GMP. Mu gice cya GMP, hasabwa ibisabwa kugira ngo habeho ibikoresho no gushushanya imiyoboro isukuye, ni ukuvuga, “Ibikoresho bihura neza n’ibikomoka ku mata bigomba kuba byoroshye kandi bitagira amenyo cyangwa ibice kugira ngo bigabanye kwegeranya imyanda y’ibiribwa, umwanda n’ibinyabuzima”. , “Ibikoresho byose by’umusaruro bigomba gutegurwa no kubakwa kugira ngo bisukure byoroshye kandi byandurwe kandi bigenzurwe byoroshye.” Imiyoboro isukuye ifite ibiranga sisitemu yigenga nubuhanga bukomeye. Kubera iyo mpamvu, iyi ngingo irasobanura byinshi ku guhitamo ibikoresho by’imiyoboro isukuye, ibisabwa kugira ngo umuntu ahure n’ibikomoka ku mata, ibisabwa byo gusudira imiyoboro, gushushanya ubwabyo, n'ibindi, bigamije guteza imbere inganda z’amata n’ubwubatsi Ikigo cyumva akamaro k’umuyoboro mwiza kwishyiriraho no kuvura.
Nubwo GMP ishyiraho ibisabwa bikomeye kubikoresho no gushushanya imiyoboro isukuye, ibintu by’ibikoresho biremereye n’imiyoboro yoroheje biracyagaragara mu nganda z’amata mu Bushinwa. Nkigice cyingenzi cyibikorwa byamata, sisitemu yimiyoboro isukuye iracyitabwaho cyane. Ntabwo bihagije biracyafite intege nke zibuza kuzamura ubwiza bwibikomoka ku mata. Ugereranije n’ibipimo bijyanye n’inganda z’amata yo hanze, haracyari byinshi byo kunonosora. Kugeza ubu, amahame y’isuku y'Abanyamerika 3-A hamwe n’ibipimo by’ibihugu by’i Burayi byita ku isuku (EHEDG) bikoreshwa cyane mu nganda z’amata yo hanze. Muri icyo gihe, inganda z’amata ziri mu itsinda rya Wyeth muri Amerika zishimangira igishushanyo mbonera cy’amata cyujuje ubuziranenge bwa farumasi zafashe icyemezo cya ASME BPE nk'icyerekezo ngenderwaho mu gushushanya no gushyiraho ibikoresho by'uruganda rukora amata n'imiyoboro, nabyo bizakorwa kumenyekanisha hepfo.
01
Amerika 3-Ibipimo byubuzima
Igipimo cyabanyamerika 3-A ni amahame mpuzamahanga yubuzima yemewe kandi yingenzi, yatangijwe nisosiyete y'Abanyamerika 3-A yubuziranenge. Ishyirahamwe ry’Abanyamerika 3A ryita ku isuku n’umuryango udaharanira inyungu uharanira guteza imbere isuku y’ibikoresho bitanga umusaruro, ibikoresho bikomoka ku binyobwa, ibikoresho by’amata n’ibikoresho by’imiti, bigamije ahanini guteza imbere umutekano w’ibiribwa n’umutekano rusange.
Isosiyete 3-A yubuziranenge yisuku yateguwe n’imiryango itanu itandukanye yo muri Amerika: Ishyirahamwe ry’Abanyamerika bakora amata (ADPI), Ihuriro mpuzamahanga ry’abatanga inganda z’ibiribwa (IAFIS), hamwe n’ishyirahamwe mpuzamahanga rishinzwe kurengera isuku ry’ibiribwa (IAFP) , Ishyirahamwe Mpuzamahanga ry’ibicuruzwa by’amata (IDFA), hamwe n’inama y’ibimenyetso 3-A. Ubuyobozi bwa 3A burimo ikigo gishinzwe ibiryo n’ibiyobyabwenge muri Amerika (FDA), Minisiteri y’ubuhinzi muri Amerika (USDA), na komite nyobozi ya 3-A.
Amerika 3-Igipimo cy’isuku gifite amategeko akomeye cyane kuri sisitemu isukuye, nko muri 63-03 ku bikoresho by’isuku:
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02
EHEDG Igishushanyo mbonera cyisuku yimashini zibiribwa
Itsinda ry’iburayi ry’isuku n’ishusho Itsinda ry’ibishushanyo mbonera by’isuku ry’iburayi (EHEDG). EHEDG yashinzwe mu 1989, ihuriro ry’abakora ibikoresho, amasosiyete akora inganda z’ibiribwa, n’ibigo nderabuzima rusange. Intego nyamukuru yaryo ni ugushiraho ibipimo bihanitse by isuku yinganda zikora ibiribwa no gupakira.
