Vim li cas Plunger Elastomer txiav txim siab Syringe Performance
Ib lub syringe pov tseg hla los yog ua tsis tiav ntawm tus cwj pwm ntawm cov khoom me me elastomeric. Lub plunger tip thiab stopper set break-tawg quab yuam, glide force, koob tshuaj raug, thiab lub foob uas tuav cov tshuaj los yog biologic nyob rau hauv lub chim. Cov cuab yeej siv hluav taws xob xaiv cov khoom siv silicone rau cov khoom no vim tias cov txheej txheem compression nyob qis qis thoob plaws qhov kub thiab txias thiab qhov chaw chemistry tolerates gamma hluav taws xob, ethylene oxide, thiab chav.
Cov neeg yuav khoom uas kho lub plunger ua cov khoom catalog feem ntau them rau qhov luv luv hauv qab. Ib qho kev hloov pauv 0.2 hli nyob rau hauv lub ntsis geometry los yog ib tug 5 Shore A hloov nyob rau hauv hardness txav so - xoob quab yuam sab nraum lub qhov rais ISO 7886-1, thiab tag nrho ib tug ntau mus rau seem los yog revalidation. Cov tsis muaj hauv qab no yog cov uas tsim nyog xauv rau hauv ib qho kev qhia ua ntej ib qho kev hais lus muaj lub ntsiab lus tiag.
Ib daim ntawv qhia txog kev tsim khoom pab pawg. Plunger cov lus qhia thiab cov stoppers feem ntau yog yuav los ua cov khoom siv molded, tsis yog cov khoom siv raw ib leeg. Tus neeg muag khoom tsim pwm, kab noj hniav suav, thiab kev tswj xyuas kev ua tiav kom muaj txiaj ntsig ntau npaum li lub hauv paus polymer ua.
Cov qauv nqi uas sib piv tsuas yog tus nqi sib xyaw ib kilogram nco qhov loj tshaj plaws sib txawv. Ib tus neeg muab khoom siv ua pov thawj 64-kab kab noj hniav nrog cov txheej txheem nruj yuav tuav cov khoom siv qis dua feem ntau ib zaug seem, tshuaj xyuas kev ua haujlwm, thiab kev pheej hmoo rov qab nkag mus rau hauv kev suav. Chav tsev nqi ntawm daim ntawv hais lus tsis tshua muaj kev cuam tshuam tus nqi tseeb ntawm cov khoom uas yuav tsum dhau qhov kev sim ua haujlwm ntawm qhov kawg ntawm kab.
LSR los yog HTV: Sib piv cov kev kho mob rau ib feem Geometry
Ob tsev neeg silicone tswj cov khoom siv koob txhaj tshuaj. Liquid silicone roj hmab (LSR) yog ob-ib platinum- kho qhov system nrog viscosity feem ntau ntawm 200,000 thiab 1,000,000 mPa·s ntawm qhov pub. Nws yog txhaj rau hauv rhuab hlau pwm ntawm 150 mus rau 180℃thiab kho nyob rau hauv 30 mus rau 90 vib nas this rau tus qauv plunger ntsis. Khoom silicone roj hmab (HTV) tuaj txog raws li cov pos hniav millable, yog zoo li tus compression, hloov, los yog txhaj molding, thiab yog vulcanized nrog ib tug peroxide los yog ib tug platinum catalyst.
Qhov kev txiav txim siab tsis tshua muaj nyob ntawm cov khoom siv ib leeg. LSR haum rau siab -cov cuab yeej kab noj hniav, kev siv tshuaj tua kab mob, thiab qhov chaw nrog cov phab ntsa nyias lossis daim di ncauj zoo. HTV haum rau cov ntu tuab, cov kev pab cuam ntim tsawg, thiab cov qauv qauv uas cov cuab yeej siv tau tshaj tawm lub sijhawm dhau mus. Lub cuab yeej 32-cav LSR tuaj yeem khiav ntau pua txhiab lub tswv yim hauv ib xyoos uas yuav luag tsis tiav. Ib feem hauv HTV xav tau deflashing thiab kev tshuaj xyuas phau ntawv tshwj tsis yog lub molder khiav nruj tswj kev txhaj tshuaj.
