1.Txoj kev xav tau rau kev ua haujlwm ntawm cov khoom siv tshuaj:
(1) Purification muaj nuj nqi;
(2) Kev ua haujlwm huv;
(3) Kev saib xyuas online thiab tswj kev ua haujlwm;
(4) Kev tiv thaiv kev nyab xeeb muaj nuj nqi;
2.GMP muaj cov cai hauv qab no rau cov khoom siv tshuaj:
(1) Nws yuav tsum muaj cov cuab yeej tsim nyog rau kev tsim khoom thiab kev lag luam zoo tshaj plaws, tsim nyog thiab muaj kev nyab xeeb;
(2) Nws yuav tsum muaj kev ua haujlwm zoo tshaj plaws thiab ntau yam kev hloov pauv kom tau raws li cov txheej txheem tshuaj;
(3) Nws tuaj yeem ua kom ntseeg tau qhov zoo sib xws hauv kev ua tshuaj;
(4) Yooj yim rau kev khiav lag luam thiab tswj;
(5) Yooj yim los ntxuav cov khoom siv sab hauv thiab sab nraud;
(6) Nws yuav tsum muaj ntau yam sib cuam tshuam kom ua tau raws li qhov yuav tsum tau ua ntawm kev sib koom tes, sib koom ua ke thiab ua ke;
(7) Ib qho yooj yim rau nruab thiab txav tau yooj yim, uas muab kev sib xyaw ua ke;
(8) Kev txheeb xyuas cov khoom siv (nrog rau hom, qauv, kev ua haujlwm, thiab lwm yam);
3.Granulation txoj kevdav siv nyob rau hauv kev tsim tshuaj yuav muab faib ua: ntub granulation, qhuav granulation thiab tshuaj tsuag granulation. High-efficiency mixing granulator yog ib qho cuab yeej uas hloov cov ntaub ntawv ntub rau hauv granules los ntawm kev sib xyaw nrog cov agitators thiab txiav nrog high-speed granulators. Muaj nuj nqi: sib tov thiab granulation;
4.Reactor nrog lub tshuab nplawm yog cov khoom siv hluav taws xob uas siv dav hauv kev lag luam tshuaj. Muaj peb hom agitators: radial flow, axial flow thiab tangential flow;
5.Qee yam agitators: (1) paddle agitator: Paddle agitators muaj ib tug loj radial mixing ntau yam thiab yuav siv tau rau tov high viscosity kua; (2) Anchor thiab thav duab agitators feem ntau yog siv rau kev sib xyaw cov kua nruab nrab thiab siab viscosity; (3) helical ribbon agitator: lub hom phiaj: Cov kua yuav nce los yog poob raws lub helicoid los txhim kho cov nyhuv axial sib xyaw, tsim cov axial ncig; Helical ribbon agitator feem ntau yog siv rau kev sib xyaw ntawm cov kua viscosity siab;
6.Qhov sib txawv ntawm cov khoom siv fermentation thiab cov reactor: Cov khoom fermentation muaj defoaming paddles thiab vent yeeb nkab; Hauv fermentation tso tsheb hlau luam, disc turbine agitators yog dav siv;
7.Cyclone separator yog cov khoom siv hluav taws xob qhuav sib cais uas cais cov plua plav tawm ntawm cov huab cua los ntawm kev siv lub zog centrifugal uas tsim los ntawm kev kub ceev rotating gaseous heterogeneous theem. Nws muaj cov qauv yooj yim thiab muaj zog ua haujlwm yooj yim. Rau kev ntxiab plua plav saum toj 5 ~ 10μm, qhov ua tau zoo yog siab tab sis rau kev sib cais ntawm cov hmoov av zoo, qhov ua tau zoo yuav qis dua. Lub hnab lim yog ib yam khoom sib cais uas siv cov khoom lim cais cov khoom ntawm cov plua plav. Kev sib cais ua haujlwm ntawm 1 ~ 5 μm cov khoom zoo yog ntau dua 99 feem pua, thiab cov plua plav ntawm 1 micron lossis txawm tias 0.1 microns tuaj yeem raug tshem tawm, tab sis qhov pom kev ua haujlwm tsawg;
8.Leaching khoom hom raws li leaching txoj kev: decoction khoom; khoom siv impregnation; cov khoom siv seepage; cov khoom siv reflow;
9.Lub hauv paus ntsiab lus ntawm ultrasonic extraction yog siv cov nyhuv cavitation, mechanical nyhuv thiab thermal nyhuv ntawm ultrasonic tsis;
10.Lub hauv paus ntsiab lus ntawm kev sib cais ntawm daim nyias nyias: Membrane yog qib molecular sib cais thiab pom qhov nruab nrab, thaum cov tshuaj los yog cov pa sib xyaw ua ke los ntawm cov membrane, nyob rau hauv qhov kev txiav txim ntawm lub siab, hluav taws xob teb los yog qhov kub thiab txias sib txawv, qee yam khoom tuaj yeem dhau los ntawm daim nyias nyias. , thaum lwm yam khoom raug xaiv los cuam tshuam, kom cov khoom sib txawv hauv cov tshuaj lossis cov khoom sib txawv ntawm cov roj sib xyaw sib cais, qhov kev sib cais no yog kev sib cais ntawm qib molecular;
