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. Moses460-377 B.C.E. Hippocrates

PasteurDenis Papin

The autoclave was finally created by Charles Chamberland- A French

microbiologist.


Transformation in design

BEFORE AFTER


Equipment design & components

Utility required 1. Pure steam2. Boiler steam3. Vaccum pump

supply4. Compressed

air5. Purified

water


Basic operation


Types of sterilizersGravity Displacement sterilizers

Dynamic air removal (with vaccum pump) sterilizers

Only for terminal sterilization

Terminal and porous load sterilization


Sterilization in JulpharTypes of Load

Non-porous loads Porous loads

Also called Hard goods load.

Liquid load for terminal sterilizationMedia 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 JulpharProduction 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 worksSteam 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 ApproachTwo 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 valueD-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 qualificationValidation equipment used in performance

Qualification or re- qualification.

Kaye Validator SIM (sensor input module

Thermocouple

Kaye Validator set-up

Feed-through


Performance qualification

• 1. Chamber vaccum leak testObjective: 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 testObjective: 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.


Performance qualificationUNEXPOSED BOWIE-DICK

KITEXPOSED BOWIE-DICK KIT



3. Empty chamber heat distributionObjective: 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


Performance qualificationHEAT DISTRIBUTION STUDY SENSOR LOCATION



4. Heat penetration studyObjective: 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

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Autoclave PPT