Fotokozeraninso Kukhathamiritsa ndi eBAG 3D Mixer

Njira zoyendetsera zamadzimadzi zanzeru m'matumba

Njira zatsopano komanso zodalirika zamathumba ogwiritsa ntchito kamodzi pagawo laukadaulo waukadaulo wokhala ndi eBAG 3D Mixer.

M'malo osinthika a Biotech, eBAG 3D Mixer yogwiritsa ntchito kamodzi imakulitsa mphamvu zamadzimadzi kuti zisakanizike bwino, sungani kusungirako ndi kunyamula mosavuta zamadzimadzi. Wopangidwa ndi mapangidwe apadera a 3D, TECNIC eBAG 3D Mixer ikukonzanso gawo laukadaulo waukadaulo powonjezera mphamvu zamadzimadzi kuti zipeze zotsatira zabwino kwambiri.

Opangidwa pansi pa mikhalidwe yolimba ya aseptic ndikuyamwitsa kwathunthu, matumbawa amatsimikizira kusabereka kwakukulu komanso chiopsezo chochepa cha kuipitsidwa. Ndi mawonekedwe osinthika omwe amakwaniritsa zosowa zenizeni za kukula, masinthidwe, ndi zokometsera, amaphatikizana mosagwirizana ndi kupanga.

Yopangidwa ndi Kupangidwa mu TECNIC Chipinda Choyera cha ISO7, matumba a 3D awa amapangidwa ndi zida zapamwamba kwambiri ndipo amalowetsedwa ndi gamma irradiation, kuwapangitsa kukhala okonzeka kugwiritsidwa ntchito molingana ndi miyezo yolimba kwambiri yamakampani opanga mankhwala. Akupezeka mu makulidwe osiyanasiyana (50L, 100L, 200L, ndi 500L), matumbawa samatha kugwidwa mwamphamvu, kuonetsetsa kuti zinthu za biopharmaceutical zili zotetezeka. Zopangidwa mwaluso kuti zizigwira ntchito mosasunthika ndi TECNIC ePLUS® Mixer SU ⇀, amapangidwa kuti agwirizane bwino ndi tank ndikusinthira ku chosakanizira cha maginito kuti mukhale otetezeka komanso ogwira mtima.

eBAG 3D Mixer kuti mupeze yankho labwino kwambiri

Chitsimikizo cha sterility
Kusavuta komanso kuchita bwino ndizofanana ndi nthawi yocheperako
Kugwiritsa ntchito mtengo
Zosintha zosiyanasiyana zosankha
Thumba scalability
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 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

 

 

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 3D imatsatira mfundo zazikuluzikulu za biocompatibility ndi physicochemical, kuphatikiza Class VI, USP 87, ISO 10993, FDA 21CFR177, ndi Eu 3.1.9. Kutsatira kwake kumawunikira kukwanira kwake pamapulogalamu osavuta a bioprocessing.

Mbiri yotsika yochotsera

Kutsatira malangizo a Bio-Process Systems Alliance (BPSA), eBAG 3D ili ndi mbiri yotsika, kuwonetsetsa kutulutsidwa kwazinthu zochepa muzogulitsa. Izi zimasunga chiyero ndi kukhulupirika kwa zinthu zopangidwa ndi bioprocessed.

Kupezeka kwa kalozera wotsimikizira

Chitsogozo chatsatanetsatane cha eBAG 3D chikupezeka mukafunsidwa. Bukuli limapereka zambiri information pa kagwiridwe kake ndi kagwiritsidwe ntchito kake, zomwe zimagwira ntchito ngati gwero lofunikira pakumvetsetsa kuthekera kwa chinthucho ndi kutsata kwake.

Miyezo yopanga zinthu

Yopangidwa mu ISO14644-1 class 7 cleanroom, eBAG 3D imapangidwa m'malo olamulidwa, kuchepetsa kwambiri kuopsa kwa kuipitsidwa. Mulingo wopangirawu ndiwofunikira pakuwonetsetsa kuti zinthuzo ndi zapamwamba komanso zodalirika.

M'nyumba ISO 7 zoyeretsa zogwiritsa ntchito kamodzi

Kapangidwe ka zinthu zomwe timagwiritsa ntchito kamodzi kokha, monga eBAG 2D ndi 3D, zimagwirizana kwambiri ndi miyezo ya ISO 7 yoyeretsa. 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.