Washing and Sterilizers

三浦工業株式会社

1
 Outline

• What is requested for Central Sterile Services

Department (CSSD)
• Information about washing
• Information about Sterilizers (Ethylene Oxide
type and steam type)
• Management Daily and regular maintenance

2
 (※)Influence on Sterilization related work and
sterilization.

Washing Sterilized subject Packing

cleanliness) Sterilizing method Item set Packing material
Material and shape
and method

Sterilization
Sterilizing agent, loading, machine
condition, sterilizing condition and
monitoring condition

Confirmation Release
Chemical indicator，Biological indicator part ,
sterilizaing record confirmation

3
 Outline

• What is requested for Central Sterile Services

Department (CSSD)
• Information about washing
• Information about Sterilizers (Ethylene Oxide
type and steam type)
• Management Daily and regular maintenance

4
 Why washing is necessary？ (１)

Most common answer that we get,

As the result pathogenic bacteria should be killed after
proper sterilization, so we put items to sterilizers.

Reason why？
In fact, it is very rare to teach the knowledge about
medical device’s sterilization and disinfection at
university medical department. Only have the
Lectures about disinfectants for such skin disinfection
or curing purpose.

5
 What is Sterilization guarantee ？
Can it be defined as “sterilized” ？
Sterilized item’s function is not impacted
It will be meaningless if items are not reusable after
sterilization.

Sterilized item’s safety is not impacted

Sterilized Items cannot be used if it is polluted.

Sterility can be granted when Sterility Assurance

Level (SAL) < 10-6 is achieved.
The possibility of sterilization error should be in the level of
one of million.
6
 Why washing is necessary？ (2)
The following will happen if no washing process before
sterilizing・・・

1. Any substance remain not only make the bioburden number

become high, also impact the penetration.

2. The risk of human body that hart by remain dirt or

disinfectant will increase.

3. (※)Sterilized without washing, the instruments may get

damage because of remaining chlorine or other substances. At
result, it increases the COST.

7
 Basic concept about sterilization and washing

Washing is
a premise to increase the possibility of sterilization
106
105 The possibility of sterilization can be
104 increased by the decreasing of
103
bioburden.
102

101

生 100
2D 4D 6D 8D 10D 12D
10-1
菌
10-2
数 Sterility Assurance Level (SAL)
10-3
●Bioburden is lower than10-6
10-4 Possibility is more than 99.9999％
10-5

10-6
10-7

10-8 99.999999%

99.9999999%
8
 Cleanliness

Dirt Heat

Ex) The color

changed after
sterilization because
Lack of cleanliness will block the heat transmission. It may also
of lack rinsing.
make dirt fixed on instruments after waring process.
It has the possibility that both microorganism number and bioburden
per unit on sterilizing objects become huge.
9
The feature of 3 major instrument cleaning
methods at medical scene

10
 The cleaning method at medical scene
• Immersion cleaning
A cleaning method that instruments will be immersed in enzyme
detergent, then dirt such as blood and body fluid will be dissolved and
removed. In general, immersion cleaning operated as a pre-cleaning
process before hand-washing cleaning or machine-washing cleaning. The
management of detergent concentration, temperature and immersion time
is important.
• Hand-washing cleaning
A cleaning method that is washed by hand. The cleaning result would
become different easily because of different staff’s working, and it is a
high infection risk.
•Machine-washing cleaning
A cleaning method that is operated by washing machine. Due to washing,
disinfection and drying can be operated automatically, it is considered
more safety and efficiency of workability. It is important to perform daily
maintenance of the washing machine and confirm cleaning performance.

11
The major methods of medical washing machine

✓ Jet type
Common called：Washer disinfector
It is standard medical-washer model which act as main
product for lots of domestic and international makers.
✓ Ultrasonic type
The most common cleaning method in Japan in
previous generation.
Well washed even the gap between small metal items.
✓ Vacuum Boiling type
Innovative cleaning method to others
The feature is that most of items can be washed by this
washer.

