{"id":2425,"date":"2024-12-17T10:45:20","date_gmt":"2024-12-17T02:45:20","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2425"},"modified":"2026-02-09T09:58:51","modified_gmt":"2026-02-09T01:58:51","slug":"eo-sterilization-equipment-and-process-characteristic-patterns-and-effect-analysis","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=2425","title":{"rendered":"EO sterilization equipment and process characteristic patterns and effect analysis"},"content":{"rendered":"\n
\"\"<\/figure><\/div>\n\n\n\n
Start cycle phase(Select parameters\/sterilization recipe)<\/td><\/tr>
Serial number<\/td>Potentially risky content<\/td>Risk assessment under existing process conditions<\/td>Risk assessment of the results after taking measures<\/td>Recommended Actions<\/td>Responsibilities and current status<\/td><\/tr>
Fault name<\/td>Cause<\/td>Failure Impact<\/td>Control Now<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td>Take action<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td><\/tr>
1<\/td>Choosing the wrong recipe<\/td>Lack of care in choosing the formulation<\/td>Invalid cycle. Affects product sterility (re-sterilization)<\/td>1. Different recipe names<\/td>6<\/td>5<\/td>10<\/td>300<\/td>1. Work instructions 2. Careful inspection before the cycle starts 3. Operator training<\/td>2<\/td>5<\/td>4<\/td>40<\/td>1. Work instructions 2. Careful inspection before starting the cycle 3. Operator training<\/td>user<\/td><\/tr>
Loss of product\/packaging functionality and integrity due to unvalidated cycle parameters<\/td>1. Different recipe names<\/td>6<\/td>4<\/td>10<\/td>240<\/td>1. Work instructions 2. Careful inspection before the cycle starts 3. Operator training<\/td>2<\/td>4<\/td>4<\/td>32<\/td>1. Work instructions 2. Careful inspection before starting the cycle 3. Operator training<\/td>user<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
Warm-up phase(Cabinet heating)<\/td><\/tr>
Serial number<\/td>Potentially risky content<\/td>Risk assessment under existing process conditions<\/td>Risk assessment of the results after taking measures<\/td>Recommended Actions<\/td>Responsibilities and current status<\/td><\/tr>
Fault name<\/td>Cause<\/td>Failure Impact<\/td>Control Now<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td>Take action<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td><\/tr>
1<\/td>The box temperature is lower than the lower limit value<\/td>Hot water circulation pump failure<\/td>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.<\/td>1. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation<\/td>5<\/td>3<\/td>2<\/td>30<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Electric heating tube failure<\/td>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.<\/td>1. Heating timeout alarm 2. Automatic heating time compensation<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Temperature sensor failure<\/td>Affects product sterility (re-sterilization)<\/td>
1. Redundant temperature sensor 2. Temperature difference exceeds limit alarm<\/td>		6<\/td>5<\/td>2<\/td>60<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr>
2<\/td>The temperature inside the cabinet is too high<\/td>Temperature sensor failure<\/td>Affects product sterility (re-sterilization)<\/td>
1. Redundant temperature sensor 2. Temperature difference exceeds limit alarm<\/td>		6<\/td>4<\/td>2<\/td>48<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
Insulation stage(Maintain cabinet temperature)<\/td><\/tr>
Serial number<\/td>Potentially risky content<\/td>Risk assessment under existing process conditions<\/td>Risk assessment of the results after taking measures<\/td>Recommended Actions<\/td>Responsibilities and current status<\/td><\/tr>
Fault name<\/td>Cause<\/td>Failure Impact<\/td>Control Now<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td>Take action<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td><\/tr>
1<\/td>The box temperature is lower than the lower limit value<\/td>Hot water circulation pump failure<\/td>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.<\/td>1. Heating timeout alarm 2. Circulating water pump overload alarm<\/td>5<\/td>3<\/td>2<\/td>30<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Electric heating tube failure<\/td>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.<\/td>1. Heating timeout alarm<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Temperature sensor failure<\/td>Affects product sterility (re-sterilization)<\/td>1. Heating timeout alarm 2. Circulating water pump overload alarm<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr>
2<\/td>The temperature inside the cabinet is too high<\/td>Temperature sensor failure<\/td>Affects product sterility (re-sterilization)<\/td>1. Heating timeout alarm 2. Circulating water pump overload alarm<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr>
