Zaɓuɓɓukan Aseptic don marufi na magunguna

Mawallafi: Smartweigh– Nauyin Kai Mai Yawa

Zaɓuɓɓukan marufi guda huɗu da za a yi la'akari da su. A yau, fasahohi daban-daban da suka shafi masana'antun magunguna da na biopharmaceutical sune: (1) ɗakunan tsafta na aji 100, (2) masu rabawa, (3) tsarin shingen shiga mai iyaka (RABS), (4) tsarin amfani guda ɗaya. Wanne ya fi dacewa da ku?​1. Ɗakin Tsafta na Aji 100: An ƙirƙiri fasahar Cleanroom a shekarun 1960 don amfani a masana'antar sararin samaniya da lantarki don guje wa gurɓatar ƙananan sassa.

Kwayoyin cuta ƙwayoyin cuta ne, kuma masana'antar magunguna ba da daɗewa ba ta fahimci cewa wannan ƙwarewar za ta iya tabbatar da iska mara tsafta. aleksandarlittlewolf - www.freepik.comPharma-gowning-young-technologist-putting-protective-rubber-gloves-production-factory-freepik-web.jpg Dakunan tsaftacewa na Class 100 sune suka fi yawa a masana'antar aseptic (aikin ISO 5 da A/B Class daidai yake), ta amfani da matatar iska mai inganci (HEPA) don cire dukkan ƙwayoyin cuta da ƙwayoyin cuta. Babban iska mai ƙarfi ko kwararar iska mai hanya ɗaya yana rage canja wurin ƙwayoyin cuta daga wani wuri zuwa wani.

A shekarun 1970, an yi cikar aseptic a kan injunan da aka ƙayyade a ƙarƙashin allunan tace HEPA. Sassan injin da ke sama da akwati suna iya haifar da gurɓatawa, kuma bayan lokaci ana motsa su gwargwadon iko a ƙasa da matakin aiki. Don ƙara yawan iskar da aka tace a kan injin, an kuma ƙara murfin tagogi na filastik.

Zanen taga yana kuma tunatar da mai aiki da ya guji taɓa injin ko samfurin. Masana'antun sun juya zuwa rufin HEPA 100% don sarrafa dukkan ɗakuna zuwa aji na 100. Wannan yana inganta sarrafawa, amma yana ƙara yawan jari da kuɗin aiki, musamman tsarin sarrafa iska.

2. Masu Rarraba Opto: A shekarun 1980 zuwa 1990, an ƙirƙiro masu rarraba don inganta shingen da ke tsakanin mutane da kayayyaki yayin da ake rage farashi. An bayyana mai rarraba a matsayin ɗaki mai tsafta a cikin akwati. Ana rufe dukkan tsarin a cikin kabad mai rufewa, wanda aka tace ta hanyar matatun HEPA.

A lokacin aiki, ba a yarda wani mai aiki ya shiga ba sai ta hanyar haɗin safar hannu. Hoton ya samo asali ne daga chase-logeman anchaselogeman-isolator-web.jpg don tsarin keɓewa (ba a nuna matatar HEPA ta sama ba). Hoton ya samo asali ne daga chase-logeman anchase-logman-isolator-inside-web.jpg yana ciyar da ciki na mai rabawa wanda ke nuna tashar safar hannu.

Bayan an gama yin aikin, za a buɗe na'urar rabawa, a tsaftace ta, sannan a shirya don aiki na gaba. Da zarar an sake rufe ta, za a cika na'urar rabawa da maganin hana bushewa, yawanci hydrogen peroxide (VHP) don tsaftace komai a ciki. Ba kamar feshi ko maganin kashe kwari na gargajiya ba, VHP yana shiga cikin ƙananan ramuka.

Da zarar an yi masa allurar rigakafi, ana yin duk wani tsari na ƙarshe ta hanyar tashar safar hannu. A ka'ida, ya kamata a yi amfani da mai raba maganin a cikin wani wuri mara tsari, kamar rumbun ajiya, ta hanyar mai aiki sanye da kayan dakin gwaje-gwaje. A ka'ida hakan ne.

