Kev ua kom tsis muaj menyuam-hauv- qhov chaw tshuab siv dej kub lossis chav ua kom tsis muaj menyuam hauv lub tank, kav dej, thiab cov khoom siv ua haujlwm. Cov khoom cua sov uas tsim cov dej kub no yuav tsum muaj qhov sib npaug sib npaug - tsis muaj corrosion, nplai, lossis hlau leaching uas tuaj yeem cuam tshuam lub xeev tsis muaj menyuam.
SIP Systems ua haujlwm li cas hauv Biopharmaceutical Facilities
Nyob rau hauv ib tug raug SIP Circuit Court, purified dej los yog huv huv chav condensate yog circulated los ntawm cov cuab yeej yuav sterilized. Cov dej yog cua sov rau qhov kub ntawm lub hom phiaj-feem ntau 121℃lossis siab dua- thiab tuav rau lub sijhawm teev tseg kom ua tiav qib kev ua kom tsis muaj menyuam (SAL) ntawm 10⁻⁶. Cov cua sov ua tiav los ntawm lub phaj- thiab- cov khoom siv hluav taws xob sib txuas nrog cov chaw cog ntoo lossis los ntawm lub tshuab rhaub dej tso ncaj qha rau hauv cov dej ntim dej.
Rau cov tsheb me me lossis cov tsheb SIP modular, cov khoom siv hluav taws xob feem ntau nyiam vim lawv cov hneev taw me me thiab cov lus teb sai. Cov ntaub ntawv nyob rau hauv kev sib cuag nrog Dej rau Txhaj Tshuaj (WFI) los yog purified dej yuav tsum tau raws li cov kev cai pharmacopeial nruj, nrog rau tsawg extractables thiab leachables, non-shdding nto, thiab kuj mus rau high-kub oxidative ib puag ncig.
Vim li cas PTFE Rhaub Txhawb Kev Ruaj Ntseg Rau SIP
PTFE-sheathed immersion heaters muab cov cua sov tshwj xeeb rau SIP dej circuits. PTFE yog inherently non-stick thiab resists scale tsim los ntawm cov dej tawv residues los yog biofilms. Qhov tseem ceeb tshaj, cov khoom leaches tsis muaj hlau ions, organic paug, los yog particulates rau hauv dej rhuab. Qhov no txhawb kev siv tau ntawm SIP lub voj voog los ntawm kev ua kom ntseeg tau tias cov khoom cua sov nws tus kheej tsis qhia cov tshuaj uas tuaj yeem ua rau tom qab desorb rau hauv cov khoom kwj lossis daim npog qhov ncauj kom tsis muaj menyuam.
Hauv ibPTFE rhaub sterilization nyob rau hauv qhov chaw SIPdaim ntawv thov, qhov du fluoropolymer nto kuj yooj yim tu niaj hnub thiab passivation. Tsis zoo li cov cua sov hlau uas tuaj yeem tsim cov oxide txheej los yog pitting thaum lub sij hawm, lub PTFE sheath tseem tsis tau hloov pauv tom qab rov ua qhov kub thiab txias. Rau cov chaw siv tshuaj biopharmaceutical uas ua haujlwm raws li Kev Ua Haujlwm Zoo Tam Sim No (cGMP), qhov kev kwv yees, tus cwj pwm tsis zoo no txo qis lub nra ntawm kev tsim nyog tom qab txhua qhov kev sib tw SIP.
Kev txwv kub thiab kev ua haujlwm tsim nyog
PTFE nthuav tawm cov tshuaj tiv thaiv zoo heev thiab purity tab sis muaj qhov siab tshaj plaws kev siv kub ntawm kwv yees li 110 degree. Rau cov ntawv thov SIP uas siv cov dej kub ntawm 85-95℃(feem ntau ua haujlwm rau kev huv es tsis yog kev ua kom tsis muaj menyuam, lossis rau cov khoom siv cua sov), PTFE immersion heaters yog qhov zoo tagnrho. Ntau qhov chaw siv tshuaj biopharmaceutical txheej txheem kev khiav hauj lwm (SOPs) qhia cov dej kub SIP ntawm 85℃rau 30 feeb ua lwm txoj hauv kev ua kom tsis muaj menyuam.
