{"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<div class=\"wp-block-uagb-image uagb-block-de5b384b wp-block-uagb-image--layout-default wp-block-uagb-image--effect-static wp-block-uagb-image--align-none\"><figure class=\"wp-block-uagb-image__figure\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-68.webp\" alt=\"\" class=\"uag-image-8473\" width=\"1024\" height=\"768\" title=\"ethylene-oxide-sterilization-68\" role=\"img\" \><\/figure><\/div>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Start cycle phase(Select parameters\/sterilization recipe)<\/td><\/tr><tr><td rowspan=\"2\">Numru tas-serje<\/td><td colspan=\"3\">Kontenut potenzjalment riskjuż<\/td><td colspan=\"5\">Valutazzjoni tar-riskju taħt kundizzjonijiet ta&#039; proċess eżistenti<\/td><td colspan=\"5\">Valutazzjoni tar-riskju tar-riżultati wara li jittieħdu miżuri<\/td><td rowspan=\"2\">Azzjonijiet Rakkomandati<\/td><td rowspan=\"2\">Responsabbiltajiet u status attwali<\/td><\/tr><tr><td>Isem tal-ħsara<\/td><td>Kawża<\/td><td>Impatt tal-falliment<\/td><td>Kontroll Issa<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><td>Ħu azzjoni<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><\/tr><tr><td rowspan=\"2\">1<\/td><td rowspan=\"2\">Tagħżel ir-riċetta ħażina<\/td><td rowspan=\"2\">Nuqqas ta &#039;kura fl-għażla tal-formulazzjoni<\/td><td>Ċiklu mhux validu. Jaffettwa l-isterilità tal-prodott (sterilizzazzjoni mill-ġdid)<\/td><td>1. Ismijiet ta &#039;riċetti differenti<\/td><td>6<\/td><td>5<\/td><td>10<\/td><td>300<\/td><td>1. Istruzzjonijiet tax-xogħol 2. Spezzjoni bir-reqqa qabel ma jibda ċ-ċiklu 3. Taħriġ tal-operatur<\/td><td>2<\/td><td>5<\/td><td>4<\/td><td>40<\/td><td>1. Istruzzjonijiet tax-xogħol 2. Spezzjoni bir-reqqa qabel ma jibda ċ-ċiklu 3. Taħriġ tal-operatur<\/td><td>utent<\/td><\/tr><tr><td>Loss of product\/packaging functionality and integrity due to unvalidated cycle parameters<\/td><td>1. Ismijiet ta &#039;riċetti differenti<\/td><td>6<\/td><td>4<\/td><td>10<\/td><td>240<\/td><td>1. Istruzzjonijiet tax-xogħol 2. Spezzjoni bir-reqqa qabel ma jibda ċ-ċiklu 3. Taħriġ tal-operatur<\/td><td>2<\/td><td>4<\/td><td>4<\/td><td>32<\/td><td>1. Istruzzjonijiet tax-xogħol 2. Spezzjoni bir-reqqa qabel ma jibda ċ-ċiklu 3. Taħriġ tal-operatur<\/td><td>utent<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Fażi ta &#039;tisħin (tisħin tal-kabinett)<\/td><\/tr><tr><td rowspan=\"2\">Numru tas-serje<\/td><td colspan=\"3\">Kontenut potenzjalment riskjuż<\/td><td colspan=\"5\">Valutazzjoni tar-riskju taħt kundizzjonijiet ta&#039; proċess eżistenti<\/td><td colspan=\"5\">Valutazzjoni tar-riskju tar-riżultati wara li jittieħdu miżuri<\/td><td rowspan=\"2\">Azzjonijiet Rakkomandati<\/td><td rowspan=\"2\">Responsabbiltajiet u status attwali<\/td><\/tr><tr><td>Isem tal-ħsara<\/td><td>Kawża<\/td><td>Impatt tal-falliment<\/td><td>Kontroll Issa<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><td>Ħu azzjoni<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><\/tr><tr><td rowspan=\"3\">1<\/td><td rowspan=\"3\">It-temperatura tal-kaxxa hija aktar baxxa mill-valur tal-limitu aktar baxx<\/td><td>Ħsara tal-pompa taċ-ċirkolazzjoni tal-ilma sħun<\/td><td>Iċ-ċiklu jissakkar fi stadju wieħed sakemm jiġi restawrat u jerġa &#039;jibda wara perjodu ta&#039; standby. Lottijiet li qabżu ċ-ċiklu kwalifikat jistgħu jerġgħu jiġu sterilizzati.<\/td><td>1. Allarm ta&#039; timeout tat-tisħin 2. Allarm ta&#039; tagħbija żejda tal-pompa tal-ilma li tiċċirkola 3. Kumpens awtomatiku tal-ħin tat-tisħin<\/td><td>5<\/td><td>3<\/td><td>2<\/td><td>30<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Falliment tat-tubu tat-tisħin elettriku<\/td><td>Iċ-ċiklu jissakkar fi stadju wieħed sakemm jiġi restawrat u jerġa &#039;jibda wara perjodu ta&#039; standby. Lottijiet li qabżu ċ-ċiklu kwalifikat jistgħu jerġgħu jiġu sterilizzati.<\/td><td>1. Allarm ta &#039;timeout tat-tisħin 2. Kumpens awtomatiku tal-ħin tat-tisħin<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Ħsara tas-sensorju tat-temperatura<\/td><td>Jaffettwa l-isterilità tal-prodott (sterilizzazzjoni mill-ġdid)<\/td><td><br>1. Sensor tat-temperatura żejda 2. Id-differenza fit-temperatura taqbeż l-allarm tal-limitu<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><tr><td>2<\/td><td>It-temperatura ġewwa l-kabinett hija għolja wisq<\/td><td>Ħsara tas-sensorju tat-temperatura<\/td><td>Jaffettwa l-isterilità tal-prodott (sterilizzazzjoni mill-ġdid)<\/td><td><br>1. Sensor tat-temperatura żejda 2. Id-differenza fit-temperatura taqbeż l-allarm tal-limitu<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Stadju ta &#039;insulazzjoni (Żomm it-temperatura tal-kabinett)<\/td><\/tr><tr><td rowspan=\"2\">Numru tas-serje<\/td><td colspan=\"3\">Kontenut potenzjalment riskjuż<\/td><td colspan=\"5\">Valutazzjoni tar-riskju taħt kundizzjonijiet ta&#039; proċess eżistenti<\/td><td colspan=\"5\">Valutazzjoni tar-riskju tar-riżultati wara li jittieħdu miżuri<\/td><td rowspan=\"2\">Azzjonijiet Rakkomandati<\/td><td rowspan=\"2\">Responsabbiltajiet u status attwali<\/td><\/tr><tr><td>Isem tal-ħsara<\/td><td>Kawża<\/td><td>Impatt tal-falliment<\/td><td>Kontroll Issa<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><td>Ħu azzjoni<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><\/tr><tr><td rowspan=\"3\">1<\/td><td rowspan=\"3\">It-temperatura tal-kaxxa hija aktar baxxa mill-valur tal-limitu aktar baxx<\/td><td>Ħsara tal-pompa taċ-ċirkolazzjoni tal-ilma sħun<\/td><td>Iċ-ċiklu jissakkar fi stadju wieħed sakemm jiġi restawrat u jerġa &#039;jibda wara perjodu ta&#039; standby. Lottijiet li qabżu ċ-ċiklu kwalifikat jistgħu jerġgħu jiġu sterilizzati.<\/td><td>1. Allarm ta &#039;timeout tat-tisħin 2. Allarm ta&#039; tagħbija żejda tal-pompa tal-ilma li tiċċirkola<\/td><td>5<\/td><td>3<\/td><td>2<\/td><td>30<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Falliment tat-tubu tat-tisħin elettriku<\/td><td>Iċ-ċiklu jissakkar fi stadju wieħed sakemm jiġi restawrat u jerġa &#039;jibda wara perjodu ta&#039; standby. Lottijiet li qabżu ċ-ċiklu kwalifikat jistgħu jerġgħu jiġu sterilizzati.