Menene juriyar yanayin zafi da ya dace?Ƙayyade "ƙofar aminci" bisa ga buƙatun tsari.
Madaidaicin kewayon juriya na zafin jiki mai girma{0}zazzabi, maɗaukaki masu inganci{1} ba a saita su ba bisa ga ka'ida ba; an ƙaddara ta ainihin yanayin zafin aiki da kewayon canjin zafin ramin tanda. Babbar ka'ida ita ce "rufe iyakar aiwatarwa yayin barin gefen tsaro."
1. Basic Temperature Resistance Bottom Line: 180 digiri
Matsakaicin zafin jiki na haifuwa a cikin tanda na rami na magunguna shine yawanci digiri 180 (misali, a cikin bushewar haifuwar wasu kwalabe na baka). Don haka, dole ne juriyar zafin tacewa ta hadu da mafi ƙarancin digiri 180 ba tare da gazawa ba. A wannan zafin jiki, kafofin watsa labarai masu tacewa, manne, da firam dole ne su kula da daidaiton tsari ba tare da nakasar zafi ba, fatattaka, ko fitar da iskar gas.
2. Daidaitawar Tsarin Al'ada: 250-300 digiri
Mafi yawan tanda a cikin wuraren samar da magunguna masu allura suna amfani da tsarin haifuwa na "digiri 250 x 30 minutes" (wanda ya dace da buƙatun GMP don sarrafa kwantena aseptic). Wasu manyan samfuran haɗari- (kamar ilimin halitta) har ma suna amfani da tsarin haifuwar filasha 300. Don haka, don irin waɗannan al'amuran, ana buƙatar babban tace mai inganci tare da juriya na digiri 300 ko sama don tabbatar da cewa ingancin tacewa baya raguwa yayin zagayowar yanayin zafi mai tsayi (8-12 hours na aiki kowace rana).
3. Matsakaicin Iyakar Aiki: 350 digiri
Wasu matakai na musamman (irin su cirewar pyrogen mai zurfi na vials lyophilized) suna buƙatar yanayin zafi sama da digiri 350. A cikin waɗannan lokuta, tacewa dole ne ya cika buƙatu masu tsauri don juriya na zafin jiki na wucin gadi na digiri 350 da dorewar yanayin zafin digiri na 320. Bugu da ƙari, dole ne a tabbatar da kwanciyar hankali ta hanyar gwaje-gwajen yanayin zafi da yawa{5} (Mafi girma ko kuma daidai da zagayowar 100).
Bayan Zazzabi: Maɗaukakin Filters{0}} Juriya na Zazzabi
A halin yanzu, biyan bukatun zafin jiki bai isa ba. Tace don busar da tanda na magunguna dole ne su mallaki halaye sau uku na "juriyar zafi, tsabta, da kwanciyar hankali":
1. Kayan Tace: Gilashin Fiber shine "Dokin Aiki"
Gilashin Filter Filter Material: Tare da juriya na zafin jiki na digiri 350-400, yana nuna kwanciyar hankali mai ƙarfi kuma baya sakin maras kyau a yanayin zafi mai girma, yana mai da shi zaɓin da aka fi so don yanayin aiki sama da digiri 300.
Haɗaɗɗen Haɗaɗɗiyar Haɗaɗɗiyar -Zazzabi{1}}Kayan Tacewa Mai Tsaya: Misali, haɗaɗɗun fiber gilashi da fiber yumbu na iya jure yanayin zafi sama da digiri 400 , amma dole ne a tabbatar da cewa babu haɗarin zubar fiber (don hana gurɓataccen akwati).
Abubuwan da aka haramta: Abubuwan polypropylene na yau da kullun da kayan tace polyester suna da juriya na zafin jiki na digiri 80-120 kawai kuma za su narke da ruɓe a yanayin zafi mai girma. An hana su sarai don amfani a cikin tanda bushewar rami.
2. Abubuwan Tsari: Kawar da "Haɗarin Zazzabi"
Firam: Yi amfani da bakin karfe 304/316 don hana tsatsa da sakin ion karfe a yanayin zafi mai girma.
Sealant: Yi amfani da robar silicone mai ɗorewa{0}}zazzabi{1} (tsawon zafin jiki Mafi girma ko dai dai da digiri 300) maimakon daidaitaccen robar nitrile (juriyar zafin jiki ƙasa da ko daidai da digiri 120) don hana tsagewa da zubewa a yanayin zafi.
Taimakon raga: Dole ne kayan ƙarfe su sha maganin wucewa don hana haɓakar yanayin zafi mai zafi da ƙurar ƙura.
3. Yarda: Ƙaddamar da "Sharuɗɗa Biyu" don Tabbatar da Tsaro
Ingantaccen Tacewa: Dole ne ya wuce gwajin daidaitaccen EN 1822, tare da ingancin H13 ko mafi girma (Mafi girma ko daidai da 99.97% @ 0.3μm) don tabbatar da kama duk ƙwayoyin cuta da ƙwayoyin cuta.
Mutunci: Bayan haifuwar yanayin zafi mai girma -, ƙetare gwajin ingancin PAO/DEHS tare da ɗigo ƙasa da ko daidai 0.01%. Dole ne sakamakon gwajin ya cika buƙatun gano bayanan GMP.
"Hadarin Boye" na Zaɓin Zazzaɓi mara kyau
Idan juriyar zafin tacewa bai dace ba, sakamakon zai iya yin barazanar ingancin magani kai tsaye:
Rashin isasshen zafin jiki: Kayan tacewa yana raguwa kuma yana yin carbonizes a yanayin zafi mai girma, yana haifar da faɗuwar faduwa cikin ingancin tacewa. Kwayoyin halitta na waje ko ɓarna na iya shiga cikin tanda kuma su gurɓata kwantena.
Wuce kima da zafin jiki: Zaɓan matsananci{0} high {{1} tace zafin jiki da makance (misali, yin amfani da matatar digiri 400 lokacin da ainihin yanayin yanayin aiki ya kai digiri 250) zai ƙara farashin kayan aiki (sauran yanayin zafi sau 2-3 ya fi tsada fiye da na al'ada) kuma yana iya haifar da juriya mai kauri fiye da tanda. ingantaccen sake zagayowar.
Maɓalli na ƙa'ida don tantance "madaidaicin zafin jiki" don babban{0}}zazzabi, mafi girma{1} tace masu inganci a cikin tanda na rami na magunguna shine a yi amfani da ainihin madaidaicin zafin tsari azaman ma'auni, ƙara 10%-20% amintaccen gefe. Misali:
Tsarin haifuwa na digiri 250 → zaɓi tacewa tare da juriya na digiri 300;
Tsarin haifuwa na digiri 300 → zaɓi tacewa tare da juriya na digiri 350.
A lokaci guda, dole ne a yi cikakkiyar ƙima bisa la'akari da kwanciyar hankali na kayan tacewa, yarda da tsari, da ƙimar farashi. Ta wannan hanya ne kawai kwantenan marufin magunguna za su iya kiyaye layinsu na ƙarshe na tsaro na tsafta a cikin matsanancin yanayi na yawan zafin jiki-, da gaske sun cika ƙaƙƙarfan buƙatun GMP don yanayin samar da magunguna mara kyau.