Mayu 20, 2020
A cikin tsarin sarrafa magunguna, danko ba siga na zaɓi ba ne - yana shafar halayen sakin ƙwayoyi kai tsaye, jin daɗi, daidaiton layin samarwa, da kwanciyar hankali samfurin ƙarshe. Ga masana'antun harhada magunguna a kudu maso gabashin Asiya da Afirka, inda yanayin zafi mai zafi, yanayin zafi da matsananciyar tsadar kayayyaki suka zama al'ada, gwajin danko yana buƙatar kulawa ta musamman.
A cikin magunguna, danko ba siga na zaɓi ba ne - yana shafar halayen sakin ƙwayoyi kai tsaye, jin daɗi, daidaitawar layin samarwa, da kwanciyar hankali samfurin ƙarshe.
Don nau'ikan nau'ikan nau'ikan ruwa na baka (syrups, dakatarwa, mafita na baka), danko yana ƙayyade adadin sakin miyagun ƙwayoyi a cikin jiki. Maɗaukakin danko da yawa yana jinkirta sakin kuma yana iya shafar inganci; ƙananan danko yana haifar da ɓarna ko rabuwa na lokaci, yana daidaita daidaiton kashi. Don alluran allura, danko yana shafar ta'aziyyar allura da yaduwar ƙwayoyi a cikin vivo. Don shirye-shirye na Topical (gels, creams), danko yana ƙayyade bazawa da mannewa.
Kudu maso Gabashin Asiya da Afirka suna ba da yanayi na musamman: masana'antun magunguna a waɗannan yankuna dole ne su shawo kan yanayin zafi mai zafi, ɗakunan ajiya mai zafi da yanayin sufuri. A kudu maso gabashin Asiya, matsakaicin matsakaicin dangi na shekara zai iya kaiwa 80% ko sama da haka, tare da yanayin zafi. a sassan Afirka, yanayin zafi na iya wuce 40 ° C. Babban yanayin zafi yana haɓaka ɓarnawar ƙwayoyi kuma yana canza halayen danko na abubuwan ƙira. Don haka, kamfanonin da ke kafa wurare ko sayayya a cikin waɗannan yankuna dole ne su haɗa abubuwan muhalli cikin ƙa'idodin gwajin ɗanɗanonsu.
Bugu da ƙari, kamfanonin harhada magunguna a kudu maso gabashin Asiya da Afirka galibi suna fuskantar matsananciyar tsadar kayayyaki. Wannan yana nufin dole ne su daidaita madaidaicin gwaji tare da ingancin farashi. NDJ-1 jerin viscometer na jujjuya dijital na dijital, tare da sauƙin aikin sa, ingantaccen ingantaccen gwaji, da farashi mai araha, shine madaidaicin farawa don dakunan gwaje-gwaje na QC a waɗannan yankuna.
Bukatun gwajin danko na magunguna sun bambanta da gaske da na sutura da tawada - kewayon dankon magunguna yawanci kunkuntar (5-5000 mPa·s), amma daidaito da buƙatun maimaitawa suna da girma sosai. Saboda haka, viscometers na jujjuyawa sune zaɓi na yau da kullun don kantin magani.
Ka'idar aiki na viscometer na jujjuya: sandal yana juyawa a cikin sauri akai-akai a cikin samfurin, kuma ana auna juriya (juriya) akan sandar don lissafta danko. Viscometer na dijital na NDJ-1E+ yana amfani da fasahar firikwensin ma'auni na lantarki mai ci gaba, samun daidaiton ± 1% da ≤0.5% maimaitawa, cikakken biyan buƙatun pharma QC.