<\/td><td>1. Allarm ta &#039;timeout tat-tisħin<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Ħsara tas-sensorju tat-temperatura<\/td><td>Jaffettwa l-isterilità tal-prodott (sterilizzazzjoni mill-ġdid)<\/td><td>1. Allarm ta &#039;timeout tat-tisħin 2. Allarm ta&#039; tagħbija żejda tal-pompa tal-ilma li tiċċirkola<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><tr><td>2<\/td><td>It-temperatura ġewwa l-kabinett hija għolja wisq<\/td><td>Ħsara tas-sensorju tat-temperatura<\/td><td>Jaffettwa l-isterilità tal-prodott (sterilizzazzjoni mill-ġdid)<\/td><td>1. Allarm ta &#039;timeout tat-tisħin 2. Allarm ta&#039; tagħbija żejda tal-pompa tal-ilma li tiċċirkola<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><tr><td>3<\/td><td>Nuqqas ta’ ħin<\/td><td>Żbalji ta&#039; Programmazzjoni<\/td><td>Irrepeti l-isterilizzazzjoni<\/td><td>1. Spezzjoni taċ-ċiklu awtomatiku<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><td>xejn<\/td><td><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Stadju ta &#039;qabel il-vakwu (It-tneħħija ta&#039; l-arja mill-kamra tippermetti li l-proċess jipproċedi taħt il-limitu tal-fjammabbiltà EO)<\/td><\/tr><tr><td rowspan=\"2\">Numru tas-serje<\/td><td colspan=\"3\">Kontenut potenzjalment riskjuż<\/td><td colspan=\"5\">Valutazzjoni tar-riskju taħt kundizzjonijiet ta&#039; proċess eżistenti<\/td><td colspan=\"5\">Valutazzjoni tar-riskju tar-riżultati wara li jittieħdu miżuri<\/td><td rowspan=\"2\">Azzjonijiet Rakkomandati<\/td><td rowspan=\"2\">Responsabbiltajiet u status attwali<\/td><\/tr><tr><td>Isem tal-ħsara<\/td><td>Kawża<\/td><td>Impatt tal-falliment<\/td><td>Kontroll Issa<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><td>Ħu azzjoni<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><\/tr><tr><td rowspan=\"3\">1<\/td><td rowspan=\"3\">Mhux biżżejjed arja mneħħija<\/td><td>Effiċjenza baxxa tal-pompa tal-vakwu<\/td><td>Iċ-ċiklu jissakkar f&#039;fażi waħda sakemm jiġi restawrat u jerġa&#039; jibda wara perjodu ta&#039; standby<\/td><td>1. Allarm ta &#039;qabel il-limitu tal-ħin tal-vakwu 2. Allarm ta&#039; tagħbija żejda tal-pompa tal-vakwu 3. Issib awtomatikament il-fluss tal-ilma u agħlaq il-pompa bla ilma<\/td><td>5<\/td><td>3<\/td><td>2<\/td><td>30<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Valv ħażin<\/td><td>Iċ-ċiklu jissakkar f&#039;fażi waħda sakemm jiġi restawrat u jerġa&#039; jibda wara perjodu ta&#039; standby<\/td><td>1. Allarm ta &#039;qabel il-limitu tal-ħin tal-vakwu 2. Allarm ta&#039; tagħbija żejda tal-pompa tal-vakwu<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Ħsara tas-sensorju tal-pressjoni<\/td><td>Periklu ta&#039; Żona Fjammjabbli<\/td><td>1. Sensor tal-pressjoni żejda 2. Allarm meta d-differenza tal-pressjoni taqbeż il-limitu<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><tr><td>2<\/td><td>Wisq vakwu<\/td><td>Ħsara tas-sensorju tal-pressjoni<\/td><td>Product and\/or packaging damage (classification)<\/td><td>1. Sensor tal-pressjoni żejda 2. L-allarm tad-differenza tal-pressjoni jinħareġ meta d-differenza tal-pressjoni tkun akbar minn 1kpa.<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Stadju ta &#039;skoperta ta&#039; tnixxija (Iċċekkja l-issikkar tal-kaxxa)<\/td><\/tr><tr><td rowspan=\"2\">Numru tas-serje<\/td><td colspan=\"3\">Kontenut potenzjalment riskjuż<\/td><td colspan=\"5\">Valutazzjoni tar-riskju taħt kundizzjonijiet ta&#039; proċess eżistenti<\/td><td colspan=\"5\">Valutazzjoni tar-riskju tar-riżultati wara li jittieħdu miżuri<\/td><td rowspan=\"2\">Azzjonijiet Rakkomandati<\/td><td rowspan=\"2\">Responsabbiltajiet u status attwali<\/td><\/tr><tr><td>Isem tal-ħsara<\/td><td>Kawża<\/td><td>Impatt tal-falliment<\/td><td>Kontroll Issa<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><td>Ħu azzjoni<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><\/tr><tr><td rowspan=\"3\">1<\/td><td rowspan=\"3\">Tnixxija tal-kabinett<\/td><td>Tnixxija tal-gasket<\/td><td>L-ebda impatt<\/td><td>1. Allarm ta &#039;falliment tat-test tan-nixxija 2. Il-proċess jintemm<\/td><td>10<\/td><td>5<\/td><td>2<\/td><td>100<\/td><td>1. Manutenzjoni preventiva<\/td><td>3<\/td><td>5<\/td><td>2<\/td><td>30<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Tnixxija tal-valv<\/td><td>L-ebda impatt<\/td><td>1. Allarm ta &#039;falliment tat-test tan-nixxija<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Tnixxija tal-kanal tal-arja tas-sistema taċ-ċirkolazzjoni<\/td><td>L-ebda impatt<\/td><td>1. Allarm ta &#039;falliment tat-test tan-nixxija<\/td><td>4<\/td><td>3<\/td><td>2<\/td><td>24<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Stadju ta &#039;sostituzzjoni tan-nitroġenu (Imla l-kamra b&#039;gass inert biex tissostitwixxi l-ossiġnu)<\/td><\/tr><tr><td rowspan=\"2\">Numru tas-serje<\/td><td colspan=\"3\">Kontenut potenzjalment riskjuż<\/td><td colspan=\"5\">Valutazzjoni tar-riskju taħt kundizzjonijiet ta&#039; proċess eżistenti<\/td><td colspan=\"5\">Valutazzjoni tar-riskju tar-riżultati wara li jittieħdu miżuri<\/td><td rowspan=\"2\">Azzjonijiet Rakkomandati<\/td><td rowspan=\"2\">Responsabbiltajiet u status attwali<\/td><\/tr><tr><td>Isem tal-ħsara<\/td><td>Kawża<\/td><td>Impatt tal-falliment<\/td><td>Kontroll Issa<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><td>Ħu azzjoni<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><\/tr><tr><td rowspan=\"3\">1<\/td><td rowspan=\"3\">Mhux biżżejjed nitroġenu jidħol fil-kamra<\/td><td>Nitroġenu insuffiċjenti<\/td><td>Iċ-ċiklu jissakkar f&#039;fażi waħda sakemm jiġi restawrat u jerġa&#039; jibda wara perjodu ta&#039; standby<\/td><td>Tmiem tal-proċess<\/td><td>3<\/td><td>3<\/td><td>2<\/td><td>18<\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><td>N\/A<\/td><td><\/td><\/tr><tr><td>Valv difettuż<\/td><td>Iċ-ċiklu jissakkar f&#039;fażi waħda sakemm jiġi