Thaum muaj tseeb sterilization yuav tsum tau kub ntawm 121℃los yog siab dua, PTFE ib leeg tsis haum. Hauv cov xwm txheej zoo li no, perfluoroalkoxy alkane (PFA) cov cua sov tau teev tseg. PFA qhia PTFE cov tshuaj inertness thiab purity profile tab sis tuaj yeem ua haujlwm tsis tu ncua mus txog 260 degree. PFA-sheathed immersion heaters muaj peev xwm ua kom sov WFI rau 121℃rau cov qauv SIP. Xwb, cov tshuab txhaj tshuaj tuaj yeem siv tau, tab sis qhov twg cov hluav taws xob immersion cua sov yog nyiam, PFA muab cov tshuaj uas siv tau, tsis yog leaching.
| SIP Temperature Range | Cov khoom siv cua sov pom zoo | Daim ntawv thov |
|---|---|---|
| 85-95 degree | PTFE | Sanitization ntawm dej loops, qis-kub SIP |
| 121℃- 130 degree | PFA | Kev ua kom tsis muaj menyuam tag nrho ntawm bioreactors, lub tank cia, thiab kav dej |
| >130℃rau 150 degree | PFA | High-temperature SIP rau cov khoom siv bioprocess tshwj xeeb |
Kev txiav txim siab zoo rau SIP Validation
Thaum siv lub PTFE los yog PFA immersion rhaub nyob rau hauv lub laub SIP, ob peb yam validation yuav tsum tau hais. Lub tshuab cua sov yuav tsum tau sau tseg raws li lub rooj sib tham USP Class VI thiab FDA 21 CFR 177.1550 rau kev sib cuag nrog cov dej kub. Extractables thiab leachables (E&L) cov kev tshawb fawb yuav tsum tau ua nyob rau ntawm qhov siab tshaj plaws npaj ua hauj lwm kub kom pom tau tias tsis muaj cov tshuaj uas ntsuas tau tsiv mus nyob rau hauv dej. Vim tias PTFE thiab PFA yog cov fluorinated polymers tag nrho, E&L profiles feem ntau pom tsuas yog cov kab ntawm cov oligomers lossis cov kuab tshuaj seem, nyob deb dua li cov kev txwv rau cov dej tshuaj.
Tsis tas li ntawd, lub rhaub hluav taws xob rwb thaiv tsev thiab sealing yuav tsum tiv taus lub thermal cycling ntawm SIP. PTFE coj thiab ya raws-pov thawj overmolding yog tus qauv nta nyob rau hauv cov tshuaj-qib immersion heaters rated rau SIP kev pab cuam.
Xaus
PTFE cov cua sov muab cov cua sov kom huv, txhim khu kev qha rau SIP dej hauv biopharmaceutical daim ntaub ntawv uas qhov kub tsis tshaj 110 degree, xws li kev siv tshuaj tua kab mob thiab cov tsheb laij teb modular SIP. Rau kev ua kom tsis muaj menyuam tag nrho ntawm 121℃thiab siab dua, PFA heaters muab tib yam uas tsis yog-leaching, scale-resistant kev ua tau zoo. Hauv kev ua kom tsis muaj menyuam, kev xaiv cov khoom siv yuav tsum xav txog cov khoom siv tau thiab cov khoom siv leachables raws li qhov ua tau zoo ntawm kev ua haujlwm thermal- thiab fluoropolymers ua tau raws li ob qho kev xav tau, ua kom muaj txiaj ntsig zoo, tsis muaj kab mob tsis muaj menyuam.
