EO sterilization equipment and process characteristic patterns and effect analysis

Start cycle phase(Select parameters/sterilization recipe)

Serial number

Potentially risky content

Risk assessment under existing process conditions

Risk assessment of the results after taking measures

Recommended Actions

Responsibilities and current status

Fault name

Cause

Failure Impact

Control Now

event

Severity

examine

Risk Prioritization

Take action

event

Severity

examine

Risk Prioritization

1

Choosing the wrong recipe

Lack of care in choosing the formulation

Invalid cycle. Affects product sterility (re-sterilization)

1. Different recipe names

6

5

10

300

1. Work instructions 2. Careful inspection before the cycle starts 3. Operator training

2

5

4

40

1. Work instructions 2. Careful inspection before starting the cycle 3. Operator training

user

Loss of product/packaging functionality and integrity due to unvalidated cycle parameters

1. Different recipe names

6

4

10

240

1. Work instructions 2. Careful inspection before the cycle starts 3. Operator training

2

4

4

32

1. Work instructions 2. Careful inspection before starting the cycle 3. Operator training

user

Warm-up phase(Cabinet heating)
Serial number	Potentially risky content			Risk assessment under existing process conditions					Risk assessment of the results after taking measures					Recommended Actions	Responsibilities and current status
	Fault name	Cause	Failure Impact	Control Now	event	Severity	examine	Risk Prioritization	Take action	event	Severity	examine	Risk Prioritization
1	The box temperature is lower than the lower limit value	Hot water circulation pump failure	The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again.	1. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation	5	3	2	30	1. Preventive maintenance	2	3	2	12	1. Preventive maintenance	user
		Electric heating tube failure	The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again.	1. Heating timeout alarm 2. Automatic heating time compensation	6	3	2	36	1. Preventive maintenance	2	3	2	12	1. Preventive maintenance	user
		Temperature sensor failure	Affects product sterility (re-sterilization)	1. Redundant temperature sensor 2. Temperature difference exceeds limit alarm	6	5	2	60	1. Preventive maintenance 2. Calibration	2	5	2	20	1. Preventive maintenance 2. Calibration	user
2	The temperature inside the cabinet is too high	Temperature sensor failure	Affects product sterility (re-sterilization)	1. Redundant temperature sensor 2. Temperature difference exceeds limit alarm	6	4	2	48	1. Preventive maintenance 2. Calibration	2	4	2	16	1. Preventive maintenance 2. Calibration	user

Insulation stage(Maintain cabinet temperature)
Serial number	Potentially risky content			Risk assessment under existing process conditions					Risk assessment of the results after taking measures					Recommended Actions	Responsibilities and current status
	Fault name	Cause	Failure Impact	Control Now	event	Severity	examine	Risk Prioritization	Take action	event	Severity	examine	Risk Prioritization
1	The box temperature is lower than the lower limit value	Hot water circulation pump failure	The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again.	1. Heating timeout alarm 2. Circulating water pump overload alarm	5	3	2	30	1. Preventive maintenance	2	3	2	12	1. Preventive maintenance	user
		Electric heating tube failure	The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again.	1. Heating timeout alarm	6	3	2	36	1. Preventive maintenance	2	3	2	12	1. Preventive maintenance	user
		Temperature sensor failure	Affects product sterility (re-sterilization)	1. Heating timeout alarm 2. Circulating water pump overload alarm	6	5	2	60	1. Preventive maintenance 2. Calibration	2	5	2	20	1. Preventive maintenance 2. Calibration	user
2	The temperature inside the cabinet is too high	Temperature sensor failure	Affects product sterility (re-sterilization)	1. Heating timeout alarm 2. Circulating water pump overload alarm	6	4	2	48	1. Preventive maintenance 2. Calibration	2	4	2	16	1. Preventive maintenance 2. Calibration	user
3	Lack of time	Programming Errors	Repeat sterilization	1. Automatic cycle inspection	2	4	2	16						none

