STERILISATION
PRACTICES
By
Dr. Iyer Ranganathan N
GLOBAL HOSPITALS
HYDERABAD
BASIC DEFINITIONS
• Sterilisation
• Disinfection
• Pasteurisation
• Filtration
CRITERIA FOR
STERILISATION
• Thermal death time.
• D value
• F value
Efficacy evaluated with the D and the F
values
HEAT
STERILISATION
1. Steam Sterilisation.
2. Flash Sterilisation
3. Dry Heat Sterilisation.
4. Low Temperature steam
formaldehyde sterilisation.
STEAM
STERILISATION
• Universally accepted form of
sterilisation. Alternative methods are
sought only if this method is not
possible.
• Autoclaving of articles- steam under
pressure, achieves very high
temperatures that can kill all bacterial
spores.
STEAM STERILISATION
Major issues in steam sterilisation:-
1. Removal of air from the autoclave.
2. Superheating.
3. Load wetness.
4. Material damage.
Removal of air from the
autoclave
Methods :-
1. Gravity displacement.
2. Dilution by mass flow
3. Dilution by pressure pulsing.
4. Pressure pulsing with gravity
displacement.
The last is by far the best accepted
method for removal of air.
Efficacy of Steam
Sterilisation
Factors influencing are :-
1. Air tightness of the steriliser.
2. Atmospheric pressure.
3. Quality of the steam.
4. Characteristics of the load.
Problems and Pitfalls
1. The use of vacuum to let in the
steam.
2. Leaks at or below the atmospheric
pressure.( Pressure pulsing)
3. Quality of the steam- depends on the
weight of dry steam in the mixture of
saturated steam and water in the
system. 100% sat steam is desirable
Problems and Pitfalls
Poor quality steam ( steam separator and a
baffle)
What happens with excess moisture:
1. The air becomes trapped in the wet load.
Circulation stops and the steam does not
penetrate.
2. The loads do not dry very easily after
sterilisation when they are initially wet.
Devices in Autoclave
1. Water separator
2. Steam baffle.
The steam velocity should not be more
than 1 ft/ second.
SUPER HEAT
This is the temperature excess above the
temp of saturated steam at the same
pressure.
Most of the superheat comes from the
jacket heat of the autoclave.
It reduces the efficiency of the
autoclave./
FLASH STERILISATION
Used for instruments that have become
contaminated in the OT and are
required very urgently for the next
case.
Non porous items- 132c for 3 minutes
Porous items- 132c for 10 minutes.
The efficacy depends on the bioburden
and the presence of organic matter.
FLASH STERILISATION-
Pitfalls
1. Inability to monitor the process
accurately- commercial indicators
and time constraints.
2. Implants should not be sterilised by
this method- dangerous for clinical
use.
Use sparingly and not for all
instruments.
DRY HEAT
STERILISATION
Primarily used in the Microbiology
laboratory for glassware and other lab
articles.
Low corrosiveness and deeper
penetration.
Longer times of incubation and heat,
damage to materials maximum.
DRY HEAT -- PITFALLS
1. Impermeability of articles with water or
moisture content.
2. Disturbed circulation of air due to
overcrowding of articles in the oven.
3. Adequate space between articles in the
air oven is needed.
4. Wrappings and barriers to be kept to a
minimum.
Central Sterile Services
Department
( CSSD)
A department that deals with preparing,
processing, storing and distributing
medical and surgical hospital supplies
required for patient diagnosis, treatment
and care.
This involves both sterile and unsterile
material.
CSSD
Why do we need one?
1. All materials come from one area after
complete processing.
2. Helps maintain high standards of quality
control.
3. It is economical to do so.
4. Training of a set of people is sufficient
for the purpose.
Working of a CSSD
Depends on;
1. Efficacy of the sterilisation process.
2. Layout of the CSSD
3. Effective quality control procedures.
4. Good infection control
5. Employee training and motivation from
time to time.
AREAS OF A CSSD
1. Receiving area.
2. Cleaning and decontamination
area.
3. Preparation and packaging area.
4. Sterilisation
5. Sterile storage area
6. Distribution of the material.
Requirements of a CSSD
1. Adequate humidity
2. Ventilation
3. Temperature
This helps to
1. Reduce bio-burden
2. Control environmental contamination
3. Provide hydration for packaging materials
4. Ensure comfortable working conditions
Requirements of a CSSD
Ventilation system;-
Clean to soiled areas, not in the reverse
direction
Clean areas- positive pressure
Soiled areas- Negative pressure
Exhaust should be working efficiently to
duct the used air from the soiled areas
to the outside or to a re-circulating duct
system.
Requirements of a CSSD
Location of the CSSD- Closest to the area of
requirement.
Elevators or chute system for transport of
material.
Automated material handling systems
Most hospitals use manual pick up systems –
cheaper and less infrastructure.
Cleaning and
Decontamination
Reasons:-
1. Removes the debris, organic matter,
blood body fluids and mucoid debris
from the instruments.
2. Decontamination is the process that
renders the instruments safe for
further handling.