11.Muaj ntau hom membranes, uas tuaj yeem muab faib ua ob pawg: organic siab polymer membranes thiab inorganic membranes. Tam sim no, cov khoom siv dav tshaj plaws hauv kev lag luam tshuaj ntau lawm yog polysulfone (PS) cov ntaub ntawv, suav txog li 32 feem pua; Cellulose cov ntaub ntawv, Cellulose acetate (CA) thiab cellulose triacetate (CTA) account rau 13 feem pua thiab 7 feem pua; Polypropylene (PAN) tso nyiaj rau 6 feem pua; Inorganic membranes suav txog 22 feem pua; Lwm cov ntaub ntawv membrane yog li 20 feem pua;
12.Classification ntawm tubular nyias zaj duab xis evaporator: nce toj-zaj duab xis evaporator, ntog-zaj duab xis evaporator thiab nce-poob zaj duab xis evaporator. Lub nce toj-zaj duab xis evaporative concentration cov cuab yeej hais txog cov kua zaj duab xis tsim nyob rau hauv lub evaporator nyob rau hauv tib txoj kev raws li cov evaporated theem nrab cov pa roj ntws, nce hauv qab mus rau saum. Nws yog tsim los ntawm plaub qhov chaw: evaporative cua sov raj, theem nrab chav ua npuas ncauj catheter, separator thiab ncig raj;
13.Tubular nyias zaj duab xis evaporator: Cov kua evaporates raws phab ntsa ntawm lub raj cua sov rau hauv zaj duab xis; Scraper evaporator: Ib qho khoom siv evaporation uas tsim cov yeeb yaj kiab ua kua los ntawm kev tig scraper; Centrifugal nyias zaj duab xis evaporator: Ib zaj duab xis nyias yog tsim los ntawm lub zog centrifugal generated los ntawm rotating centrifugal disc nyob rau hauv periphery ntawm cov tshuaj;
14.Lub hauv paus ntsiab lus ntawm molecular distillation: Molecular distillation yog qhov sib cais sai ntawm cov kua ntawm qhov kub thiab txias hauv qab nws qhov kub thiab txias hauv qab lub tshuab nqus tsev siab heev, nyob ntawm qhov sib txawv ntawm txoj kev tsis pub dawb ntawm cov molecular kev sib xyaw;
15.Txoj kev dawb ntawm molecular txav yog hais txog qhov kev ncua deb ntawm ob qhov kev sib tsoo ntawm ib lub molecule uas nyob ib sab mus rau lwm lub molecule. Txoj kev dawb ntawm molecular tsab ntawv tsa suab yog hais txog qhov nruab nrab ntawm txoj kev dawb hauv ib lub sij hawm luv luv;
16.Drying khoom: tais tshuab ziab khaub ncaws, siv tshuab ziab khaub ncaws, fluidized txaj tshuab ziab khaub ncaws, tshuab ziab khaub ncaws, tshuab nqus tsev desiccator, lub tshuab nqus tsev vacuum, microwave nqus desiccator;
17.Process dej yog cov dej siv hauv kev tsim tshuaj, suav nrog: dej haus,dej huvthiab WFI;
18.Sterilization: lub cev ua kom tsis muaj menyuam, tshuaj lom neeg kom tsis muaj menyuam, ua haujlwm aseptic. Lub cev ua kom tsis muaj menyuam: qhuav cua sov kom tsis muaj menyuam, noo noo cua sov kom tsis muaj menyuam, tawg hluav taws xob, pom kom tsis muaj menyuam. Lub cev ua kom tsis muaj menyuam yog siv dav hauv kev lag luam kws tshuaj;
19.Principle of dry heat sterilization: Principple of thermal sterilization: Cua sov tuaj yeem rhuav tshem cov hydrogen daim ntawv cog lus hauv cov protein thiab nucleic acids, yog li nws ua rau kev puas tsuaj rau nucleic acid, protein denaturation lossis coagulation. Enzymes poob lawv cov haujlwm thiab cov kab mob tuag. Qhuav cua sov kom tsis muaj menyuam muaj xws li nplaim taws sterilization, qhuav cua sov cua kom tsis muaj menyuam thiab cov cua kub ceev kom tsis muaj menyuam txoj kev. Cov khoom siv cua sov kom tsis muaj menyuam: qhov cub, qhov cub kom sov kom tsis muaj menyuam, qhov hluav taws kub kom tsis muaj menyuam.