12
 The common points should be noticed while
using machine washer －
✓ Use proper cleaner/detergent

✓ Disassemble instruments should be disassemble,

and items like forceps should remain open to allow
the water flow.

✓ Setting the washing temperature base on the

detergent, heat resistance of items, and items’
property.

13
 Vacuum Boiling Washing
✓ (※)Washing objects/instruments are immersed, and will washed
by cleaner and complex water flow from combination of pressure
change (decreasing and recovery). This is a new washing
technology.

✓ Even instruments are overlapped, or like cups, petri dish, and other
items, as long as some spaces are still exist, it is still possible to
clean most of instruments. Make washing process easier.

✓ Due to instruments are washed by water flow, flexible items such

as robber, silicon and soft plastic can be also washed. In addition,
it is possible to mix different type of instruments together for one
washing.

14
 Outline

• What is requested for Central Sterile Services

Department (CSSD)
• Information about washing
• Information about Sterilizers (Ethylene Oxide
type and steam type)
• Management Daily and regular maintenance

15
 Sterilization grantee

• Sterility Assurance Level (SAL) achieves to 10-6

SAL: Sterility assurance level
SAL 10-6 means the possibility that bacterial can still exist after sterilizing is
1/1000000 (1 out of million)

Sterilized item’s function

is not damaged.

Sterilized item’s safety

is not impacted.
 Benefit and drawback of each
sterilization method
High pressure steam
sterilization
The most established
sterilization method that
base on microbiology.
○ The first priority order to
other sterilization
method.
The items without
heat resistance
cannot be sterilized
× and the items without
resistance of pressure
change.
Hydrogen peroxide low
EOG temperature plasma
sterilization sterilization
The second order of all No toxic gas will remain on
sterilization methods. the objects, items can be used
Low temperature immediately after sterilizing.
sterilization is possible Low temperature sterilization
(37~60 deg C). is possible (about 45 deg C)
The EO gas may remain Available objects are
on the objects (toxic). limited (the process may
It takes long time to stop because of color
remove the remain EO change, absorption… etc.)
(depends on the
material, it may take Accessories like tube is
more than 8 hours). required.
Example of sterilization process

Preconditioning, Sterilizing Steam Drying

exhausting
air vacuuming
18
 Basic Process
● Pre-warm Preconditioning
The drain on the sterilizing object’ surface will be
decreased if object is warmed before filling steam (for
drying purpose).
To decrease the steam amount, shorten sterilization
time, and drying time.

● Air vacuuming
The absolute condition to steam sterilization
The steam permeability will increase if the air of
sterilizing object is removed/vacuumed.
To prevent of sterilization error
To confirm air trouble (ex. Bowie & Dick Test

19
 Basic Process
● Steam exhausting
To exhaust the steam after sterilizing
The sterilizing pack may get broken because of the
speed controlling

● Drying
The sterility has higher possibility to be impacted
if the sterilizing pack remain wet.
It is important since drying can prevent the
recontamination during storage or transportation.
20
 The points of air vacuuming
(removing) process
Replace Chamber air (to effect heat transmission and to create low water
activity) and air (contained in the sterilizing objects) by Steam.
> The sterilizing objects and packing material should available to stand the
pressure change.

> Regular checking/ evaluating the air removal performance.

> It is common to be considered that the sterilization efficacy would be

changed because of the packing method or sterilizing object.

21
 Image of air barrier/trouble
If steam is mixed with air？
If steam is existing without air？

すすめ

22
Example of air vacuuming/ removing process

Saturated Steam –
remove air forcedly method (※) Pulse-matic pre- vacuum method

Pre-vacuum – pressurizing (※) Pulse-matic pre- vacuum –

method pressurizing method
23
 Preconditioning and the temperature raising of
sterilizing object

○ × Container AAMI
Tweezers/pincet
1 role of cloth
30 pcs △
×
×
EN
135

Temperature (℃
3000
Pressure (kPa・abs

2000 130
布1巻
　AAMI
セッシ(30本
1000 　EN
コンテナ 金属 30kg
chamber

0 125
30 40 32 34 36 38 40 42
time (minute) time (minute)
24
 Preconditioning and the temperature raising of
sterilizing object