Pre-vacuum stage(Removing air from the chamber allows the process to proceed below the EO flammability limit)
Serial number	Potentially risky content			Risk assessment under existing process conditions					Risk assessment of the results after taking measures					Recommended Actions	Responsibilities and current status
	Fault name	Cause	Failure Impact	Control Now	event	Severity	examine	Risk Prioritization	Take action	event	Severity	examine	Risk Prioritization
1	Not enough air removed	Low vacuum pump efficiency	The cycle is locked in one phase until it is restored and restarted after a standby period	1. Pre-vacuum time over limit alarm 2. Vacuum pump overload alarm 3. Automatically detect water flow and shut down the waterless pump	5	3	2	30	1. Preventive maintenance	2	3	2	12	1. Preventive maintenance	user
		Wrong valve	The cycle is locked in one phase until it is restored and restarted after a standby period	1. Pre-vacuum time over limit alarm 2. Vacuum pump overload alarm	6	3	2	36	1. Preventive maintenance	2	3	2	12	1. Preventive maintenance	user
		Pressure sensor failure	Flammable Zone Hazard	1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit	6	3	2	36	1. Preventive maintenance 2. Calibration	2	3	2	12	1. Preventive maintenance 2. Calibration	user
2	Too much vacuum	Pressure sensor failure	Product and/or packaging damage (classification)	1. Redundant pressure sensor 2. Pressure difference alarm is issued when the pressure difference is greater than 1kpa.	6	4	2	48	1. Preventive maintenance 2. Calibration	2	4	2	16	1. Preventive maintenance 2. Calibration	user

Leak detection stage(Check the tightness of the box)

Serial number

Potentially risky content

Risk assessment under existing process conditions

Risk assessment of the results after taking measures

Recommended Actions

Responsibilities and current status

Fault name

Cause

Failure Impact

Control Now

event

Severity

examine

Risk Prioritization

Take action

event

Severity

examine

Risk Prioritization

1

Cabinet leakage

Gasket leakage

No impact

1. Leak test failure alarm 2. Process ends

10

5

2

100

1. Preventive maintenance

3

5

2

30

1. Preventive maintenance

user

Valve leakage

No impact

1. Leak test failure alarm

6

3

2

36

1. Preventive maintenance

2

3

2

12

1. Preventive maintenance

user

Circulation system air duct leakage

No impact

1. Leak test failure alarm

4

3

2

24

1. Preventive maintenance

2

3

2

12

1. Preventive maintenance 2. Calibration

user

Nitrogen replacement stage(Fill the chamber with an inert gas to replace oxygen)
Serial number	Potentially risky content			Risk assessment under existing process conditions					Risk assessment of the results after taking measures					Recommended Actions	Responsibilities and current status
	Fault name	Cause	Failure Impact	Control Now	event	Severity	examine	Risk Prioritization	Take action	event	Severity	examine	Risk Prioritization
1	Not enough nitrogen entering the chamber	Insufficient nitrogen	The cycle is locked in one phase until it is restored and restarted after a standby period	End of process	3	3	2	18						N/A
		Faulty valve	The cycle is locked in one phase until it is restored and restarted after a standby period	N/A	6	3	3	54	1. Preventive maintenance	2	3	3	18	1. Preventive maintenance	user
		Pressure sensor failure	Flammable Zone Hazard	1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit	6	3	2	36	1. Preventive maintenance	2	3	2	12	1. Preventive maintenance	user
2	Too much nitrogen in the cabinet door	Faulty valve	EO concentration is lower than the validated value because during EO injection, if controlled by pressure (resterilization), additional N2 is injected	1. Indoor high voltage alarm 2. End of process	6	5	4	120	1. Preventive maintenance	2	5	4	40	1. Preventive maintenance	user
		Pressure transmitter failure	Too much EO gas injected. High EO residue. Extended degassing time me)	1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit	6	5	2	60	1. Preventive maintenance 2. Calibration	2	5	2	20	1. Preventive maintenance 2. Calibration	user
3	The cabinet temperature is higher than the upper limit t		Impact on product function (sorting)	1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit	6	4	2	48	1. Preventive maintenance 2. Calibration	2	4	2	16	1. Preventive maintenance 2. Calibration	user
4	The box temperature is lower than the lower limit value	Hot water circulation pump failure	The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again.	1. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation	6	3	2	36	1. Preventive maintenance	2	3	2	12	1. Preventive maintenance	user
		Electric heating tube failure	The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again.	1. Heating timeout alarm 2. Automatic heating time compensation	6	3	3	54	1. Preventive maintenance	2	3	3	18	1. Preventive maintenance	user
		Temperature sensor failure	Affects product sterility (re-sterilization)	1. Redundant temperature sensor 2. Temperature difference exceeds limit alarm	6	5	2	60	1. Preventive maintenance 2. Calibration	2	5	2	20	1. Preventive maintenance 2. Calibration	user
		Low carburetor temperature	Affects product sterility (re-sterilization)	1. Alarm when the carburetor temperature is lower than the limit 2. Automatic heating time compensation	6	4	2	48	1. Preventive maintenance	2	4	2	16	1. Preventive maintenance	user

