Sterilization

Sterilization
Inability of living organisms to reproduce
Articles free from living organisms , spores
Process that provides an acceptably
low probability that an organism
will survive the treatment
Probability of occurrence of viable
microorganisms in a medical
product is reduced to < 10 –6 (BIS)

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 Disinfection

Clean with substance that kills pathogenic

organisms except spores
Boiling
Ultraviolet Radiation
Chemicals
 Disinfectants
 Alchols
 Aldehydes
 Iodophors
 Phenol
 Chlorhexadine
 Chlorine compounds
 Hexachlorophene
 Oxidizing agent
 Quarternary ammonium compounds
Sterilization Efficiency
 Biocidal Action
 Effective Contact with Biocidal Agent
 Appropriate Biocidal agent and Apparatus
 Severity of Treatment

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 HISTORY
BOILED WATER WOUND IRRIGATION
460-370 HIPPOCRATES
HANDS AND WOUND CLEANING
1680 PAPIN DIGESTER SAFETY VALVE
ANTHONY VAN DEVELOPED MICROSCOPE FOUNDATION
1683
LEEWANHOCK OF BACTERIOLOGY
FERMANTATION PROCESS FATHER OF
1837 SCHWAN
DISINFECTION
LOUISE MICRO ORGANISMS IN AIR BRING
1862
PASTEUR CHANGES
ANTISEPTIC SYSTEM PRINCIPLES
LISTER CHEMICAL DISINFECTION/STERLIZATION
INSTRUMENTS

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HISTORY(CONTD)
1876 BASTION MICROBES RESIST PROLONGED
BOILING AT 100 C

1877 TYNDALL BACTERIAL SPORES RESISTANT

AT 120 C

1880 CHARLES CHAMBER FIRST PRESSURE STEAM

LAND STERILIZER

1881 KOCKS WORKED ON DISINFECTION /

STERILIZATION DRY HEAT AND
STEAM UNDER PRESSURE
EFFECTIVE STERILENT
1915 W.B.UNDERWOOD AIR REMOVAL IN GRAVITY
PROCESS FATHER OF CSSD
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 IMPORTANT FACTS
 FIRST SURGICAL OPERATION TOOK PLACE IN
BABYLON ,GREECE ABOUT 4000 YEARS AGO
 STEAM USED AS A STERILENT BY ROBERT KOCH
IN 1881
 SHIMMEL BUSH DRUMS REPLACED BY
ALUMINIUM CONTAINERS IN FORTIES
 SINGLE USE PACKING MATERIAL/ NON WOVEN
INTRODUCED IN 1935/1970
MEDICAL INSTRUMENT CLASSIFICATION

 NON-CRITICAL
 Touches only intact skin; environmental surfaces
 Intermediate to low level disinfection
 SEMI-CRITICAL
 Touches mucous membranes
 High level disinfection-minimum
 CRITICAL
 Penetrates skin or mucous membranes
 Sterilization
Spaulding’s classification
COMPONENTS OF INFECTION CONTROL
SURGEON
SCRUB NURSE
STERILIZATION
STORAGE
SURROUNDING
Methods
1. Steam Sterilization
2. Dry Heat Sterilization
3. Gaseous Sterilization
4. Radiation Sterilization
5. Chemical Sterilization

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Steam Sterilization
 Saturated steam (RH-100%) is water vapors.
 Biocidal efficiency depends on
1. Moisture content –Resistance low,film formed
2. Heat Content
3. Penetration

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Steam Sterilization
 Steps
1. Heating of Chamber
2. Removal of Air
3. Sterilization of load
4. Removal of steam/ Exhaust
5. Drying / Cooling of Liquids
6. Restoration of Chamber to Atmosphere

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Type of Sterilizers
Air Removal Steri Type of Drying
System Time load /cooling
Downward 121- Porous Ejector
Displacement 126 Load
DD ( Flash ) 132- Un Fast
134 wrapped Exhaust
Downward 115- Liquids Slow
Displacement 121 Exhaust
Mechanical 134- Porous Mechanic
Evacuation 138 Load al

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 Steam Advantages:
 Readily available
 Short cycle time
 Nontoxic
 Environmentally safe
 Economical
 Use with heat and moisture stable devices
 Flash is the fastest method
 Steam Disadvantages
 Unsuitable for an increasing number of heat and
moisture sensitive devices
 Efficacy dependent upon attention to detail
 Air retention and /or condensate pooling
 Some instruments tend to loose sharpness after
repeated exposure to steam
 Water quality may promote stains or corrosion on
instruments
 Packages are damp when removed from the
sterilizer, and must be allowed to cool before
storage
 Personnel can receive burns when removing
instruments from the flash sterilizer
Dry Heat Sterilization
 Hot Air Sterilization
1. Electrically heated Ovens
2. Electrical Heater without Fan
3. Gas Ovens ( not in use )
 Penetration Time Varies with the type of
material

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Sterilization Process
1. Heating the chamber to select
sterilizing temperature
2. Sterilizing the load
3. Cooling

