LECTURE 01

Sterilization: Sterilization (Latin sterilis, unable to produce offspring or barren) is the process by
which all living cells, viable spores, viruses, and viroids are either destroyed or removed from an
object or habitat.

Sterilization is the procedure that is carried out to kill or remove all microorganisms from an
object.

Disinfection is the killing, inhibition, or removal of microorganisms that may cause disease. The
primary goal is to destroy potential pathogens, but disinfection also substantially reduces the
total microbial population. Disinfectants are agents, usually chemical, used to carry out
disinfection and are normally used only on inanimate objects.

Introduction: Sterilization is an essential stage in the processing of any product intended for
parenteral administration, or for contact with broken skin, mucosal surfaces, or internal organs,
where the threat of infection exists.

In addition, the sterilization of microbiological materials, soiled dressings and other

contaminated items is necessary to minimize the health hazard associated with these articles

Mode of action
1- Damage of proteins
2- Damage of nucleic acids
3- Inhibition of metabolism
4- Alteration of cell membrane permeability
Factors affecting sterilization
1- The time
2- The temperature
3- The types and numbers of organisms and spore present
4- The ability and properties of organisms
5- The nature and concentration of materials
 Articles to be sterilized there is a potential risk of product damage, which
for a pharmaceutical preparation may result in reduced therapeutic
efficacy, stability or patient acceptability
6- The nature and concentration of the used agents

Sterilization may be achieved by:

I- Killing of organisms by:
 Physical methods
 Chemical methods
II- Removal of organisms by:
 Mechanical methods (filtration).

Sensitivity of Microorganism
Pattern of resistance of microorganisms to sterilization processes is independent of the type
of sterilizing agent employed (heat, radiation or gas).
Vegetative forms of bacteria and fungi, along with the larger viruses, shows a greater
sensitivity to sterilization processes than small viruses and bacterial or fungal spores.

Survivor curves

They are plots of the logarithm of the fraction of survivors (microorganisms which retain
viability following a sterilization process) against the exposure time or dose.
When exposed to a killing process, populations of microorganisms generally lose their
viability in an exponential fashion, independent of the initial number of organisms. This
can be represented graphically with a ‘survivor curve’ drawn from a plot of the logarithm
of the fraction of survivors against the exposure time or dose (Fig. 20.1). Of the typical
curves obtained, all have a linear portion which may be continuous (plot A), or may be
modified by an initial shoulder (B) or by a reduced rate of kill at low survivor levels (C).
Furthermore, a short activation phase, representing an initial increase in viable count, may
be seen during the heat treatment of certain bacterial spores. Survivor curves have been
employed principally in the examination of heat sterilization methods, but can equally well
be applied to any biocidal process.
Expression of resistance

Decimal reduction time (D) or D-value

D-value is indicative of the resistance of any organism to a sterilizing agent. For radiation and
heat treatment, D-value is the time taken at a fixed temperature or the radiation dose required to
achieve a 90% reduction in viable count (i.e. a 1 log cycle reduction in survivors)