Humidification stage(Increasing the humidity of the load by injecting steam)
Serial number	Potentially risky content			Risk assessment under existing process conditions					Risk assessment of the results after taking measures					Recommended Actions	Responsibilities and current status
	Fault name	Cause	Failure Impact	Control Now	event	Severity	examine	Risk Prioritization	Take action	event	Severity	examine	Risk Prioritization
1	Insufficient steam	Steam generator failure	Affects product sterility (re-sterilization)	1. Alarm when steam pressure is lower than the limit	6	5	2	60	1. Preventive maintenance	2	5	2	20	1. Preventive maintenance	user
		Valve failure	The cycle is locked in one phase until it is restored and restarted after a standby period	1.Humidification frequency limit alarm	6	5	2	60	1. Preventive maintenance	2	5	2	20	1. Preventive maintenance	user
		Pressure transmitter/humidity sensor failure	Affects product sterility (re-sterilization)	1. Redundant pressure/humidity sensor 2. Alarm when pressure/humidity difference exceeds limit	6	5	2	60	1. Preventive maintenance 2. Calibration	2	5	2	20	1. Preventive maintenance 2. Calibration	user
		Filter clogged	The cycle is locked in one phase until it is restored and restarted after a standby period	1.Humidification frequency limit alarm	6	5	2	60	1. Preventive maintenance	2	5	2	20	1. Preventive maintenance	user
2	Too much steam injection	Faulty valve	Excessive steam injection, wet cartons (sorting)	1. Indoor high voltage alarm 2. End of process	6	5	4	120	1. Preventive maintenance	2	5	4	40	1. Preventive maintenance	user
		Pressure transmitter/humidity sensor failure	Excessive steam injection, wet cartons (sorting)	1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit	6	5	2	60	1. Preventive maintenance 2. Calibration	2	5	2	20	1. Preventive maintenance 2. Calibration	user
3	Temperature is too high	Temperature sensor failure	Impact on product functions (ranking)	1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit	6	4	2	48	1. Preventive maintenance 2. Calibration	2	4	2	16	1. Preventive maintenance 2. Calibration	user
4	The box temperature is lower than the lower limit value	Hot water circulation pump failure	The cycle is locked in one phase until it is restored and restarted after a standby period	1. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation	6	3	2	36	1. Preventive maintenance	2	4	2	16	1. Preventive maintenance	user
		Electric heating tube failure	The cycle is locked in one phase until it is restored and restarted after a standby period	1. Heating timeout alarm 2. Automatic heating time compensation	6	3	3	54	1. Preventive maintenance	2	3	3	18	1. Preventive maintenance	user
		Temperature sensor failure	Affects product sterility (re-sterilization)	1. Heating timeout alarm 2. Circulating water pump overload alarm	6	5	2	60	1. Preventive maintenance 2. Calibration	2	5	2	20	1. Preventive maintenance 2. Calibration	user

Humidification dwell phase(Balanced humidity)

Serial number

Potentially risky content

Risk assessment under existing process conditions

Risk assessment of the results after taking measures

Recommended Actions

Responsibilities and current status

Fault name

Cause

Failure Impact

Control Now

event

Severity

examine

Risk Prioritization

Take action

event

Severity

examine

Risk Prioritization

1

Lack of time

time out

Affects product sterility (re-sterilization)

