Chii chakakodzera tembiricha kuramba?Sarudza iyo "safety threshold" zvichienderana nemaitiro ekuita.
Kudzivirirwa kwetembiricha kwakakodzera -kwetembiricha, yakakwirira-masefa ekushanda zvakanaka haaisirwe chero; inotemerwa neiyo chaiyo yekushanda tembiricha uye tembiricha yekushanduka-shanduka kweiyo tunnel oveni. Nheyo yakakosha ndeye "kuvhara maitiro ekunyanyisa uchisiya nzvimbo yekuchengetedza."
1. Basic Temperature Resistance Pazasi Line: 180 degree
Iyo yakaderera sterilization tembiricha mumaovheni emishonga inowanzoita 180℃(semuenzaniso, mukuoma kuoma kwemamwe mabhodhoro edosage). Naizvozvo, tembiricha yekudzivirira kwesefa inofanirwa kusangana neiyo shoma ye180℃pasina kukundikana. Pane tembiricha iyi, iyo sefa midhiya, inonamira, uye furemu inofanirwa kuchengetedza kugadzikana pasina kupisa kwemafuta, kuputika, kana kubuda kunze.
2. Kupindirana Kwemaitiro: 250-300 degree
Mazhinji mahovhoni emukotoni munzvimbo dzekugadzira zvinodhaka anoshandisa "250 dhigirii x 30 maminetsi" sterilization process (inofambirana nezvinodiwa neGMP pakubata aseptic mudziyo). Zvimwe zve-zvinogadzirwa zvine njodzi zvakanyanya (senge biologics) zvinotoshandisa 300℃flash flash sterilization process. Naizvozvo, pamamiriro ezvinhu akadai, sefa yepamusoro-yesefa ine tembiricha inoramba 300 degrees kana kupfuura inodiwa kuti pave nechokwadi chekuti kusefa hakudzike panguva yakareba-yenguva yakareba{9}}yekupisa (8-12 maawa ekushanda pazuva).
3. Yakanyanya Kushanda Limit: 350 degree
Mamwe maitiro ane hunyanzvi (akadai seyakadzika pyrogen kubviswa kweiyo lyophilized vials) inoda tembiricha inodarika 350 degrees . Muzviitiko izvi, iyo sefa inofanirwa kuzadzisa zvakaomesesa zvinodikanwa zvenguva pfupi tembiricha yekudzivirira ye350 dhigirii uye yakamira tembiricha yekudzivirira ye320 degree. Pamusoro pazvo, kugadzikana kunofanirwa kuoneswa kuburikidza nekuyedza{5}}tembiricha yakawanda (Kupfuura kana kuenzana nemacycles 100).
Beyond Temperature: Filters' High-Temperature Resistance
Zvichakadaro, kusangana nezvinodiwa tembiricha hazvina kukwana. Mafirita emahovhoni ekuomesa tunnel yemishonga anofanirwa kuve nehunhu hutatu hwe "heat resistance, kuchena, uye kugadzikana":
1. Sefa Material: Girazi Fiber ndiyo "Workhorse"
Girazi Fiber Filter Material: Nekushivirira kwekushisa kwe 350-400 dhigirii, inoratidza kugadzikana kwekemikari yakasimba uye haisununguri kusvibiswa pakupisa kwakanyanya, zvichiita kuti ive sarudzo yakasarudzwa yemamiriro ekushanda pamusoro pe300 degree.
Composite Yakakwirira-Tembiricha-Inopikisa Sefa Material: Semuenzaniso, macomposites egirazi faibha neceramic fiber anogona kushingirira tembiricha inodarika 400 degrees , asi inofanirwa kuona kuti hapana njodzi yekudeuka kwefiber (kudzivirira kusvibiswa kwemudziyo).
