Dongosolo losungirako zinthu zotetezedwa za bioprocess

eBAG 2D Storage ndi chida chokonzeka kugwiritsa ntchito fungible

Kupanga zatsopano zosungirako zasayansi zokhala ndi magwiridwe antchito apamwamba ndi eBAG 2D Storage

M'malo osinthika a biotech, eBAG yakugwiritsa ntchito kamodzi kokha 2D Storage idzakulitsa kuyesetsa kwanu kwa bioprocessing ndikufotokozedwanso magwiridwe antchito, kalembedwe, kulimba komanso kusavuta. Zapangidwira kusungirako komanso zogwirizana ndi TECNIC zida, njira yaukadaulo iyi idzawongolera magwiridwe antchito anu a bioprocessing.

Wopangidwa mu TECNIC Chipinda Choyera cha ISO7, matumbawa amadzitamandira kuti amatha kupirira ndi zipangizo zapamwamba kwambiri ndipo amawalitsa mpweya wa gamma, akukwaniritsa miyezo yokhwima kwambiri yamakampani opanga mankhwala. Akupezeka mu makulidwe osiyanasiyana (2L, 5L, 10L, 20L, 50L), eBAG 2D Storage sikuti ndi njira yosungira; ndi umboni wa kulondola ndi kumvetsetsa kwa zovuta zomwe zimachitika tsiku ndi tsiku mu sayansi ya zamankhwala.

Zopangidwa ndi ma Port Boat apadera, eBAG 2D Storage imawonetsetsa kuti bungwe likuyenda bwino pakuyesera kofunikira, kupulumutsa nthawi ndikuwonetsetsa kuti zida zanu zili zosavuta.

Dziwani momwe zingakhalire zosavuta, magwiridwe antchito, ndi kalembedwe amafotokozedwanso mu dziko la biotech. Landirani tsogolo ndi eBAG 2D Storage kukweza zoyesayesa zanu za bioprocess kupita kumtunda watsopano.

eBAG 2D Storage imaposa kusungirako zakale

Chitsimikizo cha sterility
Kusasinthika
Kugwiritsa ntchito mtengo
Kusamalira zachilengedwe
Kusintha
Chitsimikizo chadongosolo

Ukadaulo wamakanema wamamatumba owonjezera a bioprocess

athu TECNIC Filimu Technology imapangidwira mwapamwamba kwambiri. Chilichonse mwazinthu zathu Zogwiritsa Ntchito Pamodzi chimadzisiyanitsa ndi mawonekedwe ake osanjikiza asanu, ndipo gawo lililonse limagwira ntchito inayake kuti likwaniritse kukhulupirika, kulimba, moyo wautali komanso kusalimba kwa zida. 

Gawo 1 - LPDE (50μm)
Layer 2 - TIE (10μm)
Layer 3 - EVOH (20μm)
Layer 4 - TIE (10μm)
Layer 5 - ULPDE (230μm)

athu TECNIC Filimu Technology imapangidwira mwapamwamba kwambiri. Chilichonse mwazinthu zathu Zogwiritsa Ntchito Pamodzi chimadzisiyanitsa ndi mawonekedwe ake osanjikiza asanu, ndipo gawo lililonse limagwira ntchito inayake kuti likwaniritse kukhulupirika, kulimba, moyo wautali komanso kusalimba kwa zida. 

Gawo 1 - LPDE (50μm)
Layer 2 - TIE (10μm)
Layer 3 - EVOH (20μm)
Layer 4 - TIE (10μm)
Layer 5 - ULPDE (230μm)

Kugwirizana ndi miyezo

 The eBAG 2D Storage amatsatira mfundo zazikulu za biocompatibility ndi physicochemical, kuphatikiza Kalasi VI, USP 87, ISO 10993, FDA 21CFR177, ndi Eu 3.1.9. Kutsatira uku kukuwonetsa kuyenera kwake kugwiritsidwa ntchito pazovuta za bioprocessing.

Mbiri yotsika yochotsera

Kutsatira malangizo a Bio-Process Systems Alliance (BPSA), eBAG 2D Storage ali ndi mbiri yotsika, kuonetsetsa kuti sichikutulutsa zinthu zambiri zomwe zimapangidwira, motero zimasunga chiyero ndi kukhulupirika kwa zinthu zomwe zimapangidwa ndi bioprocessed.

