Escolar Documentos
Profissional Documentos
Cultura Documentos
GMP and QA
class : B
Group 7th
1311011066 Hikmah Purnama Azani
1311011068 Puteri Yolanda
1311011069 Reza Yolanda
1311011072 Dini Lianti Azhari
1311011074 Retno Amilia
Sterilization - Overview
Objectives
Discuss definition of Sterile
Briefly describe sterilization methods
Describe approaches to be used for the
validation of a sterilization process using
Moist Heat as an example
Describe requirements for routine monitoring
and control of sterilization
Review issues that are specific to other
sterilization processes
3.00
1000 2.50
2.00
No of surviving organisms
800
1.50
1.00
600
0.50 No remaining
200 -1.00
-1.50
0 -2.00
0 1 2 3 4 5 6 7 8 9 10
No remaining 1000 368 135 50 18 7 2 1 0 0 0
Log No remaining 3.00 2.57 2.13 1.70 1.26 0.83 0.39 -0.04 -0.47 -0.91 -1.34
Time
D-Value
Example
For an initial bioburden of 102 the
sterilization process will need to
achieve an 8 log reduction in
viable organisms
This will require 8 times the D-
value (e.g. if the organism has a
D value of 2 minutes then 8 x 2 =
16 minutes will be required to
achieve an 8 log reduction and
an SAL of 10-6) (Point Z)
Determination of the
minimum Fo required is based
on the bioburden and its heat
resistance