Cov qauv kev lag luam mis rau cov kav dej huv

GMP (Kev Tsim Khoom Zoo rau cov khoom siv mis nyuj, Kev Tsim Khoom Zoo rau Cov Khoom Siv Mis) yog cov ntawv luv ntawm Cov Khoom Siv Khoom Noj Zoo Tswj Xyuas thiab yog ib qho kev tswj xyuas qib siab thiab kev tshawb fawb rau cov khoom noj siv mis. Nyob rau hauv tshooj GMP, cov kev cai yuav tsum tau muab tso rau pem hauv ntej rau cov ntaub ntawv thiab tsim cov kav dej huv, uas yog, "Cov khoom siv hauv kev sib cuag ncaj qha nrog cov khoom siv mis nyuj yuav tsum du thiab tsis muaj qhov dents lossis tawg kom txo tau cov khoom noj khoom haus khib nyiab, av thiab cov organic teeb meem" , "Tag nrho cov cuab yeej tsim khoom yuav tsum tau tsim thiab tsim kom yooj yim ntxuav thiab tshuaj tua kab mob thiab tshuaj xyuas tau yooj yim." Cov kav dej huv huv muaj cov yam ntxwv ntawm kev ywj pheej thiab muaj zog tshaj lij. Yog li no, tsab xov xwm no piav qhia txog kev xaiv cov khoom siv hauv lub raj xa dej huv, qhov kev xav tau ntawm qhov chaw rau kev sib cuag nrog cov khoom siv mis nyuj, cov kav dej siv vuam yuav tsum, tus kheej-draining tsim, thiab lwm yam, aiming los txhim kho cov khoom noj siv mis thiab kev tsim kho chav tsev kom nkag siab txog qhov tseem ceeb ntawm cov kav dej huv. installation thiab kho.

 Txawm hais tias GMP tso siab rau cov kev cai nruj rau cov khoom siv thiab tsim cov kav dej huv, qhov tshwm sim ntawm cov khoom siv hnyav thiab cov kav dej sib txuas tseem muaj nyob hauv Suav teb kev lag luam mis nyuj. Raws li ib feem tseem ceeb ntawm cov khoom siv mis nyuj, cov kav dej huv huv tseem tau txais kev saib xyuas me ntsis. Tsis txaus tseem yog qhov txuas tsis muaj zog txwv kev txhim kho cov khoom noj siv mis. Piv nrog rau cov qauv tsim nyog ntawm kev lag luam mis nyuj txawv teb chaws, tseem muaj ntau chav rau kev txhim kho. Tam sim no, American 3-A cov qauv kev nyiam huv thiab European Hygienic Engineering Design Organization cov qauv (EHEDG) tau siv dav hauv kev lag luam mis nyuj txawv teb chaws. Nyob rau tib lub sijhawm, cov chaw tsim khoom siv mis nyuj hauv Wyeth Group hauv Tebchaws Meskas uas hais txog kev tsim cov khoom siv mis nyuj uas ua tau raws li cov qauv tshuaj tau txais ASME BPE tus qauv raws li kev qhia tshwj xeeb rau kev tsim thiab kev teeb tsa ntawm cov khoom siv hauv tsev siv mis thiab cov kav dej, uas tseem yuav tau txais kev pom zoo. tau qhia hauv qab no.

01

US 3-A cov qauv kev noj qab haus huv

American 3-A tus qauv yog ib qho kev lees paub thiab tseem ceeb thoob ntiaj teb tus qauv kev noj qab haus huv, pib los ntawm American 3-A Health Standards Company. Lub koom haum American 3A Sanitary Standards Corporation yog ib lub koom haum koom tes uas tsis muaj txiaj ntsig rau kev txhawb nqa kev tu cev ntawm cov khoom siv tsim khoom noj khoom haus, cov khoom siv dej haus, cov khoom siv mis nyuj thiab cov khoom siv tshuaj lag luam, uas feem ntau txhawb kev noj qab haus huv thiab kev nyab xeeb rau pej xeem.

Lub tuam txhab 3-A Hygiene Standards Company tau koom ua ke los ntawm tsib lub koom haum sib txawv hauv Tebchaws Meskas: American Dairy Producers Association (ADPI), International Federation of Food Industry Suppliers (IAFIS), thiab International Federation for Food Sanitation Protection (IAFP) , International Dairy Products Federation (IDFA), thiab 3-A Sanitary Standards Marking Council. 3A cov thawj coj suav nrog US Food and Drug Administration (FDA), US Department of Agriculture (USDA), thiab 3-A Pawg Thawj Coj.