restawrat u jerġa&#039; jibda wara perjodu ta&#039; standby<\/td><td>N\/A<\/td><td>6<\/td><td>3<\/td><td>3<\/td><td>54<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>3<\/td><td>18<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Ħsara tas-sensorju tal-pressjoni<\/td><td>Periklu ta&#039; Żona Fjammjabbli<\/td><td>1. Sensor tal-pressjoni żejda 2. Allarm meta d-differenza tal-pressjoni taqbeż il-limitu<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td rowspan=\"2\">2<\/td><td rowspan=\"2\">Wisq nitroġenu fil-bieb tal-kabinett<\/td><td>Valv difettuż<\/td><td>Il-konċentrazzjoni tal-EO hija inqas mill-valur validat minħabba li waqt l-injezzjoni tal-EO, jekk tkun ikkontrollata bi pressjoni (risterilizzazzjoni), jiġi injettat N2 addizzjonali<\/td><td>1. Allarm ta &#039;vultaġġ għoli ta&#039; ġewwa 2. Tmiem tal-proċess<\/td><td>6<\/td><td>5<\/td><td>4<\/td><td>120<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>5<\/td><td>4<\/td><td>40<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Falliment tat-trasmettitur tal-pressjoni<\/td><td>Wisq gass EO injettat. Residwu għoli ta &#039;EO. Ħin estiż tad-degassing me)<\/td><td>1. Sensor tal-pressjoni żejda 2. Allarm meta d-differenza tal-pressjoni taqbeż il-limitu<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><tr><td>3<\/td><td>It-temperatura tal-kabinett hija ogħla mil-limitu ta &#039;fuq t<\/td><td><\/td><td>Impatt fuq il-funzjoni tal-prodott (issortjar)<\/td><td>1. Sensor tal-pressjoni żejda 2. Allarm meta d-differenza tal-pressjoni taqbeż il-limitu<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><tr><td rowspan=\"4\">4<\/td><td rowspan=\"4\">It-temperatura tal-kaxxa hija aktar baxxa mill-valur tal-limitu aktar baxx<\/td><td>Ħsara tal-pompa taċ-ċirkolazzjoni tal-ilma sħun<\/td><td>Iċ-ċiklu jissakkar fi stadju wieħed sakemm jiġi restawrat u jerġa &#039;jibda wara perjodu ta&#039; standby. Lottijiet li qabżu ċ-ċiklu kwalifikat jistgħu jerġgħu jiġu sterilizzati.<\/td><td>1. Allarm ta&#039; timeout tat-tisħin 2. Allarm ta&#039; tagħbija żejda tal-pompa tal-ilma li tiċċirkola 3. Kumpens awtomatiku tal-ħin tat-tisħin<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Falliment tat-tubu tat-tisħin elettriku<\/td><td>Iċ-ċiklu jissakkar fi stadju wieħed sakemm jiġi restawrat u jerġa &#039;jibda wara perjodu ta&#039; standby. Lottijiet li qabżu ċ-ċiklu kwalifikat jistgħu jerġgħu jiġu sterilizzati.<\/td><td>1. Allarm ta &#039;timeout tat-tisħin 2. Kumpens awtomatiku tal-ħin tat-tisħin<\/td><td>6<\/td><td>3<\/td><td>3<\/td><td>54<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>3<\/td><td>18<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Ħsara tas-sensorju tat-temperatura<\/td><td>Jaffettwa l-isterilità tal-prodott (sterilizzazzjoni mill-ġdid)<\/td><td>1. Sensor tat-temperatura żejda 2. Id-differenza fit-temperatura taqbeż l-allarm tal-limitu<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><tr><td>Temperatura baxxa tal-karburatur<\/td><td>Jaffettwa l-isterilità tal-prodott (sterilizzazzjoni mill-ġdid)<\/td><td>1. Allarm meta t-temperatura tal-karburatur tkun aktar baxxa mil-limitu 2. Kumpens awtomatiku tal-ħin tat-tisħin<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Stadju ta &#039;umidifikazzjoni (Żieda fl-umdità tat-tagħbija billi tinjetta fwar)<\/td><\/tr><tr><td rowspan=\"2\">Numru tas-serje<\/td><td colspan=\"3\">Kontenut potenzjalment riskjuż<\/td><td colspan=\"5\">Valutazzjoni tar-riskju taħt kundizzjonijiet ta&#039; proċess eżistenti<\/td><td colspan=\"5\">Valutazzjoni tar-riskju tar-riżultati wara li jittieħdu miżuri<\/td><td rowspan=\"2\">Azzjonijiet Rakkomandati<\/td><td rowspan=\"2\">Responsabbiltajiet u status attwali<\/td><\/tr><tr><td>Isem tal-ħsara<\/td><td>Kawża<\/td><td>Impatt tal-falliment<\/td><td>Kontroll Issa<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><td>Ħu azzjoni<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><\/tr><tr><td rowspan=\"4\">1<\/td><td rowspan=\"4\">Fwar insuffiċjenti<\/td><td>Ħsara tal-ġeneratur tal-fwar<\/td><td>Jaffettwa l-isterilità tal-prodott (sterilizzazzjoni mill-ġdid)<\/td><td>1. Allarm meta l-pressjoni tal-fwar tkun aktar baxxa mil-limitu<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Falliment tal-valv<\/td><td>Iċ-ċiklu jissakkar f&#039;fażi waħda sakemm jiġi restawrat u jerġa&#039; jibda wara perjodu ta&#039; standby<\/td><td>1.Allarm tal-limitu tal-frekwenza tal-umidifikazzjoni<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Pressure transmitter\/humidity sensor failure<\/td><td>Jaffettwa l-isterilità tal-prodott (sterilizzazzjoni mill-ġdid)<\/td><td>1. Redundant pressure\/humidity sensor 2. Alarm when pressure\/humidity difference exceeds limit<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><tr><td>Filtru misdud<\/td><td>Iċ-ċiklu jissakkar f&#039;fażi waħda sakemm jiġi restawrat u jerġa&#039; jibda wara perjodu ta&#039; standby<\/td><td>1.Allarm tal-limitu tal-frekwenza tal-umidifikazzjoni<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td rowspan=\"2\">2<\/td><td rowspan=\"2\">Wisq injezzjoni tal-fwar<\/td><td>Valv difettuż<\/td><td>Injezzjoni tal-fwar eċċessiv, kartun imxarrab (għażla)<\/td><td>1. Allarm ta &#039;vultaġġ għoli ta&#039; ġewwa 2. Tmiem tal-proċess<\/td><td>6<\/td><td>5<\/td><td>4<\/td><td>120<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>5<\/td><td>4<\/td><td>40<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Pressure transmitter\/humidity sensor failure<\/td><td>Injezzjoni tal-fwar eċċessiv, kartun imxarrab (għażla)<\/td><td>1. Sensor tal-pressjoni żejda 2. Allarm meta d-differenza tal-pressjoni taqbeż il-limitu<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><tr><td>3<\/td><td>It-temperatura hija għolja wisq<\/td><td>Ħsara tas-sensorju tat-temperatura<\/td><td>Impatt fuq il-funzjonijiet tal-prodott (klassifikazzjoni)<\/td><td>1. Sensor tal-pressjoni żejda 2. Allarm meta d-differenza tal-pressjoni taqbeż