3<\/td>Lack of time<\/td>Programming Errors<\/td>Repeat sterilization<\/td>1. Automatic cycle inspection<\/td>2<\/td>4<\/td>2<\/td>16<\/td><\/td><\/td><\/td><\/td><\/td>none<\/td><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
Pre-vacuum stage(Removing air from the chamber allows the process to proceed below the EO flammability limit)<\/td><\/tr>
Serial number<\/td>Potentially risky content<\/td>Risk assessment under existing process conditions<\/td>Risk assessment of the results after taking measures<\/td>Recommended Actions<\/td>Responsibilities and current status<\/td><\/tr>
Fault name<\/td>Cause<\/td>Failure Impact<\/td>Control Now<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td>Take action<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td><\/tr>
1<\/td>Not enough air removed<\/td>Low vacuum pump efficiency<\/td>The cycle is locked in one phase until it is restored and restarted after a standby period<\/td>1. Pre-vacuum time over limit alarm 2. Vacuum pump overload alarm 3. Automatically detect water flow and shut down the waterless pump<\/td>5<\/td>3<\/td>2<\/td>30<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Wrong valve<\/td>The cycle is locked in one phase until it is restored and restarted after a standby period<\/td>1. Pre-vacuum time over limit alarm 2. Vacuum pump overload alarm<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Pressure sensor failure<\/td>Flammable Zone Hazard<\/td>1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr>
2<\/td>Too much vacuum<\/td>Pressure sensor failure<\/td>Product and\/or packaging damage (classification)<\/td>1. Redundant pressure sensor 2. Pressure difference alarm is issued when the pressure difference is greater than 1kpa.<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
Leak detection stage(Check the tightness of the box)<\/td><\/tr>
Serial number<\/td>Potentially risky content<\/td>Risk assessment under existing process conditions<\/td>Risk assessment of the results after taking measures<\/td>Recommended Actions<\/td>Responsibilities and current status<\/td><\/tr>
Fault name<\/td>Cause<\/td>Failure Impact<\/td>Control Now<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td>Take action<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td><\/tr>
1<\/td>Cabinet leakage<\/td>Gasket leakage<\/td>No impact<\/td>1. Leak test failure alarm 2. Process ends<\/td>10<\/td>5<\/td>2<\/td>100<\/td>1. Preventive maintenance<\/td>3<\/td>5<\/td>2<\/td>30<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Valve leakage<\/td>No impact<\/td>1. Leak test failure alarm<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Circulation system air duct leakage<\/td>No impact<\/td>1. Leak test failure alarm<\/td>4<\/td>3<\/td>2<\/td>24<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
Nitrogen replacement stage(Fill the chamber with an inert gas to replace oxygen)<\/td><\/tr>
Serial number<\/td>Potentially risky content<\/td>Risk assessment under existing process conditions<\/td>Risk assessment of the results after taking measures<\/td>Recommended Actions<\/td>Responsibilities and current status<\/td><\/tr>
Fault name<\/td>Cause<\/td>Failure Impact<\/td>Control Now<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td>Take action<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td><\/tr>
1<\/td>Not enough nitrogen entering the chamber<\/td>Insufficient nitrogen<\/td>The cycle is locked in one phase until it is restored and restarted after a standby period<\/td>End of process<\/td>3<\/td>3<\/td>2<\/td>18<\/td><\/td><\/td><\/td><\/td><\/td>N\/A<\/td><\/td><\/tr>
Faulty valve<\/td>The cycle is locked in one phase until it is restored and restarted after a standby period<\/td>N\/A<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Pressure sensor failure<\/td>Flammable Zone Hazard<\/td>1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
2<\/td>Too much nitrogen in the cabinet door<\/td>Faulty valve<\/td>EO concentration is lower than the validated value because during EO injection, if controlled by pressure (resterilization), additional N2 is injected<\/td>1. Indoor high voltage alarm 2. End of process<\/td>6<\/td>5<\/td>4<\/td>120<\/td>1. Preventive maintenance<\/td>2<\/td>5<\/td>4<\/td>40<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Pressure transmitter failure<\/td>Too much EO gas injected. High EO residue. Extended degassing time me)<\/td>1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr>
3<\/td>The cabinet temperature is higher than the upper limit t<\/td><\/td>Impact on product function (sorting)<\/td>1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr>
