Inzwa musiyano ne eBAG 3D Open

Yakasarudzika uye inovandudza imwechete-shandisa yakavhurika bhegi rekushandisa zvakasiyana-siyana uye zvine hunyanzvi

Kusanganisa kusingaite uye kuchengetedza kwakachengeteka mu bioprocessing ne eBAG 3D Open

Kuunza iyo imwechete-kushandisa eBAG 3D Open, yakagadzirirwa kusanganisa uye inobudirira kusanganisa neyakasarudzika 3D kumisikidzwa, ichibvumira vashandisi kushanda zviri nyore zvisingaenzaniswi. Yakagadzirwa kubva kumishonga-giredhi zvinhu, bhegi iri kwete chete inochengetedza kuvimbika kwebiologicals asi zvakare inoramba kuparara kwemakemikari, ichipa musanganiswa wakakwana wekushanda, chimiro, kusimba, uye nyore.

Chinhu chakasiyana che a chiteshi chikuru chakashama muchikamu chepamusoro chinopa sarudzo dzakasiyana dze media preparation kana masisitimu ekuchengetedza mumamiriro akasiyana emuchadenga. Yakagadzirwa nezvinhu zvinogoneka, mabhegi aya anoenderana nezvinodiwa maererano nehukuru, kumisikidzwa, uye zvigadziriso, kuve nechokwadi chekubatanidzwa kusina musono mumagadzirirwo ekugadzira.

Yakagadzirwa uye inogadzirwa mukati meiyo TECNIC ISO7 Yakachena Kamuri, aya mabhegi e3D anogadzirwa nezvinhu zvemhando yepamusoro uye anoiswa gamma irradiation. Iyi inyanzvi yekuita inovimbisa kuti yakagadzirira-kushandisa, inowanikwa muhukuru kubva 50L kusvika 500L, uye inokwanisa kushingirira kubata zvakasimba kuitira kuchengetedzwa kwakachengeteka kwezvigadzirwa zvebiopharmaceutical. Iwo mabhegi akagadzirirwa kushandiswa kwevashandisi-hushamwari, ane mavara akajeka uye ergonomic zvibatiso, zvichibvumira kubatana kuri nyore kune aripo masisitimu uye seamless kubatanidzwa mumagadzirirwo ekugadzira. Sangana nedanho rinotevera rekuita uye kuvimbika neiyo Imwe-Shandisa eBAG 3D Open.

Kukwirisa kugadzirwa neyakagadzirirwa imwe-kushandisa kuchengetedza

Kureruka uye kushanda zvakanaka kwakaenzana nekuderera kushoma
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, 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

 

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
Tembiricha Resilience
GMP uye ISO zviyero

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.

Kuwanikwa kwegwaro rekusimbisa

Iyo yakadzama yekusimbisa gwara reiyo eBAG 3D inowanikwa pakukumbira. Gwaro iri rinopa zvizere information pakuita kwayo uye kukodzera kwekushandisa, kushanda sechinhu chakakosha chekunzwisisa kugona kwechigadzirwa uye kutevedzera.

Maitiro ekugadzira

Yakagadzirwa mune ISO14644-1 kirasi 7 yekuchenesa imba, iyo eBAG 3D inogadzirwa munzvimbo inodzorwa, ichideredza zvakanyanya njodzi dzekusvibiswa. Iyi chiyero chekugadzira chakakosha pakuona kuti chigadzirwa chemhando yepamusoro uye kuvimbika.

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.