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 Sterilization –Anintroduction
 Importance of sterilization
 Methods
 Advantages & Disadvantages
 Effects of Sterilization
 Conclusion and future prospects
The process of killing or
removing bacteria and all other
forms of living micro-organisms
and there spares from preparation.
Essential concept in the
preparation of sterile
pharmaceutical products
 Its aim
 is to provide a product that is safe and eliminates the
possibility of introducing microorganisms
Medical Sterilization
Prevents the Growth of Diseases
In any medical tool/device used, bacteria comes onto it. If left unchecked
or not disinfected properly, it is highly likely that bacteria willgrow.
Prevents the Spread of Diseases
If surgical equipment is not properly sterilized, patients treated are
exposed to a disease the previous patient had.
Prevents Double Surgeries
If unsterilized equipment is used, it can cause an infection leadingto
another surgery later on in order to remove it.
This is costly and can cause many life-threatening complications.
Importance of sterilization
 THREE METHOD :-
1. Physical method
a)Sterilization by filtration
b)Sterilization by radiation (gamma radiation)
2. Chemical method
a) Gaseous sterilization
b) Sterilization by disinfectant
3. Mechanical method
Pass through bacteria-proof filter
Sr.
No.
Thermal and
Physical Method of
Sterilization
Instruments used
1 Dry Heat Oven
2 Moist Heat Autoclave
3 Radiation Gamma-ray
Chamber
 Mechanism of action:
 Instrument- ‘HOT AIR
OVEN’
specially designed instrument - electrically heated and
thermostatically controlled.
Expose at 160 ºC for 1 hour.
Advantage-
it is suitable method for sterilization of
substances destroyed by moisture.
Disadvantage-
long heating time, high temperature, effect on materials
Applications-
For powders, containers and equipments
 Effectiveness-
 Mechanism of action-
 Instrument- ‘AUTOCLAVE’
Heating process in autoclave - saturated steam under pressure is allowed to
penetrated through materials for 15 minutes and temperature 121º c.
Wrapping materials-
Advantage-
micro organism are killed most efficiency in lesser time
due to high pressured saturated steam
Disadvantage-
unsuitable for materials not withstanding
temperature of 115ºC or more during heating
Applications-
Two techniques involved:
 Alteration of chemicals lead to form new compound in
cells destroying the micro-organism itself
 Vital structure like nuclear protein are destroyed killing the
micro-organism.
 e.g., Co-60 - used for gamma ray sterilization process.
Gamma rays –
 generally obtained from radio isotope(Co-60)during
disintegration of unstable atoms
 kill micro-organisms by isolating atoms of essential substanceof
cells present in them.
1. No significance rise in temperature
2. Continuous process due to short exposure
time.
 DISADVANTAGE
1. May lead to color change.
2.Solubility of preparation leading to
decomposition of certain materials.
 Absolute process
 Mechansim of action
 Liquid flow through a filter
 Types of filters
 Aseptic processing
 Applications
 Gaseous sterilization-
 Ethylene oxide used.
 Special type of chemical sterilization using gases and vapour
 The gas used is safe & non-inflammable.
 Now-a-days, ethylene oxide most widely used gaseous
sterilization agent in medical science.
1. It has penetration power quite useful for sterilizing
surgical instruments (such as catheter, needles, plastics,
disposables)
Disadvantages:
1. Very slow sterilization process
2. Very costly equipment
 Decontamination - removal of microorganisms contaminating
an object
 Preservation - preventing methods of microbes-caused
spoilage of susceptible products(pharmaceuticals, foods)
 Sanitization - removal of microbes that pose a threat to the
public health, food industry, water conditioning
sanitizer-an agent, usually a detergent, that reduces the numbers
of bacteria to a safe level
 Chemical agents
 Alcohols, aldehydes, halogen, phenols, surfactants,
heavy metals
 e.g., ethylene oxide – most commonly used for sterilisation
 Advantages:
1. Widely used in hospitals for materials that cannot
withstand steam sterilisation
 Disadvantages
1. 40-60% humidity in sterilizing chamber
 The solution to be sterilized is passed through depth-
filter or screen-filter which includes
 Particulate filters
 Microbial filters
 Final filter
 Pharmaceutical solutions are sterilized by this method.
 The micro-organism are physically removed by
absorption on the filter medium or by mechanism.
 Filtration filling and sealing processes are under a septic
condition.
 Sterilization test must be done.
There are 3 effects:
1.Gamma radiation sterilization of medical device is
common but irradiation effect at 2.5 mega rad on a bone
replacement material when started and modified property
when investigated by Creep test.
2.Irradiation increase Creep resistance of material with
the formation of crosslink and then increase in crystality
respectively.
3.Biodegradable materials sterilized by gamma radiation
may be associated with some advance effect.
 In the near future the main challenge asbiomedical
engineer is to make the sterilization process
 More reliable
 Reusable
 Non-polluting
 Costeffective
 Lesstime consumingand
 Better availability
at hospitals, pharmaceutical company, drug industry and
food processingplants.
Sterelization 08 04-2021

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Sterelization 08 04-2021

  • 1.