4<\/td>The box temperature is lower than the lower limit value<\/td>Hot water circulation pump failure<\/td>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.<\/td>1. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Electric heating tube failure<\/td>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.<\/td>1. Heating timeout alarm 2. Automatic heating time compensation<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Temperature sensor failure<\/td>Affects product sterility (re-sterilization)<\/td>1. Redundant temperature sensor 2. Temperature difference exceeds limit alarm<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr>
Low carburetor temperature<\/td>Affects product sterility (re-sterilization)<\/td>1. Alarm when the carburetor temperature is lower than the limit 2. Automatic heating time compensation<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. Preventive maintenance<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
Humidification stage(Increasing the humidity of the load by injecting steam)<\/td><\/tr>
Serial number<\/td>Potentially risky content<\/td>Risk assessment under existing process conditions<\/td>Risk assessment of the results after taking measures<\/td>Recommended Actions<\/td>Responsibilities and current status<\/td><\/tr>
Fault name<\/td>Cause<\/td>Failure Impact<\/td>Control Now<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td>Take action<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td><\/tr>
1<\/td>Insufficient steam<\/td>Steam generator failure<\/td>Affects product sterility (re-sterilization)<\/td>1. Alarm when steam pressure is lower than the limit<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. Preventive maintenance<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Valve failure<\/td>The cycle is locked in one phase until it is restored and restarted after a standby period<\/td>1.Humidification frequency limit alarm<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. Preventive maintenance<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Pressure transmitter\/humidity sensor failure<\/td>Affects product sterility (re-sterilization)<\/td>1. Redundant pressure\/humidity sensor 2. Alarm when pressure\/humidity difference exceeds limit<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr>
Filter clogged<\/td>The cycle is locked in one phase until it is restored and restarted after a standby period<\/td>1.Humidification frequency limit alarm<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. Preventive maintenance<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
2<\/td>Too much steam injection<\/td>Faulty valve<\/td>Excessive steam injection, wet cartons (sorting)<\/td>1. Indoor high voltage alarm 2. End of process<\/td>6<\/td>5<\/td>4<\/td>120<\/td>1. Preventive maintenance<\/td>2<\/td>5<\/td>4<\/td>40<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Pressure transmitter\/humidity sensor failure<\/td>Excessive steam injection, wet cartons (sorting)<\/td>1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr>
3<\/td>Temperature is too high<\/td>Temperature sensor failure<\/td>Impact on product functions (ranking)<\/td>1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr>
4<\/td>The box temperature is lower than the lower limit value<\/td>Hot water circulation pump failure<\/td>The cycle is locked in one phase until it is restored and restarted after a standby period<\/td>1. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. Preventive maintenance<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Electric heating tube failure<\/td>The cycle is locked in one phase until it is restored and restarted after a standby period<\/td>1. Heating timeout alarm 2. Automatic heating time compensation<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Temperature sensor failure<\/td>Affects product sterility (re-sterilization)<\/td>1. Heating timeout alarm 2. Circulating water pump overload alarm<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
Humidification dwell phase(Balanced humidity)<\/td><\/tr>
Serial number<\/td>Potentially risky content<\/td>Risk assessment under existing process conditions<\/td>Risk assessment of the results after taking measures<\/td>Recommended Actions<\/td>Responsibilities and current status<\/td><\/tr>
Fault name<\/td>Cause<\/td>Failure Impact<\/td>Control Now<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td>Take action<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td><\/tr>
1<\/td>Lack of time<\/td>time out<\/td>Affects product sterility (re-sterilization)<\/td>1. Automatic cycle inspection<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. Preventive maintenance<\/td>1<\/td>5<\/td>2<\/td>10<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
Nitrogen cushion stage(Fill the chamber with inert gas to dilute the oxygen)<\/td><\/tr>