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Methods of Sterilization
Hot Air
Radiant Heat
Conducted Heat
Flaming
Incineration

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Dry heat methods
Radiant Heat conducted heat
Long wavelength
Low level of energy
Oil baths in dental
Conveyor ovens not surgery
used Technique
High vacuum ovens inconvenient and
not cost
effective,temp 280o unsatisfactory

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Dry heat sterilization
 Flaming  Incineration
Wire loops Temp high
Gaseous effluent
Ster not
Combustible waste
guaranteed Solid residues contain
Low temp veg and spores of
bacteria
Short time

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Glass syringes, Needles, Sharps, Drills, Powders, Oils,

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Temperature /time
Sterilization
160oC 60 minutes
170oC 40 minutes
180oC 20 minutes
Powder ( 28gms/112gms---80/115 min)
Vaseline (28gms/112gms----110/165min)

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Limitations of dry heat
sterilization
High temperature and long time
Risk of explosion
Penetration poor in solids , nonaqueous
liquids and closed cavities
Efficiency dependent on moisture level of
cell

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 1987 45 countries signed Montreal Protocol
Document

- CFC Reduction to 50% of 1986 output levels by 1998

- Chlorofluorocarbons (CFC’s) cause destruction of

stratospheric ozone layer

- CFC used as flame retardant in a 80% CFC, 12% EO

System
 Regulatory Issues:
 1977 National Institute for Occupational Safety and
Health (NIOSH) reported EO as a possible carcinogen
 1978 Environmental Protection Agency (EPA)
reported EO as a mutagen and use would be restricted
Gaseous Sterilization
The medical equipment which can not
with stand the sterilization at higher
temperature being heat sensitive.
Demand increased in the last three
decades.

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For what it is used

Devices sterilized commercially for single

use
Reusable surgical and diagnostic
equipment
Resterilization of items opened
accidentally

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Common gaseous chemicals

Ethylene oxide (C2H4O)

Formaldehyde with steam
Hydrogen peroxide/Plasma

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•Ethylene Oxide

•Kills by alkylation's: Interfering

with the metabolism and
reproductive process of cells

•Sterilization Temperature 37-55 Deg

•Sterilization Time 3-5 hrs

•Aeration time 12-16 hrs
 •Ethylene Oxide
•ADVANTAGES •DISADVANTAGES

• Takes long time : 6 hrs for Sterilization and

12 hrs or more for aeration
• Age old practice of LTS
• Toxic Gas: Mutagenic and carcinogenic
• Does not Corrode instruments • High Installation cost

• Is a low temperature process can • Water present on the instruments can

• sterilize all kinds of instruments
combine with EO to form a toxic substance
called Ethylene Glycol
•
• Requires Pipings for EO outlet hence
immobile

• International recommendations require

regular monitoring of EO in CSSD
Limitation of ethylene oxide
sterilization
Not applicable on liquids and impervious
packaging
Process too slow for sterilization
Unsuitable for sterilization of diets
Lack of expertise in operation and supervision
Table top sterilizers not recommended

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Effect of gaseous
Act as alkylating agents
Biocidal action alters DNA of
microorganisms
Adds saturated hydrocarbon groups to
amino groups on protein molecules

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Ethylene oxide as sterilent
Highly diffusible and diffuses downward
Liquefied at low temperatures in cylinders
Boils at 10.7 and 1.5 times heavier than air
Vapors soluble in water form ethylene glycol
and chlorohydrin with Nacl
Dissolves in Rubber,Plastic,Oils,Silicones
Gas flammable, explosive

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ETO as Sterilent
Pure gas used below atmospheric
pressure
12/88 has lower pressure than co2 mix in
cylinders
Gas mixture expensive
Keep cylinders away from sunlight and
high temp
Gas polymerizes with rise in temp

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Articles sterilized by ETO
Scopes- Cysto, Endo , Resecto
Implants-Breast,ortho,pacemaker, leads
Cardiac- Cathers,cannula,Oxygenators
Equip- cryoprobes,hand pieces, Ventilators,
Nebulizers, Oxygen tents,lamps,
Transducers,Centrifuge bowls,Rubber,Electronic
equipment

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Sterilization stages
Removal of Air from Chamber
Humidification and heating of load
Sterilization of load
Removal of gas from the chamber
Aeration
Note: Process takes place below atmospheric
pressure

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Parameters for Aeration
Comp, thickness, Weight of device
Temperature, ETO concentration, Duration of
exposure
Size of packs
Arrangement of packs in machine
Absorptive property of material
Permissible level of ETO residue in device

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Aeration time
Product Temperature Aeration time
Glass, Paper, Thin
Rubber Room 24 hrs
48hrs
Gum , Rubber, PE Room
Room 96hrs
Other Plastic
Room 168hrs
PVC
8-12hrs
All above material 50—60o C

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Exposure condition with ETO
mixture 55/60/60
Mixture content (%) Conc of ETO (mg/l) Period (hrs)