1. Automatic cycle inspection

2

5

2

20

1. Preventive maintenance

1

5

2

10

1. Preventive maintenance

user

Nitrogen cushion stage(Fill the chamber with inert gas to dilute the oxygen)
Serial number	Potentially risky content			Risk assessment under existing process conditions					Risk assessment of the results after taking measures					Recommended Actions	Responsibilities and current status
	Fault name	Cause	Failure Impact	Control Now	event	Severity	examine	Risk Prioritization	Take action	event	Severity	examine	Risk Prioritization
1	Not enough nitrogen entering the cabinet	Lack of nitrogen	The cycle is locked in one phase until it is restored and restarted after a standby period	1. Check N2 pressure before starting the cycle 2. Alarm when N2 pressure is lower than the limit	3	3	2	18					0
		Valve failure	The cycle is locked in one phase until it is restored and restarted after a standby period	none	6	3	3	54	1. Preventive maintenance	2	3	3	18	user	1. Preventive maintenance
		Pressure sensor failure	Flammable Zone Hazard	1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit	6	3	2	36	1. Preventive maintenance	2	3	2	12	user	1. Preventive maintenance
2	Too much nitrogen injected into the cabinet	Faulty valve	EO concentration is lower than the validated value because during EO injection, if controlled by pressure (resterilization), additional N2 is injected	1. Indoor high voltage alarm 2. End of process	6	5	4	120	1. Preventive maintenance	2	5	4	40	user	1. Preventive maintenance
		Pressure transmitter failure	Too much EO gas injected. High EO residue. (Extend degassing time)	1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit	6	5	2	60	1. Preventive maintenance 2. Calibration	2	5	2	20	user	1. Preventive maintenance 2. Calibration
3	The temperature inside the cabinet exceeds the upper limit	Temperature sensor failure	Impact on product function (sorting)	1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit	6	4	2	48	1. Preventive maintenance 2. Calibration	2	4	2	16	user	1. Preventive maintenance 2. Calibration
4	The box temperature is lower than the lower limit value	Hot water circulation pump failure	The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again.	1. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation	6	3	2	36	1. Preventive maintenance	2	3	2	12	user	1. Preventive maintenance
		Electric heating tube failure	The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again.	1. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation	6	3	3	54	1. Preventive maintenance	2	3	3	18	user	1. Preventive maintenance
		Temperature sensor failure	Affects product sterility (re-sterilization)	1. Redundant temperature sensor 2. Temperature difference exceeds limit alarm	6	5	2	60	1. Preventive maintenance 2. Calibration	2	5	2	20	user	1. Preventive maintenance 2. Calibration
		Low carburetor temperature	Affects product sterility (re-sterilization)	1. Alarm when the carburetor temperature is lower than the limit 2. Automatic heating time compensation	6	4	2	48	1. Preventive maintenance 2. Calibration	2	4	2	16	user	1. Preventive maintenance 2. Calibration

