Kev txiav txim siab txog kev xaiv cov khoom lim cua hauv cov hmoov txhaj tshuaj npaj kev lag luam

Cov kev cai xaiv rau cov lim cua hauv kev lag luam tshuaj txhaj tshuaj (sterile ntim hmoov txhaj tshuaj thiab khov- qhuav hmoov txhaj) yog ib qho ntawm cov chaw nruj tshaj plaws ntawm tag nrho cov tshuaj formulations. Qhov kev sib tw tseem ceeb nyob hauv kev tswj hwm txoj kev pheej hmoo ntawm cov plua plav tawg thiab hla kev sib kis, thaum ua kom muaj ib puag ncig tsis muaj menyuam, thiab tseem cuam tshuam nrog kev ua haujlwm nyuaj los ntawm cov txheej txheem tshwj xeeb xws li khov- ziab thiab compressed cua.
Raws li qhov tseeb kev lag luam kev coj ua thiab GMP cov qauv, kev xaiv cov lim cua hauv kev lag luam hmoov txhaj tshuaj yuav tsum tau tsom rau tsib yam teeb meem nram qab no:

• 1. Qhov kawg lim qib: A- theem cheeb tsam (thaj chaw ntim khoom, khov- thaj chaw siv tshuab ziab khaub ncaws) nyob rau hauv kev sib cuag nrog cov khoom yuav tsum siv H14 siab- cov ntxaij lim dej ua tau zoo (nrog MPPS efficiency ntau dua lossis sib npaug li 99.995%) kom ntseeg tau tias muaj kev cuam tshuam tsis zoo ntawm cov khoom ntau dua lossis sib npaug li μ m.3 H13 qib tuaj yeem siv rau B / C qib tom qab thaj chaw, tab sis kev teeb tsa qis qis tsis pom zoo rau qib A.
• 2. Kev tiv thaiv zoo li qub thiab tawg- pov thawj tsim: Qhov no yog qhov yooj yim tshaj plaws saib tsis tau tab sis kuj yog qhov tseem ceeb tshaj plaws kev txhawj xeeb txog kev nyab xeeb. Kev txhaj tshuaj hmoov (xws li penicillin, cephalosporins, cov tshuaj hormones) yog qhov ua rau muaj hluav taws xob zoo li qub thaum lub caij thauj huab cua.
• 2.1 . Qhov yuav tsum tau muaj: Cov lim siv rau ntim thiab ntsuas chav (txawm lawv rov qab lim cua los yog cov cuab yeej tsim ua- hauv cov ntxaij lim dej) yuav tsum muaj cov txheej txheem hluav taws xob / tiv thaiv - cov haujlwm zoo li qub (qhov kev tiv thaiv nto tsawg dua lossis sib npaug li 1 × 10 ⁹ Ω), thiab cov lim dej thiab cov khoom siv hauv av yuav tsum muaj kev ntseeg siab.
• 2.2 Yog vim li cas: Cov khoom siv hluav taws xob zoo li qub tsis tsuas yog ua rau cov hmoov av adsorption txhawm rau txhawm rau lub lim dej, tab sis qhov hnyav dua, nws kuj tuaj yeem ua rau cov hmoov av tawg. Hauv thaj chaw uas muaj cov kuab tshuaj organic (xws li kev ntxuav lossis cov txheej txheem), cov lim dej thiab cov vaj tsev yuav tsum ua raws li ATEX lossis NFPA tawg - ntawv pov thawj.

Kev npaj tshuaj hmoov tsis yog tsuas yog xav tau ib puag ncig huv xwb, tab sis kuj tseem muaj cov pa roj uas tuaj yeem cuam tshuam ncaj qha nrog cov txheej txheem (xws li compressed cua thiab nitrogen) yuav tsum ua kom tsis muaj menyuam thiab plua plav- cov qauv dawb.

• 1. Compressed cua system: Cov cua compressed uas tuaj rau hauv kev sib cuag ncaj qha nrog cov hmoov los yog siv los tshuab lub puab phab ntsa ntawm lub raj mis yuav tsum tsis txhob muaj roj los yog dej.
• Kev xaiv kev teeb tsa: Nws yog ib qho tsim nyog los teeb tsa peb - theem kev pom kev sib xyaw ua ke (xws li T- qib tshem tawm 1 μ m particles → A- qib tshem tawm 0.1 μ m particles → H- qib tshem tawm 0.01 μ m particles), thiab cov ntsiab lus ntawm cov cua compressed tom qab μ m particles Tsawg dua lossis sib npaug li 0.001ppm (H-qib tus qauv) thiab tsawg dua 1 microorganism / m ³.
• 2. Nitrogen system: Nitrogen siv rau huab cua tawg lossis tiv thaiv nitrogen hauv khov - tshuab ziab khaub ncaws. Ntxiv nrog rau kev ua tiav qhov pom tseeb saum toj no, lub purity kuj yuav tsum tau ua kom tau raws li cov txheej txheem.

Txoj kev niaj hnub niaj hnub ntawm kev cob qhia cov hmoov txhaj tshuaj muaj kev siv tshuaj tua kab mob siab thiab ua kom tsis muaj menyuam (VHP vaporized hydrogen peroxide, cawv so, ntub cua sov kom tsis muaj menyuam), thiab lub cev thiab tshuaj lom neeg ntawm lub lim yog lub hauv paus rau kev ua haujlwm ntev -.