20.Principle of moist heat sterilization: Moist heat sterilization is a method of killing bacteria using saturated water vapor or boiling water. Vim qhov loj latent cua sov ntawm chav, thiab nws muaj zog nkag mus, nws yog ib qho yooj yim rau denature los yog coagulate proteins, yog li ntawd lub sterilization efficiency yog siab dua li ntawm qhuav tshav kub sterilization. Qhov tsis zoo yog tias nws tsis haum rau cov tshuaj uas nkag siab rau damp cua sov. Moist heat sterilization muaj xws li siab kom tsis muaj menyuam, ntws chav kom tsis muaj menyuam, boiling sterilization thiab qis-kub tsis sib xws sterilization. Moist heat sterilization khoom: kub siab sterilizer, kub siab sterilization txee.
21.Cov txheej txheem ntawm ampoule filling thiab sealing feem ntau muaj xws li: ampoule npaj nyob rau hauv kev txiav txim, filling, inflation, sealing thiab lwm yam txheej txheem. Lub filling feem ntau yog tsim los ntawm lub cam lever ntaus ntawv, ib tug suction thiab filling ntaus ntawv, thiab lub raj mis-defusing ntaus ntawv.
22.Rau cov ampoules uas tsim los ntawm txoj kev ua kom tsis muaj menyuam, kev ua kom tsis muaj menyuam, tshuaj tua kab mob thiab tua tsiaj yog feem ntau nqa tawm tam sim ntawd tom qab cov txheej txheem filling thiab sealing.
23.Metering hloov hom: ntsuas khob metering thiab metering twj tso kua mis metering;
24.Types ntawm ntim rau cov ntsiav tshuaj thiab tshuaj ntsiav: (1) strip packing, mas heat-sealing packing in strip shape; (2) blister ntim; (3) ntim ntim zoo li lub raj mis ntim lossis ntim hnab;
25.Classification ntawm kev ntim tshuaj: 1. unit dose ntim; 2. sab hauv pob; 3. sab nrauv pob;
26.Pharmaceutical engineering tsim feem ntau tuaj yeem muab faib ua peb theem tseem ceeb: kev ua haujlwm ua ntej tsim (nrog rau cov lus pom zoo ntawm lub sijhawm ua haujlwm, daim ntawv qhia txog kev xaiv qhov chaw, daim ntawv qhia ua ntej kev tshawb fawb thiab kev tshawb fawb txog qhov ua tau), kev tsim ua ntej thiab kev tsim qauv kos duab. Kev tsim cov duab kos duab yog ib qho ntawm cov haujlwm tseem ceeb tshaj plaws ntawm kev ua haujlwm ntawm lub tuam tsev tsim;
27.Plant site xaiv: Qhov kev ncua deb ntawm lub qhov hluav taws xob cua ntshiab ntawm lub rhiav huv ntawm kev lag luam kws tshuaj thiab txoj kab liab ntawm txoj kev tsheb ciav hlau hauv nroog ze rau ntawm txoj kev sab hauv yuav tsum siab tshaj 50m. GMP xav kom cov kws tsim tshuaj yuav tsum muaj chaw tsim khoom huv si. Feem ntau, cov chaw tsim tshuaj yog xaiv zoo tshaj plaws nyob rau hauv cheeb tsam uas muaj huab cua zoo, tsis muaj pa phem, thiab tsis muaj dej thiab av ua paug, thiab sim kom tsis txhob muaj cov pa phem ntau xws li thaj chaw hauv nroog, thaj chaw tshuaj lom neeg, thaj chaw aeolian xuab zeb, railways thiab kev loj. Yog li nyob rau hauv cov ntaub ntawv no, huab cua, qhov chaw, thiab dej zoo ntawm ib puag ncig nyob rau hauv uas cov chaw tsim tshuaj paus nyob rau hauv yuav ua tau raws li qhov yuav tsum tau ntawm ntau lawm;
28.Principles of process design:
(1) Raws li qhov ua tau, cov cuab yeej siv siab heev, cov txheej txheem ntau lawm thiab kev ua tiav kev tshawb fawb thiab thev naus laus zis tau siv los ua kom cov khoom zoo
(2) "siv cov ntaub ntawv hauv zos", kom siv tag nrho cov khoom siv hauv zos kom ua tiav cov txiaj ntsig kev lag luam zoo tshaj plaws;
(3) Cov cuab yeej siv tau zoo heev, txo cov khoom siv raw, dej thiab hluav taws xob thiab tus nqi ntawm cov khoom;
(4) Raws li GMP cov cai, txhua daim ntawv tshuaj noj yuav tsum muaj nws cov txheej txheem tsim. Xws li qhov ncauj khoom npaj thiab suppositories yog tsim raws li cov txheej txheem pa; Cov tshuaj pleev ib ce sab nraud, cov tshuaj hauv qhov ncauj, thiab cov tshuaj txhaj tshuaj (loj infusions, txhaj tshuaj me me), yog tsim los ntawm txoj kev ua kom tsis muaj menyuam; Cov hmoov tsis muaj menyuam rau kev txhaj tshuaj yuav tsum tau tsim nrog cov txheej txheem aseptic;
(5) -lactam tshuaj (xws li penicillins thiab cephalosporins) yog tsim los raws li cov txheej txheem khiav ntawm cov nroj tsuag cais. Cov tshuaj suav tshuaj suav tshuaj thiab kev npaj tshuaj biochemical suav nrog pretreatment, extraction, thiab concentration (evaporation) ntawm Suav tshuaj ntsuab nrog rau kev ntxuav lossis kho tsiaj cov kabmob, cov ntaub so ntswg thiab lwm yam kev ua haujlwm, raws li cov txheej txheem pretreatment tsim yuav tsum tau teem caij rau hauv. kev sib cais pretreatment Rhiav, thiab yuav tsum tsis txhob tov nrog cov txheej txheem tsim khoom ntawm lawv cov kev npaj;
(6) Lwm yam xws li cov tshuaj tiv thaiv kab mob, cov tshuaj hormones, tshuaj tua kab mob, tshuaj tua kab mob, cov kab mob toadstool, cov kab mob uas tsis yog cov khoom tsim tawm, cov hlwb tsim tawm thiab cov hlwb tsis muaj zog, muaj zog thiab tsis muaj zog, cov neeg tuag thiab cov kab mob nyob, cov tshuaj tiv thaiv kab mob ua ntej thiab tom qab detoxification thiab inactivated tshuaj tiv thaiv. , tib neeg cov khoom siv ntshav, tiv thaiv cov khoom siv ntau npaum li cas thiab kev npaj, txhua yam yuav tsum tau tsim thiab tsim raws li lawv cov kev cai tshwj xeeb rau cov txheej txheem tsim;
29.Cov ntsiab lus ntawm lub rooj cob qhia layout tsim nyob rau hauv lub preliminary tsim theem:
(1) Raws li "Kev Tswj Xyuas Zoo thiab Kev Tswj Xyuas Tshuaj Zoo (GMP thiab QC ntawm Cov Tshuaj)", txiav txim siab qib kev huv ntawm txhua tus txheej txheem hauv kev cob qhia;
(2) Cov txheej txheem tsim khoom, cov chaw pabcuam tsim khoom, nyob rau hauv kev tswj xyuas cov chaw pabcuam ntawm lub tiaj tus, peb-dimensional layout;
(3) Rhiav qhov chaw thiab cov tsev, qhov chaw thiab qhov ntev ntawm cov qauv;
(4) Pav ca, peb-seem txheej txheem ntawm cov cuab yeej;
(5) Aisle system, tsim khoom thauj khoom;
(6) Lub tiaj tus thiab qhov chaw tsim rau kev teeb tsa, kev ua haujlwm, thiab kev saib xyuas;
30.Cov ntsiab lus ntawm layout tsim thaum lub sij hawm tsim qauv tsim:
(1) Siv cov ntsiab lus ntawm kev cob qhia layout hauv kev tsim ua ntej;
(2) Txiav txim siab qhov taw qhia thiab qhov siab ntawm cov cuab yeej nozzle thiab ntsuas qhov sib txuas;