EO injection stage(Fill the cabinet with EO gas)
Serial number	Potentially risky content			Risk assessment under existing process conditions					Risk assessment of the results after taking measures					Recommended Actions	Responsibilities and current status
	Fault name	Cause	Failure Impact	Control Now	event	Severity	examine	Risk Prioritization	Take action	event	Severity	examine	Risk Prioritization
1	Not enough ethylene oxide is entering the cabinet	Missing EO	The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again.	1.EO cylinder hole alarm 2.EO injection timeout alarm	10	5	2	100	1. Operator training 2. EO weight check before cycle start	2	5	2	20	1. Operator training 2. EO weight check before cycle start	user
		Faulty valve	The cycle is locked in one phase until it is restored and restarted after a standby period	1.EO injection timeout alarm	6	5	2	60	1. Preventive maintenance	6	5	2	60	1. Preventive maintenance	user
		EO pipeline leakage	Batches that exceed the qualification period may be sterilized again	none	6	5	3	90	1. Preventive maintenance 2. LEL EO detector alarm	2	5	2	20	1. Preventive maintenance 2. LEL EO detector alarm	user
		Pressure sensor failure	EO concentration is lower than the validation value (re-sterilization)	1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit	6	5	2	60	1. Preventive maintenance 2. Calibration	2	5	2	20	1. Preventive maintenance 2. Calibration	user
2	Liquid EO enters the cabinet	Low carburetor temperature	The cycle is locked in one phase until it is restored and restarted after a standby period	1. The carburetor temperature is lower than the limit alarm	6	4	2	48	1. Preventive maintenance	2	4	2	16	1. Preventive maintenance	user
		Not enough water in the carburetor due to a faulty valve	The cycle is locked in one phase until it is restored and restarted after a standby period	1. The carburetor water level is lower than the limit alarm	6	4	2	48	1. Preventive maintenance	2	4	2	16	1. Preventive maintenance	user
3	Too much ethylene oxide input in the cabinet	Faulty valve	Longer quarantine, requiring additional testing	1. Indoor high voltage alarm	6	3	3	54	1. Preventive maintenance 2. EO residual inspection	2	3	3	18	1. Preventive maintenance 2. EO residual inspection	user
		Pressure sensor failure	Longer quarantine, requiring additional testing	1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit	6	3	2	36	1. Preventive maintenance 2. Calibration	2	3	2	12	1. Preventive maintenance 2. Calibration	user
4	The temperature inside the cabinet exceeds the upper limit	Temperature sensor failure	Impact on product function (sorting)	1. Redundant temperature sensor 2. Chamber high temperature alarm 3. Temperature difference exceeds limit alarm	6	4	2	48	1. Preventive maintenance 2. Calibration	2	4	2	16	1. Preventive maintenance 2. Calibration	user
5	The box temperature is lower than the lower limit value	Hot water circulation pump failure	The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again.	1. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation	6	3	2	36	1. Preventive maintenance	2	3	2	12	1. Preventive maintenance	user
		Electric heating tube failure	The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again.	1. Heating timeout alarm 2. Automatic heating time compensation	6	3	3	54	1. Preventive maintenance	2	3	3	18	1. Preventive maintenance	user
		Temperature sensor failure	Affects product sterility (re-sterilization)	1. Redundant temperature sensor 2. Temperature difference exceeds limit alarm	6	5	2	60	1. Preventive maintenance 2. Calibration	2	5	2	20	1. Preventive maintenance 2. Calibration	user
		Low carburetor temperature	Affects product sterility (re-sterilization)	1. Alarm when the carburetor temperature is lower than the limit 2. Automatic heating time compensation	6	4	2	48	1. Preventive maintenance	2	4	2	16	1. Preventive maintenance	user

Nitrogen cap stage(Add N2 to cover EO)
Serial number	Potentially risky content			Risk assessment under existing process conditions					Risk assessment of the results after taking measures					Recommended Actions	Responsibilities and current status
	Fault name	Cause	Failure Impact	Control Now	event	Severity	examine	Risk Prioritization	Take action	event	Severity	examine	Risk Prioritization
1	Not enough nitrogen entering the cabinet	Lack of nitrogen	The cycle is locked in one phase until it is restored and restarted after a standby period	1. Check N2 pressure before starting the cycle 2. Alarm when N2 pressure is lower than the limit	3	3	2	18						N/A
		Valve failure	The cycle is locked in one phase until it is restored and restarted after a standby period	none	6	3	3	54	1. Preventive maintenance	2	3	3	18	1. Preventive maintenance	user
		Pressure sensor failure	Flammable Zone Hazard	1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit	6	3	2	36	1. Preventive maintenance	2	3	2	12	1. Preventive maintenance	user
2	Too much nitrogen injected into the cabinet	Faulty valve	The cabin is under positive pressure. This cycle will end.	1. Indoor high voltage alarm 2. End of process	6	5	4	120	1. Preventive maintenance	2	5	4	40	1. Preventive maintenance	user
3	The temperature inside the cabinet exceeds the upper limit	Temperature sensor failure	Affects product sterility (re-sterilization)	1. Redundant temperature sensor 2. Chamber high temperature alarm 3. Temperature difference exceeds limit alarm	6	4	2	48	1. Preventive maintenance 2. Calibration	2	4	2	16	1. Preventive maintenance 2. Calibration	user
4	The box temperature is lower than the lower limit value	Hot water circulation pump failure	The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again.	1. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation	6	3	2	36	1. Preventive maintenance	2	3	2	12	1. Preventive maintenance	user
		Electric heating tube failure	The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again.	1. Heating timeout alarm 2. Automatic heating time compensation	6	3	3	54	1. Preventive maintenance	2	3	3	18	1. Preventive maintenance	user
		Temperature sensor failure	Affects product sterility (re-sterilization)	1. Redundant temperature sensor 2. Temperature difference exceeds limit alarm	6	5	2	60	1. Preventive maintenance 2. Calibration	2	5	2	20	1. Preventive maintenance 2. Calibration	user
		Low carburetor temperature	Affects product sterility (re-sterilization)	1. Alarm when the carburetor temperature is lower than the limit 2. Automatic heating time compensation	6	4	2	48	1. Preventive maintenance	2	4	2	16	1. Preventive maintenance	user