Serial number<\/td>Potentially risky content<\/td>Risk assessment under existing process conditions<\/td>Risk assessment of the results after taking measures<\/td>Recommended Actions<\/td>Responsibilities and current status<\/td><\/tr>
Fault name<\/td>Cause<\/td>Failure Impact<\/td>Control Now<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td>Take action<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td><\/tr>
1<\/td>Not enough nitrogen entering the cabinet<\/td>Lack of nitrogen<\/td>The cycle is locked in one phase until it is restored and restarted after a standby period<\/td>1. Check N2 pressure before starting the cycle 2. Alarm when N2 pressure is lower than the limit<\/td>3<\/td>3<\/td>2<\/td>18<\/td><\/td><\/td><\/td><\/td>0<\/td><\/td><\/td><\/tr>
Valve failure<\/td>The cycle is locked in one phase until it is restored and restarted after a standby period<\/td>none<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>3<\/td>18<\/td>user<\/td>1. Preventive maintenance<\/td><\/tr>
Pressure sensor failure<\/td>Flammable Zone Hazard<\/td>1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>2<\/td>12<\/td>user<\/td>1. Preventive maintenance<\/td><\/tr>
2<\/td>Too much nitrogen injected into the cabinet<\/td>Faulty valve<\/td>EO concentration is lower than the validated value because during EO injection, if controlled by pressure (resterilization), additional N2 is injected<\/td>1. Indoor high voltage alarm 2. End of process<\/td>6<\/td>5<\/td>4<\/td>120<\/td>1. Preventive maintenance<\/td>2<\/td>5<\/td>4<\/td>40<\/td>user<\/td>1. Preventive maintenance<\/td><\/tr>
Pressure transmitter failure<\/td>Too much EO gas injected. High EO residue. (Extend degassing time)<\/td>1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>5<\/td>2<\/td>20<\/td>user<\/td>1. Preventive maintenance 2. Calibration<\/td><\/tr>
3<\/td>The temperature inside the cabinet exceeds the upper limit<\/td>Temperature sensor failure<\/td>Impact on product function (sorting)<\/td>1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>4<\/td>2<\/td>16<\/td>user<\/td>1. Preventive maintenance 2. Calibration<\/td><\/tr>
4<\/td>The box temperature is lower than the lower limit value<\/td>Hot water circulation pump failure<\/td>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.<\/td>1. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>2<\/td>12<\/td>user<\/td>1. Preventive maintenance<\/td><\/tr>
Electric heating tube failure<\/td>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.<\/td>1. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>3<\/td>18<\/td>user<\/td>1. Preventive maintenance<\/td><\/tr>
Temperature sensor failure<\/td>Affects product sterility (re-sterilization)<\/td>1. Redundant temperature sensor 2. Temperature difference exceeds limit alarm<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>5<\/td>2<\/td>20<\/td>user<\/td>1. Preventive maintenance 2. Calibration<\/td><\/tr>
Low carburetor temperature<\/td>Affects product sterility (re-sterilization)<\/td>1. Alarm when the carburetor temperature is lower than the limit 2. Automatic heating time compensation<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>4<\/td>2<\/td>16<\/td>user<\/td>1. Preventive maintenance 2. Calibration<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
EO injection stage(Fill the cabinet with EO gas)<\/td><\/tr>
Serial number<\/td>Potentially risky content<\/td>Risk assessment under existing process conditions<\/td>Risk assessment of the results after taking measures<\/td>Recommended Actions<\/td>Responsibilities and current status<\/td><\/tr>
Fault name<\/td>Cause<\/td>Failure Impact<\/td>Control Now<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td>Take action<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td><\/tr>
1<\/td>Not enough ethylene oxide is entering the cabinet<\/td>Missing EO<\/td>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.<\/td>1.EO cylinder hole alarm 2.EO injection timeout alarm<\/td>10<\/td>5<\/td>2<\/td>100<\/td>1. Operator training 2. EO weight check before cycle start<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. Operator training 2. EO weight check before cycle start<\/td>user<\/td><\/tr>
Faulty valve<\/td>The cycle is locked in one phase until it is restored and restarted after a standby period<\/td>1.EO injection timeout alarm<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. Preventive maintenance<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
EO pipeline leakage<\/td>Batches that exceed the qualification period may be sterilized again<\/td>none<\/td>6<\/td>5<\/td>3<\/td>90<\/td>1. Preventive maintenance 2. LEL EO detector alarm<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. Preventive maintenance 2. LEL EO detector alarm<\/td>user<\/td><\/tr>
