Fambisa yako bioprocess ne eBAG 2D TFF

Yepamberi yakagadzirira-kushandisa-kamwe-kushandisa mabhegi ekugadzirisa ako downstream urongwa

eBAG 2D TFF inoenderana neTangential Flow Filtration system mune imwechete-kushandisa kumisikidza pamwe neyakakosha kuyerera.

Kuunza yakanyatsogadzirwa yakanyatsogadzirwa Imwechete-Shandisa eBAG 2D TFF, yakagadzirwa zvisina musono kuti batanidza zvisina mhosva ne TECNIC TFF masisitimu, kuve nechokwadi chekubatana kwakanaka mukati mesefa yekusefa. Dhizaini yedu yehunyanzvi inobata zvakananga kune zvinodikanwa zve-single-kushandisa application, ichipa isingaenzaniswi nyore pasina kukanganisa pakuita.

Yakagadziridzwa uye Yakagadzirwa mukati TECNIC ISO7 Yakachena Kamuri, mabhegi aya akavakwa zvinhu zvakasimba zvemhando yepamusoro uye anoiswa gamma irradiation. Nekuda kweizvozvo, ivo vakagadzirira-kushandisa zvinoenderana neyakaomesesa yemishonga indasitiri zviyero uye inowanikwa muhukuru hwakasiyana (2L, 5L, 10L, 20L, 50L) Iwo mabhegi anogona kugadziridzwa zvichienderana nehuwandu hwakasiyana hwezviteshi kuitira kuti uenderane kune zvakanyanya kudiwa zvinodiwa.

Iyo eBAG 2D TFF inopfuura bhegi chete; imhinduro yakagadzirwa nekunzwisisa kwakadzama kwematambudziko akatarisana nawo downstream maitiro mukati meiyo biotechnology indasitiri. Yakashongedzerwa nehunyanzvi Boat Port uye a Flow Kit, inokupa simba kuti ugare wakarongeka panguva dzakakosha maitiro, kuchengetedza nguva uye kuve nechokwadi chekuwana nyore kune zvishandiso zvako. Kuchengetedza kwakakosha, uye dhizaini yedu inobvumira kuchengetedzwa kwakachengeteka kwechigadzirwa chako chekupedzisira.

Pinda mune ramangwana uko kurerukira, kushanda, uye chimiro zvinosangana munharaunda ye downstream biotech. Gamuchira hunyanzvi ne eBAG 2D TFF, kuve nechokwadi chekuchengetedzwa kwemhando yepamusoro yezvigadzirwa zvebioprocess yako. Rondedzera zvaunotarisira uye tsvaga nguva itsva mu bioprocessing kunaka.

Kuvandudza bioprocess kutendeseka neBAG 2D TFF

Simbiso yekushaya mbereko
Kureruka uye kushanda zvakanaka kwakaenzana nekuderera kushoma
Various configuration options
Kuchengetedza kwezvakatipoteredza
Kubudirira
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 2D TFF inomiririra kwete chete hunyanzvi musero tsika firimu tekinoroji, asi zvakare inoisa mabhenji matsva 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 In-house 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® 2D TFF inomiririra kwete chete hunyanzvi musero tsika firimu tekinoroji, asi zvakare inoisa mabhenji mabhenji 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 In-house 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

Kuteerera nemitemo

 Iyo eBAG 2D TFF inoomerera kune yakakura biocompatibility uye physicochemical zviyero, kusanganisira Kirasi VI, USP 87, ISO 10993, FDA 21CFR177, uye Eu 3.1.9. Uku kutevedzera kunoratidza kukodzera kwayo kushandiswa mune inonzwisisika bioprocessing application.

Low extractable profile

kufuratira nhungamiro yeBio-Process Systems Alliance (BPSA), iyo eBAG 2D TFF ine yakaderera inobviswa chimiro, ichiva nechokwadi chekuti haiburitse huwandu hwakakosha hwezvinhu muchigadzirwa, nekudaro kuchengetedza kuchena uye kutendeseka kweiyo bioprocessed zvinhu.

Kuwanikwa kwegwaro rekusimbisa

Gwaro rakazara rekusimbisa rinowanikwa pakukumbira, richipa zvakadzama information pane eBAG 2D TFF kuita uye kukodzera kune akasiyana maapplication. Gwaro iri chinhu chakakosha kuti vashandisi vanzwisise kugona kwechigadzirwa uye kutevedzera.

Maitiro ekugadzira

Iyo eBAG 2D TFF inogadzirwa mune ISO14644-1 kirasi 7 yekuchenesa imba, kuve nechokwadi kuti inogadzirwa munzvimbo inodzorwa inoderedza njodzi yekusvibiswa. Iyi nhanho yekugadzira chiyero yakakosha pakuchengetedza iyo yemhando yepamusoro uye kuvimbika kwechigadzirwa.

Boat Ports mueBAG 2D

Boat ports mune yedu Imwechete-Shandisa zvigadzirwa zvakagadzirirwa kunyatsoita uye kuita zvakasiyana. Ivo vanofambisa kufambisa kwemvura isina musono, vachibvumira kuwedzera kana kubviswa kwemidhiya uye zvigadzirwa uku uchichengetedza nharaunda isina hutachiona. Aya madoko zvakare akakosha e-in-process sampling, achigonesa kuenderana kwemhando yekutarisa pasina kukanganisa kutendeka kwebhegi. TECNIC Bag Port yakashongedzerwawo kugarisa masensa akasiyana siyana, ayo anopa yakakosha data yekudzora maitiro. Chekupedzisira, dhizaini yakasimba yezviteshi izvi inogonesa kusimba uye kuenderana neyakasiyana yezvigadzirwa zvebioprocessing, zvichiita kuti ive chinhu chakakosha mune zvepamberi biotechnological mhinduro.

Mumba ISO 7 kamuri yekuchenesa yeimwe-yekushandisa zviyero

Iyo nzira yekugadzira yedu-yekushandisa bioprocessing zvigadzirwa, senge eBAG 2D uye 3D, 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.

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.