Flow kofin viscometers (Ford kofuna, Zahn kofuna), da bambanci, ana amfani da yafi a coatings da tawada, tare da ƙananan daidaito (yawanci ± 5%), sa su kasa dace da pharma aikace-aikace. Koyaya, kofuna masu gudana suna ba da sauƙi, ƙarancin farashi, da kulawar sifili, yana sa su dace da saurin tantance filin. A cikin kamfanonin harhada magunguna na Kudu maso Gabashin Asiya da na Afirka, ana amfani da kofuna masu kwarara don saurin gwaji a ƙarshen layin samarwa, yayin da na'urori masu jujjuyawar jujjuyawar ke sarrafa madaidaicin binciken dakin gwaje-gwaje.
Viscometer na DVPlus+ jerin abubuwan taɓawa shine zaɓi na ci gaba don harhada magunguna. Yana da allon taɓawa mai launi 7-inch, ajiyar bayanai, fitarwa na USB, da fitarwa ta atomatik, yana mai da shi dacewa musamman ga kamfanonin harhada magunguna waɗanda ke buƙatar bin GMP. Ayyukan taɓawa yana rage shingen horo - musamman mahimmanci a yankuna masu yawan canjin ma'aikata kamar kudu maso gabashin Asiya da Afirka.
Kamfanonin harhada magunguna a kudu maso gabashin Asiya da Afirka na fuskantar kalubalen gwajin danko da ya sha bamban da na Turai da Arewacin Amurka, musamman a fannoni uku: muhalli, sarkar samar da kayayyaki, da baiwa.
Kalubalen muhalli: Babban zafin jiki da zafi na iya shafar kayan lantarki da na'urori masu auna firikwensin viscometer. A kudu maso gabashin Asiya, matsakaicin matsakaicin dangi na shekara zai iya kaiwa 80% ko sama da haka, tare da yanayin zafi. a sassan Afirka, yanayin zafi na iya wuce 40 ° C. Babban yanayin zafi yana haɓaka ɓarnawar ƙwayoyi kuma yana canza halayen danko na abubuwan ƙira. Don haka, kamfanoni a waɗannan yankuna dole ne su haɗa abubuwan muhalli cikin ƙa'idodin gwajin ɗanɗanonsu.
Kalubalen sarkar samarwa: Sarkar samar da kayan aikin viscometer da abubuwan amfani (spindles, masu tsaro) a kudu maso gabashin Asiya da Afirka ba su da girma fiye da na Turai da Arewacin Amurka. Zaɓin mai siyarwa tare da tsayayyen hanyar rarraba gida yana da mahimmanci. Layin samfurin viscometer na FangService ya ƙunshi cikakken kewayon daga matakin shigarwa zuwa ƙwararru, tare da wuraren sabis a manyan biranen kantin magani a duk kudu maso gabashin Asiya da Afirka (Bangkok, Jakarta, Nairobi, Legas).
Kalubalen basira: Masana'antar harhada magunguna a kudu maso gabashin Asiya da Afirka sun yi girma cikin sauri a cikin 'yan shekarun nan, amma ƙwararrun injiniyoyin QC ba su da ƙarancin gaske. Sabili da haka, sauƙin amfani shine maɓalli mai mahimmanci a zaɓin viscometer. NDJ-1E allon taɓawa na jujjuyawar viscometer mai fa'ida da aikin saiti yana ba wa masu aiki da iyakacin horo don ƙware daidaitattun hanyoyin gwaji a cikin mintuna 10.
Gwajin danko a cikin kantin magani ya mamaye dukkan sarkar daga R&D zuwa samarwa. A cikin R&D, masu ƙira suna buƙatar bincika tsari daban-daban da sauri don halayen danko. A cikin gwajin sikelin matukin jirgi, dole ne a tabbatar da maimaita hanyar da daidaito. A cikin samarwa, dole ne a tabbatar da daidaiton tsari-zuwa.