il-limitu<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><tr><td rowspan=\"3\">4<\/td><td rowspan=\"3\">It-temperatura tal-kaxxa hija aktar baxxa mill-valur tal-limitu aktar baxx<\/td><td>Ħsara tal-pompa taċ-ċirkolazzjoni tal-ilma sħun<\/td><td>Iċ-ċiklu jissakkar f&#039;fażi waħda sakemm jiġi restawrat u jerġa&#039; jibda wara perjodu ta&#039; standby<\/td><td>1. Allarm ta&#039; timeout tat-tisħin 2. Allarm ta&#039; tagħbija żejda tal-pompa tal-ilma li tiċċirkola 3. Kumpens awtomatiku tal-ħin tat-tisħin<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Falliment tat-tubu tat-tisħin elettriku<\/td><td>Iċ-ċiklu jissakkar f&#039;fażi waħda sakemm jiġi restawrat u jerġa&#039; jibda wara perjodu ta&#039; standby<\/td><td>1. Allarm ta &#039;timeout tat-tisħin 2. Kumpens awtomatiku tal-ħin tat-tisħin<\/td><td>6<\/td><td>3<\/td><td>3<\/td><td>54<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>3<\/td><td>18<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Ħsara tas-sensorju tat-temperatura<\/td><td>Jaffettwa l-isterilità tal-prodott (sterilizzazzjoni mill-ġdid)<\/td><td>1. Allarm ta &#039;timeout tat-tisħin 2. Allarm ta&#039; tagħbija żejda tal-pompa tal-ilma li tiċċirkola<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Fażi ta&#039; waqfa ta&#039; umidifikazzjoni (umdità bilanċjata)<\/td><\/tr><tr><td rowspan=\"2\">Numru tas-serje<\/td><td colspan=\"3\">Kontenut potenzjalment riskjuż<\/td><td colspan=\"5\">Valutazzjoni tar-riskju taħt kundizzjonijiet ta&#039; proċess eżistenti<\/td><td colspan=\"5\">Valutazzjoni tar-riskju tar-riżultati wara li jittieħdu miżuri<\/td><td rowspan=\"2\">Azzjonijiet Rakkomandati<\/td><td rowspan=\"2\">Responsabbiltajiet u status attwali<\/td><\/tr><tr><td>Isem tal-ħsara<\/td><td>Kawża<\/td><td>Impatt tal-falliment<\/td><td>Kontroll Issa<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><td>Ħu azzjoni<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><\/tr><tr><td>1<\/td><td>Nuqqas ta’ ħin<\/td><td>ħin barra<\/td><td>Jaffettwa l-isterilità tal-prodott (sterilizzazzjoni mill-ġdid)<\/td><td>1. Spezzjoni taċ-ċiklu awtomatiku<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Manutenzjoni preventiva<\/td><td>1<\/td><td>5<\/td><td>2<\/td><td>10<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Stadju tal-kuxxin tan-nitroġenu (Imla l-kamra b&#039;gass inert biex tħallat l-ossiġnu)<\/td><\/tr><tr><td rowspan=\"2\">Numru tas-serje<\/td><td colspan=\"3\">Kontenut potenzjalment riskjuż<\/td><td colspan=\"5\">Valutazzjoni tar-riskju taħt kundizzjonijiet ta&#039; proċess eżistenti<\/td><td colspan=\"5\">Valutazzjoni tar-riskju tar-riżultati wara li jittieħdu miżuri<\/td><td rowspan=\"2\">Azzjonijiet Rakkomandati<\/td><td rowspan=\"2\">Responsabbiltajiet u status attwali<\/td><\/tr><tr><td>Isem tal-ħsara<\/td><td>Kawża<\/td><td>Impatt tal-falliment<\/td><td>Kontroll Issa<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><td>Ħu azzjoni<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><\/tr><tr><td rowspan=\"3\">1<\/td><td rowspan=\"3\">Mhux biżżejjed nitroġenu jidħol fil-kabinett<\/td><td>Nuqqas ta &#039;nitroġenu<\/td><td>Iċ-ċiklu jissakkar f&#039;fażi waħda sakemm jiġi restawrat u jerġa&#039; jibda wara perjodu ta&#039; standby<\/td><td>1. Iċċekkja l-pressjoni N2 qabel tibda ċ-ċiklu 2. Allarm meta l-pressjoni N2 tkun inqas mil-limitu<\/td><td>3<\/td><td>3<\/td><td>2<\/td><td>18<\/td><td><\/td><td><\/td><td><\/td><td><\/td><td>0<\/td><td><\/td><td><\/td><\/tr><tr><td>Falliment tal-valv<\/td><td>Iċ-ċiklu jissakkar f&#039;fażi waħda sakemm jiġi restawrat u jerġa&#039; jibda wara perjodu ta&#039; standby<\/td><td>xejn<\/td><td>6<\/td><td>3<\/td><td>3<\/td><td>54<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>3<\/td><td>18<\/td><td>utent<\/td><td>1. Manutenzjoni preventiva<\/td><\/tr><tr><td>Ħsara tas-sensorju tal-pressjoni<\/td><td>Periklu ta&#039; Żona Fjammjabbli<\/td><td>1. Sensor tal-pressjoni żejda 2. Allarm meta d-differenza tal-pressjoni taqbeż il-limitu<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>utent<\/td><td>1. Manutenzjoni preventiva<\/td><\/tr><tr><td rowspan=\"2\">2<\/td><td rowspan=\"2\">Wisq nitroġenu injettat fil-kabinett<\/td><td>Valv difettuż<\/td><td>Il-konċentrazzjoni tal-EO hija inqas mill-valur validat minħabba li waqt l-injezzjoni tal-EO, jekk tkun ikkontrollata bi pressjoni (risterilizzazzjoni), jiġi injettat N2 addizzjonali<\/td><td>1. Allarm ta &#039;vultaġġ għoli ta&#039; ġewwa 2. Tmiem tal-proċess<\/td><td>6<\/td><td>5<\/td><td>4<\/td><td>120<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>5<\/td><td>4<\/td><td>40<\/td><td>utent<\/td><td>1. Manutenzjoni preventiva<\/td><\/tr><tr><td>Falliment tat-trasmettitur tal-pressjoni<\/td><td>Wisq gass EO injettat. Residwu għoli ta &#039;EO. (Estendi l-ħin tad-degass)<\/td><td>1. Sensor tal-pressjoni żejda 2. Allarm meta d-differenza tal-pressjoni taqbeż il-limitu<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>utent<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><\/tr><tr><td>3<\/td><td>It-temperatura ġewwa l-kabinett taqbeż il-limitu ta &#039;fuq<\/td><td>Ħsara tas-sensorju tat-temperatura<\/td><td>Impatt fuq il-funzjoni tal-prodott (issortjar)<\/td><td>1. Sensor tal-pressjoni żejda 2. Allarm meta d-differenza tal-pressjoni taqbeż il-limitu<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>utent<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><\/tr><tr><td rowspan=\"4\">4<\/td><td rowspan=\"4\">It-temperatura tal-kaxxa hija aktar baxxa mill-valur tal-limitu aktar baxx<\/td><td>Ħsara tal-pompa taċ-ċirkolazzjoni tal-ilma sħun<\/td><td>Iċ-ċiklu jissakkar fi stadju wieħed sakemm jiġi restawrat u jerġa &#039;jibda wara perjodu ta&#039; standby. Lottijiet li qabżu ċ-ċiklu kwalifikat jistgħu jerġgħu jiġu sterilizzati.