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Richard Marchand MD
Medical Microbiologist and Infectious
Diseases
Assistant Professor
University of Montreal
One hospital (The CSSSSVLDLJ)
Somewhere in Quebec
Plan
History
Basic
definitions
A lot of little quizzzz
Properties of heat, steam and bugs
Process validation
Biological Indicators
Chemical Indicators
Water, water, water
Disinfection or Sterilisation ?
What
Little Quizz
Question
Reduction of 106
Temperatures of 121, 132 and 134 oC ?????
HISTORY
1862
1880
1906
1925
1932
1940
HISTORY
1950-60
1960-70
Water Boils at
100 C : fresh water in a pan with a lid
97 C : fresh water in a pan without a lid
104 C : sea water (depending on salt concentration)
Boiling never guarantees that the temperature was high enough for
bacterial proteins to coagulate
The very low water content of spores and other substances ( Heat
shock proteins also called stress proteins) protects them from denaturation
100
C at 1 ATM
121 oC at 2 ATM (1 barr)
132 oC at 3 ATM (2 barr)
80 oC at 0.5 ATM (Mont Blanc)
70 oC at 0.35 ATM (Mont Everest)
40 oC at 0.02 ATM (Mechanical vacuum)
o
Quizz Pasteur ?
Why 2 or more exposures to heat ?
Answer : For germination to happen
Why no air ?
Answer : Because the air blocks the energy
transfer toward organic matter.
SURVIVAL PROBABILITY
The
N.B. Faster does not mean more efficient, because a bug killed more slowly is not less dead.
1 can/1 BI (2.0 X 10 )
= 0-0.2 survivor
10 cans/10 BI (2.0 X 10 ) = 2 survivors (or to 7.5 min)
100 cans/100 BI (2.0 X 10 ) = 20 surv. (or to 8.5 min)
103 cans/103 BI (2.0 X 10 ) = 200 surv. (or to 9.5 min)
104 cans/104 BI (2.0 X 10 ) = 2000 surv. (or 10.5 min)
105 canss/105 BI (2.0 X 10 ) = 20000 surv.(or 11.5 min)
6
10
11
Evidence
In
Pasteurisation yesterday
In
HISTORY cont.
1960-70
1965
1979
If the temperature is lowered, bugs are killed more slowly and the D
value increases (because it takes more time to kill)
If the D value is measured at different temperature and pressure it can be seen that
a D value varies with the pressure. More the Dvalue decreases with a specific
increase of pressure, more powerful is considered the process.
Little quizzz
Question : Is all processes D values a time
dependant measure ?
Answer : No, for radiation and ozone
sterilization the Dvalue is dose dependant
SURVIVAL PROBABILITY
FOR TOPICALS :
10-3)
1 on 1000
(SAL of
1 pack/1 BI (2.0 X 10 )
= 0-0.2 survivor
10 packs/10 BI (2.0 X 10 ) = 2 survivors (or to 7.5 min)
100 packs/100 BI (2.0 X 10 ) = 20 surv. (or to 8.5 min)
103 packs/103 BI (2.0 X 10 ) = 200 surv. (or to 9.5 min)
104 packs/104 BI (2.0 X 10 ) = 2000 surv. (or 10.5 min)
105 packs/105 BI (2.0 X 10 ) = 20000 surv.(or 11.5 min)
6
10
11
Quizz
Question : Can you name a heat barrier material ?
Answer : polymers (plastics) like non porous
plastic containers, wood, rubber etc..
minutes.
Taking into account the Fvalue :
132 oC
2.0 bar
Time drops to 4 minutes
steel and
In the real . . .
Pre
conditioning
Sterilization
3.5 to 15 min
Dry time 15 to
20 minutes max.
Little quizzzzz :
Name the critical parameters of steam
sterilization
Temperature (121 oC)
Time (duration)
Humidity
Pressure (includes vacuum)
Phases of cycle (manufacturer and Europe)
0 minute
1 minute
2 minutes
3 minutes
S.A.L. 10-6
Shorter cycles
Little Quizzzzzz
f
o
t
lo
e
d
e
r
o
t
s
!
y
g
ne r
m
u
h
,
s
e
Y
Is humidity a must ?
170
C (340 oF)
160 oC (320 oF)
150 oC (300 oF)
140 oC (285 oF)
121 oC (250 oF)
o
:
:
:
:
:
60 minutes
120 minutes
150 minutes
180 minutes
12 to 14 hours
STEAM
Low energy
vapour
High energy
vapour
water
100
200
300
400
500
600
700
100
200
300
Releases hundreds of
calories of heat here.
400
500
600
700
100
200
300
400
500
600
700
100
200
300
400
500
600
700
100
200
300
400
500
600
700
Saturated steam
Dry steam
Wet steam
Supersaturated
STERILISATION VALIDATION
Sterilisation validation is arbitrarily laid on the
construction of an cycle based on the
behaviour of biologic indicators hopped to be
predictable
-) cycle developement
-) cycle
validation
-) routine monitoring
Cycle
Variability of BI
The
WHAT IS AN INDICATOR ?
On
paper
Self -contained
Sealed ampulla (spores + broth)
Spores suspension
Tube witness (pt of fusion)
It is a device conceived to
verify if the process operated as expected
reality :
We
There
3M Rapid Indicator
3M Rapid Indicator
Commercial BI
Spores
of bacterial population
Quantity of spores
Storage conditions and expiration date
Usage condition (culture media and incubation time)
Performance characteristics
Sportrol
Survivors
0 min 140,000
1.5 min
3.0 min
4.5 min
6.0 min
7.5 min
1.4
9.0 min 0.14
Complete
14,000
1,400
140
14
Attest
Survivors
0 min
1.9 min
3.8 min
5.7 min
7.6 min
9.5 min
11.4 min
250,000
25,000
2,500
250
25
2.5
0.25
Proof plus
Survivors
0 min
1.9 min
3.8 min
5.7 min
7.6 min
9.5 min
13,000
1,300
130
13
1.3
0.13
Chemspor
Survivors
0 min
4.9 min
9.8 min
14.7 min
250
25
2.5
0.25
BI in overkill method
Indicators :
Class
ISO 11140-1
Class 4
ISO 11140-1
that accept (OK or Pass) at 132 oC for 4 min MUST reject (Fail) a 131 oC for 3 minutes and
22 seconds.
: air
My daughters trick ?
Air displacement
By
gravity
By dilution (flash)
By pressure pulse
By vacuum
By pressure pulse and vacuum
(Steam Flush Pressure Pulse)
Canada
Red
stain : iron
Brown stain : Manganese, Magnesium
Green or blue stain : copper
Viscous and green Stuff : metallothropic
bacteria
Hardness
according to
regions
Water Surveillance
Water
Immunosupressed patients
Types of treatments
Needs for cleaning, disinfection and sterilization
nebulizers ; (Why ?)
Dialysis
CSR
; (Why ?)
Question period
Thank you