EHEDG yibasiye ibikoresho byo gutunganya ibiryo bigomba kuba bifite isuku nziza kandi byoroshye kuyisukura kugirango wirinde kwanduza mikorobe. Kubwibyo, ibikoresho bigomba kuba byoroshye guhanagura no kurinda ibicuruzwa kwanduzwa.
Muri EHEDG “Amabwiriza agenga ibikoresho by'isuku 2004 Amabwiriza ya kabiri”, sisitemu yo kuvoma yasobanuwe ku buryo bukurikira:
(1) Igice cya 4.1 muri rusange kigomba gukoresha ibyuma bitagira umwanda kandi birwanya ruswa;
. ni Byahiswemo; niba intumbero ya chloride Niba irenze 100ppm kandi ubushyuhe bwo gukora bukaba buri hejuru ya 50 ℃, ibikoresho bifite imbaraga zo kurwanya ruswa bigomba gukoreshwa kugirango birinde kwangirika no kwangirika kwatewe na ion ya chloride, bityo wirinde ibisigazwa bya chlorine, nka AISI316 ibyuma bitagira umwanda, kandi biri hasi ibyuma bya karubone. AISI316L ifite imikorere myiza yo gusudira kandi irakwiriye sisitemu yo kuvoma.
(3) Ubuso bwimbere bwa sisitemu yo kuvoma mu gice cya 6.4 bigomba kuba byonyine kandi byoroshye kubisukura. Ubuso butambitse bugomba kwirindwa, kandi impande zigoramye zigomba gutegurwa kugirango hirindwe amazi asigaye.
. Mugihe cyo gusudira, kurinda gaze inert bigomba gukoreshwa imbere no hanze yingingo kugirango birinde okiside yicyuma kubera ubushyuhe bwinshi. Kuri sisitemu yo kuvoma, niba imiterere yubwubatsi (nkubunini bwumwanya cyangwa ibidukikije bikora) byemewe, birasabwa gukoresha gusudira byikora orbital gushoboka bishoboka, bishobora kugenzura neza ibipimo byo gusudira hamwe nubwiza bwamasaro.
03
ASME BPE y'Abanyamerika
ASME BPE (societe y'Abanyamerika yubuhanga bwubukanishi, ibikoresho bitunganya Bio) ni igipimo cyateguwe n’umuryango w’abanyamerika w’abashinzwe imashini kugira ngo bagenzure igishushanyo mbonera, ibikoresho, inganda, kugenzura no gupima ibikoresho bikoresha ingufu za bioprocessing hamwe n’imiyoboro hamwe n’ibigize ibikoresho.
Ibipimo byasohotse bwa mbere mu 1997 kugirango bigere ku bipimo bimwe kandi byemewe kurwego rwibikoresho byifashishwa mu bicuruzwa bikomoka ku binyabuzima. Nkurwego mpuzamahanga, ASME BPE yubahiriza byimazeyo amategeko n'amabwiriza bijyanye na GMP yigihugu cyanjye na FDA yo muri Amerika. Nibisobanuro byingenzi bikoreshwa na FDA kugirango habeho umusaruro. Nibipimo byingenzi kubakora ibikoresho nibikoresho, abatanga isoko, ibigo byubwubatsi nabakoresha ibikoresho. Ibipimo bidateganijwe byatewe inkunga hamwe bigatezwa imbere kandi bigasubirwamo buri gihe.
3-A, EHEDG, ASME BPE ibyemezo byubuzima
Kugirango habeho umusaruro wibicuruzwa bisukuye cyane no kugabanya ibyago byo kwanduza ibicuruzwa, igipimo cya ASME BPE gifite ibisobanuro byihariye byikoranabuhanga ryo gusudira byikora. Kurugero, verisiyo ya 2016 ifite ingingo zikurikira:
(1) SD-4.3.1 (b) Iyo hakoreshejwe imiyoboro idafite ibyuma, 304L cyangwa 316L ibikoresho byatoranijwe muri rusange. Automatic orbital welding nuburyo bwatoranijwe bwo guhuza imiyoboro. Mucyumba gisukuye, ibice byumuyoboro bikozwe mubintu 304L cyangwa 316L. Nyirubwite, ubwubatsi nuwabikoze agomba kumvikana kuburyo bwo guhuza imiyoboro, urwego rwo kugenzura nibipimo byemewe mbere yo kwishyiriraho.
. Muri iki gihe, gusudira intoki birashobora gukorwa, ariko byumvikanyweho na nyirubwite cyangwa rwiyemezamirimo.
(3) MJ-9.6.3 Niba isaro ryujuje ibyangombwa ryujuje ubuziranenge rigaragara mugihe cyo kugenzura gusudira, hagomba gukorwa ubugenzuzi bwinyongera busabwa nibisobanuro kugeza igihe byemewe.