Kho chemistry tseem tsav cov extractables, uas tseem ceeb rau kev tswj hwm kev ua haujlwm. Platinum- kho LSR ua tsis muaj cov organic los ntawm - cov khoom thaum lub sij hawm vulcanization, thiab qhov ua kom yooj yim rau kev sim hauv USP<381>rau elastomeric kaw. Peroxide- kho HTV tawm cov kua qaub seem uas xav tau tom qab- kho thiab tshem tawm cov ntawv pov thawj ua ntej qhov tsim nyog rau daim ntawv thov kev sib cuag tshuaj.
Rau cov pab pawg tsim cov khoom siv tag nrho, lub thoob, qhov sib txuas, thiab cov tubing feem ntau siv tib cov kua silicone roj hmab platform, uas txo cov khoom siv hauv cov ntaub ntawv.
Specifications los kho ua ntej thov Quotes
Hardness thiab Break -Loose Force
Plunger cov lus qhia feem ntau poob ntawm Shore A 40 thiab Shore A 60, ntsuas ib ASTM D2240 lossis ISO 48-4. Softer tebchaw txhim kho qhov pib foob tiv thaiv phab ntsa chim thiab txo lub zog yuav tsum tau pib txav. TS EN ISO 7886-1 Kev txiav txim siab qhov kev cia siab rau kev ua kom tsis muaj zog rau cov koob txhaj tshuaj hypodermic, thaum cov txheej txheem prefilled npog los ntawm ISO 11040-4 siv cov qhov rais nruj dua. Muab cov molder nrog lub hom phiaj ntau ntxiv nrog rau cov kab siab ntev es tsis yog ib tus lej.
Compression Set thiab Seal Integrity
Cov txheej txheem compression ntsuas raws li ISO 815 lossis ASTM D395 Txoj Kev B kwv yees ntau npaum li cas cov ntsaws ruaj ruaj thaum lub sijhawm txee lub neej. Platinum- kho LSR cov lus qhia feem ntau rov qab los ntawm 8 mus rau 15 feem pua tom qab 22 teev ntawm 175℃. Peroxide- kho cov khoom feem ntau tsaws ntawm 15 thiab 25 feem pua. Cov txheej txheem siab dua txhais tau tias rov qab qeeb dua thiab muaj kev pheej hmoo ntau dua ntawm kev xau thaum lub sijhawm khaws cia ntev, qhov tseem ceeb uas loj hlob hauv qhov tseem ceeb rau cov khoom siv prefilled nrog ob- xyoo lub hom phiaj.
Lubricity thiab Extractables
Glide quab yuam nyob ntawm qhov sib xyaw thiab kev kho saum npoo ua ke. Qee cov OEMs qhia txog cov txheej txheem silicone crosslinked, qee qhov siv qib qis - kev sib txhuam LSR, thiab qee qhov ntxiv cov tshuaj - qib silicone roj. Txhua txoj kev hloov cov extractables profile. Thaum cov khoom ntim yog ib qho biologic, khaws cov roj nplua nyeem kev tsiv teb tsaws qis thiab sau cov ntaub ntawv tsiv teb tsaws chaw nyob rau hauv lub thawv kaw ntu ntawm cov kev cai xa tawm.
Cov ntaub ntawv ua raws cai rau cov lag luam uas tswj hwm
ISO 10993 thiab USP<381>
Cov cuab yeej kho mob elastomers raug soj ntsuam raws li ISO 10993-5 rau cytotoxicity thiab ISO 10993-10 lossis ISO 10993-23 rau khaus thiab rhiab heev. Elastomeric kaw rau txhaj tshuaj poob rau hauv USP<381>, uas suav nrog cov tshuaj lom neeg lom neeg, kev sim physicochemical, thiab kev ua haujlwm kom haum. Thov daim ntawv pov thawj tam sim no siv los ntawm cov neeg muag khoom sib txuas ntxiv rau ntau ntau - daim ntawv pov thawj tshwj xeeb ntawm kev tshuaj xyuas. Traceability rov qab mus rau lub hauv paus polymer ntau yog cov qauv kev coj ua rau cov cuab yeej siv cov ntaub ntawv.
