MRAGHUVARAN MPHARM 1 st SEM PHARMACEUTICS UNIVERSITY COLLEGE OF PHARMACEUTICAL SCIENCES KAKATIYA UNIVERSITY What is sterilization Definitions Sterile Free from any living organisms Sterilization Process of killing or removing microorganisms from a product to insure that it is steri ID: 143261
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Steam sterilization theory and equipment
M.RAGHUVARANM.PHARM 1st SEM (PHARMACEUTICS)UNIVERSITY COLLEGE OF PHARMACEUTICAL SCIENCESKAKATIYA UNIVERSITYSlide2
What is sterilization?
DefinitionsSterile: Free from any living organismsSterilization: Process of killing or removing microorganisms from a product to insure that it is sterileSlide3
Sterilizing AgentsType of agents
ChemicalPhysicalMoist heatDry heatMost clinics use physical agentsSlide4
Steam Sterilization: Autoclave
Pressurized device that uses heat, steam and pressure to achieve sterilization or decontaminationSlide5
Steam – AdvantagesSimple process: The only two parameters to control are time and temperature. Highly reliable and easily controlled.
Widespread capability: All hospitals and many other heath care facilities have steam sterilizers.Excellent process for reusable medical devices that are not adversely affected by temperatures >121C (up to 135 C).Excellent process for liquids that are not heat sensitive.Slide6
Steam – DisadvantagesComparatively high temperature required: Many products and packaging materials cannot tolerate temperatures of >
121C.Generally not appropriate for most single use disposable medical devices produced in high volumes and sold as sterile.Slide7
Principles of Steam Sterilization
Sterilization: the complete destruction of all forms of microbial life, including bacterial sporesSteam under pressure reaches high temperaturesSlide8
Principles of Steam Sterilization (cont.)
The “killing power” of steam is due to its latent heat of vaporization80 calories: 1 L water to boiling540 calories: 1 L boiling water to steamSlide9
Latent Heat of Vaporization
For example:Slide10Slide11
Action of Steam
Steam contacts a cooler surface, condenses, causing a huge decrease in volume and setting up a negative pressure that draws more steamCondensation occurs as long as there is a temperature differential Action of steam ensures: Surface heating, penetration, and protein coagulationSlide12
Items that CAN be Autoclaved:
Cultures and stocks of infectious materialCulture dishes and related devicesDiscarded live and attenuated vaccinesContaminated solid items such as: petri dishes, eppendorf tips, pipettes, gloves, paper towelItems for sterilizations such as; glassware media, aqueous solutionsSlide13
DO NOT Autoclave:
Any liquid containing:Toxic, volatile, or corrosive chemicalse.x. bleach, formalin, glutaraldehydeCheck MSDS before handCancer drugsDo not break down under high temperaturesHighly toxicRadioisotopesSlide14
Lumbers Room 120A
Farquharson 227A
Types of autoclavesSlide15
Parts of a Steam SterilizerControl panel with graph
Door handleOuter metal jacket-like chamber built around the inner chamberInner chamberSeries of filtersTemperature measurement of steam sensor Slide16
Components of a Steam Sterilizer
Source of steam- generate own steam or rely on steam from outside sourcePreheat metal jacket build around chamber for outside sources reduces total cycle timeThree main pipesA pipe with inline filters to bring steam to the sterilizer and the chamberA drain pipe for steam, air and water from the chamberA pipe to deliver filtered air to the chamber at eh end of the cycleSlide17
Construction of Steam Sterilizers
Steam Jacket: Surrounds the inner chamber and stores steam until pressure has been obtained.Inner Chamber: Items to be sterilized are loaded into this compartment without touching.Slide18
Construction of Steam Sterilizers
Valves:Pressure regulating: Maintains the pressure of 15 to 20 psi in the jacket.Safety Valve: Prevents excess pressure build-up.Steam trap: If pressure to high, valve opens and releases pressure.Slide19
Construction of Steam Sterilizers
Gauges: Located on front of sterilizer.Reading chamber pressureReading Jacket pressure.Safety Steam-lock Door: Located in front of chamber Weakest part of sterilizerSlide20
How to Autoclave
Which cycle to usePreparing your items for autoclavingLoading the autoclaveChoosing the cycle settingsUnloading the autoclaveAborting AutoclaveSlide21
How to Autoclave- Which cycle to use
Autoclaves run 3 types of cycle programsThe type of cycle depends on what is being autoclaved:
Liquid/Slow exhaust
* For autoclaving liquids
* Prevents liquids from boiling over
Solid/Gravity
* Best for unwrapped solid items
(ie glassware)
Solid/Vacuum
* Best for wrapped solid itemsSlide22
How to Autoclave - Preparing your items
Sign into log bookKeeps track of autoclave use for maintenance recordsUse personal protective equipment!Eye protectionHeat resistant glovesLab coatSlide23
How to Autoclave - Preparing your items
Use a primary containerContainer comes into direct contact with the contaminated or non-sterilized material or fluidDo not fill more than 75% of holding capacitySlide24
How to Autoclave - Preparing your items
Use a primary container (cont’d)Must NOT be a tightly sealed container (might explode)Primary container must permit heat (steam) penetrationLoosen screw caps or use self venting capsCap open containers with aluminum foil or muslinIf using plastic waste bags, leave a small opening
