Ua kom tiav GMP Daim Ntawv Teev Cov Ntaub Ntawv Ua Raws Cai rau Plaub Hom Kev Tiv Thaiv -Corrosion Heating Tubes hauv Fermentation Production

# Comprehensive GMP Audit Compliance Document List for Four Type of Anti-Corrosion Heating Tubes in Fermentation Production ## GMP Supporting Documents Required for 316L Stainless Steel Heating Tubes 1. Cov ntaub ntawv pov thawj raw cov ntaub ntawv Raw material storage zoning isolation record, batch conformity welding spectral components 316L stainless hlau zeb xeem daim ntawv pov thawj (MTC). 2. Cov ntaub ntawv ntawm kev tsim khoom thiab kev ua haujlwm Argon rov qab tiv thaiv vuam cov ntaub ntawv, cov ntaub ntawv pov thawj tsim nyog ntawm vuam, vuam tshuab polishing txheej txheem cov ntaub ntawv, tom qab- vuam hauv zos pickling thiab passivation ua haujlwm cav, thiab cov ntaub ntawv tseem ceeb ntawm cov yeeb nkab ntim cov ntaub ntawv ntawm-}passivation kawg cov khoom Full ultrasonic phab ntsa thickness scanning cov ntaub ntawv, hydraulic nruj ntsuas cov ntaub ntawv (1.2 lub sij hawm tsim siab, 30 feeb tuav), nto passivation zaj duab xis muaj peev xwm kuaj cov ntaub ntawv, thiab weld pom kev soj ntsuam cov duab. 4. Cov ntaub ntawv hais txog archive installation thiab transformation Pipeline cov ntaub ntawv txuam daim ntawv lees paub, carbon steel kev them nyiaj yug PTFE cais nteg cov ntaub ntawv, tube locking bundle huv si bundle debugging reports, thiab post-installation full-load sim run data. 5. Archive operation,care, and monitoring Monthly chloride ion concentration monitoring logs, bi-cov ntaub ntawv qhia txog phab ntsa thickness tshuaj xyuas txhua hli, cov ntaub ntawv khaws cia hauv peb lub hlis twg passivation, CIP acid descaling valve kev hloov pauv thiab cov ntaub ntawv kaw txhua hli, Cov ntaub ntawv pov tseg. 6. Cov ntaub ntawv pov tseg thiab rhuav tshem Cov Khoom Siv Hluav Taws Xob Cov Khoom Siv Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob Hluav Taws Xob biofilm sampling microbial detection reports, thiab batch contamination poob tuav cov ntaub ntawv rau xeb shedding xwm txheej. ## GMP Cov ntaub ntawv txhawb nqa uas yuav tsum tau muaj rau Ntshiab Titanium Cua Kub Tubes 1. Cov ntaub ntawv pov thawj cov ntaub ntawv raw cov ntaub ntawv hlau muaj pes tsawg leeg nrhiav kom pom, Qib 2 ntshiab titanium ingot Hoobkas kuaj daim ntawv pov thawj, fluorine -cov ntaub ntawv raw khoom pub dawb hauv tsev khaws khoom tswj cov ntaub ntawv, thiab sib piv PTFE lub tes tsho cais zaub mov- kev tsim khoom thiab qib- kev tsim khoom yog cov ntaub ntawv teev tseg ntawm kev tsim khoom rau kev ywj pheej titanium rhiav: siab -purity argon shield vuam, khawb- dawb mos polishing ua haujlwm, thiab tiav cov khoom fluoride residue tshuaj xyuas batch cov ntaub ntawv. 3. Cov ntaub ntawv qhia txog kev soj ntsuam zaum kawg ntawm cov khoom Tag Nrho cov duab tshuaj xyuas cov duab rau pearly dawb cov ntaub ntawv sib dhos, kev ua haujlwm siab thiab etching cov ntaub ntawv muaj nyob rau hauv 100% tube nras nto electrochemical tej zaum yuav scanning cov ntaub ntawv. 