eBAG 3D STR no ka hoʻohana hoʻokahi bioreactor solution

A TECNIC ʻeke hoʻohana hoʻokahi me ka inoa eBAG® 3D STR, it is transparent and rectangular but with rounded edges.

ʻeke cylindrical a me ka ʻeke bioprocess (eBAG® 3D STR) with rounded edges (supplies) for bioprocessing equipment

Hoʻolaʻa i ka lanakila ʻana i nā palena o nā ʻōnaehana ʻeke hoʻohana hoʻokahi

ʻO ka eBAG 3D STR kiʻekiʻe no ka lua-kumu hoʻokahi fermenter/bioreactors

I ka ʻāina ulu mau o Biotech, TECNICHoʻolālā ʻia ka eBAG 3D STR hoʻokahi hoʻohana i ka hoʻohui maikaʻi me kā mākou bioreactor hoʻohana hoʻokahi kumu ʻelua. Hoʻolaʻa ʻia i ka lanakila ʻana i nā palena ʻokoʻa i nā ʻōnaehana hoʻohana hoʻokahi, kū ka eBAG 3D STR ma ke ʻano he kumu i kūkulu ʻia, ʻokiʻoki i hoʻohālikelike ʻia no moʻomeheu mammalian. Eia kekahi, ua hana ʻia kēia ʻōnaehana hou e hoʻoponopono i nā pilikia kūikawā, e hāʻawi ana i kahi lele hoʻololi i nā hiki o ka microbial bioprocessing.

Hana ʻia ma lalo nā kūlana aseptic paʻa a kau ʻia i ka sterilization piha, ʻO kēia mau ʻeke e hōʻoia i ka sterility kiʻekiʻe a me ka liʻiliʻi o ka pōʻino. Me nā hiʻohiʻona maʻamau e hoʻolako ana i nā hoʻonohonoho kikoʻī a me nā mea pono, hoʻohui pono lākou i nā kaʻina hana.

Kūkulu ʻia a hana ʻia ma TECNIC ISO7 lumi maemae, EBAG 3D STR i kūkulu ʻia me nā mea kiʻekiʻe kiʻekiʻe a loaʻa ka gamma irradiation. ʻO ka hopena, ua mākaukau lākou e hoʻohana e like me nā kūlana koʻikoʻi o ka ʻoihana lāʻau lapaʻau a loaʻa i nā ʻano nui. (30L a hiki i 1000L). Hiki iā lākou ke kūpaʻa i ka mālama paʻa ʻana e hōʻoia i ka mālama pono ʻana o nā huahana biopharmaceutical. Hoʻolālā maikaʻi ʻia e hana pū me TECNIC ePILOT a me ePROD hoʻohana hoʻokahi Bioreactor ⇀, hana ʻia i kūpono loa i loko o ka tank a hoʻololi piha me ka huila magnetic piha e hāʻawi i ka hōʻoia i kāu kaʻina hana.

Hoʻopaʻa ʻia ka sterility no nā bioprocesses koʻikoʻi

ʻO ka hōʻoiaʻiʻo ʻana

ʻŌnaehana modular

Ka hoʻokō kāki

Nā koho hoʻonohonoho like ʻole

Hiki i ka ʻeke

Ka hōʻoia maikaʻi

Hoʻoiho i nā kikoʻī ʻenehana ⇀

ʻenehana kiʻiʻoniʻoni no ka bioprocess hoʻonui

ko kakou TECNIC ʻIke ʻenehana kiʻiʻoniʻoni no ka kiʻekiʻe kiʻekiʻe. ʻO kēlā me kēia o kā mākou huahana hoʻohana hoʻokahi e hoʻokaʻawale iā ia iho ma o kāna ʻano ʻelima-layer ʻokoʻa, me kēlā me kēia papa e lawelawe ana i kahi hana kikoʻī e hoʻopaʻa i ka pono, ka lōʻihi, ka lōʻihi a me ka sterility o nā mea hana.

Papa 1 - LPDE (50μm)

ʻO ka papa mua i hanaʻia me Low-Density Polyethylene (LPDE) e hāʻawi i nā huahana hoʻohana hoʻokahi me ka ikaika mechanical ikaika, e hōʻoia ana i ka lōʻihi a me ke kū'ē i nā mea kino. ʻO ka ʻili waho e pale ai i ka ʻeke mai nā kumu o waho a me ka mālama ʻana i nā pōʻino.

Papa 2 - TIE (10μm)

Papa 3 - EVOH (20μm)

Papa 4 - TIE (10μm)

Papa 5 - ULPDE (230μm)

I loko o ka hale ISO 7 lumi maʻemaʻe no ka hoʻohana hoʻokahi maʻamau

ʻO ke kaʻina hana no kā mākou huahana bioprocessing hoʻohana hoʻokahi, e like me ka eBAG® ʻO ka moku 2D, 3D a me SU, e hoʻokō pono i nā kūlana koʻikoʻi o kahi ISO 7 lumi maʻemaʻe ʻO kēia hoʻohālikelike kikoʻī e hōʻoiaʻiʻo i kahi kaiapuni i hoʻomalu nui ʻia, i hōʻike ʻia e ka helu ʻana o ka nui o 10,000 (≥ 0.5 μm) i kēlā me kēia mika cubic o ka ea.