10ETO/90CO2 450 06

20ETO/80 CO2 670--920 04

10 ETO / 450--850 05
90chlorofloro
methane
12ETO/88 furan 650 04

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ETO Retention in Plastics
Polyvinylchloride 1---3 %

Polystyrene 1.5---2.5%

Polyethylene 0.5---1%

Polypropylene 1---1.5%

Rubber (Nat &syn) 2---3.5%

Silicone Rubber 1.5---2%

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Ventilation in ETO Area
Minimum 10 air changes/hr
Area should be under negative pressure
Install local exhaust ventilation system
Use sterilizer with purge cycle
Use audible and visible alarm system
Use metal carts and baskets
Special alarm for leak
Operates with adequate knowledge

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Hydrogen Peroxide Gas Plasma
 Only current system that has achieved rapid cycles for general
hospital instrumentation without materials compatibility problems or
unacceptable residuals

 J&J Discovery of hydrogen peroxide as a precursor to plasma in 1985

 Advanced Sterilization Products formed as a development arm of J&J
Medical 1987
 Process trademarked as STERRAD® Sterilization
 First installations in Germany 1993
 US FDA clearance 1994
 Second generation process introduced 1997-98
•Low Temperature Hydrogen Peroxide
Gas Plasma Sterilization

•Kills by Oxidation

•Sterilization Temperature 40-50 Deg

•Sterilization Time 55 minutes

 •Low Temperature Hydrogen Peroxide Gas Plasma
Sterilization

•ADVANTAGES •DISADVANTAGES

• Economical • Can not sterilize cellulosic materials like

linen, wood
•Can sterilize all kinds of instruments including
• the heat and moisture sensitive instruments • Cannot sterilize powders and liquids

• Fast and helps in inventory reduction

•Safe for environment, healthcare workers and

• patients

• No monitoring required

• Mobile
 •Comparative Chart
•Features

STERRAD EtO

Sterilent 0.56% Conc H202 100% EtO

Sterilization Temperature 40-50 Deg C 40-60 Deg C
Sterilization Time 55 minutes 16-18 hrs
Material Compatibility High High
Safety of Health Care worker High; By product oxygen & water vapour Harmful; EtO is carcinigenic and mutagenic
Installation Easy; needs a plug point Difficult; needs pipings for aeration
Manpower Requirement Low High
Low temp steam & formaldehyde
sterilization
Sterilize at 70-75oC below atm pressure
Aqueous solution contains 37% w/v
HCHO polymerizes as white powder
Nonflammable vapors
Toxicity similar to ETO
Odorous and Irritant effect below 5ppm
Irritation of RT and Eyes, skin

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Advantages
Advantages and Disadvantages - FO
 Can sterilize heat and moisture sensitive items in
approximately 3 hours
 In newer system, FO is supplied in bags or bottles

 Disadvantages

 Formaldehyde exposure as regulated by OSHA is 0.75 ppm

over 8 hour period
 Irritating to mucous membranes, carcinogenic

 Exposure monitoring required

 Adequate ventilation and alarm system needed for older

models
Packaging Procedure
Articles thoroughly cleaned
Dried at room temperature
Absence of water droplets
Proper sealing
Remove excess air to avoid seam bursting
Avoid folding
Use proper size pouch
storage area to have 40-60 % RH for articles,
packing material

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Storage and Shelf Life
Quality of wrapping material
Condition during transport
Storage condition
Amount of handling
First in –First out

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 Packaging Procedure
Articles thoroughly cleaned
Dried at room temperature
Absence of water droplets
Proper sealing
Remove excess air to avoid seam bursting
Avoid folding
Use proper size pouch
storage area to have 40-60 % RH for articles,
packing material
Packaging Material

Linen
Paper
Plastic
Metallic Container
Foil
Medical Grade Packaging
Essentials of Packing
 Always pack dry and clean instruments
 Cover sharp instruments
 Use proper packing material
 Use double sheet
 Label packs, put date
 Apply indicator tape
 Wash the new linen before use
Do not pack in torn sheet
Do not pack tightly
 Quality control
Mechanical control
Temp, pressure, time device on machine
Biological control
Steam---Bacillus stearo thermophilus
Gas, Air, LTPS—Bacillus Subtilis/pumilus
Chemical---Tapes/Integrators
Bovie Dick test--- for air removal
Leak rate test---vacuum 1mm in ten minutes
STERILIZATION CHALLENGES
 CLEANING AND DRYING

 COMPLEX SURGICAL EQUIPMENT

 PACKAGING AND STORAGE

 TRANSPORTATION

 QUALITY TEXTILES

 EQUIPMENT PLANNING AND MAINTENANCE

 SERVICES

 REPROCESSING SINGLE USE DEVICES

 MONITORING

 QUALIFIED MANPOWER

 BUDGET AVAILABILITY
 Conclusion
Infection control is essential
Cannot escape from this concept and application
Every patient has a right to Sterilized material.
We cannot escape from this concept and
application.
• User’s have to engrave this as a
• Responsibility
• without being watched
•Thank
You