Pūnaehana no ka mālama ʻana i nā mea bioprocess paʻa

eBAG 2D Storage he mea hiki ke hoʻohana ʻia

ʻO ka mālama ʻana i ka biotech hou me ka hana kiʻekiʻe me ka eBAG 2D Storage

I ka ʻāina biotech e ulu nei, ʻo ka eBAG hoʻohana hoʻokahi 2D Storage e hoʻonui i kāu mau hana bioprocessing me ka wehewehe hou ʻana hana, kaila, lōʻihi a me ka maʻalahi. Hoʻolālā ʻia no ka mālama ʻana a kūpono me TECNIC nā mea hana, e hoʻomāmā ʻia kāu mau hana bioprocessing.

Hana ʻia ma ka TECNIC ISO7 lumi maemae, Ke hoʻokiʻekiʻe nei kēia mau ʻeke i ke kūpaʻa me nā mea kiʻekiʻe kiʻekiʻe a loaʻa i ka gamma irradiation, e hālāwai ana i nā kūlana ʻoihana lāʻau koʻikoʻi. Loaʻa i nā nui like ʻole (2L, 5L, 10L, 20L, 50L), eBAG 2D Storage ʻaʻole ia he hoʻoponopono mālama; He hōʻike ia i ka pololei a me ka hoʻomaopopo ʻana i nā luʻi e kū nei i nā hana biotechnological i kēlā me kēia lā.

Hoʻolālā ʻia me nā awa waʻa kūikawā, eBAG 2D Storage e hōʻoia i ka pono o ka hoʻonohonoho ʻana i ka wā o nā hoʻokolohua koʻikoʻi, mālama i ka manawa a me ka hōʻoia ʻana i ka maʻalahi i kāu mau mea hana.

E ʻike pehea ʻoluʻolu, hana, a me ke ʻano ua wehewehe hou ʻia i ka honua o ka biotech. E apo i ka wā e hiki mai ana me eBAG 2D Storage e hoʻokiʻekiʻe i kāu hana bioprocess i kahi kiʻekiʻe.

eBAG 2D Storage ʻoi aku ka maikaʻi o ka mālama maʻamau

ʻO ka hōʻoiaʻiʻo ʻana

Hiki ke hoʻonohonoho

Ka hoʻokō kāki

Ka hoʻomau paʻa kaiapuni

Ka hikiwawe

Ka hōʻoia maikaʻi

Hoʻoiho i nā kikoʻī ʻenehana ⇀

ʻenehana kiʻiʻoniʻoni no nā ʻeke bioprocess i hoʻonui ʻia

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)

Papa 2 - TIE (10μm)

Papa 3 - EVOH (20μm)

Papa 4 - TIE (10μm)

Papa 5 - ULPDE (230μm)

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

Ka hoʻolohe ʻana me nā hae

ʻO ka eBAG 2D Storage pili i nā kūlana biocompatibility nui a me ka physicochemical, me ka Papa VI, USP 87, ISO 10993, FDA 21CFR177, a me Eu 3.1.9. Hōʻike kēia hoʻokō i kona kūpono no ka hoʻohana ʻana i nā noi bioprocessing koʻikoʻi.

Haʻahaʻa extractable profile

Ma muli o nā alakaʻi o ka Bio-Process Systems Alliance (BPSA), ka eBAG 2D Storage he haʻahaʻa haʻahaʻa haʻahaʻa haʻahaʻa, e hōʻoiaʻiʻo ʻaʻole ia e hoʻokuʻu i nā mea nui o nā mea i loko o ka huahana, pēlā e mālama ai i ka maʻemaʻe a me ka pono o nā mea bioprocessed.

Loaʻa ke alakaʻi hōʻoia

Loaʻa kahi alakaʻi hōʻoia piha ma ke noi, hāʻawi i nā kikoʻī information ma ka eBAG 2D Storage ka hana a me ke kūpono no nā noi like ʻole. He kumu waiwai kēia alakaʻi no nā mea hoʻohana e hoʻomaopopo i ka hiki o ka huahana a me ka hoʻokō.

