How to Validate Autoclave

Written by dana schafer
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How to Validate Autoclave
Surgical equipment can be sterilised in an autoclave. (Surgical tools - scalpel, forceps, clamps, scissors - isolated image by Dmitry Rukhlenko from Fotolia.com)

Autoclaving is used for sterilisation 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 sterilise 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.

Skill level:
Moderate

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Things you need

  • Autclave
  • Data logger
  • Software for data logger
  • Computer
  • Filter paper
  • Bacterial spore sample
  • Sterilisation monitor strips
  • Daily Air Removal Test

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Instructions

  1. 1

    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.

  2. 2

    Attach a data logger to the autoclave and computer.

  3. 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.

  1. 1

    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.

  2. 2

    Prepare a filter paper with bacterial spores. Insert the spores into the autoclave at a temperature of 115 degrees Celsius for 24 hours.

  3. 3

    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.

  4. 4

    Test the amount of moisture present in the steam itself. Not enough moisture can cause the sterilisation process not to be effective. The steam must consist of 90 per cent steam and 10 per cent water.

  1. 1

    Place sterilisation monitor strips with colour references in a wrapped pack into the autoclave. Indicators on the monitor strips will validate if complete sterilisation has occurred.

  2. 2

    Place items to be sterilised in a sterilisation pouch. Colour indicators on the pouch will ensure that the temperature needed to sterilise the items was reached.

  3. 3

    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 colour on the indicator bars for validation of sterilisation.

Tips and warnings

  • Use a Validation Log to record the validation process or any problems that arise.

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