\u00danor – Retrofit L2<\/h4>\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. 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
![\"\"](\"https:\/\/www.oncomed.cz\/wp-content\/uploads\/retrofit2.jpg\")
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\u010cerven – Nov\u00fd formula\u010dn\u00ed kotel na L1<\/h4>\n
Na formulaci linky L1 jsme zavedli nov\u00fd stacion\u00e1rn\u00ed formula\u010dn\u00ed kotel K1 s objemem 1500 litr\u016f.\u00a0Vzhledem k tomu, \u017ee v\u0161echny formulace na v\u00fdrobn\u00edch link\u00e1ch budou v bl\u00edzk\u00e9 budoucnosti p\u0159evedeny na Centr\u00e1ln\u00ed formulaci, ned\u00e1valo by smysl po\u0159izovat stejn\u00fd kotel jako ten p\u016fvodn\u00ed, kter\u00fd by zanedlouho p\u0159estal b\u00fdt pou\u017eiteln\u00fd pro Centr\u00e1ln\u00ed formulaci. Proto byl nov\u00fd kotel navr\u017een a optimalizov\u00e1n tak, aby bylo jeho um\u00edst\u011bn\u00ed na linku L1 spojen\u00e9 s minim\u00e1ln\u00edm z\u00e1sahem do \u010dist\u00fdch prostor, rozvod\u016f medi\u00ed a duplikace, automatizace, proces\u016f, obsluhy kotle a formulace roztok\u016f.<\/p>\n
Srpen – FAT linky 3<\/h4>\n
Hlavn\u00edm c\u00edlem FATu bylo ov\u011b\u0159it v\u00fdrobn\u00ed postupy, kter\u00e9 se na jednotliv\u00fdch za\u0159\u00edzen\u00edch budou b\u011b\u017en\u011b prov\u00e1d\u011bt. Toto ov\u011b\u0159ov\u00e1n\u00ed bylo provedeno s ohledem na celou \u0161\u00ed\u0159i proces\u016f \u2013 od p\u0159\u00edpravy v\u00fdroby, p\u0159es pln\u011bn\u00ed a\u017e po z\u00e1v\u011bre\u010dn\u00e9 \u010di\u0161t\u011bn\u00ed po v\u00fdrob\u011b. P\u0159itom byl kladen d\u016fraz nejen na funk\u010dnost za\u0159\u00edzen\u00ed, ale tak\u00e9 na prakti\u010dnost a proveditelnost jednotliv\u00fdch \u00fakon\u016f. Kl\u00ed\u010dov\u00fdm prvkem testov\u00e1n\u00ed bylo pln\u011bn\u00ed r\u016fzn\u00fdch velikost\u00ed d\u00e1vek produktu. Byla zkoum\u00e1na p\u0159esnost d\u00e1vky, co\u017e je z\u00e1kladn\u00edm faktorem pro zaji\u0161t\u011bn\u00ed kvality v\u00fdsledn\u00e9ho produktu. Po spln\u011bn\u00ed v\u0161ech v\u00fd\u0161e zm\u00edn\u011bn\u00fdch krok\u016f byl FAT vyhodnocen jako \u00fasp\u011b\u0161n\u011b spln\u011bn\u00fd.<\/p>\n
![\"\"](\"https:\/\/www.oncomed.cz\/wp-content\/uploads\/oncomed-line3-20140102-095346-dsc-9376-hdr-1-1024x684.jpg\")
<\/p>\n
Z\u00e1\u0159\u00ed – Spu\u0161t\u011bn\u00ed RABS<\/h4>\n
RABS (Restricted Access Barrier System) je technologick\u00e9 \u0159e\u0161en\u00ed, kter\u00e9 kombinuje v\u00fdhody tradi\u010dn\u00edch \u010dist\u00fdch prostor a izol\u00e1tor\u016f. Je navr\u017eeno tak, aby minimalizovalo riziko kontaminace produkt\u016f b\u011bhem v\u00fdrobn\u00edho procesu, a z\u00e1rove\u0148 zv\u00fd\u0161ilo kvalitu v\u00fdroby a efektivitu. Toho dosahuje omezen\u00edm p\u0159\u00edstupu person\u00e1lu a dal\u0161\u00edch zdroj\u016f kontaminace ke