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Presentation 14

The document outlines sterilization processes, emphasizing the importance of achieving a sterile state by eliminating microorganisms. It details various methods of sterilization, including thermal (dry and moist heat), non-thermal (radiation and filtration), and chemical processes (ethylene oxide and β-propiolactone), along with their applications. Additionally, it discusses the effectiveness of disinfectants and factors influencing their efficacy.

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16 views

Presentation 14

The document outlines sterilization processes, emphasizing the importance of achieving a sterile state by eliminating microorganisms. It details various methods of sterilization, including thermal (dry and moist heat), non-thermal (radiation and filtration), and chemical processes (ethylene oxide and β-propiolactone), along with their applications. Additionally, it discusses the effectiveness of disinfectants and factors influencing their efficacy.

Uploaded by

adam
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Sterilization

Fourth stage/2023-2024
• Sterilization is the process designed to produce a sterile state.
• The traditional concept of the sterile state is the absolute
elimination of all living microorganisms.

• With terminal methods of sterilization of a parenteral product,


particularly steam under pressure, a probability of no more than
one non-sterile unit in a million (10 ^−6) is readily achievable.

• Aseptic is a term indicates a controlled process in which the level


of microbial contamination is reduced to the degree that
microorganisms can be excluded from a product during processing.
Sterilization
Methods
1. Thermal Methods
The lethal e ectiveness of heat on microorganisms
depends upon:

• a) the degree of heat

• b) the exposure periods

• c) the moisture present


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Thermal Method Include:

• A. Dry Heat (ex: Hot air ovens)

• B. Moist Heat (ex: Autoclave and Air-steam mixtures)


Application of dry heat sterilization

• 1) Is used for powders, containers and equipment whenever


possible.
• 2) Glass and metal equipment usually withstand dry heat sterilization
without di culty.
• 3) However, rubber and cellulosic materials undergo degradation.
• 4)Certain ingredients, such as chemicals and oleaginous vehicles, to
be used in sterile pharmaceutical preparations are sometimes
sterilized with dry heat at lower (usually, 140°C or less) temperatures.
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Application of moist heat sterilization
• 1) It is generally accepted that the most reliable thermal method of
sterilization is the use of moist heat under pressure. Therefore, this
method of sterilization should be employed whenever possible.
• 2) Aqueous pharmaceutical preparations in hermetically-sealed
containers.
• 3) Non-aqueous preparations in sealed containers cannot be sterilized
in this manner during a normal cycle because no water is present
within the container to generate steam, and thereby e ect sterilization.
• 4) Applicable to rubber closures, glassware and lters of various types.

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2. Non-thermal Methods (Cold
sterilization)
A. Radiation Sterilization

• a) Ultraviolet light (non-ionizing radiation)

• b) Ionizing radiations

• c) Electron accelerators
Application for sterilization
• 1) Accelerated electrons or gamma rays may be used to sterilize select products
by a continuous process.
• 2) The use of radiation is increasing in frequency and extent as experience is
gained with this method, particularly for the sterilization of medical plastic devices.
• 3) Availability of facilities for this method, using both energy sources, is increasing.
• 4) An individual medical device or pharmaceutical manufacturer may not justify
the high cost of a facility for radiation sterilization, but the increasing availability of
centers performing contract services is making this method a more viable option.
• 5) A number of vitamins, antibiotics and hormones in the dry state have been
successfully sterilized by radiation.
• 6)Liquid pharmaceuticals are more di cult to sterilize because of the potential
e ect of the radiations on the vehicle system as well as the drug.
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B. Filtration Sterilization
Applications
• 1) Filtration is used for nonterminal sterilization and has to be
employed under strict aseptic conditions.
• 2) It is employed for those pharmaceuticals which cannot be
sterilized by terminal processes, or to which agents like additives,
heparin and vitamins etc. are added post-sterilization.
• 3) It is used to sterilize the thermolabile pharmaceuticals, aqueous
liquids, oils, organic solutions, and air and other gases.
II. Chemical Processes of
Sterilization
Gas Sterilization

• 1. Ethylene oxide
• 2. β-propiolactone
1. Ethylene oxide
Application
• 1) Alkylation may occur with drug molecules in pharmaceutical preparations,
particularly in the liquid state. Therefore, EtO sterilization of pharmaceuticals
is limited essentially to dry powders of substances shown to be una ected.
• 2) It has an extensive application to plastic materials, rubber goods, and
delicate optical instruments.
• 3) It has been found that stainless steel equipment has a longer useful life
when sterilized with EtO instead of steam.
• 4) The e ective penetrability of EtO makes it possible to sterilize parenteral
administration sets, hypodermic needles and plastic syringes.
• 5) This method made it possible to sterilize many materials that would be
impossible to sterilize with other known methods.
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2. β-propiolactone

• The penetrability of BPL vapour has been found to be poor,


therefore, its principal use appears to be the sterilization of surfaces
in large spaces, such as entire rooms.
Surface Disinfection

• Most disinfectants do not destroy spores during any reasonable


contact period; therefore, they do not sterilize a surface.
• But when used properly may be expected to provide an aseptic
condition of the surfaces involved.
The e ectiveness of a disinfectant depends on:

• 1) the nature of the surface,hard, smooth surfaces are much easier


to disinfect than rough porous ones.
• 2) the nature and degree of contamination
• 3) the microbicidal activity of the agent employed.
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The e ectiveness of the agent will depend on:

• 1) the number of organisms present


• 2) their sensitivity to the agent.
• Therefore, it is essential to select an agent that has been proven
e ective against the common contaminants.
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“Thanks for your attention”

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