Qaphela 1: Izimo zokuvala inzalo ye-Ethylene Oxide kufanele zitholwe ngokuqinisekiswa kokuqinisekisa futhi kufanele ziqinisekiswe ngokuqapha kanye nokulawula okujwayelekile phakathi nomjikelezo wokukhipha inzalo ngamunye. Izidingo zokuqinisekisa nokulawula okujwayelekile zivezwe ku-GB 18279.

Qaphela 2: Le ndlela yokuhlola iyasebenza nasezibulala-magciwane zekilasi le-Ethylene Oxide ezifakwe kusethiwe kusengaphambili I-Ethylene oxide inzalo izinhlelo.

E.1 Izisetshenziswa

E.1.1

Kudingeka imishini emine yokuphonselwa inselelo ngale ndlela elandelayo:

• Idivayisi yokuphonselwa inselelo yenqubo iqukethe ishubhu lensimbi engagqwali kanye negumbi elivaleke kancane elilayishwe abathwali abangcolile. Ishubhu lensimbi negumbi kuxhunywe kusetshenziswa izigxivizo ze-O-ring kanye nokuxhumana okunentambo. Okuwukuphela kwendlela eya ekamelweni iwubude beshubhu.
• Ubude beshubhu bungamamitha angu-4.55 (igama), ububanzi bangaphakathi obungu-3.0 mm (igama), bunikeza isilinganiso sobude nobubanzi buka-1500:1. Ingqikithi yevolumu yangaphakathi icishe ibe ngu-32 mL, lapho i-0.85 mL ingumthamo wegumbi.

E.1.2

Izikhwama zokupakisha eziyisishiyagalombili zephepha-plastic ezithobela i-GB/T19633, YY/T0698.4, kanye ne-YY/T0698.5.

E.1.3

Izinkampani zenethiwekhi ezingcolisiwe ezithobela i-GB18281.1 ne-GB18281.2.

E.1.4

Imidiya yesiko lokuthola kabusha efanelekile yabathwali abatheleleke.

E.1.5

Ibhodwe lokulima.

E.2 Izinyathelo Zokuhlola

E.2.1

Khetha uhlelo lokuvala inzalo lwe-Ethylene Oxide oluzohlolwa.

E.2.2

Beka inkampani yenethiwekhi eyodwa engcolile egumbini lokuhlola ledivayisi ngayinye yenqubo yokuphonselwa inselelo. Goqa idivayisi ngayinye yenselelo yenqubo ngezikhwama ezimbili zokupakisha zephepha-plastiki, uvale isikhwama ngasinye ngomshini wokuvala.

E.2.3

Idivayisi yenqubo yokuphonselwa inselelo ayidingi ukuqaliswa kodwa kufanele igcinwe ku-20°C ± 5°C okungenani ihora elilodwa ngaphambi kokuhlolwa.
Qaphela: Lokhu kulingisa izimo ezimbi kakhulu.

E.2.4

Phakamisa isibulali magciwane se-Ethylene Oxide kuzinga lokushisa lokuvala inzalo, layisha izinselele ezine zenqubo esongwe ngegumbi egumbini lesibulala-magciwane le-Ethylene Oxide, bese uqala umjikelezo wokuhlola phakathi nemizuzu engu-15 ngemva kokulayisha. Isikhathi sokuchayeka se-sterilant phakathi nomjikelezo wokuhlola kufanele sibe uhhafu wesikhathi esishiwo salowo mjikelezo wokuvala inzalo ye-Ethylene Oxide.

E.2.5

Ngemuva kokuthi umjikelezo wokuhlola usuqediwe, susa imishini yenqubo yokuphonsela inselelo kusibulala-magciwane se-Ethylene Oxide.

E.2.6

Khipha abathwali abangcolile egumbini lokuhlola, babhale ngokwemiyalelo yomkhiqizi, futhi uqinisekise ukuthobelana nezidingo zesigaba 2.13.

E.2.7

Amasiko isithwali esisodwa esingcolile esingavezwanga esisuka kuqeqebana elifanayo ngokwemiyalelo yomkhiqizi; kufanele ibonise ukuba khona kwama-microorganisms asebenzayo. Uma kungenjalo, ukuhlolwa kuthathwa njengokungavumelekile, futhi ukuhlolwa kabusha kufanele kwenziwe.

E.2.8

Phinda ukuhlolwa izikhathi ezimbili ngaphezulu.

UMA UFUNA UKWAZI OKWENGEZIWE Nge-Ethylene Oxide Sterilization

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