Pressure sensor failure<\/td>EO concentration is lower than the validation value (re-sterilization)<\/td>1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr>
2<\/td>Liquid EO enters the cabinet<\/td>Low carburetor temperature<\/td>The cycle is locked in one phase until it is restored and restarted after a standby period<\/td>1. The carburetor temperature is lower than the limit alarm<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. Preventive maintenance<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Not enough water in the carburetor due to a faulty valve<\/td>The cycle is locked in one phase until it is restored and restarted after a standby period<\/td>1. The carburetor water level is lower than the limit alarm<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. Preventive maintenance<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
3<\/td>Too much ethylene oxide input in the cabinet<\/td>Faulty valve<\/td>Longer quarantine, requiring additional testing<\/td>1. Indoor high voltage alarm<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1. Preventive maintenance 2. EO residual inspection<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1. Preventive maintenance 2. EO residual inspection<\/td>user<\/td><\/tr>
Pressure sensor failure<\/td>Longer quarantine, requiring additional testing<\/td>1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr>
4<\/td>The temperature inside the cabinet exceeds the upper limit<\/td>Temperature sensor failure<\/td>Impact on product function (sorting)<\/td>1. Redundant temperature sensor 2. Chamber high temperature alarm 3. Temperature difference exceeds limit alarm<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr>
5<\/td>The box temperature is lower than the lower limit value<\/td>Hot water circulation pump failure<\/td>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.<\/td>1. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Electric heating tube failure<\/td>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.<\/td>1. Heating timeout alarm 2. Automatic heating time compensation<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Temperature sensor failure<\/td>Affects product sterility (re-sterilization)<\/td>1. Redundant temperature sensor 2. Temperature difference exceeds limit alarm<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr>
Low carburetor temperature<\/td>Affects product sterility (re-sterilization)<\/td>1. Alarm when the carburetor temperature is lower than the limit 2. Automatic heating time compensation<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. Preventive maintenance<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
Nitrogen cap stage(Add N2 to cover EO)<\/td><\/tr>
Serial number<\/td>Potentially risky content<\/td>Risk assessment under existing process conditions<\/td>Risk assessment of the results after taking measures<\/td>Recommended Actions<\/td>Responsibilities and current status<\/td><\/tr>
Fault name<\/td>Cause<\/td>Failure Impact<\/td>Control Now<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td>Take action<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td><\/tr>
1<\/td>Not enough nitrogen entering the cabinet<\/td>Lack of nitrogen<\/td>The cycle is locked in one phase until it is restored and restarted after a standby period<\/td>1. Check N2 pressure before starting the cycle 2. Alarm when N2 pressure is lower than the limit<\/td>3<\/td>3<\/td>2<\/td>18<\/td><\/td><\/td><\/td><\/td><\/td>N\/A<\/td><\/td><\/tr>
Valve failure<\/td>The cycle is locked in one phase until it is restored and restarted after a standby period<\/td>none<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Pressure sensor failure<\/td>Flammable Zone Hazard<\/td>1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
2<\/td>Too much nitrogen injected into the cabinet<\/td>Faulty valve<\/td>The cabin is under positive pressure. This cycle will end.<\/td>1. Indoor high voltage alarm 2. End of process<\/td>6<\/td>5<\/td>4<\/td>120<\/td>1. Preventive maintenance<\/td>2<\/td>5<\/td>4<\/td>40<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
3<\/td>The temperature inside the cabinet exceeds the upper limit<\/td>Temperature sensor failure<\/td>Affects product sterility (re-sterilization)<\/td>1. Redundant temperature sensor 2. Chamber high temperature alarm 3. Temperature difference exceeds limit alarm<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr>
