Ukuvumelana Kokuvalwa Kwenzalo Kwezinhlelo Zokuvimbela Inzalo

Iphepha Elimhlophe Lobuchwepheshe

1. Isingeniso

Ukuhambisana phakathi kwe-sterile barrier systems (SBS) nezinqubo zokuvala inzalo kuwukucatshangelwa kobunjiniyela okubalulekile ekwakhiweni kokupakishwa kwensiza yezokwelapha. Izinhlanganisela zenqubo yezinto ezibonakalayo ezingafanelekile zingaholela ekubulaleni okunganele ukungena, ukuwohloka kwempahla, noma ukulahleka kobuqotho besithiyo se-microbial.

Leli phepha elimhlophe lobuchwepheshe ligxile ezimisweni zokuhambisana kwezinto ze ubuchwepheshe bokuvala inzalo obusetshenziswa ngokuvamile, obugcizelelwa kakhulu I-ethylene oxide (EtO) kanye nezinqubo zokuvala inzalo ezisezingeni eliphansi ezisetshenziselwa imishini yezokwelapha eyinkimbinkimbi futhi ezwela ukushisa.

2. Izimfuneko Zesistimu Yokuvimbela Inzalo

• Ukungena ku-ejenti ekhethiwe yokubulala amagciwane
• Ukumelana nezingcindezi ezishisayo, zomzimba, namakhemikhali
• Ubuqotho be-microbial barrier post-sterilization
• Ukuzinza ngesikhathi sokugcina, ezokuthutha, nokuphatha

3. Izinqubo zokuvala inzalo kanye nokucatshangelwa kwe-SAL

Izinqubo zokuvala inzalo ziyaqinisekiswa ukuze kuzuzwe Izinga Lokuqinisekisa Ukuzala (SAL), elichaziwe. ngokuvamile 10^-6 okwemishini yezokwelapha. Ukuthola leli zinga lesiqinisekiso kudinga ukuqondanisa phakathi komklamo wedivayisi, izinto zokupakisha, namandla esistimu yokuvala inzalo.

4. Uhlolojikelele lwe-Applicable Sterilization Technologies

4.1 Ukuvalwa kwe-Ethylene Oxide (EtO).

Ukwenziwa inzalo kwe-ethylene oxide kusetshenziswa kabanzi kumadivayisi azwela ukushisa nomswakama. Izinqubo ezijwayelekile ze-EtO zisebenza ku-30-60 °C ngaphansi kwezimo zomswakama olawulwayo, okuvumela ukuvala inzalo okusebenzayo kwamajiyometri ayinkimbinkimbi kanye nezinhlelo zokupakisha ezinezimbotshana.

Ngokombono wobunjiniyela, izimboni ethylene oxide inzalo izinhlelo aklanywe njengezixazululo ezihlanganisiwe ezihlanganisa amakamelo okubulala inzalo, ukujikeleza kwegesi, ukulawula umswakama, nokuphathwa kokukhipha intuthu.

4.2 I-Low-Temperature Oxidative Sterilization

I-hydrogen peroxide (VHP) ene-vaporized hydrogen peroxide kanye ne-hydrogen peroxide gas plasma systems hlinzeka izikhathi zomjikelezo osheshayo kanye namazinga okushisa aphansi okusebenza. Kodwa-ke, izakhiwo zabo eziqinile ze-oxidative zibeka imingcele eqinile ezintweni zokupakisha ezihambisanayo uma kuqhathaniswa nokuvala inzalo kwe-EtO.

5. Ukuhlaziywa Kwezinto Ezivumelanayo

5.1 Izisetshenziswa ezinembobo zokuvala igesi

Iphepha lebanga lezokwelapha kanye nezinto ezingezona ezilukiwe ze-polyolefin zivame ukusetshenziswa kumasistimu wesithiyo oyinyumba wokuvalwa kwe-EtO ngenxa yokulawulwa kwawo i-porosity kanye nekhono lokugcina ukusebenza kwe-microbial barrier ngemva kokuvalwa inzalo.

5.2 Amafilimu Nezakhiwo Ezihlanganisiwe

Amafilimu angenakunyakaziswa kanye nezinto ezihlanganisiwe ze-laminated zisetshenziswa kabanzi ku izikhwama, ama-reels, nama-blister package. Ukuhambisana kuncike ekwakhiweni kwe-polymer, ukwakheka kwe-laminate, kanye nokumelana nokucindezeleka okushisayo okubangelwa inzalo namakhemikhali.

6. Imithelela yobunjiniyela Bokuklanywa Kwesistimu Yokuvala Inzalo

Ukuhambisana kwezinto zokupakisha kufanele kuhlolwe kanye ukusebenza kwe-sterilizer, kufaka phakathi ukufana kokusabalalisa igesi, ukulungiswa komthwalo, kanye nokusebenza kahle kokungenisa umoya kwangemva kokwenziwa inzalo.

Lokhu kubaluleke kakhulu ekukhiqizeni okukhulu kusetshenziswa imishini yezimboni EtO inzalo , lapho ukuqina kwenqubo nokulawulwa kwezinsalela kubalulekile.

7. Isitatimende Sekhono Lobunjiniyela

Amaqembu onjiniyela ayaletha Amasistimu wokuvala inzalo e-EtO kufanele ihlanganise ukucatshangelwa kokuhambisana kwephakheji ku ukwakhiwa kwesistimu, isu lokuqinisekisa, nokulawulwa kwemvelo.

Landa

Landa i-BOCON Ethylene Oxide Sterilizer Product Catalog (PDF)