OEB5 Kansarka la isku duro ee vial turnkey warshad
IVEN Pharmatechwaa bixiyaha hormoodka ah ee dhirta turnkey ee siisa xalka injineernimada isku dhafan ee warshadda dawooyinka adduunka oo dhan sida xalka IV, tallaalka, kansarka iwm, iyadoo la raacayo EU GMP, US FDA cGMP, PICS, iyo WHO GMP.
Waxaan bixinaa naqshadeynta mashruuca ugu macquulsan, qalabka tayada sare leh iyo adeegga loo habeeyay ee warshadaha dawooyinka iyo dawooyinka kala duwan ee A ilaa Z ee loogu talagalay bacda jilicsan ee aan-PVC ahayn IV xal, PP dhalada IV xal, dhalada vial IV xal, Vial iyo ampoule la isku duro, Sharoobada, Kiniinadaha & Kaabsoosha, Vacuum tube ururinta dhiiga iwm.
Maxay IVEN ku mudday oncology-ga warshadda fiilada turnkey waxa ka mid ah:
Xalka injineernimada isku dhafan ee IVEN ee warshadda fiilada oncology ee dawooyinka la isku duro waxaa ka mid ah qolka nadiifka ah, xakamaynta auto-control iyo nidaamka la socodka, nidaamka daaweynta biyaha dawooyinka, diyaarinta xalka iyo nidaamka qaybinta, dhalooyinka dhaqidda - nadiifinta iyo depyrogenation - buuxinta - joojinta - daboolka - dhaqidda dibadda, qaboojinta nidaamka qalajinta, Go'doomin nidaamka, nidaamka baakadaha, nidaamka saadka oo toos ah, nidaamka xakamaynta tayada, shaybaarka dhexe iyo iwm. Diirada saaray shuruudaha shakhsi ahaaneed ee macaamiisha, IVEN u habayn xal injineernimada si taxadar leh loogu talagalay isticmaalayaasha:
1.Dhiqida dhalooyinka kansarka ee la isku duro - nadiifinta iyo depyrogenation - buuxinta - joojinta - daboolka - khadka wax soo saarka dibadda:
Khadkaan waxaa loo isticmaalaa in lagu soo saaro fiilooyin la isku duro oo oncology ah, oo ka kooban 5 mashiinada: Mashiinka Dharka ee Ultrasonic Full Servo Driven Vertical Ultrasonic, Mashiinka Wareegga Hawada Kulul, Mashiinka Buuxinta Vial Buuxinta, Mashiinka Capping Vial iyo Mashiinka Dhaqdhaqaaqa Dibadda.
Buuxinta ka dib, waxay aadi doontaa qayb-joojin waxayna diyaar u tahay qalajinta qaboojinta, ka dibna u gudub mashiinka daboolka, ka dib, waxay aadi doontaa mashiinka dharka ee dibadda. Waxaan ku qaadaneynaa nidaamka miisaanka khadka tooska ah mashiinka buuxinta, alaabada aan u qalmin si toos ah ayaa loo diidi doonaa.
1. dhaqid
2. Nadiifinta & Depyrogenation
3. Buuxinta & Joojinta
4. duubista
5. Dhaqitaanka dibadda
6. dhammaatay
2. Qalajiyaha qaboojiyaha iyo nidaamka dejinta iyo dejintu:
Badeecooyinka lyophilized, ka dib buuxinta iyo joojinta nus-joojinta, waxaa loo gudbin doonaa si ay u qaboojiso qalajiyaha (Lyophilizer) si toos ah iyada oo loo marayo nidaamka loading auto, ka dib lyophilized, waxaa loo gudbin doonaa mashiinka daboolka by nidaamka dejin auto.
3.Nidaamka gooni u goosadka:
Maaddaama uu cudurka oncology yahay wax soo saarka sunta ah, waxaan ku qalabeyn karnaa go'dooye si aan uga ilaalinno badbaadada hawlwadeennada alaabada, si loo hubiyo in habka wax soo saarka si buuxda loo ilaaliyo nidaamka go'doominta.
Hordhac Kooban
1.Operator ayaa gabi ahaanba ka soocay aagga wax soo saarka ee muhiimka ah.
2.A heerka wax soo saarka gudaha. Qolka nadiifka ah ee heerka C/D.
3.Only ayaa furi kara go'doominta ka dib marka la xiro nidaamka, xaqiijinta ayaa lagama maarmaan u ah dib u bilaabista.
4.U habayn HPVS nadiifinta gudaha.
5. Nidaamka wareegga wareegga oo la xidhay.
6.Adopt gelitaanka hawada ee HEPA, xuubka ayaa ilaalin kara socodka hawada isku midka ah iyo shaandhada.
7. Qaab dhismeedka gudaha ah oo aan kala go 'lahayn, naqshadeynta wareegsan.
8. Qabso shaabadda la buufin karo ee albaabbada furan iyo daaqadaha galoofyada labadaba.
9.For alaabta sunta ah, isticmaal bac-in-bag-out design.