He mea koʻikoʻi kēia pae hoʻomalu no ka hōʻoia ʻana i ka sterility a me ka maikaʻi o kā mākou huahana, no ka mea e hōʻemi nui ʻia ka pilikia o ka microbial a me ka palaka. Ma ka pili ʻana i kēia mau kūlana, hōʻoia mākou e hoʻokō kēlā me kēia huahana i nā manaʻolana kiʻekiʻe o ka maʻemaʻe a me ka hana i koi ʻia i nā noi bioprocessing koʻikoʻi, e hāʻawi ana i kā mākou mea kūʻai aku i nā hopena biotechnological hilinaʻi a paʻa.

ʻElua mau kānaka i uhi piha i nā lole keʻokeʻo e hana ana i loko o kahi lumi maʻemaʻe i kahi noi ʻepekema.

ma ka puka makani, hiki ke ʻike ʻia nā kānaka ma kahi mea kanu hoʻohana hoʻokahi e hana ana

Nā kūlana kiʻekiʻe i ka bioprocessing

ʻAʻole hōʻike ka eBAG i kahi mea hou i ka ʻenehana kiʻiʻoniʻoni moʻomeheu cell, akā hoʻonohonoho pū i nā hiʻohiʻona hou i ka maikaʻi a me ka hoʻokō kānāwai. Hana ʻia kēlā me kēia eBAG ma lalo o ke koʻikoʻi Nā hana hana maikaʻi (GMP), e hōʻoia ana i kēlā me kēia huahana i nā kūlana kiʻekiʻe o ka maikaʻi a me ka palekana.

He mea koʻikoʻi ka sterilization o ka hana. Hoʻohana mākou i ka holomua hoʻoheheʻe ʻana i ka radiation nā ala, e hoʻopau pono i nā mea hoʻohaumia olaola me ka ʻole e hōʻino i ka pono o ka huahana. He mea koʻikoʻi kēia kaʻina hana sterilization no ka mālama ʻana i ka sterility a me ka palekana i nā noi koʻikoʻi.

Eia kekahi, hana ʻia ka hana o eBAG ma i loko o ka hale ISO 7 papa hana. Hoʻolālā ʻia kēia mau lumi hoʻomaʻemaʻe e kāohi i ka haumia a mālama i kahi kaiapuni aseptic, pono no ka hana ʻana i nā huahana biotechnological. ʻO ka mālama ʻana i nā kūlana ISO 7 e hōʻoia i ka hana ʻia ʻana o kēlā me kēia eBAG i kahi kaiapuni i hoʻopaʻa ʻia, e hōʻemi ana i ka pilikia o ka cross-contamination a me ka hōʻoia ʻana i ka kūlike o ka huahana.

Hoʻohui pū ʻia kēia mau ana maikaʻi a me ka hoʻokō kānāwai i kā mākou kūpaʻa i ka maikaʻi i ka hana ʻana eBAG®, hāʻawi i kā mākou mea kūʻai aku i nā huahana hilinaʻi a palekana no kā lākou noi bioprocessing koʻikoʻi.

hōʻike	koi	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

ka eBAG® ʻAʻole ia he mea hou i ka ʻenehana kiʻiʻoniʻoni moʻomeheu cell, akā hoʻonohonoho pū i nā hōʻailona hou i ka maikaʻi a me ka hoʻokō hoʻoponopono. ʻO kēlā me kēia eBAG® hana ʻia ma lalo o ke koʻikoʻi Nā hana hana maikaʻi (GMP), e hōʻoia ana i kēlā me kēia huahana i nā kūlana kiʻekiʻe o ka maikaʻi a me ka palekana.

Eia kekahi, ʻo ka hana ʻana o eBAG® hanaia ma i loko o ka hale ISO 7 papa hana. Hoʻolālā ʻia kēia mau lumi hoʻomaʻemaʻe e kāohi i ka haumia a mālama i kahi kaiapuni aseptic, pono no ka hana ʻana i nā huahana biotechnological. ʻO ka mālama ʻana i nā kūlana ISO 7 e hōʻoia i kēlā me kēia eBAG® hana ʻia i loko o kahi kaiapuni i hoʻopaʻa ʻia, e hōʻemi ana i ka hopena o ka hoʻopaʻa ʻana a me ka hōʻoia ʻana i ka paʻa ʻana o ka huahana.

hōʻike	koi	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

hōʻike	pono	hualoa'a
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

ʻeke waiwai

ʻO ka papa waho paʻa

a pau o TECNIC Hoʻolālā ʻia nā huahana hoʻohana hoʻokahi me kahi kūkulu paʻa e hōʻoiaʻiʻo i ka mālama paʻa ʻana o ka huahana. ʻO ka ikaika mechanical o kā mākou huahana e hōʻoia i ka lōʻihi a me ke kū'ē i nā mea kino o waho.

Kaiapuni maloʻo

Pahu wela

Nā kūlana GMP a me ISO

Mākaukau kā mākou hui kūʻai e kōkua iā ʻoe me nā kikoʻī loea.

E hui pū me kā mākou hui i kēia lā. Inā he mau nīnau kikoʻī kāu a i ʻole e hoʻomaka ana e ʻimi, eia mākou e alakaʻi a kōkua. E kiʻi mai i kēia manawa a e hoʻolālā pū kākou i ka wā e hiki mai ana.

E kelepona iā mākou ⇀