4. Cov ntaub ntawv hais txog archive installation thiab transformation Siv cov ntaub ntawv rau lub dual mechanical interlock nyob rau hauv lub fluoride pub pipeline, debugging cov ntaub ntawv rau cov yaj oxygen aeration system linkage, installation cov ntaub ntawv rau kev rho tawm tag nrho cov titanium 1}carbon post{3} txoj hauj lwm sib cuag {0} batch sim khiav cov ntaub ntawv. 5. Cov ntaub ntawv khaws cia, kev saib xyuas, thiab saib xyuas Real- lub sijhawm cov ntaub ntawv ntawm txhua hnub hauv online fluoride detector, peb lub hlis twg ntawm cov ntaub ntawv soj ntsuam tag nrho, cov ntaub ntawv saib xyuas tsis tu ncua rau cov cuab yeej siv aeration, cov ntaub ntawv ntawm kev laus hloov ntawm PTFE cais cov khoom siv, thiab cov ntaub ntawv sau tseg ntawm kev ua haujlwm ntawm cov pa oxygen {{5} circulation thiab 3} cov ntaub ntawv pov thawj Fluorine-cov kab mob kab mob cov ntaub ntawv pov tseg pov tseg pov tseg, huv titanium tsis kam rov ua cov ntawv xa nyiaj rov qab, thiab tag nrho -lub neej- cov cuab yeej siv hluav taws xob txo qis kev kwv yees cov ntaub ntawv. 7. Cov ntaub ntawv ntxiv rau kev soj ntsuam kev pheej hmoo soj ntsuam xyuas kom tiav 40 traceability cov ntaub ntawv {316} cov ntaub ntawv xa tawm thaum muaj xwm ceev sediment pollution batch pov tseg cov ntaub ntawv, thiab fermentation kua titanium ion residue sampling xeem ntawv qhia. ## GMP Cov ntaub ntawv txhawb nqa rau Quartz Anti-Corrosion Heating Tubes 1. Raw cov ntaub ntawv pov thawj cov ntaub ntawv pov thawj impurity tivthaiv cov ntaub ntawv tshaj tawm rau siab -purity fused quartz ingots, raw khoom Pob zeb diamond muag cov cuab yeej ua raws li daim ntawv pov thawj, plua plav {{45}cov ntaub ntawv tsis pub qhuav {44} cov txheej txheem warehouse khaws cia tas li-kev kho qhov kub thiab txias, cov ntaub ntawv xov xwm xaus kev ua tiav, thiab cov ntaub ntawv ntawm kev tiv thaiv-alkali cais kev sib dhos ua haujlwm rau cov khoom tiav. 3. Cov ntawv ceeb toom ntawm kev tshuaj xyuas zaum kawg ntawm cov khoom Tube bundle vibration damping sib dhos soj ntsuam cov ntaub ntawv, qis -cov ntaub ntawv ntsuas kev sib tw, 10 cov ntaub ntawv ntsuas kub siab Lub teeb kis tau tus mob pob txha soj ntsuam cov duab thiab cov ntaub ntawv txiav txim siab. 4. Cov ntaub ntawv hais txog archive installation thiab transformation Alkali pipeline mechanical hard interlock siv thiab yuam kaw cov ntaub ntawv, shock absorption rubber ncoo installation fastening cov ntaub ntawv, cua sov tus nqi limiting maub los debugging cov ntaub ntawv, thiab ntws tshaj tawm txo twj tso kua mis zaus {5} kev tswj xyuas kev ua haujlwm, kev tswj xyuas thiab kev tswj xyuas; alkali interlock muaj nuj nqi simulation simulation cov ntaub ntawv, peb lub hlis twg damping roj hmab hloov cov ntaub ntawv, bi-ib lub limtiam lub teeb gearbox tawg cov ntaub ntawv soj ntsuam thiab thaum muaj xwm ceev pov tseg traceability cov ntaub ntawv rau kev huam yuaj alkali misoperation tshwm sim. 6. Cov ntaub ntawv rau pov tseg thiab dismantling Lub raj tsis zoo crushing unified scrapping cov ntaub ntawv rau kev thauj mus los, cov ntawv txais nyiaj non-recyclable quartz fragments. 