(3) Cov khoom siv thiab cov khoom siv txav, tsim kev thauj mus los;
(4) Txiav txim siab qhov ntev ntawm lub tsev hais txog kev teeb tsa ntawm cov khoom siv;
(5) Txiav txim siab cov cuab yeej teeb tsa kev teeb tsa;
(6) Npaj cov kev taw qhia ntawm cov kav dej, cov twj paj nruag, cov kav dej hluav taws xob, txiav txim siab qhov chaw ntawm cov yeeb nkab gallery;
31.Cov ntsiab lus ntawm cov kav dej tsim:
(1) Xaiv cov yeeb nkab;
(2) Pipeline suav;
(3) Kev tsim cov raj xa dej;
(4) Tsim cov raj xa dej rwb thaiv tsev;
(5) Tsim cov kav dej txhawb nqa;
(6) Sau tus qauv tsim;
32.Raws li kev siv chav huv yog muab faib ua: chav huv huv thiab chav huv huv; ib puag ncig ntawm kev tsim tshuaj rhiav tuaj yeem muab faib ua: thaj chaw tsim khoom dav dav, thaj chaw tswj thiab thaj chaw huv si;
33.Raws li kev kho mob, cov dej khib nyiab tuaj yeem muab faib ua thawj, theem nrab thiab qib siab;
(1) Kev kho thawj zaug feem ntau yog siv cov txheej txheem lub cev los yog cov tshuaj yooj yim los tshem tawm cov teeb meem ntab thiab cov pa phem nyob rau hauv ib feem ntawm lub xeev raug tshem tawm hauv dej, nrog rau kev tswj hwm PH ntawm cov dej khib nyiab. Qhov kev ua qias tuaj ntawm cov dej khib nyiab thiab kev thauj khoom ntawm kev kho tom ntej tuaj yeem raug txo los ntawm kev kho thawj zaug. Kev kho thawj zaug feem ntau yog siv los ua pretreatment ntawm cov dej khib nyiab;
(2) Kev kho ob feem ntau yog hais txog kev kho mob lom. Tom qab kev kho thawj zaug ntawm cov dej khib nyiab, thiab tom qab ntawd tom qab kev kho thib ob, feem ntau ntawm cov pa phem hauv cov dej khib nyiab tuaj yeem raug tshem tawm thiab cov dej khib nyiab tuaj yeem ua kom huv ntxiv. Kev kho mob thib ob yog tsim nyog rau kev kho ntau yam dej khib nyiab uas muaj cov kab mob organic. Tom qab kev kho mob thib ob, cov dej zoo feem ntau tuaj yeem ua tau raws li cov qauv tso tawm;
(3) Kev kho mob hauv tsev kho mob yog ib hom kev kho mob uas yuav tsum tau ua kom huv huv, lub hom phiaj yog tshem tawm cov pa phem uas tsis tuaj yeem tshem tawm hauv qhov kev kho mob thib ob, suav nrog cov khoom organic uas tsis tuaj yeem decomposed los ntawm cov kab mob, cov tshuaj soluble inorganic ( xws li nitrogen thiab phosphorus, thiab lwm yam.) uas tuaj yeem ua rau eutrophication ntawm dej lub cev, nrog rau ntau yam kab mob, kab mob, thiab lwm yam. Tom qab kev kho mob tertiary, cov dej yuav tsum tau ua kom zoo ntawm cov dej saum npoo av thiab cov dej muaj dej tuaj yeem ua tau;
34.Clean Production: nws hais txog kev txhim kho tus qauv tsim tsis tu ncua, siv lub zog huv thiab cov khoom siv raw, cov cuab yeej siv siab heev thiab cov khoom siv. Tsis tas li ntawd, nws hais txog kev txhim kho kev tswj hwm, kev siv dav dav thiab lwm yam kev ntsuas kom txo tau los ntawm qhov chaw, txhim kho kev ua haujlwm ntawm kev siv cov peev txheej, thiab txo qis lossis zam kev tsim khoom, kev pabcuam thiab cov khoom siv cov pa phem hauv cov txheej txheem tsim thiab emissions, thiaj li. txo lossis tshem tawm kev puas tsuaj rau tib neeg kev noj qab haus huv thiab ib puag ncig.