Zvinhu Zvinorambidzwa: Zvakajairwa polypropylene uye polyester sefa zvinhu zvine tembiricha yekudzivirira ye80-120 chete dhigirii uye inonyungudika nekuora pakupisa kwakanyanya. Izvo zvinorambidzwa zvachose kushandiswa mumavheni ekuomesa tunnel.
2. Zvimiro Zvimiro: Bvisa "Yakakwira-Njodzi dzeTembiricha"
Frame: Shandisa 304/316 simbi isina tsvina kudzivirira ngura uye simbi ion kusunungurwa pakupisa kwakanyanya.
Sealant: Shandisa yakakwira-tembiricha-inodzivirira silicone rabha (tembiricha inodzivirirwa Yakakura kupfuura kana kuenzana ne300 digirii) pachinzvimbo cheyakajairwa nitrile rubber (kupindwa kwe tembiricha Iri pasi kana kuenzana ne120 digirii) kudzivirira kutsemuka nekuvuza pakupisa kwakanyanya.
Support Mesh: Simbi inofanira kurapwa pasiivation kudzivirira yakakwirira-tembiricha oxidation uye kugadzirwa kwezvikamu.
3. Kuteerera: Kupfuura "Double Criteria" Kuve nechokwadi Chekuchengetedza
Kushanda Kwesefa: Inofanirwa kupasa EN 1822 yakajairwa kuyedzwa, neH13 kunyatsoshanda kana kukwira (Kukura kupfuura kana kuenzana ne99.97% @ 0.3μm) kuve nechokwadi chekutorwa kwese tupukanana uye zvimedu.
Kuvimbika: Mushure mekuvharisa-tembiricha yakakwira, pasa PAO/DEHS muyedzo wekuvimbika nechiyero chekuvuza cheIsiri pasi kana kuenzana ne0.01%. Mhedzisiro yebvunzo inofanirwa kusangana neGMP data traceability zvinodiwa.
Iyo "Njodzi Dzakavanzika" dzeKusarudza Tembiricha Yakashata
Kana kupisa kwesefa kusingakodzeri, mhedzisiro yacho inogona kutyisidzira zvakananga mhando yemushonga:
Kusakwana tembiricha kuramba: Iyo sefa zvinhu zvinodzikira uye carbonizes patembiricha yakakwira, zvichikonzera kudonha kwakanyanya mukusefa. Ma microorganisms ekunze kana ma particulate anogona kupinda muovheni uye kusvibisa midziyo.
Kusaita tembiricha yakanyanyisa: Kusarudza usingafungi tembiricha{-yakakwira{1}}sefa (semuenzaniso, kushandisa 400℃sefa kana tembiricha chaiyo iri 250 degrees) kuchawedzera mutengo wemidziyo (yemhando yepamusoro{-yakakwira-tembiricha inodhura zvakapetwa ka2-3 pane mamodhi akajairika) uye zvinogonawo kukonzera kunyura kwemhepo. kutenderera kushanda zvakanaka.
Musimboti wakakosha wekuona "tembiricha yakafanira" yepamusoro-tembiricha, yakakwirira-masefa ekushanda zvakanaka mumahovhoni emishonga ndeyekushandisa tembiricha chaiyoiyo sechiyereso, uchiwedzera 10% -20% muganho wekuchengeteka. Semuyenzaniso:
250℃sterilization process → sarudza sefa ine 300℃tembiricha kuramba;
300℃sterilization process → sarudza sefa ine 350℃tembiricha kuramba.
Panguva imwecheteyo, kuongororwa kwakadzama kunofanirwa kuitwa kunoenderana nekugadzikana kwezvinhu zvemasefa, kutevedza kwemaitiro, uye mutengo unoenderana. Neiyi nzira chete ndipo panogona kuita kuti magaba ekurongedzerwa emishonga akwanise kuchengetedza mutsara wekupedzisira wekudzivirira utsanana munzvimbo ine hutsinye hwekuvharisa-tembiricha, kunyatsozadzisa zvinodiwa neGMP zvenzvimbo yekugadzirwa kwemishonga.