eBAG 3D STR yekushandisa imwe chete bioreactor mhinduro

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

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)
Layer 2 - TIE (10μm)
Layer 3 - EVOH (20μm)
Layer 4 - TIE (10μm)
Layer 5 - ULPDE (230μm)

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.

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

 

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.

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

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
Mhoteredzo isina utachiona
Kugadzikana kwekushisa
GMP uye ISO zviyero

Mumba ISO 7 kamuri yekuchenesa yeimwe-yekushandisa zviyero

Magadzirirwo ezvigadzirwa zvedu zvekushandisa-bioprocessing zvigadzirwa, senge eBAG 2D uye 3D, zvinonyatsoenderana neyakaomarara zviyero zveISO 7 yekuchenesa imba. 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.

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.