Novemba 5, 2022
Insait long laspela tenpela yia, global famasiutik saplai sen i bin kisim bikpela senis long hap bilong en — ol i bin skruim API na prodaksen bilong ol marasin i go long Yurop na Not Amerika i go long Saut-is Esia (India, Indonesia, Tailan, Vietnam) na Afrika (Isip, Saut Afrika, Kenya, Naijiria).
Insait long laspela tenpela yia, global famasiutik saplai sen i bin kisim bikpela senis long hap bilong en — ol i bin skruim API na prodaksen bilong ol marasin i go long Yurop na Not Amerika i go long Saut-is Esia (India, Indonesia, Tailan, Vietnam) na Afrika (Isip, Saut Afrika, Kenya, Naijiria). Dispela pasin i kamap bikos long ol gutpela kos na gro bilong ol lokol maket.
Tasol, dispela senis i bringim tu ol salens bilong kwaliti komplaens. Ol 'regulatory authorities' long Yurop na Amerika (olsem FDA, EMA) i laikim ol marasin we ol i kisim long ol narapela kantri long bihainim wankain mak olsem ol marasin we ol i wokim insait long kantri. Dispela i min olsem ol fama entaprais long Saut-is Esia na Afrika i mas kamapim ol QC sistem we i bihainim ol intanesenel standet, wantaim 'viscosity testing' em i wanpela bikpela samting.
Long ol odit bilong ol saplaia, ol i save lukluk long bihainim ol data bilong tes bilong 'viscosity'. Ol odita i sekim: Ol i bin kalibretim viskomita? Setifiket bilong kalibresen i stret? Ol i bin tok orait long dispela rot bilong testim? Ol i ken painim ol data bilong tes? Ol opereta i bin kisim trening? Sapos ol i no bekim gut ol dispela askim, dispela inap long mekim odit i no wok gut, na tu, dispela inap long bagarapim rejistresen bilong ol prodak long ol maket bilong Yurop na Amerika.
Long kamapim wanpela GMP-kompliant 'viscosity testing system' i nidim tripela samting: ol ikwipmen, proses, na ol wokman.
Ol samting: Pastaim, ol i mas skelim 'viscometer' - sapos ol i yusim ol 'calibration fluids' we ol i ken bihainim ol 'netional metrology standards' (olsem NIST-traceable silicone oil). FangService's DVPlus+ series touchscreen viscometer i gat wanpela 'calibration reminder function' we i save toksave long wanem taim 'calibration' i mas kamap, na dispela i save stopim ol hevi bilong odit long ol i lusim tingting long ol 'calibration'. Namba tu, ol ikwipmen i mas gat ol samting bilong lukautim gut ol data — olsem menesmen bilong ol raits bilong ol yusa, ol rot bilong odit, enkripsen bilong data, na stopim ol long bagarapim ol samting. DVPlus+ series i sapotim 21 CFR Hap 11 komplaens, we i gat ol ilektronik sain, ol odit trel, na data ekspot.
Proses: Ol i mas kamapim ol standet opereting prosedur (SOPs), we i mas tokaut klia long ol operesenel rikwaemen bilong wanwan tes step. Ol SOP i mas karamapim: redim na lukautim ol sempel, ol step bilong operesen bilong viskomita, kontrolim tempereja bilong tes, rekodim na ripotim ol data, lukautim na kalibretim ol ikwipmen. FangService i givim ol lokol-tokples SOP templet bilong ol kastoma bilong Saut-is Esia na Afrika, na i sapotim tok Inglis, Frans, Swahili, Indonesia, Tai, na Vietnam.
Ol wokman: Ol opereta i mas kisim trening na skelim olsem ol i gat save long mekim wok. Trening i mas karamapim: ol wok prinsipol bilong viskomita, ol standet opereting prosedur, ol komon foul trabelsuting, na data integriti awenes. FangService i save givim ol onlain trening kos na ol lokol trening sevis, na helpim ol opereta insait long ol Saut-is Esia na Afrika entaprais long lainim hariap ol opereting skil we i bihainim lo.
Long ol GMP odit, 'analitikel metod validesen' bilong viskomita em i wanpela bikpela step. As tingting bilong validesen em long pruvim olsem 'viscometer', aninit long ol spesifik tes kondisen, inap long kamapim ol stretpela na stretpela risalt. Ol paramita bilong validesen i gat: stretpela, stretpela, 'linear range', mak bilong painim, na strong bilong en.
Long ol fama entaprais bilong Saut-is Esia na Afrika, 'viscometer validation' i save bungim ol narakain salens. Olsem, ol leb long ol dispela rijen i no inap long gat gutpela ples bilong bosim tempereja, na dispela i save bagarapim stretpela bilong ol tes risalt. FangService's NDJ-1E+ dijitel rotesenal viskomita i gat wanpela tempereja prob na otomatik tempereja kompensesen, we i save rekodim tempereja bilong sempel long taim bilong tes na stretim ol riding bilong viskositi, na daunim hevi bilong senis bilong tempereja long ol risal bilong tes.