US 3-A sanitary standard muaj cov kev cai nruj heev ntawm cov kav dej huv huv, xws li hauv 63-03 tus qauv rau cov kav dej huv huv:

(1) Tshooj C1.1, cov yeeb nkab fittings nyob rau hauv kev sib cuag nrog cov khoom siv mis nyuj yuav tsum tau ua los ntawm AISI300 series stainless hlau, uas yog corrosion-resistant, non-toxic thiab yuav tsis migrate tshuaj mus rau hauv cov khoom noj siv mis nyuj.

(2) Ntu D1.1, qhov roughness ntawm qhov chaw Ra tus nqi ntawm stainless hlau yeeb nkab fittings nyob rau hauv kev sib cuag nrog cov khoom siv mis nyuj yuav tsum tsis txhob ntau tshaj 0.8um, thiab cov ces kaum tuag, qhov, qhov khoob, thiab lwm yam yuav tsum tau zam.

(3) Ntu D2.1, vuam nto ntawm stainless hlau nyob rau hauv kev sib cuag nrog cov khoom siv mis nyuj yuav tsum seamless welded, thiab roughness Ra tus nqi ntawm vuam nto yuav tsum tsis txhob ntau tshaj 0.8um.

(4) Ntu D4.1, cov yeeb nkab fittings thiab cov khoom siv mis nyuj sib txuas yuav tsum yog tus kheej-draining thaum txhim kho kom zoo.

02

EHEDG Hygienic Design Standard for Food Machinery

European Hygienic Engineering & Design Group European Hygiene Engineering Design Group (EHEDG). Founded hauv 1989, EHEDG yog ib qho kev koom tes ntawm cov tuam txhab tsim khoom, cov tuam txhab kev lag luam khoom noj, thiab cov koom haum saib xyuas kev noj qab haus huv. Nws lub hom phiaj tseem ceeb yog los teeb tsa cov qauv kev huv huv rau kev lag luam khoom noj thiab ntim khoom.

EHEDG tsom rau cov khoom siv ua zaub mov uas yuav tsum muaj kev tu cev zoo thiab yooj yim los ntxuav kom tsis txhob muaj kab mob microbial. Yog li ntawd, cov cuab yeej siv yuav tsum yooj yim los ntxuav thiab tiv thaiv cov khoom los ntawm kev sib kis.

Nyob rau hauv EHEDG's "Cov Lus Qhia Txog Cov Khoom Siv Huv Huv Huv Huv 2004 Thib Ob Tsab Cai", cov kav dej tau piav qhia raws li hauv qab no:

(1) Tshooj 4.1 feem ntau yuav tsum siv cov hlau tsis muaj steel nrog corrosion kuj zoo;

(2) Thaum tus nqi pH ntawm cov khoom hauv Tshooj 4.3 nyob nruab nrab ntawm 6.5-8, chloride concentration tsis tshaj 50ppm, thiab qhov kub tsis tshaj 25 ° C, AISI304 stainless hlau lossis AISI304L qis carbon hlau uas yooj yim rau vuam. feem ntau yog xaiv; Yog hais tias cov tshuaj chloride concentration Yog tias nws siab tshaj 100ppm thiab kev khiav hauj lwm kub siab tshaj 50 ℃, cov ntaub ntawv uas muaj zog corrosion kuj yuav tsum tau siv los tiv thaiv pitting thiab crevice corrosion tshwm sim los ntawm chloride ions, yog li zam chlorine residues, xws li AISI316 stainless hlau, thiab tsawg. carbon hlau. AISI316L muaj kev sib txuas zoo thiab tsim nyog rau cov kav dej.

(3) Sab hauv ntawm cov kav dej hauv Tshooj 6.4 yuav tsum yog tus kheej-drainable thiab yooj yim los ntxuav. Kab rov tav yuav tsum tau zam, thiab lub inclination lub kaum sab xis yuav tsum tau tsim kom tsis txhob tsub zuj zuj ntawm cov dej seem.

(4) Ntawm cov khoom sib cuag saum npoo hauv Tshooj 6.6, qhov sib txuas vuam yuav tsum yog seamless thiab tiaj tus thiab du. Thaum lub sij hawm vuam txheej txheem, kev tiv thaiv roj inert yuav tsum tau siv rau sab hauv thiab sab nraud sib koom ua ke kom tsis txhob oxidation ntawm cov hlau vim qhov kub thiab txias. Rau cov kav dej, yog tias muaj kev tsim kho (xws li qhov chaw loj lossis qhov chaw ua haujlwm) tso cai, nws raug nquahu kom siv lub tshuab orbital vuam ntau npaum li qhov ua tau, uas tuaj yeem tswj tau qhov vuam tsis zoo thiab vuam hlaws zoo.