7. Cov ntaub ntawv ntxiv rau kev soj ntsuam kev pheej hmoo Kev soj ntsuam Cov ntaub ntawv tiav ntawm iav micro-particle contamination batch dismantling, tag nrho cov txheej txheem archives ntawm raj rupture thaum muaj xwm ceev tuav, thiab cov microbial proliferation nrhiav kom tau cov ntaub ntawv rau frosted nto. ## GMP Cov ntaub ntawv txhawb nqa rau PFA Coated Heaters 1. Cov ntaub ntawv pov thawj raw khoom uas yog zaub mov-qib PFA fluoroplastic raw khoom daim ntawv pov thawj, carbon steel seamless substrate mill xeem daim ntawv qhia, txheej thickness txheem conformity ntaub ntawv, thiab siab -kub laus laus tiv taus raw cov ntaub ntawv soj ntsuam cov ntaub ntawv . 2. substrate xeb tshem tawm thiab ua kom nto nto ua ntej- cov ntaub ntawv kho mob, ib qho - lub sij hawm ib qho txheej txheem txheej molding ntau lawm kab ua haujlwm cav thiab daim ntawv cog lus txwv tsis pub kho thaj chaw thib ob. 3. Cov ntawv ceeb toom txog kev tshuaj xyuas zaum kawg ntawm cov khoom Visual scanning cov duab ntawm tag nrho cov nto ntawm txheej, cov ntaub ntawv txheej txheej ntau. 3. cov ntaub ntawv, thiab 95℃qhov kub thiab txias simulation simulation cov ntaub ntawv qhia txog. 4. Cov ntaub ntawv hais txog archive installation thiab transformation Pipeline khoom particulate ua ntej- lim installation debugging cov ntaub ntawv, kub tshaj -kub lub zog- tawm interlock linkage test forms, post- kev ua kom txias txias, kev txiav txim siab thiab kev txiav txim siab qeeb buffer pad nteg cov ntaub ntawv. 5. Kev ua haujlwm khaws cia, kev saib xyuas, thiab saib xyuas Lub hli lim cartridge hloov cav, ob-hli txhua hli txheej kev puas tsuaj scanning cov ntaub ntawv, nruab nrab-ntev-lub sijhawm ua haujlwm kub tsis tu ncua kev ntsuas nkhaus, thiab hydrogen peroxide tshuaj tua kab mob cov ntaub ntawv hloov kho cov ntaub ntawv pov tseg pov tseg . 6. incineration hloov cov ntawv txais nyiaj rau fluorine-muaj cov txheej txheem residue, nrog rau cov pa roj carbon steel substrate seem rov ua dua cov ntaub ntawv sau npe. 7. Cov ntaub ntawv ntxiv rau kev soj ntsuam kev pheej hmoo ntawm cov yas micro-particle impurity detection batch reports, coating flaking lossault batch} kev ua haujlwm ntau tshaj 80 tswb tag nrho cov ntaub ntawv traceability. ## Universal Mandatory GMP Archive Management Specifications rau Tag Nrho Plaub Lub Cuab Yeej Tube 1. Cov ntaub ntawv khaws cia lub sij hawm yuav tsum tau Tom qab cov khoom pov tseg tag, tag nrho cov ntaub ntawv pov thawj, cov ntaub ntawv soj ntsuam, cov ntaub ntawv khaws tseg, cov ntaub ntawv khaws tseg, thiab cov ntaub ntawv pov tseg kev sib tsoo yuav tsum tau