Sterilisation 6

Question 1

equipment for EtO characterisation?

Answer 1

pre-conditioning
steriliser
aeration area

Question 2

EtO sterilisation cycle time will vary depending on?

Answer 2

the nature of the product

Question 3

TF: the EtO sterilisation cycle graph changes shape depending on the product

Answer 3

false
stays the same shape regardless

down, straight, up slightly, straight, up alot, (EtO injected here) straight, down a lot, the ECG spike pattern 3 times

Question 4

TF: preconditioning occurs in a different chamber

Answer 4

can be either

Question 5

what is the point of pre conditioning

Answer 5

to ensure the product reaches the right humidity levels

Question 6

explain the sterilisation cycle?

Answer 6

1. Evacuation- removal of air
2. Vacuum hold (leak test)- make sure airs not getting in
3. Conditioning- starting to heat the product
4. Sterilant injection- cannisters inserted. EtO vaporises readily
5. Exposure- holding period, may be more EtO injected
6. Sterilant removal- catalytic converters which will convert EtO into CO2 and water
7. Flushing- sterile air in, often N2 or CO2 to

Question 7

explain the process of aeration

Answer 7

products exposed to N2 for 12hrs-10 days to make sure theres no EtO on the product

Question 8

are there requirements for you to specify which method should be used?

Answer 8

no

Question 9

when is the choice of method to be used decided?

Answer 9

at the design/ development stage

Question 10

when selecting the agent of sterilisation what mustn’t it do?

Answer 10

not present hazards to operators or environment

does not leave toxic residues within the product

Question 11

selection of sterilising agent characterisation forms part of?

Answer 11

the initial research and development

Question 12

what needs to go into the sterilising agent characterisation?

Answer 12

Precise description of nature & quality of sterilisation agent described- what causes the sterilisation
Microbiocidal effectiveness needs to be demonstrated eg enzyme kinetics, environmental parameters etc
Material effects, ie product compatibility
Safety and the environment

Question 13

name 4 new emerging sterilisation technologies?

Answer 13

X-RAYS
pulsed light
microwaves
gel plasma

Question 14

explain x-ray irradiation

Answer 14

ionising radiation

Question 15

TF: X-ray irritation is cheap

Answer 15

Its expensive

Question 16

X-ray irritation has _____ penetration power. what does this mean

Answer 16

low
limits the amount of product we can use
good for simple solutions

Question 17

what is pulsed light sterilisation

Answer 17

Broad spectrum white light, short pulses; UV output-

Question 18

pulsed light has _____ penetration power

Answer 18

low

Question 19

is pulsed light sterilisation ionising

Answer 19

no

Question 20

how does microwaves work?

Answer 20

Intense heating; short cycle (sec);

Question 21

what are microwaves used for?

Answer 21

solutions in vials e.g. contact lens

Question 22

Gel plasma is an alternative to?

Answer 22

EtO

Question 23

what is gel plasma sterilisation

Answer 23

Mixture of ions, free radicals, electrons & neutrons- these have the sterilising power

Question 24

gel plasma sterilisation processing time?

Answer 24

short

Question 25

problems with these new emerging sterilisation technologies?

Answer 25

unknown lethal effects 
Kill kinetics different to traditional processes 
Validation compliance 
Monitoring 
No established regulatory requirements