{"id":20332,"date":"2022-06-02T23:15:26","date_gmt":"2022-06-02T21:15:26","guid":{"rendered":"https:\/\/sw.fst.com\/magazine\/2025\/07\/co-musi-farmaceuticka-pecet-umet\/"},"modified":"2025-07-30T17:51:48","modified_gmt":"2025-07-30T15:51:48","slug":"co-musi-farmaceuticka-pecet-umet","status":"publish","type":"post","link":"https:\/\/sw.fst.com\/magazine\/cs\/2022\/06\/co-musi-farmaceuticka-pecet-umet\/","title":{"rendered":"Co mus\u00ed farmaceutick\u00e1 pe\u010de\u0165 um\u011bt"},"content":{"rendered":"\n
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V\u00fdroba<\/h2>\n\n\n\n

TEPLOTY A TLAKY<\/strong>Vysok\u00e9 teploty a tlaky se vyskytuj\u00ed nap\u0159\u00edklad p\u0159i organick\u00e9 synt\u00e9ze. Velmi n\u00edzk\u00e9 teploty se mohou vyskytnout p\u0159i v\u00fdrob\u011b vakc\u00edn nebo protein\u016f a tak\u00e9 p\u0159i separaci krve, kter\u00e1 vy\u017eaduje t\u011bsn\u011bn\u00ed, je\u017e jsou p\u0159i n\u00edzk\u00fdch teplot\u00e1ch velmi pru\u017en\u00e1. <\/p>\n\n\n\n

Odolnost v\u016f\u010di CIP\/SIP<\/strong>T\u011bsnic\u00ed materi\u00e1ly mus\u00ed b\u00fdt schopny<\/strong> odolat agresivn\u00edm m\u00e9di\u00edm, jako jsou \u010distic\u00ed prost\u0159edky CIP\/SIP.<\/p>\n\n\n\n

PR\u00c1\u0160KOV\u00c1 M\u00c9DIA<\/strong>T\u011bsn\u011bn\u00ed mus\u00ed \u010dasto odol\u00e1vat i pr\u00e1\u0161kov\u00fdm m\u00e9di\u00edm, jako jsou nap\u0159\u00edklad, kter\u00e1 se pou\u017e\u00edvaj\u00ed v tabletovac\u00edch lisech.<\/p>\n\n\n\n

AGRESIVN\u00cd CHEMICK\u00c9 L\u00c1TKY<\/strong>P\u0159i v\u00fdrob\u011b chemicky vyr\u00e1b\u011bn\u00fdch aktivn\u00edch farmaceutick\u00fdch l\u00e1tek (API) nebo diagnostik in vivo (kontrastn\u00ed l\u00e1tky a biomarkery) se pou\u017e\u00edvaj\u00ed chemick\u00e9 a toxick\u00e9 l\u00e1tky, kter\u00fdm mus\u00ed t\u011bsn\u011bn\u00ed odol\u00e1vat.<\/p>\n\n\n\n

SHODY A SCHV\u00c1LEN\u00cd<\/strong>Vzhledem k p\u0159\u00edm\u00e9mu kontaktu s vysoce \u010dist\u00fdm procesn\u00edm m\u00e9diem mus\u00ed m\u00edt t\u011bsn\u011bn\u00ed zvl\u00e1\u0161tn\u00ed schv\u00e1len\u00ed a shody pro farmaceutick\u00fd pr\u016fmysl, nap\u0159\u00edklad USP t\u0159\u00eddy VI a FDA.<\/p>\n\n\n\n

EXTRAKTABILITY<\/strong>Vzhledem k vysok\u00fdm po\u017eadavk\u016fm na \u010distotu jsou v\u00fdrobci l\u00e9\u010div povinni prov\u00e1d\u011bt studie extrahovatelnosti. Extrahovateln\u00e9 l\u00e1tky jsou chemick\u00e9 slou\u010deniny, kter\u00e9 se za ur\u010dit\u00fdch podm\u00ednek (nap\u0159. p\u0159i zv\u00fd\u0161en\u00e9 teplot\u011b nebo p\u0159i kontaktu s r\u016fzn\u00fdmi rozpou\u0161t\u011bdly) extrahuj\u00ed z obalov\u00e9ho materi\u00e1lu a migruj\u00ed do v\u00fdrobku. <\/p>\n\n\n\n

P\u0158\u00cdM\u00dd KONTAKT S PRODUKTY S VYSOKOU \u010cISTOTOU<\/strong>Proto\u017ee p\u0159i synt\u00e9ze l\u00e9\u010div ve farmaceutick\u00e9m pr\u016fmyslu nesm\u00ed vznikat \u017e\u00e1dn\u00e9 ne\u017e\u00e1douc\u00ed vedlej\u0161\u00ed produkty ani se do produktu nesm\u00ed dostat \u017e\u00e1dn\u00e9 cizorod\u00e9 l\u00e1tky, jsou po\u017eadavky na \u010distotu procesu a produktu obzvl\u00e1\u0161t\u011b vysok\u00e9. Jsou vy\u017eadov\u00e1ny t\u011bsnic\u00ed materi\u00e1ly, kter\u00e9 spolehliv\u011b zabra\u0148uj\u00ed kontaminaci a mohou bez obav p\u0159ij\u00edt do styku s produktem. <\/p>\n\n\n\n

