Kupititsa patsogolo bioprocess yanu ndi eBAG 2D TFF

Matumba apamwamba okonzeka kugwiritsa ntchito kamodzi kuti mukwaniritse bwino downstream ndondomeko

eBAG 2D TFF yogwirizana ndi Tangential Flow Filtration system pakugwiritsa ntchito kamodzi kokha limodzi ndi flowkit yapadera.

Kuyambitsa makina opangidwa mwaluso a single-Use eBAG 2D TFF, opangidwa mwaluso kuti phatikizani mopanda cholakwika ndi TECNIC Machitidwe a TFF, kuonetsetsa kuti pali kulumikizana koyenera panthawi yonse yosefera. Kapangidwe kathu katsopano kamakwaniritsa zofunikira pakugwiritsa ntchito kamodzi, kumapereka mwayi wosayerekezeka popanda kusokoneza magwiridwe antchito.

Yopangidwa ndi Kupangidwa mu TECNIC Chipinda Choyera cha ISO7, matumbawa amamangidwa zinthu zolimba zapamwamba kwambiri ndipo amawazidwa ndi mpweya wa gamma. Zotsatira zake, ali okonzeka kugwiritsidwa ntchito molingana ndi miyezo yolimba kwambiri yamakampani opanga mankhwala ndipo amapezeka m'miyeso yosiyanasiyana (2L, 5L, 10L, 20L, 50L). Matumba amatha kukhazikitsidwa malinga ndi kuchuluka kwa madoko kuti agwirizane ndi zomwe akufuna.

The eBAG 2D TFF ndi zambiri kuposa thumba; ndi yankho lopangidwa ndikumvetsetsa mozama zovuta zomwe zimakumana nazo downstream ndondomeko zamakampani a biotechnology. Okonzeka ndi Boat Port yapadera komanso a Flow Kit, kumakupatsani mphamvu kuti mukhale okonzeka panthawi yovuta, kupulumutsa nthawi ndikuwonetsetsa kuti zida zanu zili zosavuta. Chitetezo ndichofunika kwambiri, ndipo mapangidwe athu amalola kusintha kotetezeka kwa chinthu chanu chomaliza.

Lowani m'tsogolo momwe kumasuka, magwiridwe antchito, ndi masitayelo zimakumana mu gawo la downstream zasayansi. Landirani zatsopano ndi eBAG 2D TFF, kuwonetsetsa kusungidwa kwa zinthu zapamwamba za bioprocess yanu. Konzaninso zomwe mukuyembekezera ndikupeza nthawi yatsopano mu bioprocessing excellence.

Kupititsa patsogolo kukhulupirika kwa bioprocess ndi eBAG 2D TFF

Chitsimikizo cha sterility
Kusavuta komanso kuchita bwino ndizofanana ndi nthawi yocheperako
Zosintha zosiyanasiyana zosankha
Kusamalira zachilengedwe
Kusintha
Chitsimikizo chadongosolo

Tekinoloje yamakanema yopititsa patsogolo 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)

Miyezo yapamwamba mu bioprocessing

EBAG 2D TFF siyimayimira luso laukadaulo wamakanema amtundu wama cell, komanso imayika zizindikiro zatsopano 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 M'nyumba 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® 2D TFF siyimayimira luso laukadaulo wamakanema amtundu wama cell, komanso imayikanso miyeso yatsopano 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 M'nyumba 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

Kugwirizana ndi miyezo

 The eBAG 2D TFF imatsatira mfundo zazikuluzikulu za biocompatibility ndi physicochemical, kuphatikiza Kalasi VI, USP 87, ISO 10993, FDA 21CFR177, ndi Eu 3.1.9. Kutsatira uku kukuwonetsa kuyenerera kwake kugwiritsidwa ntchito pazovuta za bioprocessing.

Mbiri yotsika yochotsera

kutsata malangizo a Bio-Process Systems Alliance (BPSA), eBAG 2D TFF ili ndi mbiri yotsika, yowonetsetsa kuti siyitulutsa zinthu zambiri zomwe zimapangidwa, motero zimasunga chiyero ndi kukhulupirika kwa zinthu zomwe zidapangidwa.

Kupezeka kwa kalozera wotsimikizira

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

Miyezo yopanga zinthu

EBAG 2D TFF imapangidwa mu chipinda choyera cha ISO14644-1 kalasi 7, kuwonetsetsa kuti imapangidwa m'malo olamulidwa omwe amachepetsa chiopsezo cha kuipitsidwa. Mulingo wopangirawu ndi wofunikira kwambiri kuti zinthu zizikhala zapamwamba komanso zodalirika.

Boti Madoko mu eBAG 2D

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.