Loosen screw caps
Small openingSlide25
How to Autoclave - Preparing your items
Use a secondary containerUsed to contain any spillsThe sides of the secondary container must be sufficiently high to contain any spill that may occurTray MUST be autoclave safe
For liquids add waterSlide26
How to Autoclave - Preparing your items
Do not over load primary or secondary containersDo not fill more than 75% to allow expansion without overflowDo not pack or compress contents
Unautoclaved
Autoclaved (regular)
Autoclaved (due to being compressed & sealed)Slide27
How to Autoclave - Preparing your items
Use temperature sensitive tape Will indicate that high temperature has been achievedWill not prove that decontamination or sterilization was successfulWill assist in keeping track of autoclave and non autoclaved items
Before
AfterSlide28
How to Autoclave - Loading the autoclave
NEVER autoclave liquid loads using a solid load cycleliquids may boil over
Be cautious if autoclave was recently used
Rack may be hot
Use heat protective gloves
Make sure tray is locked on dolly
Rack may slide out unexpectedly if not lockedSlide29
How to Autoclave - Loading the autoclave
Farquharson: Tighten door so that prongs are fully extendedIf noise and/or steam escapes, abort the cycle and tighten the door moreLumbersKeep the door button pushed until the ready prompt is on the screenSlide30
How to Autoclave – Choosing the Cycle
For Liquids:20 mins / litre of liquid, 5 mins per additional litreFor Solids:Glassware (empty): 15 minsInstruments (utensils): 30 minsBiohazardous Garbage: at least 30 mins per full bagUse biological test strips to optimize durationSlide31
How to Autoclave – Unloading autoclave
Wait for autoclave to state END CYCLE before opening doorWhen opening, stand away from door openingMake sure no one is standing by door openingSlide32
How to Autoclave – Aborting
Only qualified personnel should attempt to troubleshoot an autoclaveFarquharsonLarge autoclave: push abort buttonSmall autoclave: need to manually advance through the autoclave cycleLumbersPush abort buttonSlide33
Autoclave: Performance Indicators
How to know if autoclave is functioning correctly:
Physical
- Annual testing by certified technician
- Pressure, Temperature, Cycle times, recorded on paper
Chemical
- Heat sensitive autoclave tape
- Not an indicator of successful sterilization, useful to keep track of autoclaved and unautoclaved items
Biological
- Tests ability of autoclave to sterilize effectively
- Bacillus stearothermophilus
spore strips often used because they are resistant to steam sterilization.
- EZ Test (SGM Biotech) (Fisher Sci #29801 074)
- 3M Attest Rapid Readout Biological Indicators
- Steris Verify Integrator Laminated and EO Integrators
DART
-
D
aily
A
ir
R
emoval
T
est, verifies complete air removal and checks for leaks.Slide34
Biological Indicator Controls/Spore Tests
Bacillus Stearothermophilus:is used strictly for Steam and dry heat sterilizers.Tests ability of sterilizer to kill microorganisms.Slide35
Biological Indicator
Must be incubated:Follow manufacturers instructionsUse correct temperature 131-140 degrees F.Use special incubatorIncubate for 48 hours or follow manufacturers instructionsSlide36
Biological Indicator
Record results:Negative- no color change from original.Positive- color changed is usually amber in color.Take sterilizer out of serviceReport to supervisorRecall all items sterilized in sterilizer for last 24 hour periodSlide37
Types of Steam SterilizersGravity Air Displacement Sterilizer- using gravity to remove air from the inner chamber
Prevacuum Steam Sterilizer- uses vacuum in two cycles to remove air from the inner chamberSlide38
Types of Steam Sterilizers Gravity displacement. a. Definition: Gravity pushes air through the packages and down through the drain. Sterilization begins when steam passes the thermometer and reaches the desired temperature.Slide39
Gravity DisplacementSettings:
Temperature- 250 degrees F. to 254 Degrees F.Pressure- 15 to 17 pounds per square inch(PSI)Exposure time- 30 minutes for wrapped instruments. Minimum 15 minutes.Slide40
Gravity Displacement Uses
1. Metal ware2. Glassware3. Thermoplastics.4. Linens.5. Rubber.Slide41
Pre-vacuum (high temperature) Sterilizer
Definition: Air is completely evacuated from the chamber by a vacuum. The steam-injector helps eliminate the air out of packages. Steam then penetrates the packages on all surfaces. Slide42
Pre-vacuum
Settings:Temperature: 270 degrees F. to 276 degrees F. Pressure: 27 PSI3. Exposure Time: 15 to 30 minutes.Slide43
Pre-vacuum Sterilizer
Uses. Metalware Rubber ThermoplasticsSlide44
Sterilization: How is it validated?
SteamIQ, OQ, PQ of steam sterilizerTemperature profiles of product during sterilization cycles (using thermocouples)Fractional and/or half cycles with product & B.I.s (G. stearothermophilus)Then sterility testing of product & B.I.sSlide45
References
ANSI/AAMI/ISO standards and TIRs available at www.aami.orgUSP 25 – order from www.usp.orgPBL Compliance GuidesSterility Assurance ComplianceAssessing BiocompatibilityOnline at www.pacificbiolabs.comSlide46
Thanks
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