{"id":57524,"date":"2023-02-02T09:59:14","date_gmt":"2023-02-02T08:59:14","guid":{"rendered":"https:\/\/www.oncomed.cz\/?post_type=studies&p=57524"},"modified":"2023-02-02T10:13:01","modified_gmt":"2023-02-02T09:13:01","slug":"retrofit-l2","status":"publish","type":"studies","link":"https:\/\/www.oncomed.cz\/cs\/blog\/retrofit-l2\/","title":{"rendered":"Retrofit L2"},"content":{"rendered":"
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V \u010dervnu 2021 jsme zah\u00e1jili pr\u00e1ce na projektu, kter\u00fd jsme nazvali Retrofit L2. Zad\u00e1n\u00ed pro tento projekt byla velk\u00e1 v\u00fdzva, proto\u017ee jsme t\u00edmto projektem m\u011bli vy\u0159e\u0161it nejen n\u00e1lezy audit\u016f, shodu s p\u0159edpisy v\u010detn\u011b nov\u00e9ho Annex 1, ale i v\u00fdznamn\u011b sn\u00ed\u017eit ztr\u00e1ty API p\u0159i v\u00fdrob\u011b a v neposledn\u00ed \u0159ad\u011b p\u0159ipravit Linku 2 na centr\u00e1ln\u00ed formulaci. Sou\u010dasn\u011b musel b\u00fdt Retrofit schopen vyr\u00e1b\u011bt vodn\u00e9 i nevodn\u00e9 produkty (organick\u00e1 rozpou\u0161t\u011bdla) a pro jeden z\u00a0na\u0161ich produkt\u016f b\u00fdt tak\u00e9 schopen prov\u00e9st proces flushing (v\u00fdplach filtr\u016f p\u0159ed v\u00fdrobou) steriln\u011b bez rizika pro produkt.<\/p>\n

Retrofit L2 znamen\u00e1 nahrazen\u00ed produktovodu linky 2 mobiln\u00edm\/portable (p\u0159enosn\u00fdm, v\u00fdm\u011bnn\u00fdm) \u0159e\u0161en\u00edm pro steriln\u00ed filtraci a z\u00e1rove\u0148 zm\u011bnu konceptu steriln\u00ed filtrace (redundance). Skl\u00e1d\u00e1 se ze t\u0159\u00ed hlavn\u00edch \u010d\u00e1st\u00ed: mobiln\u00ed kotel, filtra\u010dn\u00ed skid a TCU jednotka (temperature control unit). Proto\u017ee se jednalo o n\u00e1hradu aseptick\u00e9 \u010d\u00e1sti, tedy velmi rizikovou \u010d\u00e1st v\u00fdroby, rozhodli jsme se, \u017ee mus\u00edme z\u00e1rove\u0148 zachovat funk\u010dnost p\u016fvodn\u00edho produktovodu.<\/p>\n

Projekt za\u010dal sb\u00edr\u00e1n\u00edm informac\u00ed a diskusemi o mo\u017enostech \u0159e\u0161en\u00ed steriln\u00ed filtrace. Po n\u011bkolika workshopech jsme se dohodli na z\u00e1kladn\u00edm principu, nakreslili z\u00e1kladn\u00ed sch\u00e9ma a popsali na\u0161e po\u017eadavky do URS (user requirement specification). Po mnoha jedn\u00e1n\u00edch jsme nakonec jako hlavn\u00edho partnera z\u00edskali slovinskou firmu IPROS.<\/p>\n

Postupn\u011b jsme vytvo\u0159ili basic design, n\u00e1sledn\u011b detail design, kompletn\u00ed v\u00fdkresy a specifikaci v\u0161ech komponent. Za\u0159\u00edzen\u00ed se n\u00e1sledn\u011b ve firm\u011b IPROS za\u010dalo vyr\u00e1b\u011bt a po kompletaci jsme v dubnu 2022 \u00fasp\u011b\u0161n\u011b za\u0159\u00edzen\u00ed otestovali v r\u00e1mci FAT (Factory Acceptance Test). Mezit\u00edm jsme museli Linku 2 p\u0159ipravit na instalaci, co\u017e znamenalo \u00fapravy prostor\u016f, mont\u00e1\u017e lamin\u00e1rn\u00edho pole a vytvo\u0159en\u00ed p\u0159\u00edpojn\u00fdch m\u00edst. Tak\u00e9 jsme museli vy\u0159e\u0161it rozm\u00edst\u011bn\u00ed za\u0159\u00edzen\u00ed a obslu\u017enost, proto\u017ee v\u0161echna za\u0159\u00edzen\u00ed dohromady zab\u00edrala hodn\u011b m\u00edsta, proto vzniknul 3D model, kde jsme mohli simulovat rozm\u00edst\u011bn\u00ed a rozhodnout se kde co bude.<\/p>\n