<\/td><td>1. Allarm ta&#039; timeout tat-tisħin 2. Allarm ta&#039; tagħbija żejda tal-pompa tal-ilma li tiċċirkola 3. Kumpens awtomatiku tal-ħin tat-tisħin<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>utent<\/td><td>1. Manutenzjoni preventiva<\/td><\/tr><tr><td>Falliment tat-tubu tat-tisħin elettriku<\/td><td>Iċ-ċiklu jissakkar fi stadju wieħed sakemm jiġi restawrat u jerġa &#039;jibda wara perjodu ta&#039; standby. Lottijiet li qabżu ċ-ċiklu kwalifikat jistgħu jerġgħu jiġu sterilizzati.<\/td><td>1. Allarm ta&#039; timeout tat-tisħin 2. Allarm ta&#039; tagħbija żejda tal-pompa tal-ilma li tiċċirkola 3. Kumpens awtomatiku tal-ħin tat-tisħin<\/td><td>6<\/td><td>3<\/td><td>3<\/td><td>54<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>3<\/td><td>18<\/td><td>utent<\/td><td>1. Manutenzjoni preventiva<\/td><\/tr><tr><td>Ħsara tas-sensorju tat-temperatura<\/td><td>Jaffettwa l-isterilità tal-prodott (sterilizzazzjoni mill-ġdid)<\/td><td>1. Sensor tat-temperatura żejda 2. Id-differenza fit-temperatura taqbeż l-allarm tal-limitu<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>utent<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><\/tr><tr><td>Temperatura baxxa tal-karburatur<\/td><td>Jaffettwa l-isterilità tal-prodott (sterilizzazzjoni mill-ġdid)<\/td><td>1. Allarm meta t-temperatura tal-karburatur tkun aktar baxxa mil-limitu 2. Kumpens awtomatiku tal-ħin tat-tisħin<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>utent<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Stadju ta &#039;injezzjoni EO (Imla l-kabinett bil-gass EO)<\/td><\/tr><tr><td rowspan=\"2\">Numru tas-serje<\/td><td colspan=\"3\">Kontenut potenzjalment riskjuż<\/td><td colspan=\"5\">Valutazzjoni tar-riskju taħt kundizzjonijiet ta&#039; proċess eżistenti<\/td><td colspan=\"5\">Valutazzjoni tar-riskju tar-riżultati wara li jittieħdu miżuri<\/td><td rowspan=\"2\">Azzjonijiet Rakkomandati<\/td><td rowspan=\"2\">Responsabbiltajiet u status attwali<\/td><\/tr><tr><td>Isem tal-ħsara<\/td><td>Kawża<\/td><td>Impatt tal-falliment<\/td><td>Kontroll Issa<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><td>Ħu azzjoni<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><\/tr><tr><td rowspan=\"4\">1<\/td><td rowspan=\"4\">Mhux biżżejjed ossidu tal-etilene qed jidħol fil-kabinett<\/td><td>EO nieqsa<\/td><td>Iċ-ċiklu jissakkar fi stadju wieħed sakemm jiġi restawrat u jerġa &#039;jibda wara perjodu ta&#039; standby. Lottijiet li qabżu ċ-ċiklu kwalifikat jistgħu jerġgħu jiġu sterilizzati.<\/td><td>1.EO allarm ta &#039;toqba taċ-ċilindru 2.EO allarm ta&#039; timeout ta &#039;injezzjoni<\/td><td>10<\/td><td>5<\/td><td>2<\/td><td>100<\/td><td>1. Taħriġ tal-operatur 2. Kontroll tal-piż tal-EO qabel il-bidu taċ-ċiklu<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Taħriġ tal-operatur 2. Kontroll tal-piż tal-EO qabel il-bidu taċ-ċiklu<\/td><td>utent<\/td><\/tr><tr><td>Valv difettuż<\/td><td>Iċ-ċiklu jissakkar f&#039;fażi waħda sakemm jiġi restawrat u jerġa&#039; jibda wara perjodu ta&#039; standby<\/td><td>1.EO allarm timeout ta &#039;injezzjoni<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Manutenzjoni preventiva<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Tnixxija tal-pipeline EO<\/td><td>Lottijiet li jaqbżu l-perjodu ta&#039; kwalifika jistgħu jerġgħu jiġu sterilizzati<\/td><td>xejn<\/td><td>6<\/td><td>5<\/td><td>3<\/td><td>90<\/td><td>1. Manutenzjoni preventiva 2. Allarm tad-ditekter LEL EO<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Manutenzjoni preventiva 2. Allarm tad-ditekter LEL EO<\/td><td>utent<\/td><\/tr><tr><td>Ħsara tas-sensorju tal-pressjoni<\/td><td>Il-konċentrazzjoni tal-EO hija aktar baxxa mill-valur tal-validazzjoni (sterilizzazzjoni mill-ġdid)<\/td><td>1. Sensor tal-pressjoni żejda 2. Allarm meta d-differenza tal-pressjoni taqbeż il-limitu<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><tr><td rowspan=\"2\">2<\/td><td rowspan=\"2\">L-EO likwidu jidħol fil-kabinett<\/td><td>Temperatura baxxa tal-karburatur<\/td><td>Iċ-ċiklu jissakkar f&#039;fażi waħda sakemm jiġi restawrat u jerġa&#039; jibda wara perjodu ta&#039; standby<\/td><td>1. It-temperatura tal-karburatur hija aktar baxxa mill-allarm tal-limitu<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Mhux biżżejjed ilma fil-karburatur minħabba valv difettuż<\/td><td>Iċ-ċiklu jissakkar f&#039;fażi waħda sakemm jiġi restawrat u jerġa&#039; jibda wara perjodu ta&#039; standby<\/td><td>1. Il-livell tal-ilma tal-karburatur huwa aktar baxx mill-allarm tal-limitu<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td rowspan=\"2\">3<\/td><td rowspan=\"2\">Wisq input ta &#039;l-ossidu ta&#039; l-etilene fil-kabinett<\/td><td>Valv difettuż<\/td><td>Kwarantina itwal, li teħtieġ testijiet addizzjonali<\/td><td>1. Allarm ta &#039;vultaġġ għoli ta&#039; ġewwa<\/td><td>6<\/td><td>3<\/td><td>3<\/td><td>54<\/td><td>1. Manutenzjoni preventiva 2. Spezzjoni residwa EO<\/td><td>2<\/td><td>3<\/td><td>3<\/td><td>18<\/td><td>1. Manutenzjoni preventiva 2. Spezzjoni residwa EO<\/td><td>utent<\/td><\/tr><tr><td>Ħsara tas-sensorju tal-pressjoni<\/td><td>Kwarantina itwal, li teħtieġ testijiet addizzjonali<\/td><td>1. Sensor tal-pressjoni żejda 2. Allarm meta d-differenza tal-pressjoni taqbeż il-limitu<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><tr><td>4<\/td><td>It-temperatura ġewwa l-kabinett taqbeż il-limitu ta &#039;fuq<\/td><td>Ħsara tas-sensorju tat-temperatura<\/td><td>Impatt fuq il-funzjoni tal-prodott (issortjar)<\/td><td>1. Sensor tat-temperatura żejda 2. Allarme ta &#039;temperatura għolja tal-kamra 3. Id-differenza fit-temperatura taqbeż l-allarm tal-limitu<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><tr><td rowspan=\"4\">5<\/td><td rowspan=\"4\">It-temperatura tal-kaxxa hija aktar baxxa mill-valur tal-limitu aktar baxx<\/td><td>Ħsara tal-pompa taċ-ċirkolazzjoni tal-ilma sħun<\/td><td>Iċ-ċiklu jissakkar fi stadju wieħed sakemm jiġi restawrat u jerġa &#039;jibda wara perjodu ta&#039; standby. Lottijiet li qabżu ċ-ċiklu kwalifikat jistgħu jerġgħu jiġu sterilizzati.