Kupezeka kwa kalozera wotsimikizira

Kalozera wotsimikizika wathunthu umapezeka mukafunsidwa, ndikupereka mwatsatanetsatane information pa eBAG 2D Storage magwiridwe antchito komanso kukwanira kwamapulogalamu osiyanasiyana. Bukhuli ndi chida chofunikira kuti ogwiritsa ntchito amvetsetse kuthekera kwa chinthucho komanso kutsatiridwa kwake.

Miyezo yopanga zinthu

The eBAG 2D Storage amapangidwa m'chipinda choyera cha ISO14644-1 class 7, kuwonetsetsa kuti amapangidwa m'malo oyendetsedwa bwino omwe amachepetsa chiopsezo choipitsidwa. Mulingo wopangira uwu ndi wofunikira kwambiri kuti zinthu zizikhala zapamwamba komanso zodalirika.

Miyezo yapamwamba mu bioprocessing

EBAG siyimayimira luso laukadaulo wamakanema amtundu wama cell, komanso imayikanso miyeso yatsopano pamachitidwe abwino komanso kutsata malamulo. EBAG iliyonse imapangidwa movutikira Zochita Zabwino Zopanga (GMP), kuwonetsetsa kuti chinthu chilichonse chikugwirizana ndi miyezo yapamwamba kwambiri yamtundu ndi chitetezo.

Kutsekereza ndi gawo lofunikira kwambiri pakupanga. Timalemba ntchito zapamwamba kutsekereza kwa radiation njira, kuthetsa bwino tizilombo toyambitsa matenda popanda kusokoneza kukhulupirika kwa mankhwala. Njira yolerayi ndiyofunikira kwambiri pakusunga sterility ndi chitetezo pakugwiritsa ntchito zovuta.

Kuphatikiza apo, kupanga eBAG kumachitika mkati mnyumba ISO 7 zida zamagulu. Zipinda zoyeretserazi zidapangidwa kuti zizitha kuipitsidwa ndikusunga malo osakhazikika, ofunikira popanga zinthu zaukadaulo. Kutsatira miyezo ya ISO 7 kumawonetsetsa kuti eBAG iliyonse imapangidwa m'malo olamulidwa, kuchepetsa chiopsezo cha kuipitsidwa ndi kuwonetsetsa kuti zinthu sizingafanane.

Pamodzi, njira zabwinozi komanso kutsata malamulo zikuwonetsa kudzipereka kwathu pakuchita bwino kwambiri popanga eBAG, kupatsa makasitomala athu zinthu zodalirika komanso zotetezeka pakugwiritsa ntchito kwawo kwa bioprocessing.

 

mayeso

zofunika

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 ya

1 ml ya

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® sichikuyimira luso lokha muukadaulo wamakanema amtundu wama cell, komanso imayikanso zizindikiro zatsopano pamachitidwe abwino komanso kutsata malamulo. Aliyense eBAG®  amapangidwa movutikira Zochita Zabwino Zopanga (GMP), kuwonetsetsa kuti chinthu chilichonse chikugwirizana ndi miyezo yapamwamba kwambiri yamtundu ndi chitetezo.

Kutsekereza ndi gawo lofunikira kwambiri pakupanga. Timalemba ntchito zapamwamba kutsekereza kwa radiation njira, kuthetsa bwino tizilombo toyambitsa matenda popanda kusokoneza kukhulupirika kwa mankhwala. Njira yolerayi ndiyofunikira kwambiri pakusunga sterility ndi chitetezo pakugwiritsa ntchito zovuta.

Komanso, kupanga eBAG® chikuchitika mu mnyumba ISO 7 zida zamagulu. Zipinda zoyeretserazi zidapangidwa kuti zizitha kuipitsidwa ndikusunga malo osakhazikika, ofunikira popanga zinthu zaukadaulo. Kutsatira miyezo ya ISO 7 kumatsimikizira kuti aliyense eBAG® amapangidwa m'malo olamulidwa, kuchepetsa chiopsezo cha kuipitsidwa ndi kuwonetsetsa kuti mankhwala akugwirizana.

Pamodzi, miyeso iyi yabwino komanso kutsata malamulo zikuwonetsa kudzipereka kwathu pakuchita bwino kwambiri popanga eBAG®, kupatsa makasitomala athu zinthu zodalirika komanso zotetezeka pamapulogalamu awo ovuta kwambiri a bioprocessing.