Cleaning and
Decontamination
Methods for cleaning instruments:-
1. Manual cleaning.
2. Ultrasonic cleaning.
3. Automated cleaners and washers
with or without disinfectors.
Do we pre- soak instruments in soap
and water with a detergent solution?
Preparation Packaging
Pre- requisites:-
1. Should be impervious
2. Should resist punctures and tears.
3. Protect sterilised instruments indefinitely.
4. Should be durable and not delaminate
5. Suitable for printing and labeling
Ideal wrapping material is not easily detected.
Preparation and Packaging
The material used should be compatible with
the process of sterilisation.
Evaluate a material according to its utility
rather than its woven, unwoven nature,
whether it is reusable or disposable.
140 thread count muslin is the preferred
fabric. Other materials have also been tried.
Sterile Storage Area
• External surfaces may become contaminated
when stored.
• Should be close to the sterilisation area, cool and
dry with enough ventilation
• The surface of the pack should not be wet,
articles inside are liable for recontamination.
• Preferable turn around time is 24 hours for all
the routine packs.
Sterile Storage Area
• The total air changes per hour is at
least 4 changes
• The humidity should be less than 50%
• Well designated areas for storage
• Certain height from the floor, distance
form the walls and the ceiling desired
• All articles should be labelled with a
load number, date sterilised, date of
expiry and the steriliser used.
Sterile Storage Area
Shelf life of the product
Contamination- event dependent and not time
dependent.
The storage area is best located at a place away
from the sterilisation place.
Indicators of Sterilsiation
• Physical Indicators
• Chemical Indicators
• Biological Indicators
• Biologically modified P/ Ci Indicators
Physical Indicators
1. Time
2. Temperature
3. Pressure
4. Gas concentration
Most of these are done manually and recorded by
the CSSD staff on a daily basis. Deviations
from the normal are the first indication of
malfunction of an instrument.
Chemical Indicators
Provide information that the conditions necessary
for the sterilisation process were present.
The ensure
1. The sterilisation was performed
2. The loads were packed properly
3. The equipment works well and completed its
cycle without any problems
Chemical Indicators
They measure only one parameter and
not the sole proof for monitoring.
Advantages:-
1. Easy availability.
2. Low cost
3. Ease of use of these indicators.
They do not detect a particular cold spot
in a pack.
Biological Indicators
( BI’S)
A standardised spore suspension which is resistant
to all the physical methods of sterilisation
1. Paper strips inoculated with spores.
2. Self contained biological indicators( carrier
3. Enzyme based BI’S( alpha- D- glucosidase,
which is inactivated proportionately with the
spore suspension)
Biological Indicators
Commercially available BI’S have about 104 to 106 spores
of B. stearothermophilus.
The probability of the no sterility of items in the load when
the BI’S are sound is less than 1 in 1,000,000.
The sterility assurance level is 10-6
BI does not mean sterility, but provides additional means
of ensuring monitoring of the sterilisation.
Biological Indicators
Place the BI in the most challenging part
of the load.
At the front at the bottom
Near the door
How many BI’S to use in each run?
Will a positive result always indicate
instrument failure?
GAS STERILISATION
• Ethylene oxide sterilisation
• Low Temperature Steam formaldehyde
• Vapour Phase Hydrogen peroxide
• Plasma Gas sterilisation.
Ethylene Oxide ( ETO)
The mechanism is by alkylation of the
internal chemical structures of
organisms
Demerits of ETO:-
1. Explosive
2. Toxic vapours and fumes
3. Teratogenicity and Carcinogenic
potential
Ethylene Oxide
( ETO)
Prevention of toxicity
1. Proper aeration should be allowed ( 8 hours
at 60c)
2. Aeration should not be carried out in the
open. Use biosafety cabinets designed for
the purposes with proper air exchanges.
3. The type of item and the nature of the
material used makes a difference( external
application or implants)
Ethylene Oxide( ETO)
Preventing occupational exposure:-
1. Limit the number of contact hours for each worker.
( OSHA guidelines)
2. Wear an approved respirator mask and gloves while
handling instruments from ETO
3. Air changes of 10 changes/ hour, 30- 50% humidity
and a temp of 24 c is essential.
4. Direct venting to the atmosphere is essential.
Low Temperature Steam
Formaldehyde
Inject Formaldehye gas
Steam to remove all the air
Temp 73c x 2 hours
Residual formaldehye is a concern, removed
with hot steam flushes.
May be used for cystoscopes and other scopes.
Not become popular, due to the residual
formaldehyde
Vapour Phase Hydrogen
peroxide
Gaseous phase H2O2, low concentrations and
low temperatures
Short contact times and assured sterility
Possible alternative to ETO for heat sensitive
instruments
Damage potential for instruments remains
The packaging material is limited as the gas
tends to be absorbed rather than penetrate.
GAS PLASMA
STERILISATION
1. Gaseous peracetic acid
2. Low temperature H2O2 gas plasma
Ion plasma having strong radicals may
act on the molecules essential for the
metabolism and reproduction of all
living cells
The efficacy and the toxic potential is
not well understood.