<\/td><td>1. Allarm ta&#039; timeout tat-tisħin 2. Allarm ta&#039; tagħbija żejda tal-pompa tal-ilma li tiċċirkola 3. Kumpens awtomatiku tal-ħin tat-tisħin<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Falliment tat-tubu tat-tisħin elettriku<\/td><td>Iċ-ċiklu jissakkar fi stadju wieħed sakemm jiġi restawrat u jerġa &#039;jibda wara perjodu ta&#039; standby. Lottijiet li qabżu ċ-ċiklu kwalifikat jistgħu jerġgħu jiġu sterilizzati.<\/td><td>1. Allarm ta &#039;timeout tat-tisħin 2. Kumpens awtomatiku tal-ħin tat-tisħin<\/td><td>6<\/td><td>3<\/td><td>3<\/td><td>54<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>3<\/td><td>18<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Ħsara tas-sensorju tat-temperatura<\/td><td>Jaffettwa l-isterilità tal-prodott (sterilizzazzjoni mill-ġdid)<\/td><td>1. Sensor tat-temperatura żejda 2. Id-differenza fit-temperatura taqbeż l-allarm tal-limitu<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><tr><td>Temperatura baxxa tal-karburatur<\/td><td>Jaffettwa l-isterilità tal-prodott (sterilizzazzjoni mill-ġdid)<\/td><td>1. Allarm meta t-temperatura tal-karburatur tkun aktar baxxa mil-limitu 2. Kumpens awtomatiku tal-ħin tat-tisħin<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Stadju tal-kappa tan-nitroġenu (Żid N2 biex tkopri l-EO)<\/td><\/tr><tr><td rowspan=\"2\">Numru tas-serje<\/td><td colspan=\"3\">Kontenut potenzjalment riskjuż<\/td><td colspan=\"5\">Valutazzjoni tar-riskju taħt kundizzjonijiet ta&#039; proċess eżistenti<\/td><td colspan=\"5\">Valutazzjoni tar-riskju tar-riżultati wara li jittieħdu miżuri<\/td><td rowspan=\"2\">Azzjonijiet Rakkomandati<\/td><td rowspan=\"2\">Responsabbiltajiet u status attwali<\/td><\/tr><tr><td>Isem tal-ħsara<\/td><td>Kawża<\/td><td>Impatt tal-falliment<\/td><td>Kontroll Issa<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><td>Ħu azzjoni<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><\/tr><tr><td rowspan=\"3\">1<\/td><td rowspan=\"3\">Mhux biżżejjed nitroġenu jidħol fil-kabinett<\/td><td>Nuqqas ta &#039;nitroġenu<\/td><td>Iċ-ċiklu jissakkar f&#039;fażi waħda sakemm jiġi restawrat u jerġa&#039; jibda wara perjodu ta&#039; standby<\/td><td>1. Iċċekkja l-pressjoni N2 qabel tibda ċ-ċiklu 2. Allarm meta l-pressjoni N2 tkun inqas mil-limitu<\/td><td>3<\/td><td>3<\/td><td>2<\/td><td>18<\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><td>N\/A<\/td><td><\/td><\/tr><tr><td>Falliment tal-valv<\/td><td>Iċ-ċiklu jissakkar f&#039;fażi waħda sakemm jiġi restawrat u jerġa&#039; jibda wara perjodu ta&#039; standby<\/td><td>xejn<\/td><td>6<\/td><td>3<\/td><td>3<\/td><td>54<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>3<\/td><td>18<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Ħsara tas-sensorju tal-pressjoni<\/td><td>Periklu ta&#039; Żona Fjammjabbli<\/td><td>1. Sensor tal-pressjoni żejda 2. Allarm meta d-differenza tal-pressjoni taqbeż il-limitu<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>2<\/td><td>Wisq nitroġenu injettat fil-kabinett<\/td><td>Valv difettuż<\/td><td>Il-kabina tinsab taħt pressjoni pożittiva. Dan iċ-ċiklu se jispiċċa.<\/td><td>1. Allarm ta &#039;vultaġġ għoli ta&#039; ġewwa 2. Tmiem tal-proċess<\/td><td>6<\/td><td>5<\/td><td>4<\/td><td>120<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>5<\/td><td>4<\/td><td>40<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>3<\/td><td>It-temperatura ġewwa l-kabinett taqbeż il-limitu ta &#039;fuq<\/td><td>Ħsara tas-sensorju tat-temperatura<\/td><td>Jaffettwa l-isterilità tal-prodott (sterilizzazzjoni mill-ġdid)<\/td><td>1. Sensor tat-temperatura żejda 2. Allarme ta &#039;temperatura għolja tal-kamra 3. Id-differenza fit-temperatura taqbeż l-allarm tal-limitu<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><tr><td rowspan=\"4\">4<\/td><td rowspan=\"4\">It-temperatura tal-kaxxa hija aktar baxxa mill-valur tal-limitu aktar baxx<\/td><td>Ħsara tal-pompa taċ-ċirkolazzjoni tal-ilma sħun<\/td><td>Iċ-ċiklu jissakkar fi stadju wieħed sakemm jiġi restawrat u jerġa &#039;jibda wara perjodu ta&#039; standby. Lottijiet li qabżu ċ-ċiklu kwalifikat jistgħu jerġgħu jiġu sterilizzati.<\/td><td>1. Allarm ta&#039; timeout tat-tisħin 2. Allarm ta&#039; tagħbija żejda tal-pompa tal-ilma li tiċċirkola 3. Kumpens awtomatiku tal-ħin tat-tisħin<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Falliment tat-tubu tat-tisħin elettriku<\/td><td>Iċ-ċiklu jissakkar fi stadju wieħed sakemm jiġi restawrat u jerġa &#039;jibda wara perjodu ta&#039; standby. Lottijiet li qabżu ċ-ċiklu kwalifikat jistgħu jerġgħu jiġu sterilizzati.<\/td><td>1. Allarm ta &#039;timeout tat-tisħin 2. Kumpens awtomatiku tal-ħin tat-tisħin<\/td><td>6<\/td><td>3<\/td><td>3<\/td><td>54<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>3<\/td><td>18<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Ħsara tas-sensorju tat-temperatura<\/td><td>Jaffettwa l-isterilità tal-prodott (sterilizzazzjoni mill-ġdid)<\/td><td>1. Sensor tat-temperatura żejda 2. Id-differenza fit-temperatura taqbeż l-allarm tal-limitu<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><tr><td>Temperatura baxxa tal-karburatur<\/td><td>Jaffettwa l-isterilità tal-prodott (sterilizzazzjoni mill-ġdid)<\/td><td>1. Allarm meta t-temperatura tal-karburatur tkun aktar baxxa mil-limitu 2. Kumpens awtomatiku tal-ħin tat-tisħin<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Stadju ta&#039; espożizzjoni EO (Iddiżinfetta l-prodott)<\/td><\/tr><tr><td rowspan=\"2\">Numru tas-serje<\/td><td colspan=\"3\">Kontenut potenzjalment riskjuż<\/td><td colspan=\"5\">Valutazzjoni tar-riskju taħt kundizzjonijiet ta&#039; proċess eżistenti<\/td><td colspan=\"5\">Valutazzjoni tar-riskju tar-riżultati wara li jittieħdu miżuri<\/td><td rowspan=\"2\">Azzjonijiet Rakkomandati<\/td><td rowspan=\"2\">Responsabbiltajiet u status attwali<\/td><\/tr><tr><td>Isem tal-ħsara<\/td><td>Kawża<\/td><td>Impatt tal-falliment<\/td><td>Kontroll Issa<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><td>Ħu azzjoni<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><\/tr><tr><td>1<\/td><td>Nuqqas ta’ ħin<\/td><td>Żbalji ta&#039; Programmazzjoni<\/td><td>Irrepeti l-isterilizzazzjoni<\/td><td>1. Spezzjoni taċ-ċiklu awtomatiku<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Manutenzjoni preventiva<\/td><td>1<\/td><td>5<\/td><td>2<\/td><td>10<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td rowspan=\"3\">2<\/td><td rowspan=\"3\">It-temperatura tal-kaxxa hija aktar baxxa mil-limitu aktar baxx t<\/td><td>Ħsara tal-pompa taċ-ċirkolazzjoni tal-ilma sħun<\/td><td>Iċ-ċiklu jissakkar fi stadju wieħed sakemm jiġi restawrat u jerġa &#039;jibda wara perjodu ta&#039; standby. Lottijiet li qabżu ċ-ċiklu kwalifikat jistgħu jerġgħu jiġu sterilizzati.