Autoclave Testing
Autoclaves shall be tested before being placed into service and then periodically for effectiveness.
Sterilization bags often have a "sterilization indicator mark" that typically darkens when sterilization temperatures have been reached. Comparing the mark on an unprocessed bag to a bag that has been properly cycled will show an obvious visual difference.
There are physical, chemical and biological indicators that can be used to ensure an autoclave reaches the correct temperature for the correct amount of time.
Chemical indicators can be found on medical packaging and autoclave tape, and these change color once the correct conditions have been met. This color change indicates that the object inside the package, or under the tape, has been autoclaved sufficiently. Biological indicators include attest devices. These contain spores of a heat-resistant bacterium, Geobacillus stearothermophilus. If the autoclave does not reach the right temperature, the spores will germinate, and their metabolism will change the color of a pH-sensitive chemical. Physical indicators often consist of an alloy designed to melt only after being subjected to 121°C or 249°F for 15 minutes. If the alloy melts, the change will be visible.
In addition to these indicators, autoclaves have timers, temperature and pressure gauges that can be viewed from the outside.
Periodicity
Every 40 hours of use (Required for autoclaves that are used to inactivate human or non-human primate blood, tissues, clinical samples, or human pathogens.)
Every 6 months (Required for autoclaves that are used to inactivate other material.
Method
A commercially available test indicator kit that uses bacterial spores (Bacillus stearothermophilus) is the approved method of testing autoclave efficiency. Most spore vial test kits require 56 to 60°C incubation of the autoclaved test vial along with a non-autoclaved control vial. Incubation causes surviving spores to grow.
New autoclaves
Before placing an autoclave into service, a test load approximating the weight and density of the type of waste generated shall be autoclaved with test spore vials. The spore vials should be placed at the bottom, top, front, rear, and center of the autoclave chamber. This can be achieved by either:
placing vials at those positions within one large test load, OR
making several smaller test packs with 1 vial at the center of each and placing the packs at those locations within the chamber.
The appropriate parameters for sterilization including temperature, pressure, and treatment time shall be determined in this way.
Autoclaves already in use
For periodic testing, place a spore vial in the very center of a test load prior to autoclaving.
Storage Information
Please read the product information sheet for appropriate storage information, but, in general, spore vials should not be frozen. Each batch of vials has an expiration date. Vials should not be used after their expiration date.
Record Keeping
The following records regarding autoclave use must be kept:
On-site maintenance records
Autoclave use log (Each load of material inactivated shall be logged as follows:)
Date, time, and operator's name
Contact information: Lab, room number, phone number
Is this biohazardous material?
Record the temperature, pressure, and length of time the load is sterilized. Please note that temperature sensitive autoclave tape is not sufficient to indicate that the load reached sterilization conditions because the tape will change color at lower temperatures
Save the autoclave print-out, if the autoclave has a working printer.
Autoclave Operating Procedures
A written sterilization procedure shall be in place for each workplace. This shall include the following:
Parameters
Appropriate parameters for sterilization shall be determined from the testing with spore vials.
The time it takes to sterilize a load will change depending upon the load density and the sterilization cycle one chooses. Tests have been performed which imitate these various situations. Please follow the established guidelines.
Protocol
Identification of standard treatment containers and proper load placement shall be made.
Cleaning
The autoclave and work areas shall be cleaned after every use and the work area shall be disinfected, as needed.
Autoclave Operation and Safety Training
Autoclave training should be given to the operator.The training is geared toward the research staff. It goes over proper use of autoclaves and how they may be maintained and used properly. Safety training is also given.
Disclaimer
The content of this issue is presented for general information only as perceived by the writer of the article. Reader should independently verify the correctness and accuracy of the material before using the same for any purpose whatsoever. The Company or Management or Staff of Puneet Industries or the Writer shall not be responsible for any inaccuracy or error in the article
Autoclave TestingAutoclaves shall be tested before being placed into service and then periodically for effectiveness.Sterilization bags often have a "sterilization indicator mark" that typically darkens when sterilization temperatures have been reached. Comparing the mark on an unprocessed bag to a bag that has been properly cycled will show an obvious visual difference.There are physical, chemical and biological indicators that can be used to ensure an autoclave reaches the correct temperature for the correct amount of time.Chemical indicators can be found on medical packaging and autoclave tape, and these change color once the correct conditions have been met. This color change indicates that the object inside the package, or under the tape, has been autoclaved sufficiently. Biological indicators include attest devices. These contain spores of a heat-resistant bacterium, Geobacillus stearothermophilus. If the autoclave does not reach the right temperature, the spores will germinate, and their metabolism will change the color of a pH-sensitive chemical. Physical indicators often consist of an alloy designed to melt only after being subjected to 121°C or 249°F for 15 minutes. If the alloy melts, the change will be visible.In addition to these indicators, autoclaves have timers, temperature and pressure gauges that can be viewed from the outside.PeriodicityEvery 40 hours of use (Required for autoclaves that are used to inactivate human or non-human primate blood, tissues, clinical samples, or human pathogens.)Every 6 months (Required for autoclaves that are used to inactivate other material.MethodA commercially available test indicator kit that uses bacterial spores (Bacillus stearothermophilus) is the approved method of testing autoclave efficiency. Most spore vial test kits require 56 to 60°C incubation of the autoclaved test vial along with a non-autoclaved control vial. Incubation causes surviving spores to grow.New autoclavesBefore placing an autoclave into service, a test load approximating the weight and density of the type of waste generated shall be autoclaved with test spore vials. The spore vials should be placed at the bottom, top, front, rear, and center of the autoclave chamber. This can be achieved by either:placing vials at those positions within one large test load, ORmaking several smaller test packs with 1 vial at the center of each and placing the packs at those locations within the chamber.The appropriate parameters for sterilization including temperature, pressure, and treatment time shall be determined in this way.Autoclaves already in useFor periodic testing, place a spore vial in the very center of a test load prior to autoclaving.Storage InformationPlease read the product information sheet for appropriate storage information, but, in general, spore vials should not be frozen. Each batch of vials has an expiration date. Vials should not be used after their expiration date.Record KeepingThe following records regarding autoclave use must be kept:On-site maintenance recordsAutoclave use log (Each load of material inactivated shall be logged as follows:)Date, time, and operator's nameContact information: Lab, room number, phone numberIs this biohazardous material?Record the temperature, pressure, and length of time the load is sterilized. Please note that temperature sensitive autoclave tape is not sufficient to indicate that the load reached sterilization conditions because the tape will change color at lower temperaturesSave the autoclave print-out, if the autoclave has a working printer. Autoclave Operating ProceduresA written sterilization procedure shall be in place for each workplace. This shall include the following:ParametersAppropriate parameters for sterilization shall be determined from the testing with spore vials.The time it takes to sterilize a load will change depending upon the load density and the sterilization cycle one chooses. Tests have been performed which imitate these various situations. Please follow the established guidelines.ProtocolIdentification of standard treatment containers and proper load placement shall be made.CleaningThe autoclave and work areas shall be cleaned after every use and the work area shall be disinfected, as needed. Autoclave Operation and Safety TrainingAutoclave training should be given to the operator.The training is geared toward the research staff. It goes over proper use of autoclaves and how they may be maintained and used properly. Safety training is also given. DisclaimerThe content of this issue is presented for general information only as perceived by the writer of the article. Reader should independently verify the correctness and accuracy of the material before using the same for any purpose whatsoever. The Company or Management or Staff of Puneet Industries or the Writer shall not be responsible for any inaccuracy or error in the article
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