4<\/td>The box temperature is lower than the lower limit value<\/td>Hot water circulation pump failure<\/td>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.<\/td>1. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Electric heating tube failure<\/td>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.<\/td>1. Heating timeout alarm 2. Automatic heating time compensation<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Temperature sensor failure<\/td>Affects product sterility (re-sterilization)<\/td>1. Redundant temperature sensor 2. Temperature difference exceeds limit alarm<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr>
Low carburetor temperature<\/td>Affects product sterility (re-sterilization)<\/td>1. Alarm when the carburetor temperature is lower than the limit 2. Automatic heating time compensation<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. Preventive maintenance<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
EO exposure stage(Disinfect the product)<\/td><\/tr>
Serial number<\/td>Potentially risky content<\/td>Risk assessment under existing process conditions<\/td>Risk assessment of the results after taking measures<\/td>Recommended Actions<\/td>Responsibilities and current status<\/td><\/tr>
Fault name<\/td>Cause<\/td>Failure Impact<\/td>Control Now<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td>Take action<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td><\/tr>
1<\/td>Lack of time<\/td>Programming Errors<\/td>Repeat sterilization<\/td>1. Automatic cycle inspection<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. Preventive maintenance<\/td>1<\/td>5<\/td>2<\/td>10<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
2<\/td>The box temperature is lower than the lower limit t<\/td>Hot water circulation pump failure<\/td>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.<\/td>Heating timeout 2. Circulating water pump overload alarm 3. Automatic heating time compensation<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Electric heating tube failure<\/td>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.<\/td>1. Heating timeout alarm 2. Automatic heating time compensation<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Temperature sensor failure<\/td>Affects product sterility (re-sterilization)<\/td>1. Redundant temperature sensor 2. Temperature difference exceeds limit alarm<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr>
3<\/td>The temperature inside the cabinet exceeds the upper limit<\/td>Temperature sensor failure<\/td>Affects product sterility (re-sterilization)<\/td>1. Redundant temperature sensor 2. Chamber high temperature alarm 3. Temperature alarm<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr>
4<\/td>Not getting a sufficiently homogeneous EO mixture<\/td>Circulation fan failure<\/td>Affects product sterility (re-sterilization)<\/td>1. Low speed alarm<\/td>6<\/td>5<\/td>3<\/td>90<\/td>1. Preventive maintenance<\/td>2<\/td>5<\/td>3<\/td>30<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Product positioning very close to the cavity wall<\/td>Affects product sterility (re-sterilization)<\/td>1.Guardrail is used to prevent the product from contacting the cavity wall<\/td>2<\/td>5<\/td>3<\/td>30<\/td><\/td><\/td><\/td><\/td>0<\/td>N\/A<\/td><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
EO Removal Phase(Create vacuum\/remove sterilization gas)<\/td><\/tr>
Serial number<\/td>Potentially risky content<\/td>Risk assessment under existing process conditions<\/td>Risk assessment of the results after taking measures<\/td>Recommended Actions<\/td>Responsibilities and current status<\/td><\/tr>
Fault name<\/td>Cause<\/td>Failure Impact<\/td>Control Now<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td>Take action<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td><\/tr>
1<\/td>Not purging enough gas<\/td>Inefficient vacuum pump<\/td>The cycle is locked in one phase until it is restored and restarted after a standby period<\/td>1.EO removal timeout alarm 2.Vacuum pump overload alarm 3.Automatically detect water flow and shut down the waterless pump<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Faulty valve<\/td>The cycle is locked in one phase until it is restored and restarted after a standby period<\/td>1.EO removal timeout alarm 2.Vacuum pump overload alarm<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Pressure sensor failure<\/td>Longer isolation time and additional testing required due to less EO gas being removed<\/td>1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr>
2<\/td>Exhaust too much gas<\/td>Pressure sensor failure<\/td>Product and\/or packaging damage (classification)<\/td>1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
Nitrogen purge stage(Ensure that the indoor environment is not flammable)<\/td><\/tr>
Serial number<\/td>Potentially risky content<\/td>Risk assessment under existing process conditions<\/td>Risk assessment of the results after taking measures<\/td>Recommended Actions<\/td>Responsibilities and current status<\/td><\/tr>