<\/td><td>Timeout tat-tisħin 2. Allarm ta &#039;tagħbija żejda tal-pompa tal-ilma li tiċċirkola 3. Kumpens awtomatiku tal-ħin tat-tisħin<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Falliment tat-tubu tat-tisħin elettriku<\/td><td>Iċ-ċiklu jissakkar f&#039;fażi waħda sakemm jerġa&#039; jibda u jerġa&#039; jibda wara perjodu ta&#039; standby. Lottijiet li qabżu ċ-ċiklu kwalifikat jistgħu jerġgħu jiġu sterilizzati.<\/td><td>1. Allarm ta &#039;timeout tat-tisħin 2. Kumpens awtomatiku tal-ħin tat-tisħin<\/td><td>6<\/td><td>3<\/td><td>3<\/td><td>54<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>3<\/td><td>18<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Ħsara tas-sensorju tat-temperatura<\/td><td>Jaffettwa l-isterilità tal-prodott (sterilizzazzjoni mill-ġdid)<\/td><td>1. Sensor tat-temperatura żejda 2. Id-differenza fit-temperatura taqbeż l-allarm tal-limitu<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><tr><td>3<\/td><td>It-temperatura ġewwa l-kabinett taqbeż il-limitu ta &#039;fuq<\/td><td>Ħsara tas-sensorju tat-temperatura<\/td><td>Jaffettwa l-isterilità tal-prodott (sterilizzazzjoni mill-ġdid)<\/td><td>1. Sensor tat-temperatura żejda 2. Allarme ta &#039;temperatura għolja tal-kamra 3. Allarm tat-temperatura<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><tr><td rowspan=\"2\">4<\/td><td rowspan=\"2\">Li ma jkollix taħlita EO omoġenja biżżejjed<\/td><td>Ħsara tal-fann taċ-ċirkolazzjoni<\/td><td>Jaffettwa l-isterilità tal-prodott (sterilizzazzjoni mill-ġdid)<\/td><td>1. Allarm ta &#039;veloċità baxxa<\/td><td>6<\/td><td>5<\/td><td>3<\/td><td>90<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>5<\/td><td>3<\/td><td>30<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Pożizzjonament tal-prodott qrib ħafna tal-ħajt tal-kavità<\/td><td>Jaffettwa l-isterilità tal-prodott (sterilizzazzjoni mill-ġdid)<\/td><td>1.Guardrail jintuża biex jipprevjeni l-prodott milli jikkuntattja l-ħajt tal-kavità<\/td><td>2<\/td><td>5<\/td><td>3<\/td><td>30<\/td><td><\/td><td><\/td><td><\/td><td><\/td><td>0<\/td><td>N\/A<\/td><td><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">EO Removal Phase(Create vacuum\/remove sterilization gas)<\/td><\/tr><tr><td rowspan=\"2\">Numru tas-serje<\/td><td colspan=\"3\">Kontenut potenzjalment riskjuż<\/td><td colspan=\"5\">Valutazzjoni tar-riskju taħt kundizzjonijiet ta&#039; proċess eżistenti<\/td><td colspan=\"5\">Valutazzjoni tar-riskju tar-riżultati wara li jittieħdu miżuri<\/td><td rowspan=\"2\">Azzjonijiet Rakkomandati<\/td><td rowspan=\"2\">Responsabbiltajiet u status attwali<\/td><\/tr><tr><td>Isem tal-ħsara<\/td><td>Kawża<\/td><td>Impatt tal-falliment<\/td><td>Kontroll Issa<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><td>Ħu azzjoni<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><\/tr><tr><td rowspan=\"3\">1<\/td><td rowspan=\"3\">Mhux tnaddaf biżżejjed gass<\/td><td>Pompa tal-vakwu ineffiċjenti<\/td><td>Iċ-ċiklu jissakkar f&#039;fażi waħda sakemm jiġi restawrat u jerġa&#039; jibda wara perjodu ta&#039; standby<\/td><td>1.Allarm ta&#039; timeout għat-tneħħija ta&#039; l-EO 2.Allarm ta&#039; tagħbija eċċessiva tal-pompa tal-vakwu 3.Skopri awtomatikament il-fluss tal-ilma u agħlaq il-pompa bla ilma<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Valv difettuż<\/td><td>Iċ-ċiklu jissakkar f&#039;fażi waħda sakemm jiġi restawrat u jerġa&#039; jibda wara perjodu ta&#039; standby<\/td><td>1.Allarm ta &#039;timeout ta&#039; tneħħija ta &#039;EO 2.Allarm ta&#039; tagħbija żejda tal-pompa tal-vakwu<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Ħsara tas-sensorju tal-pressjoni<\/td><td>Ħin itwal ta &#039;iżolament u ttestjar addizzjonali meħtieġa minħabba li qed jitneħħa inqas gass EO<\/td><td>1. Sensor tal-pressjoni żejda 2. Allarm meta d-differenza tal-pressjoni taqbeż il-limitu<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><tr><td>2<\/td><td>Exhaust wisq gass<\/td><td>Ħsara tas-sensorju tal-pressjoni<\/td><td>Product and\/or packaging damage (classification)<\/td><td>1. Sensor tal-pressjoni żejda 2. Allarm meta d-differenza tal-pressjoni taqbeż il-limitu<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Stadju tat-tindif tan-nitroġenu (Iżgura li l-ambjent ta &#039;ġewwa ma jaqbadx)<\/td><\/tr><tr><td rowspan=\"2\">Numru tas-serje<\/td><td colspan=\"3\">Kontenut potenzjalment riskjuż<\/td><td colspan=\"5\">Valutazzjoni tar-riskju taħt kundizzjonijiet ta&#039; proċess eżistenti<\/td><td colspan=\"5\">Valutazzjoni tar-riskju tar-riżultati wara li jittieħdu miżuri<\/td><td rowspan=\"2\">Azzjonijiet Rakkomandati<\/td><td rowspan=\"2\">Responsabbiltajiet u status attwali<\/td><\/tr><tr><td>Isem tal-ħsara<\/td><td>Kawża<\/td><td>Impatt tal-falliment<\/td><td>Kontroll Issa<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><td>Ħu azzjoni<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><\/tr><tr><td rowspan=\"4\">1<\/td><td rowspan=\"4\">Mhux biżżejjed nitroġenu jidħol fil-kamra<\/td><td>Nuqqas ta &#039;nitroġenu<\/td><td>Iċ-ċiklu jissakkar f&#039;fażi waħda sakemm jiġi restawrat u jerġa&#039; jibda wara perjodu ta&#039; standby<\/td><td>1. Iċċekkja l-pressjoni N2 qabel tibda ċ-ċiklu 2. Allarm meta l-pressjoni N2 tkun inqas mil-limitu<\/td><td>3<\/td><td>3<\/td><td>2<\/td><td>18<\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><td>N\/A<\/td><td><\/td><\/tr><tr><td>Valv