FDA, EU MDR, thiab REACH
Rau Tebchaws Meskas cov ntaub ntawv xa tawm yuav tsum tau teev nyob rau hauv Daim Ntawv Qhia Tshuaj Tshuaj thiab ua raws li FDA 21 CFR 177.2600 qhov twg nws siv rau cov khoom siv roj hmab. Rau Tebchaws Europe, EU MDR 2017/745 yuav tsum tau ua tiav cov ntaub ntawv qhia ntxiv ntxiv rau REACH SVHC tshaj tawm. Tshooj 33 cov luag num kev sib txuas lus siv tau thaum SVHC cov ntsiab lus siab tshaj 0.1 feem pua ntawm qhov hnyav ntawm tsab xov xwm, thiab qhov pib raug kuaj xyuas ib feem, tsis yog ib qho khoom xa tuaj.
Sterilization Compatibility
Silicone lees txais peb txoj kev lag luam tseem ceeb kom tsis muaj menyuam. Gamma hluav taws xob ntawm 25 kGy, validated raws li ISO 11137, yog txoj kev uas feem ntau siv rau ib leeg - siv syringes. Ethylene oxide nyob rau hauv ISO 11135 haum rau cov cua sov- cov rooj sib txoos rhiab thiab yuav tsum tau tswj cov aeration kom tshem tawm cov khoom seem. Steam autoclave cycles raws li ISO 17665 haum cov khoom siv rov siv tau uas pom rov ua dua.
Radiation tuaj yeem hla los yog saws -scission polymer nyob ntawm koob tshuaj thiab cov khoom sib xyaw. Cov qib kev kho mob LSR khaws cia lub zog tensile thiab elongation tom qab 25 kGy, thaum qee qhov qis - hardness formulations stiffen ntsuas. Nug cov ntaub ntawv ua ntej thiab tom qab ua kom tsis muaj menyuam ntawm cov koob tshuaj tiag tiag uas koj npaj siab yuav siv, suav nrog elongation tuav ntsuas raws ISO 37. Sterilization yog cov tswv yim tsim es tsis yog cov kauj ruam ua tiav, thiab hloov cov txheej txheem lig hauv qhov kev pab cuam yuam pab pawg ntaus ntawv rov qab mus rau qhov tseeb.
Kev txwv qhov seem rau ethylene oxide ua raws ISO 10993-7, thiab cov koob tshuaj tau tso cai nyob ntawm seb lub sijhawm sib cuag ntawm lub cuab yeej. Cov cuab yeej tiv tauj luv luv muaj qhov txwv nruj dua li cov khoom siv sib tiv tauj ntev, yog li lub voj voog ua kom tsis muaj menyuam thiab lub sijhawm aeration yuav tsum tau npaj tawm tsam kev siv tshuaj kho mob es tsis yog lub Hoobkas teeb tsa. Lub molder uas nkag siab txog qhov sib txawv no yuav chij qhov txwv ua ntej tus qauv tsim khov.
Tooling, Cycle Time, thiab Unit Cost
Chav tsev tus nqi rau lub plunger taub tawg rau hauv cov khoom, lub sij hawm voj voog, cavitation, thiab tawm los. LSR compound nqa tus nqi siab dua ib kilogram dua li HTV, tsis tau 32 lossis 64 kab noj hniav LSR cov cuab yeej tuaj yeem cuam tshuam qhov sib txawv ntawm qhov ntim los ntawm lub voj voog luv luv thiab ze rau -zero deflash. Txoj cai ua haujlwm ntawm tus ntiv tes xoo tso LSR ua ntej ntawm HTV saum toj no kwv yees li 500,000 qhov chaw hauv ib xyoos rau cov lus qhia me me, muab qhov kev zov me nyuam pom zoo rau cov cuab yeej siv.
