Dziwani kusiyana ndi eBAG 3D Open

Chikwama chapadera komanso chaukadaulo chogwiritsa ntchito kamodzi kokha kuti chigwiritsidwe ntchito mosiyanasiyana komanso moyenera

Kusakaniza kosavuta komanso kusungidwa kotetezedwa mu bioprocessing ndi eBAG 3D Open

Kuyambitsa eBAG imodzi yokha 3D Open, yopangidwira kusakanikirana kosavuta komanso koyenera ndi kasinthidwe kake kapadera ka 3D, kulola ogwiritsa ntchito kuti azigwira ntchito mosavuta. Opangidwa kuchokera ku zida zamagulu amankhwala, thumba ili osati lokha amasunga kukhulupirika kwa biologics komanso amakana kuwonongeka kwa mankhwala, kupereka kusakanikirana koyenera kwa magwiridwe antchito, kalembedwe, kulimba, komanso kusavuta.

Chodziwika cha a doko lalikulu lotseguka kumtunda amapereka njira zosiyanasiyana za media preparation kapena makina osungiramo zinthu zosiyanasiyana zakuthambo. Zopangidwa ndi zinthu zomwe mungasinthire makonda, matumbawa amakwaniritsa zosowa zenizeni malinga ndi kukula, masinthidwe, ndi zomangira, kuwonetsetsa kusakanikirana kosasunthika munjira zopangira.

Kupangidwa ndi kupangidwa mkati mwa TECNIC Chipinda Choyera cha ISO7, matumba a 3D awa amapangidwa ndi zida zapamwamba kwambiri ndipo amalowetsedwa ndi gamma. Njira yosamalitsayi imatsimikizira kuti ndi okonzeka kugwiritsidwa ntchito, kupezeka mumiyeso kuyambira 50L mpaka 500L, komanso wokhoza kupirira kugwiriridwa mwamphamvu kuti mukhale ndi chitetezo cha mankhwala a biopharmaceutical. Matumbawa amapangidwa kuti azigwira ntchito momasuka, okhala ndi zolembera zomveka bwino komanso zogwirira ntchito za ergonomic, zomwe zimalola kulumikizana kosavuta ndi machitidwe omwe alipo komanso kuphatikiza kosasinthika munjira zopangira. Khalani ndi gawo lotsatira lakuchita bwino komanso kudalirika ndi Single-Use eBAG 3D Open.

Kukulitsa zokolola ndi kusungirako komwe kumagwiritsidwa ntchito kamodzi

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

 

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 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.