difettuż<\/td><td>Iċ-ċiklu jissakkar f&#039;fażi waħda sakemm jiġi restawrat u jerġa&#039; jibda wara perjodu ta&#039; standby<\/td><td>xejn<\/td><td>6<\/td><td>3<\/td><td>3<\/td><td>54<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>3<\/td><td>18<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td rowspan=\"2\">Ħsara tas-sensorju tal-pressjoni<\/td><td>Periklu ta&#039; Żona Fjammjabbli<\/td><td>1. Sensor tal-pressjoni żejda 2. Allarm meta d-differenza tal-pressjoni taqbeż il-limitu<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Kwarantini itwal jeħtieġu testijiet addizzjonali<\/td><td>1. Sensor tal-pressjoni żejda 2. Allarm meta d-differenza tal-pressjoni taqbeż il-limitu<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Air cleaning stage(Create vacuum\/remove residual sterilization gas, eliminate residual EO)<\/td><\/tr><tr><td rowspan=\"2\">Numru tas-serje<\/td><td colspan=\"3\">Kontenut potenzjalment riskjuż<\/td><td colspan=\"5\">Valutazzjoni tar-riskju taħt kundizzjonijiet ta&#039; proċess eżistenti<\/td><td colspan=\"5\">Valutazzjoni tar-riskju tar-riżultati wara li jittieħdu miżuri<\/td><td rowspan=\"2\">Azzjonijiet Rakkomandati<\/td><td rowspan=\"2\">Responsabbiltajiet u status attwali<\/td><\/tr><tr><td>Isem tal-ħsara<\/td><td>Kawża<\/td><td>Impatt tal-falliment<\/td><td>Kontroll Issa<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><td>Ħu azzjoni<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><\/tr><tr><td rowspan=\"3\">1<\/td><td rowspan=\"3\">Mhux tnaddaf biżżejjed gass<\/td><td>Pompa tal-vakwu ineffiċjenti<\/td><td>Iċ-ċiklu jissakkar f&#039;fażi waħda sakemm jiġi restawrat u jerġa&#039; jibda wara perjodu ta&#039; standby<\/td><td>1.Allarm ta&#039; timeout għat-tneħħija ta&#039; l-EO 2.Allarm ta&#039; tagħbija eċċessiva tal-pompa tal-vakwu 3.Skopri awtomatikament il-fluss tal-ilma u agħlaq il-pompa bla ilma<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Valv difettuż<\/td><td>Iċ-ċiklu jissakkar f&#039;fażi waħda sakemm jiġi restawrat u jerġa&#039; jibda wara perjodu ta&#039; standby<\/td><td>1.Allarm ta &#039;timeout ta&#039; tneħħija ta &#039;EO 2.Allarm ta&#039; tagħbija żejda tal-pompa tal-vakwu<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Ħsara tas-sensorju tal-pressjoni<\/td><td>Ħin itwal ta &#039;iżolament u ttestjar addizzjonali meħtieġa minħabba li qed jitneħħa inqas gass EO<\/td><td>1. Sensor tal-pressjoni żejda 2. Allarm meta d-differenza tal-pressjoni taqbeż il-limitu<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><tr><td>2<\/td><td>Exhaust wisq gass<\/td><td>Ħsara tas-sensorju tal-pressjoni<\/td><td>Product and\/or packaging damage (classification)<\/td><td>1. Sensor tal-pressjoni żejda 2. Allarm meta d-differenza tal-pressjoni taqbeż il-limitu<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><tr><td rowspan=\"3\">3<\/td><td rowspan=\"3\">Arja insuffiċjenti fil-kabina<\/td><td>Valv difettuż<\/td><td>Iċ-ċiklu jissakkar f&#039;fażi waħda sakemm jiġi restawrat u jerġa&#039; jibda wara perjodu ta&#039; standby<\/td><td>1. Ħin ta &#039;injezzjoni tal-gass fuq l-allarm tal-limitu<\/td><td>6<\/td><td>4<\/td><td>3<\/td><td>72<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>4<\/td><td>3<\/td><td>24<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Filtru misdud<\/td><td>Iċ-ċiklu jissakkar f&#039;fażi waħda sakemm jiġi restawrat u jerġa&#039; jibda wara perjodu ta&#039; standby<\/td><td>1. Ħin ta &#039;injezzjoni tal-gass fuq l-allarm tal-limitu<\/td><td>6<\/td><td>4<\/td><td>3<\/td><td>72<\/td><td>1. Manutenzjoni preventiva<\/td><td>2<\/td><td>4<\/td><td>3<\/td><td>24<\/td><td>1. Manutenzjoni preventiva<\/td><td>utent<\/td><\/tr><tr><td>Ħsara tas-sensorju tal-pressjoni<\/td><td>Kwarantini itwal jeħtieġu testijiet addizzjonali<\/td><td>1. Sensor tal-pressjoni żejda 2. Allarm meta d-differenza tal-pressjoni taqbeż il-limitu<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Manutenzjoni preventiva 2. Kalibrazzjoni<\/td><td>utent<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Stadju tat-tneħħija (Neħħi r-residwu mill-prodott)<\/td><\/tr><tr><td rowspan=\"2\">Numru tas-serje<\/td><td colspan=\"3\">Kontenut potenzjalment riskjuż<\/td><td colspan=\"5\">Valutazzjoni tar-riskju taħt kundizzjonijiet ta&#039; proċess eżistenti<\/td><td colspan=\"5\">Valutazzjoni tar-riskju tar-riżultati wara li jittieħdu miżuri<\/td><td rowspan=\"2\">Azzjonijiet Rakkomandati<\/td><td rowspan=\"2\">Responsabbiltajiet u status attwali<\/td><\/tr><tr><td>Isem tal-ħsara<\/td><td>Kawża<\/td><td>Impatt tal-falliment<\/td><td>Kontroll Issa<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><td>Ħu azzjoni<\/td><td>avveniment<\/td><td>Severità<\/td><td>teżamina<\/td><td>Prijoritizzazzjoni tar-Riskju<\/td><\/tr><tr><td>1<\/td><td>Il-ħin tal-arjazzjoni huwa inqas mill-ħin speċifikat<\/td><td>Żbalji ta&#039; Programmazzjoni<\/td><td>Irrepeti l-isterilizzazzjoni<\/td><td>1. Spezzjoni taċ-ċiklu awtomatiku<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Ibda mill-ġdid il-kompjuter tiegħek regolarment<\/td><td>1<\/td><td>3<\/td><td>2<\/td><td>6<\/td><td>1. Ibda mill-ġdid il-kompjuter tiegħek regolarment<\/td><td>utent<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more-about-ethylene-oxide-sterilization\">JEKK TIXTIEQ TAF AKTAR Dwar l-Isterilizzazzjoni tal-Ossidu tal-Etilene<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Telefon:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Email:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sit Lokali: Kamra 1202, Caitong Zhongxin, Distrett Xiasha, Belt Hangzhou, Provinċja ta &#039;Zhejiang, Ċina<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Websajt:<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">&nbsp;zjbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>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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