| Parameter | LSR (kua silicone roj hmab) | HTV (khoom silicone roj hmab) | Qhov tseem ceeb ntawm tus neeg yuav khoom |
|---|---|---|---|
| Hardness ntau yam | Ntug A 20 txog 70 | Ntug A 30 txog 80 | Tuav- lub qhov rais xoob quab yuam |
| Pub viscosity | 200,000 rau 1,000,000 mPa·s | Millable cov pos hniav | Automation qib |
| Kho lub voj voog | Ci ntawm 30 mus rau 90 s ntawm 150 txog 180 degrees | 120 mus rau 300 s compression | Unit nqi ntawm ntim |
| Ua tiav | Nyob ze flashless | Deflashing yuav tsum tau | Chav kawm huv huv |
| Compression teeb, ISO 815, 22 h ntawm 175 degree | 8 mus rau 15 feem pua | 15 mus rau 25 feem pua | foob lub neej |
| Extractables tswj | Tight, platinum kho | Yuav tsum tau tshaj tawm - kho | USP<381> |
Cov cuab yeej steel xaiv tsim nyog tib yam nkaus li cov kab noj hniav suav. LSR pwm xav tau cov kab noj hniav tawv thiab kev tswj xyuas qhov kub thiab txias, vim tias 5℃kis thoob plaws lub platen hloov kho lub xeev thiab hardness ntawm kab noj hniav mus rau kab noj hniav. Cov peev nyiaj rau kev saib xyuas thermal thiab rau kev tsim pwm uas txhawb nqa kev sib npaug. Cov cuab yeej pheej yig tshaj plaws feem ntau dhau los ua qhov kev txiav txim siab kim tshaj plaws hauv qhov kev pab cuam.
Kev Tshawb Fawb Kev Tshawb Fawb thiab Tshaj Tawm ntau
Txhais cov phiaj xwm kev tshuaj xyuas tuaj hauv daim ntawv xaj yuav khoom. Cov kev kuaj xyuas muaj xws li hardness ntawm peb lub ntsiab lus rau ib pawg kab noj hniav, kev tshuaj xyuas qhov ntev tiv thaiv kev kos duab siv ISO 3302-1 cov chav kawm kam rau ua, compression teem rau ntawm cov slab kho los ntawm tib qhov ntau, thiab cov qauv pom kev npog flash, kua muag, thiab kev sib kis. Khaws ib qho qauv rau ib qho rau traceability. Thaum ib lub cuab yeej nyob rau hauv kev tshuaj xyuas, cov ntaub ntawv tshuaj xyuas yog pov thawj, thiab cov ntaub ntawv nyias tsim kom muaj kev pheej hmoo.
Cov txheej txheem kev txheeb xyuas ntawm hardness thiab qhov hnyav thoob plaws qhov kev tsim khoom ua rau lub teeb liab ntawm drift thaum ntxov. Ib tus neeg muag khoom uas teev cov nqi no rau ib qho kev hloov pauv tuaj yeem ntes qhov teeb meem kho lossis noj tshuaj ua ntej qhov chaw mus txog tus neeg siv khoom, thiab cov kab kos no dhau los ua pov thawj muaj txiaj ntsig thaum lub sijhawm kuaj xyuas. Thov kom tswj txoj kev npaj ua ib feem ntawm pob khoom tsim nyog, tsis yog daim ntawv pov thawj ntawm kev tshuaj xyuas xwb.
Cov neeg muab khoom uas sau cov kab noj hniav -qib traceability ua rau kev tshawb nrhiav sai. Cov neeg muab khoom lag luam uas tsis tuaj yeem yuav qeeb cov lus teb tsis txaus siab rau kev nkag mus.
Kev Tshawb Fawb Kev Tshawb Fawb thiab Quote Thov
Ua ntej xa RFQ, paub meej txog rau yam khoom. Lub hom phiaj hardness nrog kam rau ua. Tuav-Xaiv thiab glide force windows. Sterilization method thiab koob tshuaj. Extractables thiab leachables yuav tsum tau. Txhua xyoo ntim thiab cov cuab yeej ua tswv cuab. Cov kev cai xa tawm uas nyob ntawm ib feem. Ib tus neeg muag khoom tuaj yeem teb rau tag nrho rau yam tsis muaj kev ua raws li -ib puag ncig yog tsim nyog khaws cia.
ANYSIL muab kev kho mob qib LSR thiab HTV cov khoom sib xyaw ua ke nrog cov lus qhia molded plunger thiab nres, txhawb nqa los ntawm cov ntaub ntawv rau ISO 10993, USP<381>, thiab REACH. Xa koj cov duab kos thiab cov lus qhia kom qhib cov lus hais, thiab peb yuav rov qab cov lus pom zoo nrog kev ua siab ntev thiab lub sijhawm ua haujlwm. Thov ib tsab ntawv. Rau qhov chaw uas ua ke nrog lub hau molded nrog ib lub thoob los yog lub raj, cov khoom siv silicone roj hmab npog npog sab extrusion ntawm lub rooj sib txoos.