04
Gushyira mu bikorwa amahame mpuzamahanga y’inganda
Igipimo cy’isuku 3-A cyavutse mu myaka ya za 1920 kandi ni amahame mpuzamahanga akoreshwa mu kugereranya igishushanyo mbonera cy’ibikoresho mu nganda z’amata. Kuva ryatera imbere, hafi yamasosiyete yose y’amata, amasosiyete y’ubwubatsi, abakora ibikoresho, n’abakozi bo muri Amerika ya Ruguru barayikoresheje. Biremewe kandi muri rusange mubindi bice byisi. Isosiyete irashobora gusaba 3-A icyemezo cyimiyoboro, ibyuma bifata imiyoboro, indangagaciro, pompe nibindi bikoresho byisuku. 3-A izategura abasesengura gukora ibizamini ku bicuruzwa no gusuzuma imishinga, no gutanga icyemezo cya 3A cyubuzima nyuma yo gutsinda isuzuma.
Nubwo ubuzima bw’uburayi EHEDG bwatangiye nyuma kurenza Amerika 3-A, bwateye imbere byihuse. Uburyo bwo gutanga ibyemezo burakomeye kuruta Amerika 3-A. Isosiyete isaba igomba kohereza ibikoresho byemeza muri laboratoire yihariye yo kwipimisha i Burayi kugirango isuzumwe. Kurugero, mugupima pompe ya centrifugal, gusa mugihe hanzuwe ko ubushobozi bwo kwisukura bwa pompe byibuze butari munsi yubushobozi bwo kwisukura bwumuyoboro uhujwe, birashobora kuboneka ikimenyetso cyicyemezo cya EHEDG igihe cyagenwe.
Igipimo cya ASME BPE gifite amateka yimyaka igera kuri 20 kuva cyashingwa mu 1997. Ikoreshwa mu nganda nini zose zikoreshwa mu binyabuzima n’ibigo by’ubwubatsi, abakora ibikoresho, n’abakozi. Mu nganda z’amata, Wyeth, nkisosiyete ya Fortune 500, inganda zayo z’amata zemeje amahame ya ASME BPE nkuyobora mu bijyanye no gushushanya no gushyiraho ibikoresho by’uruganda rw’amata n’imiyoboro. Barazwe imicungire yumusaruro winganda zimiti kandi bafata tekinoroji yo gusudira byikora kugirango hubakwe umurongo utunganya amata.
Tekinoroji yo gusudira yikora itezimbere ubwiza bwamata
Muri iki gihe, mu gihe igihugu cyita cyane ku kwihaza mu biribwa, umutekano w’ibikomoka ku mata wabaye ikintu cy’ibanze. Nkumuntu utanga ibikoresho byinganda zamata, ninshingano ninshingano zo gutanga ibikoresho nibikoresho byujuje ubuziranenge bifasha kwemeza ubwiza bwibikomoka ku mata.
Tekinoroji yo gusudira mu buryo bwikora irashobora kwemeza ko gusudira bidasubirwaho biturutse ku bintu byabantu, kandi ibipimo byo gusudira nkibipimo bya tungsten, intera iriho, nubuvuduko bwizunguruka birahagaze. Ibipimo byateganijwe hamwe no kwikora byikora byerekana ibipimo byo gusudira biroroshye kubahiriza ibisabwa bisanzwe kandi umusaruro wo gusudira ni mwinshi. Nkuko bigaragara ku gishushanyo cya 3, imiyoboro yatanzwe nyuma yo gusudira byikora.
Inyungu ni kimwe mu bintu buri rwiyemezamirimo w’amata agomba gutekereza. Binyuze mu isesengura ryibiciro, usanga gukoresha tekinoroji yo gusudira byikora bisaba gusa isosiyete yubwubatsi guha ibikoresho imashini yo gusudira byikora, ariko igiciro rusange cyikigo cy’amata kizagabanuka cyane:
1. Kugabanya amafaranga yumurimo wo gusudira imiyoboro;
2. Kubera ko amasaro yo gusudira ari amwe kandi meza, kandi ntibyoroshye gukora inguni zapfuye, ikiguzi cyo gukora imiyoboro ya buri munsi CIP iragabanuka;
3. Impanuka z'umutekano wo gusudira za sisitemu y'imiyoboro ziragabanuka cyane, kandi ibiciro by’ingaruka z’umutekano w’amata biragabanuka cyane;
4. Ubwiza bwo gusudira bwa sisitemu yimiyoboro yizewe, ubwiza bwibikomoka ku mata buremewe, kandi ikiguzi cyo gupima ibicuruzwa no gupima imiyoboro kiragabanuka.
Igihe cyo kohereza: Ukuboza-19-2023