  • 2.  Sterilization –Anintroduction  Importance of sterilization  Methods  Advantages & Disadvantages  Effects of Sterilization  Conclusion and future prospects
  • 3. The process of killing or removing bacteria and all other forms of living micro-organisms and there spares from preparation. Essential concept in the preparation of sterile pharmaceutical products  Its aim  is to provide a product that is safe and eliminates the possibility of introducing microorganisms
  • 4. Medical Sterilization Prevents the Growth of Diseases In any medical tool/device used, bacteria comes onto it. If left unchecked or not disinfected properly, it is highly likely that bacteria willgrow. Prevents the Spread of Diseases If surgical equipment is not properly sterilized, patients treated are exposed to a disease the previous patient had. Prevents Double Surgeries If unsterilized equipment is used, it can cause an infection leadingto another surgery later on in order to remove it. This is costly and can cause many life-threatening complications. Importance of sterilization
  • 5.
  • 6.
  • 7.  THREE METHOD :- 1. Physical method a)Sterilization by filtration b)Sterilization by radiation (gamma radiation) 2. Chemical method a) Gaseous sterilization b) Sterilization by disinfectant 3. Mechanical method Pass through bacteria-proof filter
  • 8.
  • 9. Sr. No. Thermal and Physical Method of Sterilization Instruments used 1 Dry Heat Oven 2 Moist Heat Autoclave 3 Radiation Gamma-ray Chamber
  • 10.  Mechanism of action:  Instrument- ‘HOT AIR OVEN’ specially designed instrument - electrically heated and thermostatically controlled. Expose at 160 ºC for 1 hour. Advantage- it is suitable method for sterilization of substances destroyed by moisture. Disadvantage- long heating time, high temperature, effect on materials Applications- For powders, containers and equipments
  • 11.  Effectiveness-  Mechanism of action-  Instrument- ‘AUTOCLAVE’ Heating process in autoclave - saturated steam under pressure is allowed to penetrated through materials for 15 minutes and temperature 121º c. Wrapping materials- Advantage- micro organism are killed most efficiency in lesser time due to high pressured saturated steam Disadvantage- unsuitable for materials not withstanding temperature of 115ºC or more during heating Applications-
  • 12.
  • 13. Two techniques involved:  Alteration of chemicals lead to form new compound in cells destroying the micro-organism itself  Vital structure like nuclear protein are destroyed killing the micro-organism.  e.g., Co-60 - used for gamma ray sterilization process. Gamma rays –  generally obtained from radio isotope(Co-60)during disintegration of unstable atoms  kill micro-organisms by isolating atoms of essential substanceof cells present in them.
  • 14.
  • 15. 1. No significance rise in temperature 2. Continuous process due to short exposure time.  DISADVANTAGE 1. May lead to color change. 2.Solubility of preparation leading to decomposition of certain materials.
  • 16.  Absolute process  Mechansim of action  Liquid flow through a filter  Types of filters  Aseptic processing  Applications
  • 17.
  • 18.
  • 19.  Gaseous sterilization-  Ethylene oxide used.  Special type of chemical sterilization using gases and vapour  The gas used is safe & non-inflammable.  Now-a-days, ethylene oxide most widely used gaseous sterilization agent in medical science.
  • 20. 1. It has penetration power quite useful for sterilizing surgical instruments (such as catheter, needles, plastics, disposables) Disadvantages: 1. Very slow sterilization process 2. Very costly equipment
  • 21.  Decontamination - removal of microorganisms contaminating an object  Preservation - preventing methods of microbes-caused spoilage of susceptible products(pharmaceuticals, foods)  Sanitization - removal of microbes that pose a threat to the public health, food industry, water conditioning sanitizer-an agent, usually a detergent, that reduces the numbers of bacteria to a safe level
  • 22.  Chemical agents  Alcohols, aldehydes, halogen, phenols, surfactants, heavy metals  e.g., ethylene oxide – most commonly used for sterilisation  Advantages: 1. Widely used in hospitals for materials that cannot withstand steam sterilisation  Disadvantages 1. 40-60% humidity in sterilizing chamber
  • 23.  The solution to be sterilized is passed through depth- filter or screen-filter which includes  Particulate filters  Microbial filters  Final filter  Pharmaceutical solutions are sterilized by this method.  The micro-organism are physically removed by absorption on the filter medium or by mechanism.  Filtration filling and sealing processes are under a septic condition.  Sterilization test must be done.
  • 24. There are 3 effects: 1.Gamma radiation sterilization of medical device is common but irradiation effect at 2.5 mega rad on a bone replacement material when started and modified property when investigated by Creep test. 2.Irradiation increase Creep resistance of material with the formation of crosslink and then increase in crystality respectively. 3.Biodegradable materials sterilized by gamma radiation may be associated with some advance effect.
  • 25.  In the near future the main challenge asbiomedical engineer is to make the sterilization process  More reliable  Reusable  Non-polluting  Costeffective  Lesstime consumingand  Better availability at hospitals, pharmaceutical company, drug industry and food processingplants.