A gaskiya ma, kamfanoni da yawa sun sanya na'urorin keɓewa a cikin ɗakunan tsafta na aji 100. Wannan yana ba da ƙarin rufin tsaftacewa, amma amfanin shine a ƙirƙiri na'urar keɓewa don gujewa. 3. Tsarin Shamaki Mai Iyaka (RABS): RABS sulhu ne tsakanin tsarin buɗewa da tsarin keɓewa, RABS ya ƙunshi tsarin a cikin wani shinge mai tsauri.

Ayyukan aiki suna shiga ta tashar safar hannu. Fasahar Syntegon Pharma Syntegon-Pharma- products_filling da Closing_FXS_3100-web.jpg RABS ɗin da aka buɗe yana miƙewa zuwa rufin, yana dogara da tsarin sarrafa iska da tacewa na ɗakin. RABS ɗin da aka rufe yana ɗauke da tsarin sarrafa iska da tacewa nasa.

RABS tana da fa'idodi masu yawa akan masu raba kayan gida saboda sauƙin sa. Wannan gaskiya ne musamman idan ana iya samun su a cikin ɗakunan tsafta da ake da su sannan a rage farashin gini. Bukatar gina ɗaki mai tsafta yana rage wasu tanadin kuɗi idan aka kwatanta da masu raba kayan gida.

4. Tsarin da za a iya zubarwa: Tsarin sarrafa kayayyakin da za a iya zubarwa yana ƙara shahara a aikace-aikacen aseptic. Waɗannan tsarin suna ɗauke da jakar filastik don maye gurbin gwangwanin ƙarfe na gargajiya. Jakar ta zo a cikin kunshin riga tare da duk matatun mai, bututu, tashoshin jiragen ruwa, bututun cikawa, da sauran kayan haɗi da ake buƙata.

An rufe shi a cikin jaka mai kariya kuma an yi masa maganin kashe ƙwayoyin cuta. Na'urar masana'anta tana kammala aikinta kuma a shirye take don aiki. Hoton da aka bayar daga sartorioussaritus Img_OctoPlus-_4154-web.jpg Wasu masana'antun suna ba da tsarin amfani na musamman guda ɗaya, gami da Sartorius (PreVAS ɗinsa - wanda aka riga aka tabbatar, wanda aka riga aka haɗa, wanda aka riga aka tsaftace - Project Syntegon), Pall Corporation (tsarin Biotech ɗinsa na amfani da jima'i bayan jima'i) da sauransu.

A cewar Marion Monstier, Sartorius Freeze-Thaw Products Manager, fa'idodin tsarin amfani da shi sau ɗaya sun haɗa da: • Tsarin rufewa yana rage canja wurin samfura da sarrafa su, yana rage haɗarin gurɓatawa. • Sauya tsarin amfani da shi sau ɗaya tsakanin ayyukan samfura yana kawar da yuwuwar gurɓatawa ta hanyar tsatsa saboda rashin cikawa ko rashin dacewa da tsaftacewa. • Idan aka kwatanta da tsarin da za a iya sake amfani da shi, waɗannan tsarin madadin suna rage lokacin canzawa da saitawa.

• Suna kawar da buƙatun tabbatar da tsaftacewa. • Suna fitar da ruwa sosai, ta haka suna ƙara dawo da samfurin.

Mawallafi: Smartweigh– Masu kera Nauyin Kaya da yawa

Mawallafi: Smartweigh– Mai Nauyin Layi

Mawallafi: Smartweigh– Injin Shiryawa Mai Layi

Mawallafi: Smartweigh– Injin Shirya Nauyin Nauyi Mai Girma Mai Girma

Mawallafi: Smartweigh– Tire Denester

Mawallafi: Smartweigh– Injin Shiryawa na Clamshell

Mawallafi: Smartweigh– Haɗa Nauyin Haɗaka

Mawallafi: Smartweigh– Injin shiryawa na Doypack

Mawallafi: Smartweigh– Injin shirya Jakar da aka riga aka yi

Mawallafi: Smartweigh– Injin Shiryawa na Rotary

Mawallafi: Smartweigh– Injin Marufi a Tsaye

Mawallafi: Smartweigh– Injin Shiryawa na VFFS