Who Guidelines for Autoclave Validation
WHO has its validation procedures and methodologies for autoclaving to be adhered to while autoclaving any item. As a result, these must be checked before purchasing or selling any item to ensure the highest standards of quality and safety. Therefore, here are the guidelines, which have been simplified for ease of access by manufacturers and distribution stores to guide their purchase and sale decisions and by end users to know what to expect from distributors and manufacturers. Below are WHO guidelines on autoclave validation
WHO Autoclave Validation Guidelines
WHO has also provided its recommendations on methods that must be followed to do the autoclave validation for the various aspects of it. They are as follows:
WHO Validation Guidelines
In reference to biological indicators, as a biological indicator shall be placed in the load during a full autoclave cycle. Afterward, it should be incubated. The information to be gathered here is:
WHO Guidelines 1
Is it still alive?
How many hours will it take the spores to multiply before they are gone?
Using this incubation procedure, you may be able to test the following:
- The sterilization cycle.
- Different load patterns
- The efficacy of the sterilization cycle at the desired time interval.
- Steam sterilizer cycles that have been modified.
WHO Guidelines 2
Routine Testing
The sterilization process should be tested every week or after every load of biohazardous materials, at the least. After some time has elapsed, one should check the results, retest, and revalidate the biological indicator (BI).
WHO Guidelines 3
Fréquence
Periodically, the cycle must be revalidated using this process.
WHO Guidelines 4
Equipment
The autoclave's steam, electrical, and water lines should all be calibrated.
WHO Guidelines 5
Maintaining Accuracy
The equipment is supposed to provide heat through temperature and pressure gauges and resistance. If not, there should be an alarm system and timeclock
WHO Guidelines 6
Temperature, Pressure, and Duration
The sterilization methods should be executed at a particular temperature and pressure and duration.
WHO Guidelines 7
Location of thermometer
The thermometer should be placed in a fixed position on a rack or shelf that will be sterilized during every cycle.
WHO Guidelines 8
Maintaining Accuracy
Instruments used in the measurement process should be calibrated at least every three years.
WHO Guidelines 9
Time and Temperature
Time and temperature are directly proportional. The greater the temperature, the shorter the time.
WHO Guidelines 10
The temperature increases
The sterilization procedure should be executed in a specific direction and procedure until the temperature increases.
WHO Guidelines 11
Temperature Indication
For three full minutes, the maximum temperature in the sterilization chamber should be indicated or registered.
WHO Guidelines 12
Maintenance
The autoclave should be well maintained and serviced at least once a year by an experienced, certified, and expert service provider. This will ensure quality maintenance.
WHO Guidelines 13
Formation des opérateurs
Operating, maintenance, service technicians should be qualified and well trained, competent and experienced.
WHO Guidelines 14
Efficacité
The autoclave should be effective for a specified time, and temperature and pressure levels should be appropriate.
WHO Guidelines 15
Inspection of records
Validation records need to be available for inspection. This should include a demonstration.
WHO Guidelines 16
Documentation à l'appui
Installation, commissioning, and service specifications, manufacturer¡¯s data should be part of the documentation
WHO Guidelines 17
Achèvement
It should be complete upon its completion
WHO Guidelines 18
Facilité d'utilisation
Operating manuals, maintenance manuals, and documentation should be made readily available in a manner that is easily understandable.
WHO Guidelines 19
Laboratory Performance
Laboratory should have sufficient performance
WHO Guidelines 20
Performance
Should have good performance for temperature, humidity, and other standards.
WHO Guidelines 21
Equipment Inspection
Personnel should perform equipment inspection and verification.
WHO Guidelines 22
Pressure, Temperature, and Time Settings
Equipment should have pressure, temperature, and time settings and function and have the ability to automatically record and store.
WHO Guidelines 23
Heat Supply
Supplies of heat and cold air should be provided.
WHO Guidelines 24
Maintenance
The autoclave machine should be well maintained at all times. This will give room for quality maintenance at the time of need.
WHO Guidelines 25
Parts and Accessories
Replacement parts and accessories should be made available to the user at the right time.
WHO Guidelines 26
Installation
Suppliers should provide installation manuals and checklists.
WHO Guidelines 27
Utilities
Utilities should be operational. This is not to be faulty but should be available where the autoclave is to be used.
WHO Guidelines 28
Vacuum Source
Vacuum sources should be provided as per the manufactures¡¯ guidelines.
WHO Guidelines 29
Time-temperature Relationship
The time-temperature relationship should be direct. For more heat, less time is required, and vice versa.
WHO Guidelines 30
Alarm Systems
Alarm systems and timeclock should be provided.
WHO Guidelines 31
Performance
Validation data must be checked for performance.
WHO Guidelines 32
Pression
Pressure should be specified in pounds per square inch (psi).
WHO Guidelines 33
Température
Temperature must also be indicated for temperature to rise.
WHO Guidelines 34
Qualification Test
Equipment qualification (IQ) is defined as the validation test at three points.