Na tu, ol fama entaprais bilong Saut-is Esia na Afrika i no save gat ol saveman bilong mekim wok painimaut. FangService i save givim wanpela 'validesen sevis paket' we i gat tes plen disain, tes eksekesen, data riviu, na rait bilong validesen ripot, na helpim ol klaien long pinisim viskomita validesen. Ol validesen enjinia bilong mipela i gat gutpela save long GMP odit na ol i save gut long FDA, EMA, na WHO odit standet.
Periodic viscometer calibration em i wanpela besik GMP komplaens rikwaemen. Tasol, long Saut-is Esia na Afrika, kisim ol sevis bilong kalibresen we ol i ken painim em i no isi — ol infrastraksa bilong 'metrological' long planti kantri i no kamap gut yet, na ol i no inap long tok tru olsem ol sevis bilong kalibresen i stap na kamap long taim stret.
FangService i bin kamapim wanpela kalibresen sevis netwok long Saut-is Esia na Afrika. Mipela i gat ol senta bilong kalibresen long Bangkok, Jakarta, Ho Chi Minh Siti, Nairobi, Lagos, na Cairo, we i gat ol 'NIST-traceable standard viscosity fluids' na ol profesenel kalibresen enjinia. Mipela i save givim ol 'on-site calibration' na 'send-in' 'calibration service modes', wantaim 'calibration intervals' bilong 6 o 12-pela mun, na ol 'calibration setifiket' we inap long bihainim ol intanesenel standet.
Long ol kampani we i no gat bikpela mani, mipela i save givim tu 'serim kalibresen sevis' — planti kampani i ken bung wantaim long baim ol sevis bilong kalibresen long serim ol kos. Dispela model em i bikpela samting tru namel long ol liklik na namel sais fama entaprais long Saut-is Esia na Afrika.
Na tu, DVPlus+ series 'touchscreen viscometer' bilong FangService i sapotim 'self-calibration' — dispela masin i save painimaut otomatik 'spindle rotation resistance' na skelim wantaim ol 'built-in reference values', na kamapim wanpela 'self-calibration' ripot. Maski 'self-calibration' i no inap long senisim 'formal external calibration', em i wok olsem wanpela helpim rot bilong bosim kwaliti bilong olgeta de, na i helpim ol kampani long holim strongpela tingting long wok bilong ol ikwipmen namel long ol 'formal calibration'.
Long redi long ol saplaia odit, ol fama entaprais bilong Saut-is Esia na Afrika i mas redi pastaim:
Pastaim, yu mas meksua olsem ol setifiket bilong 'viscometer' i stret na ol i ken painim long ol intanesenel 'metrological' sistem. Sapos yu yusim FangService ikwipmen, yu ken mekim wok bilong kalibresen isi tru long rot bilong kalibresen sevis netwok bilong mipela.
Namba tu, kamapim wanpela gutpela sistem bilong rekot bilong ol tes. Olgeta tes i mas rekodim: nem bilong sempel, namba bilong 'batch', deit bilong tes, tempereja bilong tes, mak bilong 'viscosity', sain bilong opereta. DVPlus+ series 'touchscreen interface' na 'data export function' i mekim dispela wok i isi.
Namba tri, redim ol SOP na ol rekot bilong trening. Ol SOP i mas karamapim olgeta rot bilong skelim 'viscosity' we ol i save yusim planti taim, na ol rekot bilong trening i mas gat ol deit bilong trening bilong opereta, ol samting bilong trening, na ol risal bilong asesmen.
Namba foa, mekim ol intanel odit oltaim. Ol intanel odit em i nambawan rot bilong luksave long ol hevi bilong bihainim lo. Mipela i rekomendim yu long mekim wanpela intanel odit long olgeta kwata, sekim wok bilong 'viscometer', ol rekot bilong tes i gutpela o nogat, na wok bilong SOP.
FangService i givim wanpela 'GMP Kompliens Pekej' bilong ol fama entaprais bilong Saut-is Esia na Afrika, we i gat: ol rekomendesen bilong makim viskomita, ol sevis bilong kalibresen, ol SOP templet, operesenel trening, na intanel odit sapot. Gol bilong mipela em long helpim ol entaprais long kamapim ol QC sistem we i bihainim ol intanesenel standet insait long baset konstraksen, na mekim ol saplaia odit i kamap gut. View the Viscosity Measurement Instruments Collection
Tokim mipela long projek senario na ol samting yu nidim, na mipela bai painim stretpela solusen na givim yu wanpela kwot insait long 24 aua.
Kisim wanpela fri kwotNDJ-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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