How to Validate Autoclave
Autoclaving is used for sterilization purposes and must go through the Good Manufacturing Practice (GMP) process of validation. Validating an autoclave ensures that all requirements for the device usage have been met. Important variables in the validation process include temperature and steam. The autoclave is used to sterilize biohazardous wastes, surgical accessories, laboratory and surgical glassware, microbiology media and biological liquids; therefore, temperature and steam are responsible for ensuring that no biological organisms survive the autoclave process.
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Things You'll Need
- Autclave
- Data logger
- Software for data logger
- Computer
- Filter paper
- Bacterial spore sample
- Sterilization monitor strips
- Daily Air Removal Test
Instructions
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Validating Temperature Level
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Test the autoclave and ensure the temperature can reach and maintain 115, 121 and 132 degrees Celsius. The high temperature speeds up the killing process of microorganisms.
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2
Attach a data logger to the autoclave and computer.
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3
Read the data from the data logger on your computer. Data of all physical parameters, including temperature, will be recorded and saved. This measure ensures your autoclave is working properly and that you will follow any necessary requirements.
Validating Steam
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4
Supply dry steam to the autoclave. The steam in an autoclave produces heat from the condensation and kills any microorganisms present. Test the steam method by using a biological indicator.
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5
Prepare a filter paper with bacterial spores. Insert the spores into the autoclave at a temperature of 115 degrees Celsius for 24 hours.
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6
Remove the filter paper and look under the microscope for any live spores. All spores should be dead from the steam, indicating an effective process.
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Test the amount of moisture present in the steam itself. Not enough moisture can cause the sterilization process not to be effective. The steam must consist of 90 percent steam and 10 percent water.
Other Methods to Ensure Sterilization
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8
Place sterilization monitor strips with color references in a wrapped pack into the autoclave. Indicators on the monitor strips will validate if complete sterilization has occurred.
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9
Place items to be sterilized in a sterilization pouch. Color indicators on the pouch will ensure that the temperature needed to sterilize the items was reached.
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10
Use the Daily Air Removal Test. This test is placed into the autoclave for a four-minute test cycle at a high temperature. Look for a black color on the indicator bars for validation of sterilization.
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Tips & Warnings
Use a Validation Log to record the validation process or any problems that arise.
References
- Photo Credit Surgical tools - scalpel, forceps, clamps, scissors - isolated image by Dmitry Rukhlenko from Fotolia.com