WHO Guidelines 35
Operational Qualification (OQ)
Operational qualification (OQ) is a test that establishes that the autoclave or the equipment under test operates according to the expected functionality for effective functionality.
WHO Guidelines 36
Qualification des performances (PQ)
Performance qualification (PQ) means the test that ensures that the equipment or autoclave performs to specification. The information to be gathered here is:
WHO Guidelines 37
Is it still alive?
How many hours will it take the spores to multiply before they are gone?
Using this incubation procedure, you may be able to test the following:
- The sterilization cycle.
- Different load patterns
- The efficacy of the sterilization cycle at the desired time interval.
- Steam sterilizer cycles that have been modified.
WHO Guidelines 38
Routine Testing
The sterilization process should be tested every week or after every load of biohazardous materials, at the least. After some time has elapsed, one should check the results, retest, and revalidate the biological indicator (BI).
WHO Guidelines 39
Fréquence
Periodically, the cycle must be revalidated using this process.
WHO Guidelines 40
Equipment
The autoclave's steam, electrical, and water lines should all be calibrated.
WHO Guidelines 41
Maintaining Accuracy
The equipment is supposed to provide heat through temperature and pressure gauges and resistance. If not, there should be an alarm system and timeclock
WHO Guidelines 42
Temperature, Pressure, and Duration
The sterilization methods should be executed at a particular temperature and pressure and duration.
WHO Guidelines 43
Location of thermometer
The thermometer should be placed in a fixed position on a rack or shelf that will be sterilized during every cycle.
WHO Guidelines 44
Maintaining Accuracy
Instruments used in the measurement process should be calibrated at least every three years.
WHO Guidelines 45
Time and Temperature
Time and temperature are directly proportional. The greater the temperature, the shorter the time.
WHO Guidelines 46
The temperature increases
The sterilization procedure should be executed in a specific direction and procedure until the temperature increases.
WHO Guidelines 47
Temperature Indication
For three full minutes, the maximum temperature in the sterilization chamber should be indicated or registered.
WHO Guidelines 48
Maintenance
The autoclave should be well maintained and serviced at least once a year by an experienced, certified, and expert service provider. This will ensure quality maintenance.
WHO Guidelines 49
Formation des opérateurs
Operating, maintenance, service technicians should be qualified and well trained, competent and experienced.
WHO Guidelines 50
Efficacité
The autoclave should be effective for a specified time, and temperature and pressure levels should be appropriate.
WHO Guidelines 51
Inspection of records
Validation records need to be available for inspection. This should include a demonstration.
WHO Guidelines 52
Documentation à l'appui
Installation, commissioning, and service specifications, manufacturer¡¯s data should be part of the documentation
WHO Guidelines 53
Achèvement
It should be complete upon its completion
WHO Guidelines 54
Facilité d'utilisation
Operating manuals, maintenance manuals, and documentation should be made readily available in a manner that is easily understandable.
WHO Guidelines 55
Laboratory Performance
Laboratory should have sufficient performance
WHO Guidelines 56
Performance
Should have good performance for temperature, humidity, and other standards.
WHO Guidelines 57
Equipment Inspection
Personnel should perform equipment inspection and verification.
WHO Guidelines 58
Pressure, Temperature, and Time Settings
Equipment should have pressure, temperature, and time settings and function and have the ability to automatically record and store.
WHO Guidelines 59
Heat Supply
Supplies of heat and cold air should be provided.
WHO Guidelines 60
Maintenance
The autoclave machine should be well maintained at all times. This will give room for quality maintenance at the time of need.
WHO Guidelines 61
Parts and Accessories
Replacement parts and accessories should be made available to the user at the right time.
WHO Guidelines 62
Installation
Suppliers should provide installation manuals and checklists.
WHO Guidelines 63
Utilities
Utilities should be operational. This is not to be faulty but should be available where the autoclave is to be used.
WHO Guidelines 64
Vacuum Source
Vacuum sources should be provided as per the manufactures¡¯ guidelines.
WHO Guidelines 65
Time-temperature Relationship
The time-temperature relationship should be direct. For more heat, less time is required, and vice versa.
WHO Guidelines 66
Alarm Systems
Alarm systems and timeclock should be provided.
WHO Guidelines 67
Performance
Validation data must be checked for performance.
WHO Guidelines 68
Pression
Pressure should be specified in pounds per square inch (psi).
WHO Guidelines 69
Température
Temperature must also be indicated for temperature to rise.
WHO Guidelines 70
Qualification Test
Equipment qualification (IQ) is defined as the validation test at three points.
WHO Guidelines 71
Operational Qualification (OQ)
Operational qualification (OQ) is a test that establishes that the autoclave or the equipment under test operates according to the expected functionality for effective functionality.
WHO Guidelines 72
Qualification des performances (PQ)
Performance qualification (PQ) means the test that ensures that the equipment or autoclave performs to specification. The information to be gathered here is:
WHO Guidelines 73
Is it still alive?
How many hours will it take the spores to multiply before they are gone?
Using this incubation procedure, you may be able to test the following:
- The sterilization cycle.
