Define Optimization ne eBAG 3D Mixer
Smart liquid inobata mhinduro mumabhegi
Inovandudza uye yakavimbika imwe-yekushandisa bhegi mhinduro dzeiyo biotech chikamu neBAG 3D Mixer.
Munzvimbo inoshanduka yeBiotech, iyo chete-shandisa eBAG 3D Musanganiswa inokwidziridza mafambiro emvura ekusanganisa kwakanaka, chengetedza kuchengetedza uye kutakura nyore kwezvinwiwa. Yakagadzirwa neyakasiyana 3D dhizaini, TECNIC eBAG 3D Musanganiswa vari kugadziridza iyo biotech chikamu nekusimudzira mafambiro emvura kune isingaenzaniswi mhando yemhedzisiro.
Yakagadzirwa pasi pezvakaomesesa aseptic mamiriro uye akaiswa pasi pesero yakazara, mabhegi aya anovimbisa high sterility uye njodzi shoma yekusvibiswa. Nezvimiro zvinogoneka zvinogadzirisa zvinodikanwa zvehukuru, zvigadziriso, uye zvigadziriso, ivo vanobatana zvisina mutsetse mukugadzira maitiro.
Yakagadziridzwa uye Yakagadzirwa mukati TECNIC ISO7 Yakachena Kamuri, aya mabhegi e3D anogadzirwa nemhando yepamusoro uye anovhenekwa negamma irradiation, achiita kuti agadzirire-kushandisa-maererano neakasimba eindasitiri yemishonga zviyero. Inowanikwa mumhando dzakasiyana-siyana (50L, 100L, 200L, uye 500L), mabhegi aya anoshingirira kubata zvakasimba, kuve nechokwadi chekuchengetedzwa kwemidziyo yebiopharmaceutical. Yakagadzirwa zvine hungwaru kushanda zvisina musono nayo TECNIC ePLUS® Musanganiswa SU ⇀, dzakagadzirwa kuti dzikwane zvakakwana mu tank uye gadzirisa kune yakazara magineti musanganisi kune yakachengeteka uye inoshanda maitiro.
eBAG 3D Mixer yemhinduro yepamusoro
Effortlessly tailor the eBAG 3D Mixer to accommodate diverse volumes by selecting the preferred number of ports. Our standard configuration options offer flexibility in terms of the number of ports, locations, and types, ranging from 4 ports to 11 ports. Each bag includes 4x pitch blade impellers for magnetic agitations at the bottom, along with an inlet port, exhaust filter, and a harvest port. Some of the additional port includes single-use sensors for measuring conductivity or the pH of your solution.
Ongorora huwandu hwezvibatanidza uye tubing sarudzo, dzakadai seKurumidza Couplers, Tri-Clamp (TC), Aseptic Connectors, C-Flex 374, uye Luer Connectors. Idzi sarudzo dzinovimbisa kubatanidzwa kusina musono, zvichipa kuenderana neyako yakasarudzika setup. Simudza mashandiro ako ekushanda nekumbundikira kuwanda kunopihwa kuburikidza neaya akasiyana magadzirirwo sarudzo.
Firimu tekinoroji yekuvandudza bioprocess
Our TECNIC Firimu Tekinoroji yakanyatso kugadzirirwa yemhando yepamusoro. Yese yedu Yese-Kushandisa zvigadzirwa inozvisiyanisa neyakasiyana-shanu-layer chimiro, ine imwe neimwe dhizaini inoshanda rakati basa kukwirisa kutendeseka, kusimba, hupenyu hurefu uye sterility yemidziyo.
Mumba ISO 7 kamuri yekuchenesa yeimwe-yekushandisa zviyero
Iyo nzira yekugadzira yedu-yekushandisa bioprocessing zvigadzirwa, senge eBAG® 2D, 3D uye SU ngarava, inonyatso kuenderana neakaomesesa zviyero zve ISO 7 imba yakachena Ichi chakasarudzika chinovimbisa nharaunda inodzorwa zvakanyanya, inoratidzwa nehupamhi hwechikamu chegumi chegumi (≥ 10,000 μm) pa cubic mita yemhepo.
Iyi nhanho yekutonga yakakosha pakuona kusabereka uye kunaka kwezvigadzirwa zvedu, sezvo ichideredza zvakanyanya njodzi yekusvibiswa kwehutachiona. Nekuomerera kune aya mazinga, isu tinoona kuti chigadzirwa chega chega chinosangana netarisiro huru yekuchena uye mashandiro anodiwa mune inonzwisisika bioprocessing application, ichipa vatengi vedu mhinduro dzakavimbika uye dzinoenderana biotechnological.
