{"id":171525,"date":"2025-03-07T07:41:03","date_gmt":"2025-03-07T07:41:03","guid":{"rendered":"https:\/\/www.maryatech.com\/?post_type=product&p=171525"},"modified":"2025-03-07T07:41:07","modified_gmt":"2025-03-07T07:41:07","slug":"farmaceitisko-preparatu-veidosanas-sistema","status":"publish","type":"product","link":"https:\/\/www.maryatech.com\/lv\/product\/pharmaceutical-formulation-system\/","title":{"rendered":"Farmaceitisko prepar\u0101tu veido\u0161anas sist\u0113ma"},"content":{"rendered":"

Sagatavo\u0161anas sist\u0113mas klasifik\u0101cija\uff1a<\/h2>\n

1\uff09 Visp\u0101r\u0113j\u0101 sagatavo\u0161anas sist\u0113ma: T\u0101 tiek izmantota visp\u0101r\u0113jai mazu molekulu \u0137\u012bmiskai sagatavo\u0161anai, piem\u0113ram, \u016bdens injekcij\u0101m, liofiliz\u0113ta pulvera injekcij\u0101m u. tml.<\/p>\n

2\uff09Kompleksa sagatavo\u0161anas sist\u0113ma: To izmanto prepar\u0101tu ar sare\u017e\u0123\u012btiem procesiem, piem\u0113ram, suspensiju, emulsiju, liposomu, mikrosf\u0113ru un citu \u012bpa\u0161u prepar\u0101tu ra\u017eo\u0161an\u0101.<\/p>\n

3\uff09Biolo\u0123isk\u0101 sagatavo\u0161anas sist\u0113ma: To izmanto visu veidu produktu sagatavo\u0161anai, izmantojot biolo\u0123isk\u0101s in\u017eenierijas tehnolo\u0123ijas, piem\u0113ram, antivielu, vakc\u012bnu, asins produktu, rekombinantu prote\u012bnu u. c. pusfabrik\u0101tu sagatavo\u0161anai, un to var izmantot ar\u012b barotnes, att\u012br\u012b\u0161anas bufera un citu pal\u012bg\u0161\u0137idro prepar\u0101tu ra\u017eo\u0161anai.<\/p>\n

4\uff09CIP staciju sist\u0113ma: To izmanto da\u017e\u0101du prepar\u0101tu un bioreaktoru sist\u0113mu tvert\u0146u un cauru\u013cvadu t\u012br\u012b\u0161anai tie\u0161saist\u0113, un to var kontrol\u0113t atsevi\u0161\u0137i vai integr\u0113t ar cit\u0101m sist\u0113m\u0101m.<\/p>\n

Sagatavo\u0161anas sist\u0113mas veiktsp\u0113jas raksturojums\uff1a<\/strong><\/h5>\n

Visp\u0101r\u0113j\u0101 sagatavo\u0161anas sist\u0113ma<\/h3>\n
    \n
  1. Sist\u0113ma var b\u016bt piln\u012bb\u0101 autom\u0101tiska, armodul\u0101ru konstrukciju, un t\u0101s turpm\u0101k\u0101 uzst\u0101d\u012b\u0161ana un apkope ir \u0113rta.<\/li>\n
  2. CIP un SIP autom\u0101tisk\u0101s vad\u012bbas sist\u0113mu var iesl\u0113gt ar vienu tausti\u0146u, kas var autom\u0101tiski noteikt t\u012br\u012b\u0161anas un steriliz\u0101cijas beigas, ar recep\u0161u p\u0101rvald\u012bbu, elektronisko parakstu, elektroniskajiem ierakstiem, rev\u012bzijas izseko\u0161anu un cit\u0101m datora funkcij\u0101m.<\/li>\n
  3. Kad iek\u0101rta darbojas, t\u0101 var kontrol\u0113t galveno z\u0101\u013cu procesa parametru (piem\u0113ram, temperat\u016bra, iz\u0161\u0137\u012bdu\u0161ais sk\u0101beklis, PH u. c.) ra\u017eo\u0161anu, k\u0101 ar\u012b autom\u0101tiski tos noteikt un br\u012bdin\u0101t, ja ir \u012bpa\u0161i apst\u0101k\u013ci, kas neatbilst noteiktajiem parametriem, lai nov\u0113rstu z\u0101\u013cu kvalit\u0101tes probl\u0113mas.<\/li>\n
  4. Sist\u0113ma atbilst ASME BPE un GMP konstrukcijas koncepcij\u0101m, 3D aklo st\u016bru pras\u012bb\u0101m un \u013cauj veikt nep\u0101rtrauktu ra\u017eo\u0161anu ar nelielu atlikumu daudzumu.<\/li>\n
  5. Pirms iek\u0101rtas izgatavo\u0161anas m\u016bsu r\u016bpn\u012bc\u0101 m\u0113s veicam tr\u012bsdimensiju projekt\u0113\u0161anu \"viens pret vienu\", lai racionaliz\u0113tu cauru\u013cvadu, v\u0101rstu, instrumentu u. c. izvietojumu sist\u0113m\u0101 un padar\u012btu iek\u0101rtas darb\u012bbu lietot\u0101jam draudz\u012bg\u0101ku.<\/li>\n<\/ol>\n