○ ○

○ ○

○
136

Temperature (℃ 135
3000
Pressure (kPa・abs

2000 134 布1巻

　AAMI
セッシ 30本
　EN
コンテナ 金属 20kg
1000 　chamber

133 36 38 40 42 44 46
0
20 30 40
time (minute)
time (minute)
25
 High pressure steam
sterilization
Sterilization tem. Keeping time
121℃ 15 min
126℃ 10 min
134℃ 3 min
※ISO/DIS17665

Sterilization tem. Keeping time

115-118℃ 30 min
121-124℃ 15 min
126-129℃ 10 min
※第14改正 日本薬局方
 The world's sterilization process

• UK 134℃ 3.5 min

• Germany 134℃ 4.0 min
• Finland etc. 134℃ 5.3 min
• Spain 134℃ 7.0 min
• France 134℃ 18.0 min
• Australia 134℃ 3.5min
• Brazil 134℃ 7.0 min
• South Africa 134℃ 5.0 min
Japan 135℃ 8.0 min

Mr.Helmut Raake(BROWNE) , サクラ精機株式会社

第 ６回日本手術医学会総会 トピックスセミナー Nov. 11,2004 一部改訂
Drying

The less drain is better

Ventilation is good
The issue that caused by drying problem

• The barrier property will decrease because

of remaining water

• The sterilizing pack may break especially

the damage on paper surface
The process of steam sterilizer
Dry
pressure
Pulse drying

Continuous vacuum drying

Combination drying
The feature of each drying process
● Pulse drying
1 Repeating of pressure reducing and pressure recovery
2 Effective on fibrous products
( Boiling by pressurizing, Surface diffusion by absorption, and moving inner
water to the surface are promoted. )

● Continuous vacuuming drying

1 Continuous keeping the chamber under vacuumed condition
2 Effective on metallic items

● Combination drying
First Continuous vacuuming drying and then Pulse drying
When large amount of metal items and clothes are combined and when drying
trouble occurs, this process will use according to the situation.
 Location of
condensed water

Sterilization Technology for the Health Care Facility

/Reichert Young
Reasons of drying
trouble

• Machine error
Lack of pressure reducing level

• Placing location
The water drop from above to bottom

• Sterilizing object’s packing

Overfill, impacted by packing material
(container
Reasons of drying trouble

• Steam quality
Scattering of steam drain・surface adhesion

• Sterilizing object’s material

Water absorption, metallic material

• Environment factors
Weather temperature, humility and seasonal factors

• Others
Equipment, human factor/error
 Potential risk that lead drying problem

The direction/stack
The stack method, method of
place method and sterilizing pack
overlap inside
of items set.
The scattering of
The drain comes steam drain come
from upside with supplied steam

Attention of
The ventilation of ventilation and weight
overlapped part
 The drying process
(the stack/ place method of sterilizing object)
 (※) Due to items are well
arranged by layers, the towel
with good hygroscopicity
can be also used.

Keep sterilized items in the

pack and place lots amount
in one container.
Low temperature sterilization
method

38
 Toxicity of sterilant
• Ethylene Oxide: Acute toxicity, Skin irritation, Eye
irritation, Mutagenicity, Reproductive toxicity,
carcinogenic

• Formaldehyde: Acute toxicity, Skin irritation, Eye

irritation, Mutagenicity, carcinogenic

• Hydrogen peroxide: Acute toxicity, Skin irritation, Eye

irritation, Mutagenicity, Reproductive toxicity

– “It is not useful as a sterilant if it is not toxic. “

ASHCSP Text
EOG Sterilization method

H H

H C C H

O
40
 Theory of EOG sterilization

OH NH2
O
Bacteria + H2-C-C-H2
HOOC SH Ethylene oxide

Supplied as humidity O- CH2CH2OH

Catalysis NH - CH2CH2OH
H2O
Killing
Fungus
Alkylation reaction S - CH2CH2OH
ＣOO - CH2CH2OH
41
 4 required conditions of EOG
sterilization

