eBAG 3D STR yekushandisa imwe chete bioreactor mhinduro

A TECNIC bhegi rimwe chete rine zita eBAG® 3D STR, inoonekera uye ine rectangular asi ine mipendero.

transparent cylindrical uye bioprocess bag (eBAG® 3D STR) ine mipendero yakatenderedzwa (zvishandiso) zvekushandisa bioprocessing

Yakatsaurirwa kukunda zvisingakwanisi zve-single-use bag systems

Yepamberi eBAG 3D STR yehuviri-chinangwa imwe yekuvirisa/bioreactors

Munzvimbo inogara ichishanduka yeBiotech, TECNIC's Single-Use eBAG 3D STR yakagadzirwa nehungwaru kuti sanganisa zvisina musono neyedu-chinangwa-Kumwe-Shandisa bioreactor. Yakazvipira kukunda zvipimo zvemukati mune imwechete-kushandisa masisitimu, iyo eBAG 3D STR inomira sechinangwa-chakavakwa, chekucheka-kumucheto mhinduro yakagadzirirwa mammalian culture. Zvakare, iyi yekuvandudza sisitimu inogadzirwa zvine hungwaru kuti igadzirise matambudziko chaiwo, ichipa shanduko yekuchinja mukugona kweiyo microbial bioprocessing.

Yakagadzirwa under stringent aseptic mamiriro uye akaiswa kune yakazara sterilization, mabhegi aya anovimbisa kubereka kwakanyanya uye njodzi shoma yekusvibiswa. Iine customizable maficha anoenderana neakasarudzika saizi masisitimu uye mafirita, iwo musono anobatanidza mukugadzira maitiro.

Yakagadziridzwa uye Yakagadzirwa mukati TECNIC ISO7 Yakachena Kamuri, eBAG 3D STR yakavakwa yakasimba nemhando yepamusoro uye inoenda kugamma irradiation. Nekuda kweizvozvo, ivo vakagadzirira-kushandisa zvinoenderana neyakaomesesa yemishonga indasitiri zviyero uye anowanikwa muhukuru hwakasiyana. (30L kusvika 1000L). Ivo vanogona kumira kubata kwakasimba kuti ive nechokwadi chekuchengetedzwa kwemidziyo yebiopharmaceutical. Yakagadzirwa zvakakwana kushanda nayo TECNIC ePILOT uye ePROD Imwe Kushandisa Bioreactor ⇀, yakagadzirwa kuti ikwane zvakakwana mu tank uye gadzirisa zvizere neiyo yakazara magineti musanganiswa kuti upe vimbiso mukuita kwako.

Yakavimbiswa sterility kune inonzwisisika bioprocesses

Simbiso yekushaya mbereko

Modular maitiro

Mari-inoshanda

Various configuration options

Bag scalability

Quality assurance

Dhaunirodha ruzivo rwehunyanzvi ⇀

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.

Layer 1 - LPDE (50μm)

Yekutanga layer yakagadzirwa neLow-Density Polyethylene (LPDE) inopa iyo Imwechete-Shandisa zvigadzirwa zvine simba rakasimba remuchina, kuve nechokwadi chekusimba uye kuramba kune zvinhu zvemuviri. Iyo yekunze shell inodzivirira bhegi kubva kune ekunze zvinhu uye kubata kukuvadza.

Layer 2 - TIE (10μm)

Layer 3 - EVOH (20μm)

Layer 4 - TIE (10μm)

Layer 5 - ULPDE (230μm)

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.

Vanhu vaviri vakafukidzwa zvachose nembatya chena vachishanda mukamuri rakachena mune yesainzi application.

nepahwindo, vanhu vanogona kuonekwa mune imwe-kushandisa chirimwa kushanda

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®, 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

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.

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.

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 Zvakanaka Kugadzira Maitiro (GMP), kuve nechokwadi chekuti chigadzirwa chese chinosangana nemhando yepamusoro yemhando uye chengetedzo.

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

Rakasimba rekunze layer

vose TECNIC Zvigadzirwa zveKushandisa Kamwechete zvakagadzirirwa nekuvaka kwakasimba kuvimbisa kuchengetedza kwakachengeteka kwechigadzirwa. Iyo mechanical simba rezvigadzirwa zvedu inovimbisa kusimba uye kuramba kune zvekunze zvinhu zvemuviri.

Mhoteredzo isina utachiona

Kugadzikana kwekushisa

GMP uye ISO zviyero

Chikwata chedu chekutengesa chakagadzirira kukubatsira neruzivo rwehunyanzvi.

Bata nechikwata chedu nhasi. Kunyangwe uine mibvunzo chaiyo kana kuti uchangotanga kuongorora, tiri pano kukutungamira nekubatsira. Svika izvozvi tigadzirise ramangwana pamwe chete.

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