Gutera inshinge zitanga amazi Sytem hamwe nubushyuhe

Ibisobanuro ku bicuruzwa

Amazi yo gutera inshinge nugukoresha cyane sterile mugutegura sterile imyiteguro.Ibisabwa byujuje ubuziranenge bwamazi yo guterwa byateganijwe cyane muri farumasi.Usibye ibintu bisanzwe bigenzurwa kumazi yatoboye, nka acide, chloride, sulfate, calcium, ammonium, dioxyde de carbone, ibintu byoroshye okiside, ibintu bidahindagurika, hamwe nibyuma biremereye, bigomba no gutsinda ikizamini cya pyrogene.GMP isobanura neza ko gutegura, kubika, no gukwirakwiza amazi meza n'amazi yo gutera inshinge bigomba gukumira ikwirakwizwa no kwanduza mikorobe.Ibikoresho bikoreshwa mu bigega byo kubika no mu miyoboro bigomba kuba bidafite uburozi kandi birwanya ruswa.

Ibisabwa byujuje ubuziranenge ibikoresho byo gutunganya amazi ni ibi bikurikira:

Amazi yo gutera inshinge akoreshwa nk'umuti wo gutegura ibisubizo byo gutera inshinge hamwe nogukaraba sterile, cyangwa mugukaraba ibikoresho (gukaraba neza), gukaraba burundu ibyuma bya reberi, kubyara amavuta meza, hamwe nubuvuzi bwa clinique yamazi ya elegitoronike yumuti watewe inshinge za sterile, infusion, inshinge zamazi, nibindi. Kuberako imiti yateguwe yinjizwa mumubiri binyuze mumitsi cyangwa imiyoborere yimitsi, ibisabwa byujuje ubuziranenge ni byinshi cyane kandi bigomba kuba byujuje ibisabwa byatewe inshinge zitandukanye mubijyanye no kutabyara, kubura pyrogene, kumvikana, amashanyarazi agomba kuba > 1MΩ / cm, endotoxine ya bagiteri <0.25EU / ml, hamwe na mikorobe <50CFU / ml.

Ibindi bipimo by’amazi bigomba kuba byujuje ibipimo by’imiti y’amazi meza kandi bikagira ingufu nkeya za karubone (urugero rwa ppb).Ibi birashobora gukurikiranwa hifashishijwe isesengura ryihariye rya karubone isanzwe, ishobora kwinjizwa mumazi yo gutera inshinge cyangwa umuyoboro wo kugaruka kugirango icyarimwe ikurikirane amashanyarazi hamwe nagaciro k'ubushyuhe.Usibye kuba wujuje ibisabwa byamazi meza, amazi yatewe inshinge agomba no kuba afite bacteri zingana na <50CFU / ml hanyuma agatsinda ikizamini cya pyrogene.

Ukurikije amabwiriza ya GMP, sisitemu y’amazi meza kandi yatewe inshinge zigomba kwemezwa na GMP mbere yuko zikoreshwa.Niba ibicuruzwa bigomba koherezwa hanze, bigomba kandi kubahiriza ibisabwa bijyanye na USP, FDA, cGMP, nibindi. Kugira ngo byoroherezwe gukoreshwa hamwe nubuhanga butandukanye bwo kuvura kugirango bakureho umwanda mumazi, Imbonerahamwe 1 irerekana urutonde rwamazi asabwa muri USP GMP n'ingaruka z'uburyo butandukanye bwo kuvura bwo gukuraho umwanda mu mazi nkuko bikubiye mu mabwiriza yo gushyira mu bikorwa Ubushinwa GMP.Gutegura, kubika, no gukwirakwiza amazi yo gutera inshinge bigomba gukumira ikwirakwizwa no kwanduza mikorobe.Ibikoresho bikoreshwa mu bigega byo kubika no mu miyoboro bigomba kuba bidafite uburozi kandi birwanya ruswa.Igishushanyo nogushiraho imiyoboro igomba kwirinda impera zipfuye hamwe nimiyoboro ihumye.Hagomba gushyirwaho inzinguzingo zo gusukura no kuboneza urubyaro.Icyambu cyo guhumeka ikigega cyo kubika amazi yatewe inshinge kigomba gushyirwaho hamwe na hydrophobique bactericidal filter idatanga fibre.Amazi yo guterwa arashobora kubikwa ukoresheje ubushyuhe buri hejuru ya 80 ℃, kuzenguruka ubushyuhe hejuru ya 65 ℃, cyangwa ububiko buri munsi ya 4 ℃.

Imiyoboro ikoreshwa mubikoresho byo kwitegura amazi yo gutera inshinge muri rusange ikoresha plastike ya ABS yubuhanga cyangwa PVC, PPR, cyangwa nibindi bikoresho bikwiye.Nyamara, uburyo bwo gukwirakwiza amazi asukuye n’amazi yo gutera inshinge bigomba gukoresha ibikoresho bijyanye nu miti yo kwanduza imiti, pasteurisation, guhagarika ubushyuhe, nibindi, nka PVDF, ABS, PPR, nibyiza cyane ibyuma bitagira umwanda, cyane cyane ubwoko bwa 316L.Ibyuma bitagira umwanda ni ijambo rusange, tuvuze rwose, rigabanijwemo ibyuma bitagira umwanda hamwe nicyuma kirwanya aside.Ibyuma bitagira umwanda ni ubwoko bwibyuma birwanya ruswa nibitangazamakuru bidakomeye nkumwuka, umwuka, namazi, ariko ntibishobora kwangirika kwangirika nibitangazamakuru bitera imiti nka acide, alkalis, numunyu, kandi bifite imiterere idafite umwanda.

