3.4.1.1 Ukukhiqizwa Kwamadivayisi Asebenza Ngezinselelo (PCD)
I-Process Challenge Device (PCD) iwuhlelo lwenselelo ye-microbiological esetshenziselwa ukuhlola izinga lokubulala lamapharamitha enqubo akhethiwe. Ngokuvamile idivayisi noma iphakheji yokuhlola equkethe izinkomba zebhayoloji (isb., izinhlamvu ze-Bacillus atrophaeus ezinesibalo se-spore esaziwayo). Ukumelana ne-PCD enqubweni yokuvala inzalo kufanele kube kukhulu noma kulingane nokumelana nomthwalo wemvelo we-microbial endaweni okunzima kakhulu ukuyibulala inzalo yomkhiqizo. Inani lama-PCD kufanele lihlangabezane nezidingo ezivezwe kuThebula C.3 leSithasiselo C kokuthi GB18279.1-2015. Ama-PCD ahlukaniswa ama-PCD angaphakathi (IPCD) nama-PCD angaphandle (EPCD).
a)Ukukhiqizwa kwe-PCD yangaphakathi (IPCD).
Ama-PCD angaphakathi ngokuvamile angamadivayisi ezokwelapha akhethwe inkampani ukumela umndeni womkhiqizo. Ngokusekelwe ekwakhiweni nasekubunjweni kwezinto ezibonakalayo, le mikhiqizo ithathwa njengeminye enzima kakhulu ukuyibulala amagciwane. Izinkomba zebhayoloji (BI) zibekwe endaweni okunzima kakhulu ukuyibulala inzalo yomkhiqizo, iqinisekisa ukuthi inqubo yokuvala inzalo ayiwavimbi amashaneli noma iphazamise ukwakheka komkhiqizo.
Beka inkomba yebhayoloji (BI) endaweni okunzima ukuyibulala inzalo yomkhiqizo, noma ujove i-microorganism yokuhlola (isb., i-Bacillus atrophaeus) endaweni enezimo zokuvala inzalo okunzima kakhulu ukufeza. ukumelana njengendawo enzima kakhulu yokubulala amagciwane emkhiqizweni.
Ama-IPCD avamile ahlanganisa, kodwa awakhawulelwe ku:
Ukubeka inkampani yenethiwekhi engcolile phakathi kwezingxenye ezifana namaringi, amakhanda e-piston, amawasha, noma amaphistoni esirinji.Ukubeka inselele ye-microorganism phakathi kwe-lumen ye-catheter, bese usebenzisa izinyibilikisi ezinamathelayo noma izixhumi ukuze uvale kabusha i-catheter futhi ubuyisele ubuqotho bomkhiqizo.Ukubeka inselele ye-microorganism endaweni obonakalayo yepiston.
b)Ukukhiqizwa kwe-PCD yangaphandle (EPCD).
Ama-PCD angaphandle abekwe ngaphandle komkhiqizo olayishiwe. Ama-EPCD ngokuvamile asetshenziselwa ukucubungula okujwayelekile futhi alandwa emthwalweni ngemva kokwelashwa. Ukumelana kwe-EPCD nomthwalo webhayoloji womkhiqizo ovalelwe amagciwane kufanele kuqhathaniswe nokumelana kwe-IPCD. I-EPCD kufanele futhi imele umkhiqizo onzima kakhulu ukuvala inzalo emthwalweni.
Ubudlelwano phakathi kwama-EPCD namasampula omkhiqizo ongcolile kufanele bubuyekezwe ngezikhathi ezithile ukuze kuqinisekiswe ukuthi azikho izinguquko ezenzeke emkhiqizweni ovalelwe amagciwane nokuthi i-EPCD isamele umkhiqizo onzima kakhulu ukuwuvala ekulayishweni kwawo.
Uma ubeka i-BI ku-PCD, i-PCD kufanele okungenani ibe nokumelana okufanayo njengendawo okunzima ukuyibulala amagciwane emkhiqizweni.