     <\/p>\n

    Sare\u017e\u0123\u012bta sagatavo\u0161anas sist\u0113ma<\/h3>\n
      \n
    1. M\u0113s izmantosim ANSYS \u0161\u0137idrumu anal\u012bzes programmat\u016bru, lai simul\u0113tu re\u0101lo \u0161\u0137idruma st\u0101vokli tvertn\u0113 un, pamatojoties uz to, izv\u0113l\u0113tos piem\u0113rotus mais\u012bt\u0101jus un \u0161\u0137\u0113res, lai nodro\u0161in\u0101tu, ka laboratorijas procesu var netrauc\u0113ti p\u0101rnest uz liela m\u0113roga ra\u017eo\u0161anu.<\/li>\n
    2. M\u0113s izmantosim augstas precizit\u0101tes e\u013c\u013cas un \u016bdens f\u0101zes p\u0101rs\u016bkn\u0113\u0161anas s\u016bk\u0146us, lai stingri kontrol\u0113tu e\u013c\u013cas un \u016bdens f\u0101zes sajauk\u0161anas attiec\u012bbu, t\u0101d\u0113j\u0101di nodro\u0161inot emul\u0123\u0113\u0161anas efektu.<\/li>\n
    3. Ja farmaceitisko prepar\u0101tu ra\u017eo\u0161anai tiek izmantotas b\u012bstamas izejvielas, m\u0113s uzst\u0101d\u012bsim izolatorus sagatavo\u0161anas sist\u0113mas padeves zon\u0101, lai nodro\u0161in\u0101tu API padeves procesa sterilit\u0101ti un person\u0101la aizsardz\u012bbu.<\/li>\n
    4. Sajauk\u0161anas tvertnes ir pieejamas \u012bpa\u0161as formas, lai sasniegtu \u013coti mazu minim\u0101lo sajauk\u0161anas tilpumu.<\/li>\n
    5. Suspensijas produktiem m\u0113s izmantosim cirkul\u0113jo\u0161\u0101 cauru\u013cvada konstrukciju, lai izvair\u012btos no nevienm\u0113r\u012bga produkta sast\u0101va, ko izraisa suspend\u0113to da\u013ci\u0146u nogulsn\u0113\u0161an\u0101s farmaceitiskaj\u0101 viel\u0101, ko izraisa ilgsto\u0161a pild\u012b\u0161ana.<\/li>\n<\/ol>\n

       <\/p>\n

      Biolo\u0123isk\u0101s sagatavo\u0161anas sist\u0113ma<\/h3>\n
        \n
      1. Sagatavo\u0161anas sist\u0113ma sazin\u0101s ar ferment\u0101cijas sist\u0113mu un att\u012br\u012b\u0161anas sist\u0113mu un var autom\u0101tiski pieg\u0101d\u0101t barotni un att\u012br\u012btu pal\u012bg\u0161\u0137idrumu uz nor\u0101d\u012bto vietu, un to var elast\u012bgi p\u0101rsl\u0113gt.<\/li>\n
      2. Sagatavo\u0161anas sist\u0113mas t\u0113rauda karkasu un tvertnes var novietot attiec\u012bgi C un B klases zon\u0101s, t\u0101d\u0113j\u0101di samazinot pies\u0101r\u0146ojuma risku, kas saist\u012bts ar person\u0101la darb\u012bb\u0101m.<\/li>\n
      3. Iek\u0101rtas galvenaj\u0101s da\u013c\u0101s m\u0113s izmantojam dubultus v\u0101rstus un v\u0101rstu atgriezenisk\u0101s saites ier\u012bci, lai nepast\u0101v\u0113tu \u0161\u0137\u0113rskontamin\u0101cijas risks starp t\u012br\u012b\u0161anas un materi\u0101la cauru\u013cvadu.<\/li>\n
      4. Sist\u0113ma ir apr\u012bkota ar aseptisku sav\u0101k\u0161anas tvertni, un \u0161\u0137idruma filtra kasetni var test\u0113t tie\u0161saist\u0113 p\u0113c SIP, saska\u0146\u0101 ar ES LRP un FDA pras\u012bb\u0101m.<\/li>\n<\/ol>\n

        Iek\u0101rt\u0101 ir izmantota SCADA autom\u0101tisk\u0101s vad\u012bbas sist\u0113ma, kas jebkur\u0101 laik\u0101 var uzraudz\u012bt un kontrol\u0113t lauka iek\u0101rtas, k\u0101 ar\u012b centr\u0101laj\u0101 vad\u012bbas telp\u0101 veikt datu ieg\u016b\u0161anu, iek\u0101rtu kontroli, m\u0113r\u012bjumus, parametru regul\u0113\u0161anu un visu veidu sign\u0101lu trauksmes sign\u0101lus u. c.<\/p>","protected":false},"excerpt":{"rendered":"

        Farmaceitisk\u0101s formul\u0113\u0161anas sist\u0113ma ir farm\u0101cijas iek\u0101rtu veids, ko izmanto \u0161\u0137idrumu sajauk\u0161anai un doz\u0113\u0161anai, pievienojot API \u0161\u0137\u012bdin\u0101t\u0101jam, piem\u0113ram, \u016bdenim injekcij\u0101m, un p\u0113c mais\u012b\u0161anas, sild\u012b\u0161anas, steriliz\u0101cijas un filtr\u0113\u0161anas to formul\u0113jot v\u0113lam\u0101s koncentr\u0101cijas farmaceitisk\u0101 viel\u0101.<\/p>","protected":false},"featured_media":171526,"template":"","meta":{"om_disable_all_campaigns":false,"_templately_pack_id":"","_templately_imported_at":"","_templately_source":"","_templately_import_session_id":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center 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