.Iyo umubare wa Reynolds Re ugeze ku 10,000 kandi ugakora urujya n'uruza, birashobora gutuma habaho ibihe bibi kugirango imikurire ya mikorobe ikure.Ibinyuranye na byo, niba amakuru arambuye yuburyo bwa sisitemu yamazi nogukora bititabwaho, bikavamo umuvuduko muke cyane, inkuta zumuyoboro utoroshye, cyangwa imiyoboro ihumye mumuyoboro, cyangwa gukoresha imiyoboro idakwiye yubatswe, nibindi, mikorobe irashobora rwose Wishingikirize kumiterere ifatika yatewe no kwiyubakira ubworozi bwabo - biofilm, izana ingaruka nibibazo kumikorere no gucunga buri munsi amazi meza hamwe na sisitemu yo gutera inshinge.

(II) Ibisabwa byibanze kuri sisitemu yo gutera inshinge

Sisitemu yo gutera inshinge igizwe nibikoresho byo gutunganya amazi, ibikoresho byo kubikamo, pompe zo gukwirakwiza, hamwe nimiyoboro.Sisitemu yo gutunganya amazi irashobora kwanduzwa n’amazi meza n’ibintu byo hanze.Guhumanya amazi mabi nisoko nyamukuru yo kwanduza sisitemu yo gutunganya amazi.Pharmacopeia yo muri Amerika, Pharmacopeia yu Burayi, na Pharmacopeia yo mu Bushinwa byose birasaba neza ko amazi meza y’amazi ya farumasi agomba kuba yujuje nibura ubuziranenge bw’amazi yo kunywa.Niba amazi yo kunywa atujujwe, hagomba gufatwa ingamba zo kubanza kubivura.Kubera ko coli ya Escherichia ari ikimenyetso cy’amazi yanduye, hari ibisabwa bigaragara kuri Escherichia coli mumazi yo kunywa ku rwego mpuzamahanga.Izindi bagiteri zanduza ntizigabanijwe kandi zigaragara mubipimo nka "bagiteri zose zibara".Ubushinwa buteganya urugero rwa bagiteri 100 / ml ku mubare wa bagiteri zose, byerekana ko hari mikorobe yanduye mu mazi mbisi yujuje ubuziranenge bw’amazi yo kunywa, kandi na bagiteri nyamukuru zanduza sisitemu zo gutunganya amazi ni bacteri za Gram-mbi.Ibindi bintu nkibyambu bitarinze kurindwa kubigega byabitswe cyangwa gukoresha filtri ntoya, cyangwa gutemba kwamazi ava mumasoko yanduye, birashobora kandi gutera umwanda hanze.

Byongeye kandi, hariho umwanda w'imbere mugihe cyo gutegura no gukoresha sisitemu yo gutunganya amazi.Kwanduza imbere bifitanye isano rya bugufi no gushushanya, guhitamo ibikoresho, gukora, kubungabunga, kubika, no gukoresha uburyo bwo gutunganya amazi.Ibikoresho bitandukanye byo gutunganya amazi birashobora guhinduka isoko yimbere yo kwanduza mikorobe, nka mikorobe mvaruganda mumazi mbisi yamamazwa hejuru ya karubone ikora, ibisigara byo guhana ion, membrane ultrafiltration, nibindi bikoresho, bigakora biofilm.Microorganism ziba muri biofilm zirinzwe na biofilm kandi muri rusange ntabwo ziterwa nudukoko.Indi soko yanduye ibaho muri sisitemu yo gukwirakwiza.Microorganismes irashobora gukora ubukoloni hejuru yimiyoboro, imiyoboro, n'utundi turere hanyuma ikagwira aho, igakora ibinyabuzima, bityo bigahinduka isoko yanduye.Kubwibyo, ibigo bimwe byamahanga bifite amahame akomeye yo gushushanya uburyo bwo gutunganya amazi.

(III) Uburyo bwo gukoresha sisitemu y'amazi yo gutera

Urebye isuku isanzwe no kwanduza sisitemu yo gukwirakwiza imiyoboro, mubusanzwe hariho uburyo bubiri bwo gukoresha amazi meza no guterwa amazi.Imwe muriyo ni ibikorwa, aho amazi akorerwa mubice, bisa nibicuruzwa.Igikorwa cya "batch" kigamije ahanini gutekereza ku mutekano, kuko ubu buryo bushobora gutandukanya amazi runaka mugihe cyibizamini kugeza ikizamini kirangiye.Ibindi ni umusaruro uhoraho, uzwi ku izina rya "gukomeza", aho amazi ashobora gukorerwa mugihe akoreshwa.