Yakakwirira mwero mu bioprocessing
Iyo eBAG inomiririra kwete chete hunyanzvi musero tsika firimu tekinoroji, asi zvakare inoisa mabhenji mabhenji mumhando uye kutevedza kwemitemo. EBAG yega yega inogadzirwa pasi pekuomesera Maitiro akanaka ekugadzira (GMP), kuve nechokwadi chekuti chigadzirwa chese chinosangana nemhando yepamusoro yemhando uye chengetedzo.
Sterilization chinhu chakakosha pakugadzirwa. Isu tinoshandisa advanced mwaranzi sterilization nzira, zvinobudirira kubvisa zvipenyu zvinosvibisa pasina kukanganisa kuvimbika kwechigadzirwa. Iyi sterilization maitiro akakosha pakuchengetedza sterility uye chengetedzo mumashandisirwo ane hunyanzvi.
Uyezve, kugadzirwa kwe eBAG kunoitika mukati mumba ISO 7 Classified zvivakwa. Idzi dzimba dzekuchenesa dzakagadzirirwa kudzora kusvibiswa uye kuchengetedza nzvimbo yeeseptic, yakakosha pakugadzirwa kwezvinhu zvebiotechnological. Kutevedzera ISO 7 zviyero kunovimbisa kuti eBAG yega yega inogadzirwa munzvimbo inodzorwa, ichideredza njodzi yekusvibiswa uye kuve nechokwadi chekuenderana kwechigadzirwa.
Pamwe chete, aya matanho emhando uye kutevedza kwemitemo kunoratidza kuzvipira kwedu kune kugona mukugadzira eBAG, tichipa vatengi vedu zvigadzirwa zvakavimbika uye zvakachengeteka zvekushandisa kwavo kwakakosha bioprocessing.
|
bvunzo |
zvinodiwa |
Results |
|
USP <788> Particulate Matter in Injections |
Pass |
Pass |
|
USP <88> Systemic Toxicity |
Pass |
Pass |
|
USP <88> Intracutaneous |
Pass |
Pass |
|
USP <88> Implantation |
Pass |
Pass |
|
USP <87> Cytotoxicity, Agar Diffusion |
Pass |
Pass |
|
USP <87> Cytotoxicity, Elution |
Pass |
Pass |
|
USP <85> Kinetic-Chromogenic LAL |
0,25 EU/ml |
0,006 EU/ml |
|
USP <661.1> Physicochemical-Non Volatile |
15 mg |
1 mg |
|
USP <661.1> Physicochemical-Residue on Ignition |
5 mg |
1 mg |
|
USP <661.1>Physicochemical-Heavy Metals |
1 ppm |
1 ppm |
|
USP ≤661.1>Physicochemical-Buffering Capacity |
10 ml |
1 ml |
|
ISO 10993-4 In-Vitro Hemolysis Study |
Non-haemolytic |
Non-haemolytic |
|
Irradiation Dosage |
25-50 kGy |
25-50 kGy |
|
EP <3.2.2.1> Plastic Containers for Aqueous Solutions for Parenteral Infusion |
Pass |
Pass |
The eBAG® inomiririra kwete chete hunyanzvi musero tsika firimu tekinoroji, asi zvakare inoisa mabhenji matsva mumhando uye kutevedza kwemitemo. Mumwe nomumwe eBAG® inogadzirwa pasi pe stringent Maitiro akanaka ekugadzira (GMP), kuve nechokwadi chekuti chigadzirwa chese chinosangana nemhando yepamusoro yemhando uye chengetedzo.
Sterilization chinhu chakakosha pakugadzirwa. Isu tinoshandisa advanced mwaranzi sterilization nzira, zvinobudirira kubvisa zvipenyu zvinosvibisa pasina kukanganisa kuvimbika kwechigadzirwa. Iyi sterilization maitiro akakosha pakuchengetedza sterility uye chengetedzo mumashandisirwo ane hunyanzvi.