Gas concentration Humidity

Temperature Time
Humidified medical
material
P

42
 4 required conditions of EOG
sterilization
POINTS
• Gas concentration: the higher concentration is the
shorter sterilization time
• Temperature: the sterilization time will decrease
when rising temperature
• Humidity: Swelling fungus/bacterial bodies and
allowing gas to easily permeate inside.
• Time: It has proportion between the process time
and sterilizing effect.

43
 Cylinder type sterilizer

✓ The mixed EO gas (20% EO + 80% CO2) is the most common

selection. (In JAPAN)
✓ Bigger sterilization capacity
✓ Usually selected by the facility like huge hospital or sterilization
center that with huge amount of sterilizing objects 44
 EOG sterilizer

✓The gas is either 95% EOG or 100% EOG

✓The sterilizing time is short because of the high gas concentration
✓All operations are down under atmospheric pressure, so the
possibility of gas leakage is low.
✓It is getting popular to normal hospitals due to the high safety
design 45
 (※)Comparison of positive / negative
pressure type
Positive pressure
type
(※)Sterilization Outline Processing with big amount
is possible
Sterilization time Long
Gas leakage Higher possibility
Running cost Cheap
Environmental burden Air pollution due to exhaust
gas
Cylinder management Be careful of running out of
Liquid material
Negative pressure
type
Limited by cartridge
regulation, the maximum
capacity is 250L.
Short
Lower possibility
Expensive
Lower impact due to use
small amount
Easier because of single use
type
46
 The EOG sterilization process
The air will be removed because it is an
Pressure reducing obstacle to EOG permeation. Eg.
concentration decrease

Steam ・Water, humidification is necessary

Humidification as sterilization conditions

To keep temperature, concentration,

Sterilizing humidity for sterilizing

To remove the high concentration EOG by

Washing repeating the pressure reducing and pressure
recovery.
To remove the EOG that remain on
sterilizing object.
Metallic and glass items are not required this
Aeration process.
The required aeration time is depending on
the sterilizing objects.
47
 Aeration
The process to remove the remain EOG or the EOG absorbed by the objects.

Washing：To remove the remaining EOG in

the chamber
Aeration：To remove the EOG the remain on
the sterilizing objects.
NO BIG DIFFERENT between above two
method.

•The EOG will be removed by

repeat the cycle of pressure reducing
and pressure recovering
•The air will be continues pumped
though sterile filter to the chamber
by operating the vacuumed pump.
48
 The suggestion of remaining EO
concentration from FDA
EO(ppm)
The instruments that will be implanted into human body

Small lower than 10g 250

Midian 10 – 100g 100
Large more than 100g 25
Intrauterine contraceptive device 5
Intraocular lens 25
Instruments that use for mucous membrane 250
Instruments that use for blood 25
Used outside of body
Instruments that use for skin 250
Hand brush with sponge for Surgery purpose 25
49
 Suggested Aeration time

Base on the PVC aeration time

Suggested by AORN, AAMI, AHA

Temperature Aeration time

37℃ 32～36 hours

50℃ 12 hours

60℃ 8 hours

50
 Aeration time is impacted by the
following factors
• Product material e.g. easy to remove or not)

• Product shape e.g. simple shape, thin shape

• Sterilizing condition gas concentration,

temperature

• Aeration condition temperature, air flow rate,

control

• Load condition large amount, small amount

51
 Outline

• What is requested for Central Sterile Services

Department (CSSD)
• Information about washing
• Information about Sterilizers (Ethylene Oxide
type and steam type)
• Management Daily and regular maintenance

52
Daily monitoring and
management

53
 The difference of washing indicators
Before washing 0.5% RY-0100 0.5% RY-0500

Washing First washing 50℃15 min First washing 50℃15 min

condition Second washing 90℃5 min No Second washing
(with tube
washing)
TOSI

TOSI
Lumcheck

EVIT-SP

EVIT

Pure Check アミドブラック1B染色後

Alkali

Neskos

54
Clean check
54
 For improving the washing quality
✓ Select the right washer (washing machine) base on
instruments’ condition, also select the right cleaner
(detergent) base on the material.

