Onye edemede: Smartweigh-Multihead Ibu arọ
Nhọrọ nkwakọ ngwaahịa aseptic anọ ị ga-atụle. Taa, teknụzụ dị iche iche na-elekwasị anya na ndị na-emepụta ọgwụ na biopharmaceutical bụ: (1) ụlọ dị ọcha 100 zuru oke, (2) ndị na-ekewapụ onwe ha, (3) sistemu ihe mgbochi ohere (RABS), (4) sistemu eji eme otu. Kedu nke kacha mma maka gị? 1. Ime ụlọ dị ọcha nke klaasị 100: Emebere teknụzụ ime ụlọ dị ọcha n'afọ ndị 1960 maka ojiji na ụlọ ọrụ ikuku na eletrọnịkị iji zere mmetọ nke obere akụkụ.
Bakteria bụ ụmụ irighiri ihe, ụlọ ọrụ na-emepụta ọgwụ chọpụtara n'oge na-adịghị anya na nka nwere ike ime ka ikuku ghara ịdị ọcha. aleksandarlittlewolf - www.freepik.comPharma-gowning-young-technologist-putting-protective-rubber-gloves-production-factory-freepik-web.jpg Klas 100 dị ọcha bụ ihe a na-ahụkarị na nrụpụta aseptic (ISO 5 na arụmọrụ klaasị A/B). bụ ihe nhata), na-eji ihe nzacha ikuku dị elu (HEPA) na-ewepụ ihe niile na nje bacteria. Nnukwu ụda laminar ma ọ bụ unidirectional ikuku ikuku na-ebelata nnyefe nke irighiri ihe site n'otu ebe gaa na nke ọzọ.
N'afọ ndị 1970, a na-eme ndochi aseptic na igwe dị iche iche n'okpuru ogwe nzacha HEPA. Akụkụ igwe dị n'elu akpa ahụ bụ ihe nwere ike ibute ọrịa, na ka oge na-aga, a na-ebugharị ya ka o kwere mee n'okpuru ọkwa ọrụ. Iji tinye uche nke ọma ikuku akọrọ na igwe, agbakwunyewokwa ihe mkpuchi windo plastik.
Uwe windo na-echetakwara onye ọrụ ka ọ zere imetụ igwe ma ọ bụ ngwaahịa aka. Ndị na-emepụta ihe tụgharịrị gaa na 100% HEPA n'uko ụlọ iji chịkwaa ọnụ ụlọ dum na klas 100. Nke a na-eme ka njikwa dị mma, ma na-abawanye ego ego na ụgwọ ọrụ, karịsịa usoro njikwa ikuku.
2. Opto-Isolators: N'ime 80s na 90s, e mepụtara ndị na-emepụta ihe iji meziwanye ihe mgbochi n'etiti ndị mmadụ na ngwaahịa ma na-ebelata ọnụ ahịa. A kọwapụtara onye kewapụrụ dị ka ọnụ ụlọ dị ọcha n'ime igbe. A na-emechi usoro niile n'ime kabinet mechiri emechi, na-agbanye ikuku site na nzacha HEPA.
Mgbe a na-arụ ọrụ, ọ nweghị onye na-arụ ọrụ agaghị ekwe ka ọ bata ma e wezụga site na interface uwe aka. Foto sitere n'ikike nke chase-logeman anchaselogeman-isolator-web.jpg maka sistemụ kewapụrụ (nyocha HEPA n'elu anaghị egosi). Foto sitere n'ikike nke chase-logeman anchase-logman-isolator-inside-web.jpg na-enye nri dịpụrụ adịpụ nke na-egosi ọdụ ụgbọ mmiri.
Mgbe emechara ihe nrụpụta, a ga-emepe onye na-akpachapụ anya, hichaa ya ma dịrị njikere maka ọsọ ọzọ. Ozugbo etinyere ya, onye na-ese ihe na-ejupụta na sterilant, nke na-abụkarị vapor hydrogen peroxide (VHP), iji sụọ ihe niile dị n'ime ya. N'adịghị ka ịgba ọgwụ ọdịnala ma ọ bụ mkpocha ahịhịa, VHP na-abanye n'ime obere oghere.