muab khaws cia rau tsawg kawg tsib xyoos kom ua tau raws li tag nrho cov ntaub ntawv traceability rau cov ntaub ntawv siv hluav taws xob rau cov ntaub ntawv pov thawj {{5} thiab cov ntaub ntawv tsis tu ncua ntawm GMP. Tag nrho cov ntaub ntawv xeem, cov duab tshuaj xyuas, thiab cov ntaub ntawv ua haujlwm yuav tsum tau synchronizedly khaws cia rau hauv cov khoom siv hluav taws xob huab cua tswj lub platform thiab khi cov ntawv khaws cia. Cov ntaub ntawv sau tes yuav tsum pom tseeb, yam tsis muaj kev tshem tawm, hloov pauv, lossis nplooj ntawv tsis raug tshem tawm . 3. Kos npe txoj cai thiab kev tswj hwm version Cov kev qhia tshwj xeeb, cov phiaj xwm kev saib xyuas, thiab kev sib txuas sib txuas ntawm qhov pib yuav tsum tau muab cov lej tswj hwm. Tsuas yog cov kws tsim khoom tsim nyog tau txais kev tso cai los kos npe rau kev tshuaj xyuas thiab cov ntaub ntawv lees paub, uas yuav tsum suav nrog hnub tim thiab lub npe ua tiav . 4. Qhov tseem ceeb yuav tsum tau ua yog batch traceability. Txhawm rau kom ua tiav lub neej voj voog ib qho -code traceability, txhua lub hnab ntim khoom yuav raug muab cov khoom siv tshwj xeeb serial tooj, khi cov khoom siv raw batch naj npawb, xa khoom kuaj batch, cov ntaub ntawv tsim kho, txhua lub sijhawm tu, thiab cov ntaub ntawv pov tseg zaum kawg . 5. Mechanism for document sorting ua ntej audit Compile ywj siab cais MPret cov ntaub ntawv ceev ceev ntawm-kev tshuaj xyuas qhov chaw; ua lub quarterly faib sorting ntawm tag nrho cov cua kub tube archive ntaub ntawv; ntxiv cov ntawv ceeb toom uas ploj lawm thiab cov ntaub ntawv khaws cia ua ntej. ## Cov ntsiab lus tseem ceeb ntawm kev ua raws li kev pheej hmoo ntawm ntau yam khoom siv hluav taws xob cua sov tau tshwm sim hauv GMP cov ntaub ntawv txheeb xyuas sib txawv. Cov ntaub ntawv tshawb fawb tseem ceeb hauv cov ntaub ntawv txhawb nqa quartz yog cov ntaub ntawv ntawm kev tshuaj xyuas tawg, alkali interlock test, thiab iav fragment paug pov tseg. Cov ntaub ntawv tsis muaj steel hlau tsom rau kev saib xyuas cov tshuaj chloride corrosion thiab hnyav hlau residue kuaj cov ntaub ntawv, thaum cov ntaub ntawv titanium raj yog lub hauv paus rau kev tiv thaiv fluoride pollution thiab passivation zaj duab xis stability tshuaj xyuas cov ntaub ntawv. Kev kuaj xyuas qhov tseeb ntawm txheej txheej, cov ntaub ntawv ntsuas kub sib cuam tshuam, thiab fluorine- muaj cov ntawv pov thawj pov tseg pov tseg yog qhov tseem ceeb ntawm PFA coated heater archives. Cov ntaub ntawv pov thawj puv -cov ntaub ntawv txhawb nqa uas ua tiav, tus qauv tsim, thiab tshawb xyuas tuaj yeem tiv thaiv tsis tau{101}} cov kev nplua thaum lub sijhawm ua haujlwm GMP tshuaj xyuas, tshem tawm cov kab ke tsis zoo cuam tshuam nrog cov khoom siv cua sov, thiab paub meej tias tag nrho cov txheej txheem ntawm cov khoom siv cua sov, kev teeb tsa, kev ua haujlwm, kev saib xyuas, thiab kev tshem tawm ua tau raws li cov qauv kev tswj xyuas tshuaj.