Hawlaha kale
1.CIP/SIP system (SIP by VHP).
2.Qaybta Counter ee Korjoogteynta onlaynka ah.
3.Sampler Qayb Hawo-qaadan Karo.
4.Koriyaha uumi-dhaliyaha Hydrogen Dioxide.
5.Glove-ka-daaciyaha.
6.Anemometer.
7.H/T Sensor.
8.ATEX Qiimaynta.
9.Equinox Statility Test Module.
10.Aaladaha Sambalka Hawada.
11.Bag-in-bag-out filter Beddelida Guryaha.
4.Nidaamka baakaynta:
Waxay dhammayn kartaa fiilada la isku duro ee oncology baadhis toos ah oo iftiin leh, kormeerka daadinta, calaamadaynta, finan leh baakadaha aasaasiga ah, iyo xidhidhiyaha kartoonada.
Waxaan ku qalabeyn karnaa furitaanka kartoonnada dhoofinta tooska ah, buug-tilmaameedka iyo gelinta shahaadada, xirida kartoonnada, xirida kartoonnada, calaamadeynta, nidaamka raadinta xogta, iyo nidaamka diidmada auto, kaas oo diidi kara kartoonada miisaan khaldan, ama kuwa leh calaamad aan u qalmin.
5.Daawaynta biyaha dawooyinka:
Waxaa ka mid ah daaweynta biyaha la sifeeyay (2RO+EDI), biyaha nadiifiya (WFI), iyo dhaliyaha uumiga saafiga ah. Taangiga PW iyo taangiga WFI ayaa sidoo kale lagu daray.
6.Qol nadiif ah & HVAC
Waxaa ka mid ah darbiyada qolka nadiifka ah, saqafka saqafka, daaqadaha, albaabada, sagxadaha, nalka, unugga hawo haynta, filtarrada HEPA, marinnada hawada, digniinta, nidaamka xakamaynta baabuurta iwm. .
7.Black utility
Waxaa ka mid ah nidaamka kombaresarka hawada iyo nidaamka kuleyliyaha si loo helo hawo ciriiri ah oo lama huraanka ah iyo uumiga la isku duro ee vial oncology.
8.Laboratory
Waxaa ka mid ah dhammaan noocyada qalabka baaritaanka shaybaarka, iyo alaabta guryaha shaybaarka si loo tijaabiyo shaybaarrada cansarka ee vial ee la isku duro iyo walxaha ceeriin, sida qolka xasilloonida, HPLC, nuugista atomiga, spectrometer ultraviolet, spectrometer afar geesoodka ah iwm.
9. Qaybinta & nidaamka dhuumaha
Waxaa ka mid ah dhammaan noocyada dhuumaha geeddi-socodka iyo dhuumaha warshadaha ee looga baahan yahay warshadda weelka oncology ee la isku duro, sida biyaha la safeeyey, biyaha la duro, uumiga saafiga ah, biyaha qaboojinta, biyaha la qaboojiyey, hawada cufan, uumiga warshadaha iwm.
IVENHayso koox farsamo iyo injineernimo aad u xirfad leh, tababarkayada goobta iyo taageerada iibka kadib waxay ku siin kartaa dammaanad farsamo oo wakhti dheer ah warshadaada furaha dareeraha ee AAN-PVC IV:
IVEN Dukumentiyada kala duwan ayaa kaa caawin kara inaad heshoShahaadada GMP & FDAsi sahlan oo loogu talagalay warshaddaada dareeraha IV (oo ay ku jiraan IQ / OQ / PQ / DQ / FAT / SAT iwm labadaba nooca Ingiriisiga iyo Shiinaha):
Xirfadda IVEN iyo waayo-aragnimada waxay kaa caawin kartaa inaad dhammayso dhammaan warshadda furaha furaha IV ee wakhtiga ugu gaaban oo aad ka fogaato dhammaan noocyada khatarta ah:
IVENHayso koox farsamo iyo injineernimo aad u xirfad leh, tababarkayada goobta iyo taageerada iibka kadib waxay ku siin kartaa dammaanad farsamo oo wakhti dheer ah warshadaada furaha dareeraha ee AAN-PVC IV:
Ilaa hadda, waxaanu hore u siinay boqollaal qalab dawo ah iyo qalab caafimaad in ka badan 50 waddan.
Dhanka kale, waxaan ka caawinay macaamiisheenala dhisay in ka badan 20+ warshado dawo iyo dawooyin ahUzbekistan, Tajikistan, Indonesia, Thailand, Saudi, Iraq, Nigeria, Uganda, Tanzania, Ethiopia, Myanmar iwm. Dhammaan mashaariicdani waxay ku guulaysteen macaamiisheena iyo dawladooda faallooyin sare.
Waxaan sidoo kale dhoofin our line-soo-saarka xal IV in Germany.
Indonesia IV dhalada turnkey warshad
Vietnam IV dhalada turnkey warshad
Uzbekistan IV dhalada turnkey warshad
Tayland oo la isku duri karo warshad furaha fijaan ah
Tajikistan IV dhalada turnkey warshad