Fault name<\/td>Cause<\/td>Failure Impact<\/td>Control Now<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td>Take action<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td><\/tr>
1<\/td>Not enough nitrogen entering the chamber<\/td>Lack of nitrogen<\/td>The cycle is locked in one phase until it is restored and restarted after a standby period<\/td>1. Check N2 pressure before starting the cycle 2. Alarm when N2 pressure is lower than the limit<\/td>3<\/td>3<\/td>2<\/td>18<\/td><\/td><\/td><\/td><\/td><\/td>N\/A<\/td><\/td><\/tr>
Faulty valve<\/td>The cycle is locked in one phase until it is restored and restarted after a standby period<\/td>none<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Pressure sensor failure<\/td>Flammable Zone Hazard<\/td>1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Longer quarantines require additional testing<\/td>1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
Air cleaning stage(Create vacuum\/remove residual sterilization gas, eliminate residual EO)<\/td><\/tr>
Serial number<\/td>Potentially risky content<\/td>Risk assessment under existing process conditions<\/td>Risk assessment of the results after taking measures<\/td>Recommended Actions<\/td>Responsibilities and current status<\/td><\/tr>
Fault name<\/td>Cause<\/td>Failure Impact<\/td>Control Now<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td>Take action<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td><\/tr>
1<\/td>Not purging enough gas<\/td>Inefficient vacuum pump<\/td>The cycle is locked in one phase until it is restored and restarted after a standby period<\/td>1.EO removal timeout alarm 2.Vacuum pump overload alarm 3.Automatically detect water flow and shut down the waterless pump<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Faulty valve<\/td>The cycle is locked in one phase until it is restored and restarted after a standby period<\/td>1.EO removal timeout alarm 2.Vacuum pump overload alarm<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. Preventive maintenance<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Pressure sensor failure<\/td>Longer isolation time and additional testing required due to less EO gas being removed<\/td>1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr>
2<\/td>Exhaust too much gas<\/td>Pressure sensor failure<\/td>Product and\/or packaging damage (classification)<\/td>1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr>
3<\/td>Insufficient air in the cabin<\/td>Faulty valve<\/td>The cycle is locked in one phase until it is restored and restarted after a standby period<\/td>1. Gas injection time over limit alarm<\/td>6<\/td>4<\/td>3<\/td>72<\/td>1. Preventive maintenance<\/td>2<\/td>4<\/td>3<\/td>24<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Filter clogged<\/td>The cycle is locked in one phase until it is restored and restarted after a standby period<\/td>1. Gas injection time over limit alarm<\/td>6<\/td>4<\/td>3<\/td>72<\/td>1. Preventive maintenance<\/td>2<\/td>4<\/td>3<\/td>24<\/td>1. Preventive maintenance<\/td>user<\/td><\/tr>
Pressure sensor failure<\/td>Longer quarantines require additional testing<\/td>1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. Preventive maintenance 2. Calibration<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. Preventive maintenance 2. Calibration<\/td>user<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
Removal stage(Remove residue from the product)<\/td><\/tr>
Serial number<\/td>Potentially risky content<\/td>Risk assessment under existing process conditions<\/td>Risk assessment of the results after taking measures<\/td>Recommended Actions<\/td>Responsibilities and current status<\/td><\/tr>
Fault name<\/td>Cause<\/td>Failure Impact<\/td>Control Now<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td>Take action<\/td>event<\/td>Severity<\/td>examine<\/td>Risk Prioritization<\/td><\/tr>
1<\/td>Aeration time is less than the specified time<\/td>Programming Errors<\/td>Repeat sterilization<\/td>1. Automatic cycle inspection<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. Restart your computer regularly<\/td>1<\/td>3<\/td>2<\/td>6<\/td>1. Restart your computer regularly<\/td>user<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

IF YOU WANT TO KNOW MORE About Ethylene Oxide Sterilization<\/h2>\n\n\n\n

Phone: +8619975258603<\/a><\/p>\n\n\n\n

Email: hayley@hzbocon.com<\/a><\/p>\n\n\n\n

Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China<\/p>\n\n\n\n

Website: hzbocon.com<\/a> zjbocon.com<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

Start cycle phase(Select parameters\/sterilization recipe) Serial number Potentially risky content Risk assessment under existing process conditions Risk assessment of the 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