✓ As far as possible, use the machine washing instead of

hand-washing.
Sterilization quality relevant to the huge change of Bioburden.

If the washing quality can be improved, then the possibly of re-sterilizing that
caused by the sterilizing error/ trouble can be decreased.
Total working efficiency can be also improved by the same reason.

In order to improve the sterilization quality and decrease the staff’s infection
risk, let’s review the washing process again 55
Sterilization
confirmation

56
 The sterilization daily management
✓ Checking the machine performance is normal
The parts that impact sterilization performance Air
removal capacity, the shift and control of temperature/
pressure

✓ Checking/ evaluating the sterilizing operation

can be completed correctly

✓ Deciding the operation guideline by using

chemical indicator and biological indicator.
57
 Sterilization control
(Sterilization monitoring)
• Mechanical monitoring
Recorder (temperature, pressure, time)
Sterilizer’s maintain management
• Chemical monitoring Chemical indicator
Checking the sterilizing condition by chemical reaction, Selection base on
purpose (ISO)
Different maker may have different outcome
• Biology monitoring (Biological Indicator
Sterilization confirmed by bacteria
Outcome may change because of time, cost and place

58
 Biological Indicator BI
• Biological indicator or test pack
Fungus is used as indicator to confirm sterilization is completed.
– High pressure steam sterilization
Geobacillus stearothermophilus ATCC 7953 Culture temperature 56℃
– Ethylene oxide gas sterilization
Bacillus atrophaeus ATCC 9372 Culture temperature 37℃
– Hydrogen peroxide gas plasma sterilization
Geobacillus stearothermophilus ATCC 7953 Culture temperature 58℃
Bacillus atrophaeus ATCC 9372 Culture temperature 37℃

59
 Chemical indicator CI
• The outcome show immediately right after sterilization process

• The condition can be checked by placing the CI inside of packing

• Design for different application(inside or outside of package)

• CI is not confirmed that fungus have been actual killed. it is an

evidence to show the environment conditions are suitable for killing
fungus

60
 Chemical Indicator Type
Type 1 ： Process Indicators

Type 2 ： Indicators for use in specific tests

Type 3 ： Single variable indicators

Type 4 ： Multi-variable indicators

Type 5 ： Integrating indicators

Type 6 ： Cycle Specific Indicators

61
 Indicator selection guidelines

✓Using correct indicator for target fungus

✓Selecting the correct indicator by understanding

the indicator class for target purpose

✓Selecting the indicator that respond to the managed

sterilizing conditions
e.g. Sterilizing temperature / time)

62
 The example of sterilizer recording chart
Temperature Pressure memory
memory Red:
Sterilizing
Temperature
temperature

Sterilizing
pressure
Gray: Pressure
10 min

Direction
Atmospheric Vacuum level
pressure

Air removal
performance
63
 Bowie & Dick Test

Evaluating results by compare

the color different between the
central part and the edge part.
Fold the edge part to the
central and compare the color
difference. 64
Management by
indicator
pack control

CI should be placed into all pack

for checking the sterilizing
condition
If necessary, BI can be placed
for checking that bacteria is
killed or not 65
 Troubleshooting when color is not
well changed
Do not operate sterilization until identifying the reason
and passing the retest.

