Autoclave PPT

www.julphar.net Gulf Pharmaceutical Industrieswww.julphar.net Gulf Pharmaceutical Industries
Autoclave (Steam sterilizer)
October 2015
Prepared By:
Vishal Katiyar

www.julphar.net Gulf Pharmaceutical Industries
Introduction and history
 The name comes from Greek auto-,
ultimately meaning self, and
Latin clavis meaning key—a self-
locking device.
 1450 B.C.E. Moses
460-377 B.C.E. Hippocrates
Pasteur
Denis Papin
 The autoclave was finally created by
Charles Chamberland- A French
microbiologist.

Transformation in design
BEFORE AFTER

Equipment design & components
Utility required
1. Pure steam
2. Boiler steam
3. Vaccum pump
supply
4. Compressed
air
5. Purified
water

Basic operation

Types of sterilizers
Gravity
Displacement
sterilizers
Dynamic air removal
(with vaccum pump)
sterilizers
Only for terminal
sterilization
Terminal and porous load sterilization

Sterilization in Julphar
Types of Load
Non-porous loads Porous loads
 Also called Hard goods load.
Liquid load for terminal
sterilization
Media cycles in microbiology lab.
 No pre- post vaccum required
 Sterilized by gravity
displacement method or sterilizers.
Also called wrapped goods load.
 Pre and post vaccum required
Glassware and unwrapped load
in microbiology lab.
 Pre and post vaccum required
 Sterilization of garments,
silicon tubing, filters, machine
parts, rubber stoppers and seals.

Sterilization in Julphar
Production Loads
Machine parts load Garments load

What is Sterilization
Sterilization can be defined as any process that effectively kills or
eliminates microorganisms, their spores and vegetative cells (such
as fungi, bacteria, viruses) from a surface, equipment, or biological
culture medium.
The level of microbiological inactivation can be described by an
exponential function called SAL (Sterility assurance level).
For example: A SAL of 10-6 of means that the probability of single
microorganism being present on sterilized item/ article is one in
one million after it undergone through sterilization process.
Steam sterilization can be defined by log reduction in population
of microorganisms.

How steam sterilization works
Steam is an effective sterilant for two reasons.
First, steam is an extremely effective “carrier” of thermal energy. It is many times
more effective in conveying this type of energy to the item than is hot (dry) air.
Due of its high heat of enthalpy: 438 KJ/ mole
Second, steam is an effective sterilant because any resistant, protective outer layer
of the microorganisms can be softened by the steam , allowing coagulation of the
sensitive inner proteins of the microorganism.
Sterilization parameters:
Temperature: 121.1°C (considered as base temperature for sterilization)
Pressure: 15 lbs (1.12 Bar)
Time: 15 to 30 minutes (time shall be vary according to approach of
sterilization)

Sterilization Approach
Two types of sterilization approach
Overkill Approach Bioburden Approach
Overkill sterilization
primarily is applied to the
moist-heat processing of
materials, supplies, and other
heat-stable goods.
"This is usually achieved by
providing a minimum 12-log
reduction of microorganisms
considering worst case of D-
value at 121.1 °C.
For items that are heat sensitive
and can not withstand an overkill
approach. It is necessary to
collect the bioburden data and
possibly D-value data.
This will reduce the sterilization
cycle time.
For example: 134
CFU(bioburden)
To reduce the bioburden from
134 to 01 = log (134) = 2.14
minutes.

D and Z value
D-value refers to decimal reduction time and is the time
required at a given temperature to kill 90% of the exposed
microorganisms or to reduce the population by 1 log reduction.

D and Z value
Z- value is the temperature required for one log10 reduction in
the D-value.

Performance qualification
Validation equipment used in performance
Qualification or re- qualification.
Kaye Validator SIM (sensor input
module
Thermocouple
Kaye Validator set-up
Feed-through

• 1. Chamber vaccum leak test
Objective: Objective of this test is to check the integrity
of chamber and ensure that the rate of vacuum drop is
within the acceptable limits.
• Acceptance criteria: 1.3mbar/ minute
• Use: To ensure microorganisms and air entrance into
autoclave chamber.
Test to be carried out in performance
Qualification or re- qualification.

2. Bowie-Dick test
Objective: Pre-vaccum pulses are sufficient to remove
the entrapped air or non-condensable gases so as to
facilitate rapid and even steam penetration into all parts
of the load.
• Acceptance criteria: Test- kit colour should change
from yellow to black .
Use: To ensure complete removal of air from autoclave
chamber through pre-vaccum pulses.

UNEXPOSED BOWIE-DICK
KIT
EXPOSED BOWIE-DICK KIT

3. Empty chamber heat distribution
Objective: Objective of this test is to ensure that equipment
is suitable for even dstribution of heat in the sterilizer
chamber when operated with pre-defined parameters.
• Acceptance criteria: Temperature: NLT 121°C
Sterilization Time NLT 30 minute

HEAT DISTRIBUTION STUDY SENSOR LOCATION

4. Heat penetration study
Objective: Objective of this test is to ensure that equipment
is suitable for sterilization of loaded articles in the sterilizer
chamber.
• Acceptance criteria: Temperature: 121°C – 124°C
Sterilization Time NLT 30 minute
Equilibration time:- NMT 30 Sec.
Biological Indicator should not show any growth
Use: To check and ensure sterilization of articles in load.

5. Assurance of sterilization:
Physical challenge: By temperature mapping.
Chemical challenge: Autoclable tape.

5. Assurance of sterilization:
Biological challenge: By keeping the biological indicator (Geobacillus
stearothermophilus, population = 106 ) inside the sterilizing articles.
For Porous loads For Liquid loads

Thank you


Autoclave PPT

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