Po instalaci za\u0159\u00edzen\u00ed v r\u00e1mci jarn\u00ed zar\u00e1\u017eky v\u00a0dubnu 2022 prob\u011bhla kvalifikace p\u016fvodn\u00edho produktovodu, kter\u00fd jsme ovlivnily napojen\u00edm nov\u00e9ho za\u0159\u00edzen\u00ed. Byla provedena kvalifikace v\u010detn\u011b media fill na p\u016fvodn\u00ed \u010d\u00e1sti. T\u00edm byla spln\u011bna podm\u00ednka m\u00edt p\u016fvodn\u00ed produktovod ve validn\u00edm stavu a mohli jsme zah\u00e1jit komer\u010dn\u00ed v\u00fdrobu.<\/p>\n

B\u011bhem komer\u010dn\u00ed v\u00fdroby na p\u016fvodn\u00edm produktovodu za\u010dala dlouh\u00e1 pr\u00e1ce na automatizaci a kvalifikaci Retrofitu. Toto jsme rozd\u011blili do n\u011bkolika etap, prvn\u00ed etapou byly automatiza\u010dn\u00ed f\u00e1ze pro CIP a SIP.Po p\u0159evzet\u00ed za\u0159\u00edzen\u00ed jsme pokra\u010dovali v\u00a0programov\u00e1n\u00ed automatiza\u010dn\u00edch f\u00e1z\u00ed a tak\u00e9 v\u00a0kvalifikac\u00edch.<\/p>\n

Prvn\u00ed kvalifikac\u00ed byly \u010dist\u00edc\u00ed procesy CIP a steriliza\u010dn\u00ed procesy SIP. Kvalifikace byla provedena extern\u00ed firmou EDR v\u010detn\u011b su\u0161\u00edc\u00edch f\u00e1z\u00ed. Toto byl prvn\u00ed p\u0159edpoklad pro v\u00fdrobu media fill na nov\u00e9m za\u0159\u00edzen\u00ed.<\/p>\n

Media fill byla provedena v\u00a0rozsahu t\u0159\u00ed po sob\u011b jdouc\u00edch \u0161ar\u017e\u00edch, v\u010detn\u011b ov\u011b\u0159en\u00ed nov\u00fdch proces\u016f a stanoven\u00ed nov\u00fdch holding period. V\u0161echny t\u0159i b\u011bhy byly v\u010detn\u011b vzork\u016f vyhovuj\u00edc\u00ed.<\/p>\n

Od z\u00e1\u0159\u00ed do prosince 2022 to byla velmi aktivn\u00ed pr\u00e1ce na programov\u00e1n\u00ed a hlavn\u011b testov\u00e1n\u00ed, proto\u017ee p\u0159i b\u011b\u017e\u00edc\u00ed v\u00fdrob\u011b to nebylo snadn\u00e9. Testy jsme mohli prov\u00e1d\u011bt jen mimo v\u00fdrobu, tak\u017ee jsme ob\u011btovali mnoho v\u00edkend\u016f. Sou\u010d\u00e1st\u00ed testov\u00e1n\u00ed byla i tvorba postup\u016f a opera\u010dn\u00edch karet.<\/p>\n

Postupn\u011b jsme se dopracovali k\u00a0funk\u010dn\u00edm f\u00e1z\u00edm a mohli zah\u00e1jit nejd\u0159\u00edve testovac\u00ed v\u00fdrobu produktu a n\u00e1sledn\u011b i validaci. Projekt je moment\u00e1ln\u011b ve f\u00e1zi dokon\u010den\u00ed a p\u0159ed\u00e1n\u00ed v\u00fdrob\u011b. Celkov\u011b projekt trval zhruba 1,5 roku, b\u011bhem projektu jsme vytvo\u0159ili cca 150 dokument\u016f, naprogramovali a otestovali 44 automatiza\u010dn\u00edch f\u00e1z\u00ed.<\/p>\n

V\u00fdsledkem projektu je funk\u010dn\u00ed mobiln\u00ed \u0159e\u0161en\u00ed pro steriln\u00ed filtraci s\u00a0mo\u017enost\u00ed vyr\u00e1b\u011bt vodn\u00e9 i nevodn\u00e9 produkty a z\u00e1rove\u0148 m\u00edt vysokou jistotu na sterilitu produktu a velmi n\u00edzk\u00e9 ztr\u00e1ty API.<\/p>\n<\/div>\n<\/div>\n\n\n\n\n

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