kritick\u00fdm oblastem v\u00fdroby. Z pohledu Annexu 1 a z\u00e1kazn\u00edk\u016f se jedn\u00e1 o nutnost, kterou jsme museli zav\u00e9st, pokud chceme pokra\u010dovat s v\u00fdrobou na lince 1. Jako u v\u011bt\u0161iny nov\u00fdch technologi\u00ed i zaveden\u00ed RABS vy\u017eadovalo v\u00fdznamn\u00e9 po\u010d\u00e1te\u010dn\u00ed investice. Velkou v\u00fdzvou byla u\u017e samotn\u00e1 instalace za\u0159\u00edzen\u00ed, kdy spr\u00e1vn\u00e9 zaveden\u00ed RABS vy\u017eadovalo komplexn\u00ed rekonstrukci v\u00fdrobn\u00edho prostoru. RABS nab\u00edz\u00ed \u0159adu v\u00fdhod, v\u010detn\u011b zv\u00fd\u0161en\u00e9 bezpe\u010dnosti produkt\u016f a zlep\u0161en\u00e9 efektivity v\u00fdrobn\u00edch proces\u016f. A\u010dkoli existuj\u00ed ur\u010dit\u00e9 v\u00fdzvy spojen\u00e9 s jeho zaveden\u00edm a pou\u017e\u00edv\u00e1n\u00edm, v\u011b\u0159\u00edme, \u017ee potenci\u00e1ln\u00ed v\u00fdhody \u010dasto p\u0159eva\u017euj\u00ed nad mo\u017en\u00fdmi nev\u00fdhodami.<\/p>\n
![\"\"](\"https:\/\/www.oncomed.cz\/wp-content\/uploads\/input-wheel-1-768x1024.jpg\")
<\/p>\n
Z\u00e1\u0159\u00ed – vyd\u00e1n\u00ed prvn\u00edho nefinan\u010dn\u00edho reportingu (ESG report)<\/h4>\n
Vyd\u00e1n\u00ed prvn\u00edho nefinan\u010dn\u00edho reportingu, zalo\u017een\u00e9ho na environment\u00e1ln\u00ed, soci\u00e1ln\u00ed a spr\u00e1vn\u00ed krit\u00e9ri\u00edch, p\u0159edstavovalo z\u00e1sadn\u00ed miln\u00edk v oblasti firemn\u00ed transparentnosti a odpov\u011bdnosti. Pro na\u0161i spole\u010dnost toto vyd\u00e1n\u00ed znamen\u00e1 posun od tradi\u010dn\u00edho zam\u011b\u0159en\u00ed pouze na finan\u010dn\u00ed v\u00fdsledky k podrobn\u011bj\u0161\u00edmu zp\u0159\u00edstupn\u011bn\u00ed informac\u00ed o na\u0161em vlivu na \u017eivotn\u00ed prost\u0159ed\u00ed, soci\u00e1ln\u00edch ot\u00e1zk\u00e1ch a spr\u00e1vn\u00edm \u0159\u00edzen\u00ed spole\u010dnosti. Tento report obsahuje informace o na\u0161ich environment\u00e1ln\u00edch iniciativ\u00e1ch, jako jsou snahy o sni\u017eov\u00e1n\u00ed uhl\u00edkov\u00e9 stopy \u010di vyu\u017e\u00edv\u00e1n\u00ed obnoviteln\u00fdch zdroj\u016f energie, ale tak\u00e9 o na\u0161em p\u0159\u00edstupu k zam\u011bstnaneck\u00fdm pr\u00e1v\u016fm, diverzit\u011b, a soci\u00e1ln\u00edmu zapojen\u00ed v komunit\u011b.<\/p>\n
\u0158\u00edjen – Sb\u00edrka Kol\u00e1\u010d pro hospic<\/h4>\n
Sb\u00edrka Kol\u00e1\u010d pro Hospic je dojemnou a d\u016fle\u017eitou iniciativou, kter\u00e1 spojuje komunitu ve prosp\u011bch t\u011bch, kte\u0159\u00ed pot\u0159ebuj\u00ed na\u0161i podporu a p\u00e9\u010di v jejich nesnadn\u00e9 cest\u011b. P\u0159isp\u011bn\u00edm k t\u00e9to sb\u00edrce se st\u00e1v\u00e1me sou\u010d\u00e1st\u00ed posl\u00e1n\u00ed poskytovat pomoc a podporu t\u011bm, kte\u0159\u00ed proch\u00e1zej\u00ed obt\u00ed\u017en\u00fdm obdob\u00edm. Spole\u010dn\u011b s\u00a0BioVendorem se poda\u0159ila vybrat rekordn\u011b vysok\u00e1 \u010d\u00e1stka t\u00e9m\u011b\u0159 25\u00a0000 K\u010d. V\u00fdt\u011b\u017eek z leto\u0161n\u00edho ro\u010dn\u00edku charita vyu\u017eije na rozvoj hospicov\u00e9 p\u00e9\u010de, n\u00e1kup zdravotnick\u00e9ho materi\u00e1lu a l\u00e9\u010div.<\/p>\n