Ama-EPCD ajwayelekile ahlanganisa, kodwa awakhawulelwe kulokhu:
Ukubeka inkomba yebhayoloji (BI) ngaphakathi kokupakishwa komkhiqizo noma okulinganayo, njengezikhwama zepulasitiki, ezibe sezifakwa ngaphakathi kwemvilophu yase-Manila.Ukufaka inkomba yebhayoloji esikhwameni sepulasitiki esiwugqinsi esigoqwe inani elithile lezikhathi.Ukubeka inkomba yezinto eziphilayo ezingxenyeni ezihlukahlukene zesirinji, njengakumshini wokuwasha wepiston noma i-piston heads enamashubhu epulasitiki engeziwe. ukupakisha.
Ama-PCD akhiqizwa ngale ndlela engenhla apakishwa kusetshenziswa izindlela ezifanayo njengemikhiqizo evamile yokukhiqiza, asatshalaliswa ngokulinganayo phakathi komthwalo womkhiqizo, futhi abekwe ukuze amboze izindawo ezibandayo ngaphakathi kwegumbi lokubulala amagciwane.
3.4.1.2 Ukuhlola Umjikelezo Ongaphelele (I-Short Cycle).
Ngemva kokukhetha i-PCD, ukufaneleka kwayo kuqinisekiswa ngokuqhuba umjikelezo wengxenye. Indlela yokuhlola imi kanje:
a) Nquma izindlela zokubeka ama-PCD, amasampula okuhlola, nezinzwa ngokusekelwe emiphumeleni yokuhlola yokusebenza. Inombolo nokusabalalisa kwama-PCD kufanele kwanele. Uma i-EPCD ekhethiwe isetshenziselwa ukuqapha inqubo yokuvala inzalo okujwayelekile, kufanele ibekwe emthwalweni womkhiqizo ngokuya ngohlelo kanye nenqubo.
b) Ngokusekelwe kunani lika-D, isikhathi se-ST, nesikhathi se-KT senkomba yezinto eziphilayo, setha isikhathi sokuchayeka esifushane. Eminye imingcele kufanele ihlolwe emkhawulweni ophansi wamapharamitha wenqubo yokuvala inzalo. Indlela yokuhlola kufanele ibhekisele ku-Appendix A ye-GB18281.2. Ngemuva kokuthi isikhathi sokuchayeka sesiphelile, susa umkhiqizo, i-IPCD, ne-EPCD ukuze kutshalwe amagciwane bese ubheka imiphumela.
Imiphumela yokulima kufanele ibonise ukuthi ukumelana kwe-PCD kukhulu noma kulingana nokumelana nomthwalo webhayoloji wendawo enzima kakhulu yokubulala amagciwane emkhiqizweni:
I-IPCD ne-EPCD kufanele zibe negethivu ingxenye; umphumela omubi ngokuphelele noma omuhle ngokuphelele ungabonisa ukwehluleka kokuhlolwa.Ukumelana kwe-IPCD kufanele kube kukhulu kunomkhiqizo, futhi ukumelana kwe-EPCD kufanele kube kukhulu noma kulingane nalokho kwe-IPCD.
Uma imiphumela ingahlangabezani nokulindelwe, phenya imbangela. Ngokuvamile, ukulungiswa kokumelana ne-PCD noma imingcele yokuvala inzalo kuyadingeka, okulandelwa ukuphinda kuhlolwe kuze kube yilapho imiphumela ihambisana nokulindelwe. Uma yomithathu (umkhiqizo, i-IPCD, ne-EPCD) ingabonisi ukukhula kwamagciwane, yehlisa isikhathi sokuchayeka ku-EO ngokufanele bese uhlola futhi. Uma konke kukhombisa ukukhula kwe-microbial, khulisa isikhathi sokuchayeka kwe-EO uphinde uhlole.
3.4.1.3 Ukuhlolwa Komjikelezo Oyingxenye
Ngemva kokuphothula ngempumelelo ukuhlolwa komjikelezo omfushane, sebenzisa izivivinyo ezintathu ezilandelanayo zomjikelezo wesigamu ukuze ubonise ukusebenza kahle (SAL = 10^-6) kanye nokuphindaphindeka kwenqubo yokuvala inzalo ye-EO. Indlela yokuhlola imi kanje:
Setha ubunyumba benkomba yebhayoloji njengezinga, futhi usethe amanye amapharamitha wenqubo yokuvala inzalo emkhawulweni ophansi wamapharamitha wokuvala inzalo (isb., isikhathi sokudlulisa ukwelashwa kwangaphambili ngaphakathi kwebanga elishiwo). Kancane kancane nciphisa ngesigamu isikhathi sokuchayeka kokuvala inzalo senqubo yokuqala yokuvala inzalo futhi ususe izinkomba zebhayoloji ku-PCD ngemva kwezikhathi ezihlukene zokuvala inzalo. Zilime endaweni eyinyumba kuze kuqinisekiswe ubunyumba. Isikhathi esifushane kakhulu sokuvala inzalo (isikhathi esibucayi) esinqunywe ngaleyo ndlela kuzoba isikhathi somjikelezo wesigamu, futhi okungenani ukuhlolwa okubili kufanele kwenziwe ngesikhathi esifushane esifanayo.