03

American ASME BPE tus qauv

ASME BPE (Asmeskas zej zog ntawm cov neeg kho tshuab engineering, Bio Processing Equipment) yog tus qauv tsim los ntawm American Society of Mechanical Engineers los tswj kev tsim, khoom siv, kev tsim khoom, tshuaj xyuas thiab kuaj cov khoom siv bioprocessing thiab cov kav dej thiab lawv cov khoom txuas ntxiv.

Tus txheej txheem tau luam tawm thawj zaug hauv xyoo 1997 kom ua tiav cov qauv zoo ib yam thiab cov qib siab zoo rau cov khoom siv tsim khoom siv hauv cov khoom hauv kev lag luam biopharmaceutical. Raws li tus qauv thoob ntiaj teb, ASME BPE ua raws li cov kev cai thiab cov cai ntawm kuv lub teb chaws GMP thiab US FDA. Nws yog ib qho tseem ceeb specification siv los ntawm FDA los xyuas kom meej ntau lawm. Nws yog tus qauv tseem ceeb rau cov khoom siv thiab cov khoom lag luam, cov chaw muag khoom, cov tuam txhab engineering thiab cov neeg siv khoom. Ib qho qauv tsis tsim nyog uas tau koom ua ke txhawb nqa thiab tsim kho thiab hloov kho ib ntus.

3-A, EHEDG, ASME BPE daim ntawv pov thawj kev noj qab haus huv tus qauv

Txhawm rau kom ntseeg tau tias cov khoom lag luam huv huv thiab txo qhov kev pheej hmoo ntawm cov khoom sib kis, ASME BPE tus qauv muaj cov lus piav qhia tshwj xeeb ntawm kev siv vuam tshuab tsis siv neeg. Piv txwv li, 2016 version muaj cov kev cai hauv qab no:

(1) SD-4.3.1(b) Thaum siv cov kav hlau stainless, 304L lossis 316L feem ntau xaiv cov khoom siv. Tsis siv neeg orbital vuam yog txoj kev nyiam ntawm cov yeeb nkab txuas. Hauv chav huv, cov khoom siv yeeb nkab yog ua los ntawm 304L lossis 316L cov khoom. Tus tswv, kev tsim kho thiab cov chaw tsim khoom yuav tsum tau ua tiav qhov kev pom zoo ntawm txoj kev sib txuas ntawm cov yeeb nkab, qib tshuaj xyuas thiab cov qauv kev lees paub ua ntej kev teeb tsa.

(2) MJ-3.4 pipeline welding tsim yuav tsum siv orbital tsis siv neeg vuam, tshwj tsis yog qhov loj lossis qhov chaw tsis tso cai. Hauv qhov no, tes vuam tuaj yeem ua tau, tab sis tsuas yog nrog kev pom zoo ntawm tus tswv lossis tus neeg cog lus.

(3) MJ-9.6.3.2 Tom qab tsis siv neeg vuam, tsawg kawg 20% ​​ntawm cov hlaws hauv cov hlaws yuav tsum tau randomly soj ntsuam nrog ib tug endoscope. Yog tias cov hlaws tsis tsim nyog tau tshwm sim thaum lub sijhawm kuaj vuam, kev tshuaj xyuas ntxiv yuav tsum tau ua raws li qhov yuav tsum tau ua ntawm qhov tshwj xeeb kom txog rau thaum nws tau txais.

04

Kev siv thoob ntiaj teb cov qauv kev lag luam mis nyuj

3-A tus qauv kev tu cev tau yug los hauv xyoo 1920 thiab yog tus qauv thoob ntiaj teb siv los ua qauv kev tu cev ntawm cov khoom siv hauv kev lag luam mis nyuj. Txij li thaum nws txoj kev loj hlob, yuav luag tag nrho cov tuam txhab mis nyuj, cov tuam txhab engineering, cov tuam txhab tsim khoom, thiab cov neeg sawv cev hauv North America tau siv nws. Nws kuj yog feem ntau txais nyob rau hauv lwm qhov chaw ntawm lub ntiaj teb no. Cov tuam txhab tuaj yeem thov rau 3-A daim ntawv pov thawj rau cov kav dej, cov yeeb nkab fittings, li qub, twj tso kua mis thiab lwm yam khoom siv huv. 3-A yuav npaj cov kws tshuaj ntsuam xyuas los ua cov khoom lag luam ntawm qhov chaw kuaj thiab ntsuas kev lag luam, thiab muab daim ntawv pov thawj kev noj qab haus huv 3A tom qab dhau qhov kev tshuaj xyuas.