• 1. Cov khoom siv sab nrauv: 304 lossis 316L stainless hlau thav duab yuav tsum raug xaiv, thiab galvanized thav duab lossis ntawv thav duab raug txwv nruj heev. Stainless hlau yog resistant rau tshuaj tua kab mob corrosion,

Tsis txhob xeb thiab particle contamination.

• 2. Sealing qauv:
• 2.1 Cov kua roj tank foob: Rau lub davhlau ya nyob twg siab - cov lim dej ua haujlwm tau teeb tsa hauv thaj chaw A / B, nws raug nquahu kom siv cov kua tank seal (gel foob) lossis stainless hlau ncej + corrosion resistant silicone gasket los xyuas kom meej tias tsis muaj sab to txawm tias nyob rau hauv lub siab hloov.
• 2.2 BIBO (lub hnab hauv lub hnab tawm): Rau cov tshuaj tiv thaiv hmoov ntau ntau (xws li penicillin), lub siab -cov lim lim yuav tsum tau txais cov qauv BIBO kom tsis txhob muaj kev sib cuag ntawm cov neeg ua haujlwm thiab cov plua plav lom thaum hloov.

Hauv kev lag luam tshuaj txhaj tshuaj, kev xaiv tsuas yog qhov pib xwb, thiab nws tseem ceeb dua los xyuas kom meej tias cov khoom uas tau xaiv tuaj yeem dhau validation thiab ua tiav cov ntaub ntawv traceability.

• 1. Lub Hoobkas yuav tsum muaj: Txhua qhov siab - lim dej yuav tsum tau tshuaj xyuas thiab kuaj xyuas ib qho los ntawm ib qho ua ntej tawm hauv lub Hoobkas, thiab yuav tsum tau nrog ib tus lej tshwj xeeb thiab kev tshuaj xyuas lub Hoobkas los pab txhawb GMP traceability.
• 2. Kev txheeb xyuas tom qab kev teeb tsa:
• 2.1 PAO leak detection: Tom qab kev teeb tsa, PAO (poly alpha olefin) aerosol scanning leak detection yuav tsum tau nqa tawm, thiab tus qauv xau feem ntau yog tsawg dua lossis sib npaug li 0.01% (xws li kev xa tawm ntawm ib kaum txhiab).
• 2.2 Cua ceev thiab ntws kev taw qhia: Qhov A- theem cheeb tsam yuav tsum tau xyuas kom meej tias qhov nruab nrab cua ceev ntawm ib qho - txoj kev ntws yog nyob nruab nrab ntawm 0.36-0.54m / s, thiab cov streamline yog sib npaug.
• 2.3 Kev saib xyuas hauv online: Thaum xaiv, kev txiav txim siab yuav tsum tau muab rau seb lub lim puas muaj qhov sib txawv ntawm qhov sib txawv ntawm qhov sib txawv ntawm qhov sib txawv rau kev sib txuas rau BMS / EMS system, kom ua tiav qhov tseeb - lub sijhawm ntsuas qhov sib txawv thiab tsis siv neeg lub tswb (xws li lub tswb thaum qhov kev tawm tsam nce mus txog ob zaug tus nqi pib lossis 450Pa), thiab kom tsis txhob ua haujlwm dhau sijhawm.

• 1. Lub tshuab ziab khaub ncaws khov: Thaum lub sij hawm ua kom tsis muaj menyuam, muaj ntau cov dej ntub thiab kub hauv lub tshuab ziab khaub ncaws.
• Qhov yuav tsum tau muaj: Cov cua lim thiab lub tshuab nqus tsev twj tso kua mis lim siv rau khov - tshuab ziab khaub ncaws yuav tsum tuaj yeem tiv taus cov pa ntshiab lossis qhuav cua sov ntawm 121℃lossis txawm 135 degree, thiab cov khoom siv lim yuav tsum muaj hydrophobicity thiab kub tsis kam (xws li PTFE zaj duab xis).
• 2. High viscosity / moisture absorbing plua plav: Rau cov hmoov koob ntau yam uas nquag nqus dej los yog muaj viscosity siab, yog tias cov cua rov qab siv rau hauv chav ntim khoom, nws raug nquahu kom siv PTFE coated lim khoom rau cov lim cua rov qab. Qhov saum npoo yog du, cov hmoov tsis yooj yim rau adhere, thiab nws yog yooj yim rau pulse rov qab tshuab los ntxuav cov plua plav, tsis txhob surge tiv thaiv.

Cov lus qhia luv luv
Kev xaiv cov lim dej hauv kev lag luam hmoov txhaj tshuaj tuaj yeem ua raws li cov hauv qab no:

• 1. A- theem cheeb tsam: H14 stainless hlau ncej + tiv thaiv - cov khoom siv lim zoo li qub + kua tank foob, them nyiaj rau VHP corrosion kuj.
• 2. Cov txheej txheem roj: peb-theem filtration + xoom qib roj- tus qauv dawb, tsom mus rau microbial tuav peev xwm.
• 3. Cov chaw rhiab heev / muaj kev phom sij: BIBO qauv + tawg - ntawv pov thawj pov thawj, xyuam xim rau kev tiv thaiv kev ua haujlwm.
• 4. Cov kev cai dav dav: Tshawb xyuas ib qho los ntawm ib qho, ua PAO leak detection, thiab saib xyuas qhov sib txawv hauv online, ua tib zoo saib xyuas cov ntaub ntawv ncaj ncees.