Validation of sterilization methods

Presented by
• Ashish Neupane
• Aaradhana Mahato
 Validation of sterilization
methods
Validation may be defined as “ Establishing
documented evidence which provides a
high degree of assurance that a specific
process will consistently produce a product
meeting its pre-determined specifications
and quality attributes.
  “sterile”?
• Free from microorganisms
•  In practice no such absolute statement
regarding absence of microorganisms
can be proven.
Sterilization
a process of complete removal of all living
organism and viruses at a given condition
is called sterilization.
 Commonly used methods of sterilization

•  Dry Heat
• Moist Heat
• Gas (Ethylene oxide)
• Radiation (Gamma or Electron)
• Filtration
• Others - UV, Steam and formaldehyde, hydrogen
peroxide
 Dry Heat sterilization
• Dry heat is one of the most commonly
used methods to sterilize .
• Higher temperatures and longer
exposure times required.
• Dry heat sterilization is often used for
heat-stable oils, ointments and powders.
 Typical cycles: for dry heat sterilization

• 160 C for 120 minutes

• 170 C for 60 minutes
• 180 C for 30 minutes
Validation studies of Dry-heat sterilizers
•  Validation studies conducted on dry-heat
sterilizers can be divided into two basic
components.
• One component envelops all the physical
processes, which must be validated, such as
temperature control, air particulate levels, and belt
speeds.
• Second component involve the process destroys
both microbial and pyrogenic (inducing fever)
contaminants.
 VALIDATION OF AUTOCLAVE
• This procedure is used to assess the efficiency
and performance of autoclaves.
• it is quality assurance procedure which are
used to ensure that the autoclave reaches
adequate temperature for an adequate
amount of holding time to sterilize biological
agents and wastes
 The principal Is that:-
• Boiling point of water can be increase by
increase in atmospheric pressure.

• For most of the purpose temperature is

maintain at 121 C for 15 to 30 minute with 15
psi.
Validation of Membrane Filteration
• filtration is the separation of solids from a liquid by
passage through a filter medium. Membrane
filtration is used for sterilization of drug product and
used in sterilization process.
• There are two types of filter used in filtration
process:
• Depth filters: Consist of fibrous or granular
materials so packed as to form twisted channels of
minute dimensions.
• Membrane filters: These are porous membrane
about 0.1 mm thick, made of cellulose acetate,
cellulose nitrate, polycarbonate, and polyvinylidene
fluoride, or some other synthetic material.`
Validation of radiation sterilization process

Defined as dose of radiation necessary to produce

a 90% reduction in a number of indicator
microbial cells
It depends on factors such as
1. temperature
2. Moisture
3. Organism species
4. Chemical environment/physical surface on which
indicator microorganism is attached.
• Ionizing radiation can damage the DNA
(genes) in cells, which in turn may lead to
cancer.
• Ionization radiation
• x ray , gamma ray are utilized for sterilization.
• it have high penetration power.
• So for this reason gamma ray are utilized in
food industry to sterilized canned food.
 References
• Nash, R.A. and Watcher,
• A. H. “Pharmaceutical process validation ”Third
edition Agalloco James.
• Carleton J. Fredric “Validation of Pharmaceutical
Processes” ; Third edition Pharmaguideline.
• Berry I.R., and Nash R.A., ”Pharmaceutical
Process validation” second edition, revised and
expanded; Marcel Dekker series;