Uyezve, kugadzirwa kwe eBAG® kunoitika mukati mumba ISO 7 Classified zvivakwa. Idzi dzimba dzekuchenesa dzakagadzirirwa kudzora kusvibiswa uye kuchengetedza nzvimbo yeeseptic, yakakosha pakugadzirwa kwezvinhu zvebiotechnological. Kutevedzera ISO 7 zviyero kunovimbisa kuti imwe neimwe eBAG® inogadzirwa munzvimbo inodzorwa, ichideredza njodzi yekusvibiswa uye kuve nechokwadi chekuenderana kwechigadzirwa.
Pamwe chete, aya matanho emhando uye kutevedza kwemitemo kunoratidza kuzvipira kwedu kune kugona mukugadzira eBAG®, kupa vatengi vedu zvigadzirwa zvakavimbika uye zvakachengeteka kune avo akakosha bioprocessing application.
|
bvunzo |
zvinodiwa |
Results |
|
USP <788> Particulate Matter in Injections |
Pass |
Pass |
|
USP <88> Systemic Toxicity |
Pass |
Pass |
|
USP <88> Intracutaneous |
Pass |
Pass |
|
USP <88> Implantation |
Pass |
Pass |
|
USP <87> Cytotoxicity, Agar Diffusion |
Pass |
Pass |
|
USP <87> Cytotoxicity, Elution |
Pass |
Pass |
|
USP <85> Kinetic-Chromogenic LAL |
0,25 EU/ml |
0,006 EU/ml |
|
USP <661.1> Physicochemical-Non Volatile |
15 mg |
1 mg |
|
USP <661.1> Physicochemical-Residue on Ignition |
5 mg |
1 mg |
|
USP <661.1>Physicochemical-Heavy Metals |
1 ppm |
1 ppm |
|
USP ≤661.1>Physicochemical-Buffering Capacity |
10 ml |
1 ml |
|
ISO 10993-4 In-Vitro Hemolysis Study |
Non-haemolytic |
Non-haemolytic |
|
Irradiation Dosage |
25-50 kGy |
25-50 kGy |
|
EP <3.2.2.1> Plastic Containers for Aqueous Solutions for Parenteral Infusion |
Pass |
Pass |
|
bvunzo |
Need |
mugumisiro |
|
USP <788> Particulate Matter in Injections |
Pass |
Pass |
|
USP <88> Systemic Toxicity |
Pass |
Pass |
|
USP <88> Intracutaneous |
Pass |
Pass |
|
USP <88> Implantation |
Pass |
Pass |
|
USP <87> Cytotoxicity, Agar Diffusion |
Pass |
Pass |
|
USP <87> Cytotoxicity, Elution |
Pass |
Pass |
|
USP <85> Kinetic-Chromogenic LAL |
0,25 EU/ml |
0,006 EU/ml |
|
USP <661.1> Physicochemical-Non Volatile |
15 mg |
1 mg |
|
USP <661.1> Physicochemical-Residue on Ignition |
5 mg |
1 mg |
|
USP <661.1>Physicochemical-Heavy Metals |
1 ppm |
1 ppm |
|
USP ≤661.1>Physicochemical-Buffering Capacity |
10 ml |
1 ml |
|
ISO 10993-4 In-Vitro Hemolysis Study |
Non-haemolytic |
Non-haemolytic |
|
Irradiation Dosage |
25-50 kGy |
25-50 kGy |
|
EP <3.2.2.1> Plastic Containers for Aqueous Solutions for Parenteral Infusion |
Pass |
Pass |
Bag properties
-> 25 kGy, isina kusimbiswa isina utachiona
-Inyanzvi sarudzo ine yakasimbiswa sterilization uye 2-year sherufu hupenyu
Uku kuchinjika mumasarudzo ekuita sterillization inovimbisa kuti zvigadzirwa zvedu zvese zvinogona kusangana zvakasiyana siyana zvinodiwa zvevatengi vedu.
Kuteerera nemitemo
Iyo eBAG 3D inoomerera kune yakakura biocompatibility uye physicochemical zviyero, kusanganisira Kirasi VI, USP 87, ISO 10993, FDA 21CFR177, uye Eu 3.1.9. Kuteerera kwayo kunoratidza kukodzera kwayo kune yakatetepa bioprocessing application.
Low extractable profile
Kutevera Bio-Process Systems Alliance (BPSA) nhungamiro, iyo eBAG 3D inoratidzira yakaderera inobviswa chimiro, ichiva nechokwadi chekushomeka kwezvinhu kuburitswa muchigadzirwa. Izvi zvinochengetedza kuchena uye kutendeseka kwezvinhu bioprocessed.