Ozugbo ịgba ọgwụ mgbochi ọrịa, a na-eme nhazi ikpeazụ ọ bụla site na ọdụ ụgbọ mmiri. Na tiori, ọ ga-ekwe omume ịrụ ọrụ isolator n'ime oghere a na-achịkwaghị achịkwa, dị ka ụlọ nkwakọba ihe, site n'aka onye na-arụ ọrụ yi uwe lab. N'echiche, ọ bụ.
N'ezie, ọtụtụ ụlọ ọrụ etinyela ndị na-ekewapụta ihe na klas 100 dị ọcha. Nke a na-enye mgbakwunye ihicha, mana uru ọ bara bụ imepụta ihe dịpụrụ adịpụ iji zere. 3. Restricted Access Barrier System (RABS): RABS bụ nkwekọrịta n'etiti usoro mepere emepe na usoro dịpụrụ adịpụ, RABS nwere usoro ahụ n'ime mkpuchi siri ike.
Ntinye aka na-arụ ọrụ na-abanye n'ọdụ ụgbọ mmiri aka. Teknụzụ Syntegon Pharma Syntegon-Pharma- ngwaahịa_filling na Closing_FXS_3100-web.jpg RABS mepere emepe na-agbatị n'uko ụlọ, dabere na njikwa ikuku na usoro nzacha ụlọ. RABS mechiri emechi nwere usoro njikwa ikuku na nzacha nke ya.
RABS nwere uru bara uru dị ukwuu karịa ndị na-ekewapụ onwe ya n'ihi ịdị mfe ya. Nke a bụ eziokwu karịsịa ma ọ bụrụ na ha nwere ike ịnọ n'ime ụlọ dị ọcha wee wedata ego eji arụ ụlọ. Mkpa iji wuo ọnụ ụlọ dị ọcha na-akwụ ụgwọ ụfọdụ n'ime ego echekwabara ma e jiri ya tụnyere ndị na-anọpụ iche.
4. Sistemụ mkpofu: Usoro njikwa ngwaahịa a na-atụfu na-aghọwanye ewu ewu na ngwa aseptic. Usoro ndị a nwere akpa rọba iji dochie ike igwe ọdịnala. Akpa a na-eji ihe nzacha niile, tubing, ọdụ ụgbọ mmiri, nozzles na-ejuputa na ngwa ndị ọzọ a chọrọ akpakọba akpa ya.
A na-achichi ya n'ime akpa nchekwa wee mebie ya. Ngwa ndị na-emepụta ihe na-emecha usoro sterile na njikere maka ịrụ ọrụ. Foto site n'ikike nke sartorioussaritus Img_OctoPlus-_4154-web.jpg Ụfọdụ ndị na-emepụta ihe na-enye usoro eji eme otu ihe, gụnyere Sartorius (PreVAS - nke a kwadoro, tupu ekpokọta ya, tupu sterilized - Project Syntegon), Pall Corporation (Biotech ya ozugbo eji mmekọahụ eme ihe. Sistemu) wdg.
Dị ka Marion Monstier si kwuo, Sartorius Freeze-Thaw Products Manager, uru nke otu usoro eji eme ihe gụnyere: • Sistemu mechiri emechi na-ebelata nnyefe ngwaahịa na njikwa, na-ebelata ihe ize ndụ nke mmetọ. • Dochie otu usoro eji eme ihe n'etiti ọsọ ngwaahịa na-ewepụ ohere nke mmetọ obe n'ihi nhicha ezughị oke ma ọ bụ na-ekwesịghị ekwesị. • Tụnyere sistemu enwere ike iji, usoro ndị a na-ebelata ngbanwe na oge ntọlite .
• Ha na-ewepụ ihe nkwado nkwado ihicha. • Ha na-agbapụta nke ọma, si otú ahụ na-abawanye mgbake ngwaahịa.
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