Layin samfurin viscometer na FangService yana rufe dukkan matakai guda uku. Don R&D, ana ba da shawarar viscometer na DV79A na jujjuya - yana goyan bayan kewayon 0.1-1,000,000 mPa·s, tare da nau'ikan igiya 18 da na'urorin haɗi da yawa, dacewa da buƙatun haɓaka ƙira iri-iri. Don matukin jirgi da matakan samarwa, ana ba da shawarar DVPlus+ jerin viscometer touchscreen - yana goyan bayan ajiyar bayanai, hanyoyin dubawa, da sarrafa haƙƙin mai amfani, tare da bin ƙa'idodin ƙasa da ƙasa kamar 21 CFR Sashe na 11.
Don kamfanonin harhada magunguna na kudu maso gabashin Asiya da na Afirka tare da ƙarancin kasafin kuɗi, jerin NDJ-1 suna ba da cikakkiyar ɗaukar hoto daga R&D zuwa QC. Viscometer na dijital na NDJ-1E + yana goyan bayan 0.1-2,000,000 mPa·s, tare da ma'auni na 1-4 na daidaitattun lambobi da binciken zafin jiki, wanda ya isa ga mafi yawan ruwa na baka, allura, da gwaje-gwajen danko na shirye-shirye. Tsarin sa na yau da kullun yana nufin kamfanoni na iya farawa da tsari na asali kuma su ƙara kayan aiki kamar yadda kasuwancin ke haɓaka - musamman mahimmanci a kasuwanni masu tasowa inda kasafin kuɗi ke da ƙarfi.
Lokacin kafa dakin gwajin danko na magunguna a kudu maso gabashin Asiya ko Afirka, dole ne a yi la'akari da girma uku: yanayi, farashi, da tsari.
Muhalli: Ba da fifikon wuraren lab tare da samun isasshe na asali ko babu kwandishan. Viscometers dole ne su sami damar aiki mai faɗin zafin jiki. FangService's NDJ-1 da DVPlus+ jerin sun wuce babban zafin jiki, gwajin muhalli mai zafi (40°C/90% RH, 72 hours), dace da yanayin dakin gwaje-gwaje na yau da kullun a kudu maso gabashin Asiya da Afirka.
Farashin: Ɗauki dabarar siyan 'kayan aikin kayan aiki + maɓalli na kayan haɗi'. Daya NDJ-1E+ dijital jujjuya viscometer (kimanin RMB 15,000-20,000) tare da yawan zafin jiki na wanka da kuma daidaitattun igiyoyi na iya saduwa da 80% na buƙatun gwaji na yau da kullun. Lokacin da ci gaban kasuwanci yana buƙatar daidaito mafi girma ko ƙarin fasali, haɓaka zuwa jerin DVPlus+. Ka'ida: Hukumomin sarrafa magunguna a cikin ƙasashen kudu maso gabashin Asiya (kamar Thailand FDA, Indonesia BPOM, Vietnam DAV) duk suna buƙatar kamfanonin harhada magunguna su sami tsarin QC mai ƙarfi. Dole ne bayanan gwajin danko ya zama abin ganowa kuma ana iya maimaita su. Zaɓin ISO 17025-madaidaicin viscometers da kafa daidaitattun hanyoyin aiki (SOPs) sune buƙatu na yau da kullun don wuce binciken GMP. Ƙungiyoyin fasaha na FangService na iya ba da samfuran SOP na cikin gida da horon aiki ga abokan ciniki na kudu maso gabashin Asiya da na Afirka, suna taimaka wa kamfanoni da sauri su aiwatar da bincike na tsari. View the Viscosity Measurement Instruments Collection
Faɗa mana yanayin aikin ku da buƙatun ku, kuma za mu dace da mafita mai kyau kuma za mu ba da ƙima a cikin sa'o'i 24.
Samu Magana KyautaNDJ-1 series digital rotational viscometers, NDJ-1C-T/NDJ-1F-T high-temperature viscometers, DVPlus+ series touchscreen viscometers, DV79A premium rotational viscometer, DV2TLV high-temperature viscometer — five series covering the complete needs from entry-level to professional. Wide-temperature design, high-temperature options, portable versions — specifically optimized for the pharmaceutical and water treatment industries in Southeast Asia and Africa.
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