EO exposure stage(Disinfect the product)
Serial number	Potentially risky content			Risk assessment under existing process conditions					Risk assessment of the results after taking measures					Recommended Actions	Responsibilities and current status
	Fault name	Cause	Failure Impact	Control Now	event	Severity	examine	Risk Prioritization	Take action	event	Severity	examine	Risk Prioritization
1	Lack of time	Programming Errors	Repeat sterilization	1. Automatic cycle inspection	2	5	2	20	1. Preventive maintenance	1	5	2	10	1. Preventive maintenance	user
2	The box temperature is lower than the lower limit t	Hot water circulation pump failure	The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again.	Heating timeout 2. Circulating water pump overload alarm 3. Automatic heating time compensation	6	3	2	36	1. Preventive maintenance	2	3	2	12	1. Preventive maintenance	user
		Electric heating tube failure	The cycle is locked in one phase until it is resumed and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again.	1. Heating timeout alarm 2. Automatic heating time compensation	6	3	3	54	1. Preventive maintenance	2	3	3	18	1. Preventive maintenance	user
		Temperature sensor failure	Affects product sterility (re-sterilization)	1. Redundant temperature sensor 2. Temperature difference exceeds limit alarm	6	5	2	60	1. Preventive maintenance 2. Calibration	2	5	2	20	1. Preventive maintenance 2. Calibration	user
3	The temperature inside the cabinet exceeds the upper limit	Temperature sensor failure	Affects product sterility (re-sterilization)	1. Redundant temperature sensor 2. Chamber high temperature alarm 3. Temperature alarm	6	4	2	48	1. Preventive maintenance 2. Calibration	2	4	2	16	1. Preventive maintenance 2. Calibration	user
4	Not getting a sufficiently homogeneous EO mixture	Circulation fan failure	Affects product sterility (re-sterilization)	1. Low speed alarm	6	5	3	90	1. Preventive maintenance	2	5	3	30	1. Preventive maintenance	user
		Product positioning very close to the cavity wall	Affects product sterility (re-sterilization)	1.Guardrail is used to prevent the product from contacting the cavity wall	2	5	3	30					0	N/A

EO Removal Phase(Create vacuum/remove sterilization gas)
Serial number	Potentially risky content			Risk assessment under existing process conditions					Risk assessment of the results after taking measures					Recommended Actions	Responsibilities and current status
	Fault name	Cause	Failure Impact	Control Now	event	Severity	examine	Risk Prioritization	Take action	event	Severity	examine	Risk Prioritization
1	Not purging enough gas	Inefficient vacuum pump	The cycle is locked in one phase until it is restored and restarted after a standby period	1.EO removal timeout alarm 2.Vacuum pump overload alarm 3.Automatically detect water flow and shut down the waterless pump	6	3	2	36	1. Preventive maintenance	2	3	2	12	1. Preventive maintenance	user
		Faulty valve	The cycle is locked in one phase until it is restored and restarted after a standby period	1.EO removal timeout alarm 2.Vacuum pump overload alarm	6	3	2	36	1. Preventive maintenance	2	3	2	12	1. Preventive maintenance	user
		Pressure sensor failure	Longer isolation time and additional testing required due to less EO gas being removed	1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit	6	3	2	36	1. Preventive maintenance 2. Calibration	2	3	2	12	1. Preventive maintenance 2. Calibration	user
2	Exhaust too much gas	Pressure sensor failure	Product and/or packaging damage (classification)	1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit	6	4	2	48	1. Preventive maintenance 2. Calibration	2	4	2	16	1. Preventive maintenance 2. Calibration	user