Txawm hais tias European EHEDG tus qauv kev noj qab haus huv pib tom qab US 3-A tus qauv, nws tau tsim sai heev. Nws cov txheej txheem ntawv pov thawj yog nruj dua li US 3-A tus qauv. Lub tuam txhab thov yuav tsum xa cov khoom pov thawj mus rau lub chaw kuaj mob tshwj xeeb hauv Tebchaws Europe rau kev sim. Piv txwv li, nyob rau hauv qhov kev ntsuam xyuas ntawm lub twj tso kua mis centrifugal, tsuas yog thaum nws tau txiav txim siab tias lub peev xwm ntawm tus kheej tu lub twj tso kua mis yog yam tsawg kawg nkaus tsis muaj tsawg tshaj li tus kheej tu lub peev xwm ntawm cov txuas ncaj pipelines, lub EHEDG daim ntawv pov thawj cim yuav tsum tau. ib lub sij hawm teev tseg.

ASME BPE tus qauv muaj keeb kwm ze li ntawm 20 xyoo txij li thaum nws tsim nyob rau hauv 1997. Nws yog siv nyob rau hauv yuav luag tag nrho cov loj biopharmaceutical industries thiab engineering tuam txhab uas muag, khoom manufacturers, thiab cov neeg sawv cev. Hauv kev lag luam khoom noj siv mis, Wyeth, ua lub tuam txhab Fortune 500, nws cov chaw tsim khoom siv mis nyuj tau txais ASME BPE cov qauv raws li kev qhia tshwj xeeb rau kev tsim thiab kev teeb tsa cov khoom siv hauv tsev thiab cov kav dej. Lawv tau txais txiaj ntsig kev tswj hwm cov ntsiab lus ntawm cov chaw tsim tshuaj thiab tau txais kev siv tshuab vuam tsis siv neeg los tsim cov khoom siv mis nyuj ua cov kab ntau lawm.

Tsis siv neeg vuam tshuab txhim kho cov khoom noj siv mis zoo

Niaj hnub no, raws li lub teb chaws them nyiaj rau kev nyab xeeb ntawm zaub mov, kev nyab xeeb ntawm cov khoom siv mis nyuj tau dhau los ua qhov tseem ceeb tshaj plaws. Raws li tus neeg muag khoom ntawm cov khoom siv hauv tsev siv mis nyuj, nws yog lub luag haujlwm thiab lub luag haujlwm los muab cov khoom siv zoo thiab cov khoom siv uas pab ua kom cov khoom siv mis nyuj zoo.

Tsis siv neeg vuam tshuab tuaj yeem ua kom ntseeg tau qhov sib xws ntawm vuam yam tsis muaj kev cuam tshuam ntawm tib neeg, thiab cov txheej txheem vuam tsis xws li tungsten pas nrig nrug, tam sim no, thiab kev sib hloov ceev yog ruaj khov. Programmable tsis thiab tsis siv neeg kaw ntawm vuam tsis yog ib qho yooj yim kom tau raws li tus qauv yuav tsum tau thiab cov vuam ntau lawm efficiency siab. Raws li pom nyob rau hauv daim duab 3, cov kav dej renderings tom qab tsis siv neeg vuam.

Kev khwv tau los yog ib qho ntawm cov khoom lag luam uas txhua tus lag luam ua lag luam yuav tsum xav txog. Los ntawm kev txheeb xyuas tus nqi, nws pom tau tias kev siv cov tshuab vuam tsis siv neeg tsuas yog xav tau lub tuam txhab tsim kho kom muaj lub tshuab vuam tsis siv neeg, tab sis tag nrho cov nqi ntawm lub tuam txhab cov khoom noj siv mis yuav txo qis heev:

1. Txo cov nqi zog rau cov kav raj xa dej;

2. Vim tias cov hlaws hlaws zoo li qub thiab zoo huv si, thiab nws tsis yooj yim rau kev tsim cov fab tuag, tus nqi ntawm cov kav dej txhua hnub CIP tu yog txo;

3. Cov kev pheej hmoo ntawm kev nyab xeeb ntawm cov raj xa dej tau txo qis heev, thiab kev lag luam cov nqi kev nyab xeeb kev nyab xeeb raug txo qis heev;

4. Lub vuam zoo ntawm cov kav dej yog txhim khu kev qha, qhov zoo ntawm cov khoom siv mis nyuj yog guaranteed, thiab cov nqi ntawm cov khoom kuaj thiab cov kav dej yuav txo tau.