Nā kūlana hana

ʻO ka eBAG 2D Storage hana ʻia i loko o kahi lumi hoʻomaʻemaʻe ISO14644-1 papa 7, e hōʻoiaʻiʻo ana e hana ʻia ia i loko o kahi kaiapuni i hoʻopaʻa ʻia e hōʻemi i ka hopena o ka hoʻohaumia ʻana. He mea koʻikoʻi kēia pae o ka hana maʻamau no ka mālama ʻana i ke kūlana kiʻekiʻe a me ka hilinaʻi o ka huahana.

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 hoʻoponopono i kā mākou kūpaʻa i ka maikaʻi i ka hana ʻana i ka eBAG, e hāʻawi ana 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.

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

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

Kaiapuni maloʻo

Palena wela

Nā kūlana GMP a me ISO

eBAG® 2D TFF hoʻopiha ʻia me ka wai kala ʻulaʻula, ma ka ʻeke hiki iā ʻoe ke ʻike a TECNIC pepili

Nā Awa Waʻa ma eBAG 2D Storage

Hoʻolālā ʻia nā awa waʻa i kā mākou huahana hoʻohana hoʻokahi no ka pololei a me ka versatility. Hoʻomaʻamaʻa lākou i ka hoʻololi ʻana o ka wai, e ʻae ai i ka hoʻohui a i ʻole ka wehe ʻana i nā media a me nā huahana ʻoiai e mālama ana i kahi kaiapuni sterile. He kī nō hoʻi kēia mau awa no ka hōʻiliʻili ʻana i ke kaʻina hana, e ʻae ai i ka nānā ʻana i ka maikaʻi me ka ʻole e hōʻole i ka pono o ka ʻeke. TECNIC Hoʻolako pū ʻia ʻo Bag Port e hoʻokipa i nā mea ʻike like ʻole, e hāʻawi ana i ka ʻikepili koʻikoʻi no ka hoʻokele kaʻina hana. ʻO ka mea hope loa, ʻo ka hoʻolālā paʻa o kēia mau awa e hōʻoia i ka lōʻihi a me ka hoʻohālikelike ʻana me kahi ʻano o nā mea hana bioprocessing, e hoʻolilo iā lākou i mea koʻikoʻi i nā hoʻonā biotechnological holomua.

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 ⇀

More information ⇀

eBAG 2D Storage he mea hiki ke hoʻohana ʻia

ʻO ka mālama ʻana i ka biotech hou me ka hana kiʻekiʻe me ka eBAG 2D Storage

eBAG 2D Storage ʻoi aku ka maikaʻi o ka mālama maʻamau

ʻO ka hōʻoiaʻiʻo ʻana

Hiki ke hoʻonohonoho

Ka hoʻokō kāki

Ka hoʻomau paʻa kaiapuni

Ka hikiwawe

Ka hōʻoia maikaʻi

Hoʻoiho i nā kikoʻī ʻenehana ⇀

ʻenehana kiʻiʻoniʻoni no nā ʻeke bioprocess i hoʻonui ʻia

Papa 1 - LPDE (50μm)

Papa 2 - TIE (10μm)

Papa 3 - EVOH (20μm)

Papa 4 - TIE (10μm)

Papa 5 - ULPDE (230μm)

Papa 1 - LPDE (50μm)

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

Ka hoʻolohe ʻana me nā hae

Haʻahaʻa extractable profile

Loaʻa ke alakaʻi hōʻoia

Nā kūlana hana

Nā kūlana kiʻekiʻe i ka bioprocessing

ʻeke waiwai

ʻO ka papa waho paʻa

Kaiapuni maloʻo

Palena wela

Nā kūlana GMP a me ISO

Nā Awa Waʻa ma eBAG 2D Storage

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

Ke Kūlana Kūikawā

Nā noi ma Biotechnology

Nā Pōmaikaʻi o ka Pono

Paʻa a me ka hilinaʻi

Hoʻonui no TECNIC

Ke Kūlana Kūikawā

Nā noi ma Biotechnology

Nā Pōmaikaʻi o ka Pono

Paʻa a me ka hilinaʻi

Ke Kūlana Kūikawā

Nā noi ma Biotechnology

Nā Pōmaikaʻi o ka Pono

Paʻa a me ka hilinaʻi