Nitrogen purge stage(Ensure that the indoor environment is not flammable)
Serial number	Potentially risky content			Risk assessment under existing process conditions					Risk assessment of the results after taking measures					Recommended Actions	Responsibilities and current status
	Fault name	Cause	Failure Impact	Control Now	event	Severity	examine	Risk Prioritization	Take action	event	Severity	examine	Risk Prioritization
1	Not enough nitrogen entering the chamber	Lack of nitrogen	The cycle is locked in one phase until it is restored and restarted after a standby period	1. Check N2 pressure before starting the cycle 2. Alarm when N2 pressure is lower than the limit	3	3	2	18						N/A
		Faulty valve	The cycle is locked in one phase until it is restored and restarted after a standby period	none	6	3	3	54	1. Preventive maintenance	2	3	3	18	1. Preventive maintenance	user
		Pressure sensor failure	Flammable Zone Hazard	1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit	6	3	2	36	1. Preventive maintenance	2	3	2	12	1. Preventive maintenance	user
			Longer quarantines require additional testing	1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit	6	3	2	36	1. Preventive maintenance	2	3	2	12	1. Preventive maintenance	user

Air cleaning stage(Create vacuum/remove residual sterilization gas, eliminate residual EO)
Serial number	Potentially risky content			Risk assessment under existing process conditions					Risk assessment of the results after taking measures					Recommended Actions	Responsibilities and current status
	Fault name	Cause	Failure Impact	Control Now	event	Severity	examine	Risk Prioritization	Take action	event	Severity	examine	Risk Prioritization
1	Not purging enough gas	Inefficient vacuum pump	The cycle is locked in one phase until it is restored and restarted after a standby period	1.EO removal timeout alarm 2.Vacuum pump overload alarm 3.Automatically detect water flow and shut down the waterless pump	6	3	2	36	1. Preventive maintenance	2	3	2	12	1. Preventive maintenance	user
		Faulty valve	The cycle is locked in one phase until it is restored and restarted after a standby period	1.EO removal timeout alarm 2.Vacuum pump overload alarm	6	3	2	36	1. Preventive maintenance	2	3	2	12	1. Preventive maintenance	user
		Pressure sensor failure	Longer isolation time and additional testing required due to less EO gas being removed	1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit	6	3	2	36	1. Preventive maintenance 2. Calibration	2	3	2	12	1. Preventive maintenance 2. Calibration	user
2	Exhaust too much gas	Pressure sensor failure	Product and/or packaging damage (classification)	1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit	6	4	2	48	1. Preventive maintenance 2. Calibration	2	4	2	16	1. Preventive maintenance 2. Calibration	user
3	Insufficient air in the cabin	Faulty valve	The cycle is locked in one phase until it is restored and restarted after a standby period	1. Gas injection time over limit alarm	6	4	3	72	1. Preventive maintenance	2	4	3	24	1. Preventive maintenance	user
		Filter clogged	The cycle is locked in one phase until it is restored and restarted after a standby period	1. Gas injection time over limit alarm	6	4	3	72	1. Preventive maintenance	2	4	3	24	1. Preventive maintenance	user
		Pressure sensor failure	Longer quarantines require additional testing	1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit	6	3	2	36	1. Preventive maintenance 2. Calibration	2	4	2	16	1. Preventive maintenance 2. Calibration	user

Removal stage(Remove residue from the product)

Serial number

Potentially risky content

Risk assessment under existing process conditions

Risk assessment of the results after taking measures

Recommended Actions

Responsibilities and current status

Fault name

Cause

Failure Impact

Control Now

event

Severity

examine

Risk Prioritization

Take action

event

Severity

examine

Risk Prioritization

1

Aeration time is less than the specified time

Programming Errors

Repeat sterilization

1. Automatic cycle inspection

2

3

2

12

1. Restart your computer regularly

1

3

2

6

1. Restart your computer regularly

user

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