Factor
Machine error
Vacuumed pump has low performance, water temperature,
air leakage, pressure lost in exhaust part, Process control
error temperature sensor, pressure sensor , Exhausting
drain error

Utility error
Mass contamination of Non-condensable gas in the
atmosphere / decreasing steam dryness
66
 Operation record
● Assuming a problem after release, keep all record
for traceable.
1 When and which sterilizer were used that object.
Sterilizing conditions (sterilizing object type,
control setting, sterilizing setting time, etc.
Record during operation
Temperature Maximum/ minimum , sterilizing time,
pressure Maximum/ minimum , checking record chart
Indicator outcome
Bowie Dick, Ｉ， Ｉ)
The expire date of sterilizer, repair, maintenance,
calibration record
Signature of operation staff, supervisor 67
STERILIZER SAFETY MANAGEMENT
PERFORMANCE INSPECTION

68
 Purpose of sterilizer maintenance

• To grantee the safety of pressure vessel, Performance

inspection, Regular self-checking

• To avoid any sterilizer failure, Bowie Dick Test, The

regular inspection by sterilizer maker, Record chart
confirmation

• To grantee the sterilization quality

The specific verification from sterilizer maker
(Validation)

69
 Avoid the sterilizer failure

 Sterilizer is complicated machine that includes

Auto valve, pressure regulation valve, vacuum
pump, and the filters to avoid those instruments
failure.

 In general, even one of parts has problem/ get

failure, the sterilizer cannot operate normally.

 It is important to have regular maintenance to

avoid/prevent the trouble happen.

70
 Performance Keeping

Temperature sensor
checking

Pressure sensor
checking

The accuracy can be kept by regular

calibration.
Setting expire date (Usually 1 year) 71
 Regular self-checking
The checking that end-user should complete regularly.
It should not be confused with performance inspection.
• Once per month for first type pressure vessel
Once per year for the small pressure vessel and second type
pressure vessel
• Daily check if sterilizer has crack or not / packing has damage or
not. (normally visual checking)
• Those checking should be completed by the staff who actually
operating sterilization process or the staff who managing facility.
It is dangerous to check sterilizer when it still warm.

72
 Regular checking task

1. Chamber
with crack / without crack
2. Door
tightening condition
3. Packing
with damage / without damage

Basically it is vessel checking, not

checking relevant to sterilization
(Attention!)
73
 Example of regular self-checking sheet
Company/Client name Signature

Vessel Subject number Signature

Checked
by

Month
Checking subject Checking item Day
(※) Inspection results
1.1 Chamber crack, damage, corrosion Good・No Good・No Good・No Good・No Good・No Good・No Good・No Good・No Good・No
2.1 Door packing damage, deformation Good・No Good・No Good・No Good・No Good・No Good・No Good・No Good・No Good・No
crack at welding part,
2.2 Edge plate corrosion, thinning Good・No Good・No Good・No Good・No Good・No Good・No Good・No Good・No Good・No

Door tightening steam leakage Good・No Good・No Good・No Good・No Good・No Good・No Good・No Good・No Good・No
2.3 condition (※) alarm notification Good・No Good・No Good・No Good・No Good・No Good・No Good・No Good・No Good・No

Handle’s rotation Good・No Good・No Good・No Good・No Good・No Good・No Good・No Good・No Good・No
Strange sound during opening/closin
2.4 Door operation Good・No Good・No Good・No Good・No Good・No Good・No Good・No Good・No Good・No
g
(※)operation of obstacle detection Good・No Good・No Good・No Good・No Good・No Good・No Good・No Good・No Good・No

Piping/ valve steam leakage, water leakage, corros

3.1 leakage ion Good・No Good・No Good・No Good・No Good・No Good・No Good・No Good・No Good・No

3.2 safety valve leakage Good・No Good・No Good・No Good・No Good・No Good・No Good・No Good・No Good・No

water intrusion, discoloration,

Pressure gauge dirt pointer bending Good・No Good・No Good・No Good・No Good・No Good・No Good・No Good・No Good・No

4.1 Inner chamber pre Accuracy at zero point,

Good・No Good・No Good・No Good・No Good・No Good・No Good・No Good・No Good・No
ssure gauge below red line
Outer chamber pre
below red line Good・No Good・No Good・No Good・No Good・No Good・No Good・No Good・No Good・No 74
Thank you for your attention

75