Heat Sterilization

 Moist heat

 Dry heat
 Moist heat
Autoclave
Autoclave working
• Steam enters the chamber jacket, passes through an operating
valve and enters the rear of the chamber behind a baffle plate.
It flows forward and down through the chamber and the load,
exiting at the front bottom. A pressure regulator maintains
jacket and chamber pressure at a minimum of 15 psi, the
pressure required for steam to reach 121ºC (250ºF).
Overpressure protection is provided by a safety valve.
Chemical measurements
• Autoclave tape or other indicators such as Bowie Dick
Define Sterile
• Sterile Free from viable microorganisms.
• Sterilization
• Any physical or chemical process which destroys all life forms, with
special regard to microorganisms (including bacteria and sporogenous
forms), and inactivates viruses. Therefore the terms "sterile" and
"sterilization", in a strictly biological sense, describe the absence or
destruction of all viable microorganisms. In other words, they are
absolute terms: an object or system is either "sterile" or "not sterile".
• BP/ EP Monograph - XVIII
• Sterility is the absence of viable micro-organisms.
• It is essential that the effect of the chosen sterilisation procedure on
the product (including its final container or package) is investigated to
ensure effectiveness and the integrity of the product and that the
procedure is validated before being applied in practice
• What is the terminal sterilization?
Industry Rules –
Terminal Sterilisation (BP/EP)
• Wherever possible, a process in which the product is sterilised in its
final container (terminal sterilisation) is chosen.
• If terminal sterilisation is not possible, filtration through a bacteria-
retentive filter or aseptic processing is used;
F0 value
• F0 value is used to determine the exposure time of material
for sterilization at a particular temperature.

• F0 value is the time in minute for the specified temperature that

gives the same thermal lethality as at 121 °C in one minute.

• Exposure at 121 °C for one minute, the F0 value is equal to one

F0 value
• Exposure at 121 °C for two minute, the F0 value is equal to two.
• If the exposure Temperature increased from 121 °C then the
F0 value will not equal to one………….

• But……

• The F 0 Value Will be increased as the temperature increased.

F0 value
• If the exposure Temperature decreased from 121 °C then the
F0 value will not equal to one………….

• But……

• The F 0 Value Will be decreased as the temperature decreased.

F0 value
• The formula will be apply for the calculation of F0 value.
• The Formula is
Example
If the “T” is 121 °C If the “T” is 122 °C
Δt = 1 minute Δt = 1 minute
Z value = 10 Z value = 10
F0 = ? F0 = ?
F0 = Δt x 10(T-121/10) F0 = Δt x 10(T-121/10)
F0 = 1 x 10(121-121/10) F0 = 1 x 10(122-121/10)
F0 = 1 x 10(0/10) F0 = 1 x 10(1/10)
F0 = 1 x 100 F0 = 1 x 100.1
F0 = 1 x 1 F0 = 1 x 1.26
F0 = 1 Answer F0 = 1.26 Answer
Why Are Autoclaves Essential?
• Easiest way to sterilize large volumes of heat tolerant materials.
• More effective than dry heat (lower temperature /shorter time
• Not as messy as chemicals and more reliable
• No need for radiation shielding etc.
Dry Heat Oven & Tunnel
Hot Air Oven
Dry Heat Sterilizer Working Principal
•
Sterilizing by dry heat is accomplished by conduction. The heat is
absorbed by the outside surface of the item, then passes towards the
center of the item, layer by layer. The entire item will eventually reach
the temperature required for sterilization to take place.
• Dry heat does most of the damage by oxidizing molecules.  The
essential cell constituents are destroyed and the organism dies. The
temperature is maintained for almost an hour to kill the most difficult
of the resistant spores.
• Oxidation means the addition of oxygen to a molecule or the
removal of hydrogen from a molecule.

• Reduction means the addition of hydrogen to a molecule or the

removal of oxygen from a molecule.
Critical parameters needed for successful
sterilization
• Article wrapping.
• Chamber load pattern
• Air removal (steam displacement or vacuum)
• Moisture (saturated steam)
• Pressure / vacuum conditions
• Temperature
• Cycle Time and “Dwell” Time
• Contact with surfaces:
• Packaging permeable to moist heat
• Items designed to allow contact
• Items designed to allow air removal
Thanks
QUESTIONS