

Question 30

what are the advantages of F0 value

Answer 30

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

Question 31

what items is EtO sterilisation used for

Answer 31

disposable items, medical devices

Question 32

what are the three stages of EtO sterilisation

Answer 32

pre conditioning steriliser aeration

Question 33

what are the disadvantages of EtO sterilisation

Answer 33

toxic residues, operator safety

Question 34

3 things to consider when selecting agent

Answer 34

not hazardous process no toxic residues in product microbial effectievers

Question 35

what is the test of sterility

Answer 35

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

Question 36

how to reduce false positives with the test of sterility

Answer 36

trai personelle environmentally controlled area sterilize test equipment and materials

Question 37

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

Answer 37

presence of a cidal substance | intervals between treatment and testing

Question 38

what is the test for sterility

Answer 38

testing for absence of microorganisms and frequency of contamination

Question 39

disadvantages of the test fro sterility

Answer 39

imprecise as it assumes sample represents the whole batch

Question 40

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

Answer 40

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

Question 41

depylrogenation conditions

Answer 41

dry heat at 250 degrees for 45 mins