Contamination control part 2 Flashcards
is a single microbial cell either viable or dead
can be both
will all viable cells die at the same time
no
how do you work out the inactivation factor
10 t/d
what is D
value of parameter of sterilisation
required to reduce number of viable organisms by 90%
what are the two approaches of sterilisation
overkill method
bioburden method
what is the overkill method
cycles based on inactivation of N organisms with greater resistance
minimum SAL is set
are they sterilised in their final containers in overkill?
yes
are they terminally or non terminally sterilised in overkill
terminally method
where is it manufactured in overkill
cleaning room
where is the bioburden method sterilised
prepared in aseptic conditions
from materials that have been sterilised previously
is it non terminally or terminally sterilised with bioburden
non terminally sterilised
where is it processed in bioburden
in the cleanroom until it is sterilised
what happens once bioburden is sterilised
filled in final container in aseptic area
what is the best method of sterilisation
heat
which bacteria is heat sensitive
vegetative bacteria