- Different load patterns
- The efficacy of the sterilization cycle at the desired time interval.
- Steam sterilizer cycles that have been modified.
WHO Guidelines 74
Routine Testing
The sterilization process should be tested every week or after every load of biohazardous materials, at the least. After some time has elapsed, one should check the results, retest, and revalidate the biological indicator (BI).
WHO Guidelines 75
Fréquence
Periodically, the cycle must be revalidated using this process.
WHO Guidelines 76
Equipment
The autoclave's steam, electrical, and water lines should all be calibrated.
WHO Guidelines 77
Maintaining Accuracy
The equipment is supposed to provide heat through temperature and pressure gauges and resistance. If not, there should be an alarm system and timeclock
WHO Guidelines 78
Temperature, Pressure, and Duration
The sterilization methods should be executed at a particular temperature and pressure and duration.
WHO Guidelines 79
Location of thermometer
The thermometer should be placed in a fixed position on a rack or shelf that will be sterilized during every cycle.
WHO Guidelines 80
Maintaining Accuracy
Instruments used in the measurement process should be calibrated at least every three years.
WHO Guidelines 81
Time and Temperature
Time and temperature are directly proportional. The greater the temperature, the shorter the time.
WHO Guidelines 82
The temperature increases
The sterilization procedure should be executed in a specific direction and procedure until the temperature increases.
WHO Guidelines 83
Temperature Indication
For three full minutes, the maximum temperature in the sterilization chamber should be indicated or registered.
WHO Guidelines 84
Maintenance
The autoclave should be well maintained and serviced at least once a year by an experienced, certified, and expert service provider. This will ensure quality maintenance.
WHO Guidelines 85
Formation des opérateurs
Operating, maintenance, service technicians should be qualified and well trained, competent and experienced.
WHO Guidelines 86
Efficacité
The autoclave should be effective for a specified time, and temperature and pressure levels should be appropriate.
WHO Guidelines 87
Inspection of records
Validation records need to be available for inspection. This should include a demonstration.
WHO Guidelines 88
Documentation à l'appui
Installation, commissioning, and service specifications, manufacturer¡¯s data should be part of the documentation
WHO Guidelines 89
Achèvement
It should be complete upon its completion
WHO Guidelines 90
Facilité d'utilisation
Operating manuals, maintenance manuals, and documentation should be made readily available in a manner that is easily understandable.
WHO Guidelines 91
Laboratory Performance
Laboratory should have sufficient performance
WHO Guidelines 92
Performance
Should have good performance for temperature, humidity, and other standards.
WHO Guidelines 93
Equipment Inspection
Personnel should perform equipment inspection and verification.
WHO Guidelines 94
Pressure, Temperature, and Time Settings
Equipment should have pressure, temperature, and time settings and function and have the ability to automatically record and store.
WHO Guidelines 95
Heat Supply
Supplies of heat and cold air should be provided.
WHO Guidelines 96
Maintenance
The autoclave machine should be well maintained at all times. This will give room for quality maintenance at the time of need.
WHO Guidelines 97
Parts and Accessories
Replacement parts and accessories should be made available to the user at the right time.
WHO Guidelines 98
Installation
Suppliers should provide installation manuals and checklists.
WHO Guidelines 99
Utilities
Utilities should be operational. This is not to be faulty but should be available where the autoclave is to be used.
WHO Guidelines 100
Vacuum Source
Vacuum sources should be provided as per the manufactures¡¯ guidelines.
WHO Guidelines 101
Time-temperature Relationship
The time-temperature relationship should be direct. For more heat, less time is required, and vice versa.
WHO Guidelines 102
Alarm Systems
Alarm systems and timeclock should be provided.
WHO Guidelines 103
Performance
Validation data must be checked for performance.
WHO Guidelines 104
Pression
Pressure should be specified in pounds per square inch (psi).
WHO Guidelines 105
Température
Temperature must also be indicated for temperature to rise.
The validation of autoclave is the recorded verification that an autoclave may keep the degree of sterilization required.
Where the WHO has issued several pre-validation information required, conditions required before the validation can start, Installation Qualifications (IQs), operational qualification (OQs), and performance qualifications (PQs) for effective functionality.
Therefore, while this article has concentrated on the WHO Guidelines on autoclave validation, this means the documentation process that unequivocally reveals that a clearly-demonstrated configuration has been performed. To find out more about WHO autoclave validation guidelines kindly click HERE.
The sterilization of autoclaves is done through steam under pressure, dry heat in an oven, or an alternate sterilization method like ethylene oxide. Autoclaving, the process of using high-pressure steam, has been widely used to sterilize medical instruments, laboratory equipment, and other materials. Steam sterilization cycles must be validated to guarantee that all biological life, including bacterial spores, is effectively killed.
WHO recommends that every process and equipment should go through a validation process before, during, and after. This will guarantee that the autoclave system, equipment, and process of sterilization meet specifications and will achieve consistent results for a period of time. The autoclaving cycle must be validated each time for assurance of safety.
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