The document discusses autoclaves and sterilization processes at Julphar pharmaceutical industries. It provides background on the history and development of autoclaves. It describes the basic components and operation of autoclaves. There are different types of sterilizers and sterilization approaches used depending on the load. The document outlines sterilization validation tests performed at Julphar like chamber leak tests, Bowie-Dick tests, and heat distribution/penetration studies to ensure proper sterilization.
Sterilization: F0 - what it means - how to calculate it - how to use itFedegari Group
F0: A technical note
- What it means
- How to calculate it
- How to use it for adjustment, control and
validation of moist-heat sterilization processes
Sterilization: F0 - what it means - how to calculate it - how to use itFedegari Group
F0: A technical note
- What it means
- How to calculate it
- How to use it for adjustment, control and
validation of moist-heat sterilization processes
Autoclave, types of autoclave, horizontal autoclave, vertical autoclave, vacuum type autoclave, pressure cooker type autoclave. their purpose, precaution, etc....
The above PPT includes different methods of sterilization- Dry heat, Moist heat, Radiation and Chemical methods. It also includes principle and working of hot air oven and autoclave.
Sterilization (or sterilisation) referring to any process that eliminates (removes) or kills (deactivates) all forms of life and other biological agents (such as prions, as well as viruses which some do not consider to be alive but are biological pathogens nonetheless), including transmissible agents (such as fungi, bacteria, viruses, prions, spore forms, unicellular eukaryotic organisms such as Plasmodium, etc.) present in a specified region, such as a surface, a volume of fluid, medication, or in a compound such as biological culture media
Sterilization Process and methods of sterilizationShahnawaz Ahmad
Presented by Shahnawaz Ahmad.
Various methods of sterilization used in microbiology or other field.
contents ;
terms used in sterilization
types of sterilization
physical method
chemical method
radiation
filtration
gaseous.
Autoclave, types of autoclave, horizontal autoclave, vertical autoclave, vacuum type autoclave, pressure cooker type autoclave. their purpose, precaution, etc....
The above PPT includes different methods of sterilization- Dry heat, Moist heat, Radiation and Chemical methods. It also includes principle and working of hot air oven and autoclave.
Sterilization (or sterilisation) referring to any process that eliminates (removes) or kills (deactivates) all forms of life and other biological agents (such as prions, as well as viruses which some do not consider to be alive but are biological pathogens nonetheless), including transmissible agents (such as fungi, bacteria, viruses, prions, spore forms, unicellular eukaryotic organisms such as Plasmodium, etc.) present in a specified region, such as a surface, a volume of fluid, medication, or in a compound such as biological culture media
Sterilization Process and methods of sterilizationShahnawaz Ahmad
Presented by Shahnawaz Ahmad.
Various methods of sterilization used in microbiology or other field.
contents ;
terms used in sterilization
types of sterilization
physical method
chemical method
radiation
filtration
gaseous.
An autoclave is a device used to sterilize equipment and supplies by subjecting them to high pressure saturated steam at 121 °C for around 15–20 minutes depending on the size of the load and the contents. It was invented by Charles Chamberland in 1879, although a precursor known as the steam digester was created by Denis Papin in 1679. The name comes from Greek auto-, ultimately meaning self, and Latin clavis meaning key—a self-locking device.
Validation is the process of checking of the process, equipment and method whereas qualification is solely done for equipment and qualification of instrument helps in quality of pharmaceutical product.
Sterilization.pdf Sterilization is the complete destruction of microorganisms...Talal Albudayri
Introduction
Sterilization is the complete destruction of
microorganisms including bacterial spores. This level
of decontamination is required for all reusable
invasive medical devices (RMD).
Ideally, sterilization methods:
• Have rapid throughput
• Are easily validated
• Are capable of processing wrapped items to
enable storage after processing without the risk of
environmental contamination of processed items.
Welcome to our Slideshare presentation on the Qualification of Autoclave, an essential process to ensure the effective sterilization of medical instruments and equipment. In this presentation, we will explore the significance of autoclave qualification, its various stages, and the critical factors involved in maintaining sterilization safety.
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Autoclave Steam Sterilizer is used in Microbiology, QC & Research laboratory in the Pharma industry for sterilization by steam. This laboratory sterilizer helps to demonstrate the temperature distribution in the loaded chamber is acceptable and that the items within the chamber receive a uniform heat treatment.
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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.
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Types of sterilizers
Gravity
Displacement
sterilizers
Dynamic air removal
(with vaccum pump)
sterilizers
Only for terminal
sterilization
Terminal and porous load sterilization
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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.
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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.
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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)
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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.
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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.
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Performance qualification
Validation equipment used in performance
Qualification or re- qualification.
Kaye Validator SIM (sensor input
module
Thermocouple
Kaye Validator set-up
Feed-through
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Performance qualification
• 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.
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Performance 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.
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Performance qualification
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
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Performance qualification
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.
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Performance qualification
5. Assurance of sterilization:
Physical challenge: By temperature mapping.
Chemical challenge: Autoclable tape.
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Performance qualification
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