 

mayeso

zofunika

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 ya

1 ml ya

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®  sichikuyimira luso lokha muukadaulo wamakanema amtundu wama cell, komanso imayikanso zizindikiro zatsopano pamachitidwe abwino komanso kutsata malamulo. Aliyense eBAG®  amapangidwa movutikira Njira Zabwino Zopangira (GMP), kuwonetsetsa kuti chinthu chilichonse chikugwirizana ndi miyezo yapamwamba kwambiri yamtundu ndi chitetezo.

Kutsekereza ndi gawo lofunikira kwambiri pakupanga. Timalemba ntchito zapamwamba kutsekereza kwa radiation njira, kuthetsa bwino tizilombo toyambitsa matenda popanda kusokoneza kukhulupirika kwa mankhwala. Njira yolerayi ndiyofunikira kwambiri pakusunga sterility ndi chitetezo pakugwiritsa ntchito zovuta.

Komanso, kupanga eBAG® chikuchitika mu mnyumba ISO 7 zida zamagulu. Zipinda zoyeretserazi zidapangidwa kuti zizitha kuipitsidwa ndikusunga malo osakhazikika, ofunikira popanga zinthu zaukadaulo. Kutsatira miyezo ya ISO 7 kumatsimikizira kuti aliyense eBAG® amapangidwa m'malo olamulidwa, kuchepetsa chiopsezo cha kuipitsidwa ndi kuwonetsetsa kuti mankhwala akugwirizana.

Pamodzi, miyeso iyi yabwino komanso kutsata malamulo zikuwonetsa kudzipereka kwathu pakuchita bwino kwambiri popanga eBAG®, kupatsa makasitomala athu zinthu zodalirika komanso zotetezeka pamapulogalamu awo ovuta kwambiri a bioprocessing.

 

mayeso

amafunika

chifukwa

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 ya

1 ml ya

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

 

Thumba katundu

Wosanjikiza wakunja wolimba
Malo osabala
Kupirira Kutentha
Miyezo ya GMP ndi ISO

Boti Ports mu eBAG 2D Storage

Madoko amaboti muzinthu zathu Zogwiritsa Ntchito Kamodzi adapangidwa kuti azilondola komanso azisinthasintha. Amathandizira kusamutsa kwamadzimadzi kosasunthika, kulola kuwonjezera kapena kuchotsedwa kwa media ndi zinthu ndikusunga malo osabala. Madokowa ndiwonso ofunikira pakuyesa sampuli, kupangitsa kuyang'anira mosasintha popanda kusokoneza kukhulupirika kwa thumba. TECNIC Bag Port ilinso ndi zida zokhala ndi masensa osiyanasiyana, omwe amapereka chidziwitso chofunikira pakuwongolera njira. Pomaliza, mapangidwe olimba a madokowa amatsimikizira kulimba komanso kugwirizanirana ndi zida zingapo zopangira bioprocessing, zomwe zimawapangitsa kukhala gawo lofunikira pamayankho apamwamba asayansi yazachilengedwe.

M'nyumba ISO 7 zoyeretsa zogwiritsa ntchito kamodzi

Njira yopangira zinthu zomwe timagwiritsa ntchito kamodzi kokha, monga eBAG 2D ndi 3D, zimagwirizana kwambiri ndi mfundo zokhwima za ISO 7 chipinda choyera. Gulu lenilenili limatsimikizira malo olamulidwa kwambiri, omwe amadziwika ndi kuchuluka kwa tinthu 10,000 (≥ 0.5 μm) pa kiyubiki mita ya mpweya. 

Kuwongolera uku ndikofunikira kwambiri pakuwonetsetsa kusabereka komanso mtundu wazinthu zathu, chifukwa kumachepetsa kwambiri chiopsezo cha kuipitsidwa ndi tizilombo tating'onoting'ono. Potsatira mfundozi, timawonetsetsa kuti chinthu chilichonse chikukwaniritsa ziyembekezo zazikulu zaukhondo ndi magwiridwe antchito omwe amafunikira pakugwiritsa ntchito ukadaulo wa bioprocessing, kupatsa makasitomala athu mayankho odalirika komanso osasinthika a biotechnological.

Gulu lathu lazogulitsa ndi lokonzeka kukuthandizani ndi zambiri zaukadaulo.

Lumikizanani ndi gulu lathu lero. Kaya muli ndi mafunso enieni kapena mwangoyamba kumene kufufuza, tili pano kuti tikutsogolereni ndikukuthandizani. Fikirani tsopano ndikupanga tsogolo limodzi.