IV) Gucunga buri munsi sisitemu y'amazi yo gutera inshinge Imicungire ya buri munsi ya sisitemu y'amazi, harimo gukora no kuyitaho, ifite akamaro kanini mukwemeza no gukoresha bisanzwe.Niyo mpamvu, hagomba gushyirwaho gahunda yo kubungabunga no gukumira hagamijwe kureba niba gahunda y’amazi ihora imeze neza.Ibirimo birimo:

Uburyo bwo gukoresha no gufata neza sisitemu y'amazi;
Gahunda yo gukurikirana ibipimo byingenzi byubuziranenge bwamazi nibipimo bikora, harimo na kalibibikoresho byingenzi;
Gahunda yo kwanduza bisanzwe / gahunda yo kuboneza urubyaro;
Gahunda yo kubungabunga ibikoresho byo gutunganya amazi;
Uburyo bwo gucunga ibikoresho bikomeye byo gutunganya amazi (harimo ibice byingenzi), uburyo bwo gukwirakwiza imiyoboro, nuburyo bukoreshwa.

Ibisabwa kubikoresho byabanje kuvurwa:

Ibikoresho byabanjirije gutunganya amazi meza bigomba gushyirwaho hakurikijwe ubwiza bw’amazi meza, kandi igisabwa ni ukubanza kuzuza igipimo cy’amazi yo kunywa.
Ibitangazamakuru byinshi byungurura hamwe nogukoresha amazi bigomba kuba bishobora gukora byogusubira inyuma, kuvugurura, no gusohora.
Akayunguruzo ka karubone ikora ni ahantu ibintu kama byegeranya.Mu rwego rwo kwirinda indwara ya bagiteri na bagiteri kwanduza endotoxine, hiyongereyeho icyifuzo cyo gukaraba mu buryo bwikora, kwanduza amavuta bishobora no gukoreshwa.
Kubera ko ubukana bwa 255 nm yumurambararo wumucyo UV uterwa na UV ugereranije nigihe, ibikoresho bifite igihe cyo gufata amajwi na metero zimbaraga birakenewe.Igice cyacengewe kigomba gukoresha 316L ibyuma bitagira umwanda, kandi itara rya quartz rigomba gutandukana.
Amazi asukuye nyuma yo kunyura mu buriri buvanze-deionizer agomba kuzenguruka kugirango amazi meza agabanuke.Nyamara, kuvanga-uburiri bwa deionizer birashobora gukuraho gusa cations na anion mumazi, kandi ntabwo ari byiza gukuraho endotoxine.

Ibisabwa kugirango habeho amazi yo guterwa (parike isukuye) mubikoresho byo gutunganya amazi: Amazi yo gutera inshinge arashobora kuboneka hakoreshejwe distillation, osmose revers, ultrafiltration, nibindi. Ibihugu bitandukanye byagaragaje uburyo busobanutse bwo gukora amazi yatewe, nka:

Pharmacopeia yo muri Leta zunze ubumwe za Amerika (integuro ya 24) ivuga ko “amazi yo gutera inshinge agomba kuboneka hifashishijwe uburyo bwo gutunganya amazi cyangwa guhinduranya osmose y’amazi yujuje ibisabwa n’ishyirahamwe ry’abanyamerika bashinzwe kurengera ibidukikije n’ibidukikije, Umuryango w’ubumwe bw’ibihugu by’Uburayi, cyangwa Ubuyapani busabwa n'amategeko.”
Pharmacopeia yo mu Burayi (integuro yo mu 1997) ivuga ko “amazi yo gutera inshinge abonwa no kuvoma neza amazi yujuje ubuziranenge bwemewe n'amategeko yo kunywa cyangwa amazi meza.”
Pharmacopeia yo mu Bushinwa (integuro ya 2000) isobanura ko "iki gicuruzwa (amazi yo gutera inshinge) ari amazi aboneka mu kuvoma amazi meza."Birashobora kugaragara ko amazi asukuye yabonywe no kuyungurura aribwo buryo bwemewe ku rwego mpuzamahanga bwo gutanga amazi yo gutera inshinge, mugihe umwuka mwiza ushobora kuboneka ukoresheje imashini imwe y’amazi yo kubitsa cyangwa amashanyarazi atandukanye.

Kurandura bigira ingaruka nziza zo kuvanaho ibintu kama n’ibinyabuzima bidahindagurika, harimo ibintu byahagaritswe, colloide, bagiteri, virusi, endotoxine, n’indi myanda iri mu mazi mbisi.Imiterere, imikorere, ibikoresho byuma, uburyo bwo gukora, nubwiza bwamazi meza yimashini yamazi ya distillation byose bizagira ingaruka kumiterere yamazi yatewe."Ingaruka-nyinshi" ya mashini yamazi yingirakamaro cyane yerekeza kubungabunga ingufu, aho ingufu zumuriro zishobora gukoreshwa inshuro nyinshi.Ikintu cyingenzi mugukuraho endotoxine mumashini yamazi ya distillation ni itandukanya amazi.