Listopad – Podeps\u00e1n\u00ed memoranda<\/h4>\n
P\u0159ipojen\u00ed k Pride Business F\u00f3ru zt\u011bles\u0148uje na\u0161e z\u00e1vazky k p\u0159ijet\u00ed na\u0161ich z\u00e1kladn\u00edch hodnot – \u010dlov\u011bk a otev\u0159enost. V r\u00e1mci t\u011bchto hodnot pln\u011b podporujeme rovnost, slav\u00edme rozmanitost a povzbuzujeme odvahu. Na\u0161\u00edm neot\u0159esiteln\u00fdm c\u00edlem je ct\u00edt a oce\u0148ovat ka\u017edou jednotlivou osobu na z\u00e1klad\u011b jej\u00ed lidskosti, bez ohledu na rozd\u00edly jako je pohlav\u00ed, rasov\u00e1 p\u0159\u00edslu\u0161nost, n\u00e1rodnost, n\u00e1bo\u017eenstv\u00ed, v\u011bk, vzd\u011bl\u00e1n\u00ed a dal\u0161\u00ed.<\/p>\n<\/div>\n<\/div>\n\n","protected":false},"author":3,"featured_media":0,"template":"","meta":{"_acf_changed":false,"advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories_studies":[13,15],"class_list":["post-58638","studies","type-studies","status-publish","hentry"],"acf":[],"aioseo_notices":[],"featured_img":false,"coauthors":[],"author_meta":{"author_link":"https:\/\/www.oncomed.cz\/cs\/author\/jorova\/","display_name":"Zuzana Jorov\u00e1"},"relative_dates":{"created":"Posted 2 roky ago","modified":"Updated 2 roky ago"},"absolute_dates":{"created":"Posted on 9. 1. 2024","modified":"Updated on 16. 1. 2024"},"absolute_dates_time":{"created":"Posted on 9. 1. 2024 10:34","modified":"Updated on 16. 1. 2024 9:35"},"featured_img_caption":"","tax_additional":{"categories_studies":{"linked":["\u010cl\u00e1nky<\/a>","Novinky<\/a>"],"unlinked":["\u010cl\u00e1nky<\/span>","Novinky<\/span>"],"slug":"categories_studies","name":"Kategorie blogu"},"translation_priority":{"linked":["Optional<\/a>"],"unlinked":["Optional<\/span>"],"slug":"translation_priority","name":"Translation Priorities"}},"series_order":"","_links":{"self":[{"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/studies\/58638","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/studies"}],"about":[{"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/types\/studies"}],"version-history":[{"count":5,"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/studies\/58638\/revisions"}],"predecessor-version":[{"id":58690,"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/studies\/58638\/revisions\/58690"}],"wp:attachment":[{"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/media?parent=58638"}],"wp:term":[{"taxonomy":"categories_studies","embeddable":true,"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/categories_studies?post=58638"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}