Yomithathu imiphumela yokuhlolwa kufanele ibonise ukungasebenzi okuphelele kwazo zonke izinkomba zebhayoloji (ukubalwa kwekholoni yokuqala kungabi ngaphansi kuka-1×10^6) ukuze kuqinisekiswe ubuncane besikhathi sokuchayeka se-EO esisebenzayo. Isikhathi sokuchayeka enqubweni evamile yokuvala inzalo kufanele okungenani sibe kabili kulesi sikhathi esincane.
Imiphumela yokutshalwa kwezinkomba zebhayoloji kufanele ikhombise wonke ama-IPCD kanye nama-EPCDs negative. Uma ukuhlolwa komjikelezo omfushane kukhombisa ukuthi ukumelana kwe-EPCD kukhulu kunokwe-IPCD, i-EPCD ingase ibonise ukuqiniseka okuncane.
Uma imiphumela ingafinyeleli okulindelekile, phenya imbangela futhi ngokuvamile ulungise imingcele yokuvala inzalo ngaphambi kokuphinda uhlole kuze kube yilapho imiphumela ihambisana nokulindelwe.
Isibonelo:
Cabanga ukuthi isikhathi sokuchayeka sokuvala inzalo kwesigamu sokuqala amahora ama-4. Uma inyumba, yehlisa isikhathi sokuchayeka sibe amahora ama-2 ngokuhlolwa okulandelayo; uma ukukhula kwe-microbial kwenzeka, khulisa isikhathi sokuchayeka ngokusekelwe ekuchayekeni kwamahora angu-4.
Cabanga ukuthi isikhathi sokuchayeka sokuvala inzalo kwesigamu sesibili amahora ama-2. Uma inyumba, yehlisa isikhathi sokuchayeka sibe yihora elingu-1 lokuhlolwa okulandelayo; uma ukukhula kwe-microbial kwenzeka, nweba isikhathi sokuchayeka sibe amahora ama-3.
Cabanga ukuthi isikhathi sesithathu somjikelezo wokuvala inzalo amahora angu-3. Uma inyumba, phinda ukuhlolwa kwamahora angu-3 kabili. Uma yonke imiphumela iyinyumba, qinisekisa amahora angu-3 njengesikhathi esincane esisebenzayo. Uma ukukhula kwe-microbial kwenzeka, phinda ukuhlolwa ngokuchayeka kwamahora angu-4, futhi uma yonke imiphumela iyinyumba, qinisekisa amahora angu-4 njengesikhathi esincane esisebenzayo.
3.4.1.4 Ukuhlolwa Komjikelezo Ogcwele
Phakathi nokuhlolwa komjikelezo ogcwele, setha isikhathi sokuchayeka se-EO sibe kabili kunesilinganiso esincane somjikelezo wesigamu sesikhathi esisebenzayo, kanye neminye imingcele emkhawulweni ongaphezulu wemingcele yokuvala inzalo ukuze uqinisekise ukwethembeka nokukhiqizwa kabusha kwenqubo yokuvala inzalo.
Inani lezinzwa lokushisa nelomswakama elisetshenzisiwe kufanele lihlangabezane nezidingo ze-Appendix C ku-GB18279.1, lisatshalaliswe ngokulinganayo ngaphakathi komthwalo wokuvalwa inzalo. Amaphoyinti okubekwa kwenzwa yokushisa kufanele afake kokubili izindawo ezibandayo nezishisayo ngaphakathi kwegumbi lesibulala-magciwane ngesikhathi se-Operational Qualification (OQ).
Ngemva kokuhlolwa, imiphumela yokutshalwa komkhiqizo kanye ne-EPCD kufanele ibonise ubunyumba obuphelele (konke kubi).
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