HYGIENICK\u00dd DESIGN<\/strong>Vzhledem k p\u0159\u00edsn\u00fdm hygienick\u00fdm p\u0159edpis\u016fm by t\u011bsn\u011bn\u00ed m\u011bla b\u00fdt konstruov\u00e1na v souladu s hygienick\u00fdm designem, aby byla zaji\u0161t\u011bna spolehliv\u00e1 \u010distitelnost syst\u00e9m\u016f a t\u00edm i steriln\u00ed procesy.<\/p>\n\n\n\n

\u010cIST\u00c1 VODA (WFI A DI VODA<\/strong>)Jak voda WFI (voda pro vst\u0159ikov\u00e1n\u00ed, demineralizovan\u00e1 ultra\u010dist\u00e1 voda), tak voda DI (pln\u011b demineralizovan\u00e1 voda) kladou obrovsk\u00e9 n\u00e1roky na elastomerov\u00e9 materi\u00e1ly. Je t\u0159eba pou\u017e\u00edvat t\u011bsnic\u00ed materi\u00e1ly, kter\u00e9 jsou odoln\u00e9 v\u016f\u010di t\u011bmto m\u00e9di\u00edm p\u0159i dlouhodob\u00e9m pou\u017e\u00edv\u00e1n\u00ed. <\/p>\n<\/div><\/div>\n\n

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Kontrola kvality a balen\u00ed<\/h2>\n\n\n\n

SLEDOVATELNOST<\/strong>Aby byla zaru\u010dena \u010distota \u0161ar\u017ee, v\u011bnuje se zvl\u00e1\u0161tn\u00ed pozornost dokumentaci proces\u016f. Plomby proto vy\u017eaduj\u00ed bezpe\u010dnostn\u00ed zna\u010den\u00ed, nap\u0159\u00edklad laserov\u00e9 zna\u010den\u00ed, pomoc\u00ed kter\u00e9ho lze z\u00edskat informace o ozna\u010den\u00ed v\u00fdrobku, konstrukci, rozm\u011brech, materi\u00e1lu elastomeru, datu v\u00fdroby a s\u00e9riov\u00e9m \u010d\u00edsle. To umo\u017e\u0148uje spolehlivou sledovatelnost plomb. <\/p>\n<\/div><\/div>\n\n

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\"\"<\/figure>\n\n\n\n

Vysoce \u010dist\u00fd kone\u010dn\u00fd produkt<\/h2>\n\n\n\n

LEACHABLES ..<\/strong>.… jsou chemick\u00e9 slou\u010deniny, kter\u00e9 se uvol\u0148uj\u00ed z obalov\u00fdch materi\u00e1l\u016f, n\u00e1t\u011br\u016f atd. za b\u011b\u017en\u00fdch podm\u00ednek prost\u0159ed\u00ed b\u011bhem \u017eivotnosti v\u00fdrobku. V\u00fdrobci l\u00e9\u010div\u00fdch p\u0159\u00edpravk\u016f jsou proto povinni prov\u00e1d\u011bt rozs\u00e1hl\u00e9 studie t\u00fdkaj\u00edc\u00ed se t\u00e9to problematiky. To proto, aby bylo zaji\u0161t\u011bno, \u017ee se z obalov\u00fdch materi\u00e1l\u016f b\u011bhem skladov\u00e1n\u00ed neuvol\u0148uj\u00ed \u017e\u00e1dn\u00e9 \u0161kodliv\u00e9 slo\u017eky elastomerov\u00e9 sm\u011bsi, kter\u00e9 by p\u0159e\u0161ly do v\u00fdrobku. <\/p>\n<\/div><\/div>\n

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\r\n \r\n <\/i>\r\n <\/a>\r\n <\/span>\r\n<\/div><\/div>","protected":false},"excerpt":{"rendered":"

V\u00fdroba TEPLOTY A TLAKYVysok\u00e9 teploty a tlaky se vyskytuj\u00ed nap\u0159\u00edklad p\u0159i organick\u00e9 synt\u00e9ze. Velmi n\u00edzk\u00e9 teploty se mohou vyskytnout p\u0159i v\u00fdrob\u011b vakc\u00edn nebo protein\u016f a tak\u00e9 p\u0159i separaci krve, kter\u00e1…<\/p>\n","protected":false},"author":3,"featured_media":20336,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[1335],"tags":[1512],"powerkit_post_featured":[],"class_list":["post-20332","post","type-post","status-publish","format-standard","has-post-thumbnail","category-technologie-a-inovace","tag-vydani-03_2022-cz"],"_links":{"self":[{"href":"https:\/\/sw.fst.com\/magazine\/cs\/wp-json\/wp\/v2\/posts\/20332","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sw.fst.com\/magazine\/cs\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/sw.fst.com\/magazine\/cs\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/sw.fst.com\/magazine\/cs\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/sw.fst.com\/magazine\/cs\/wp-json\/wp\/v2\/comments?post=20332"}],"version-history":[{"count":1,"href":"https:\/\/sw.fst.com\/magazine\/cs\/wp-json\/wp\/v2\/posts\/20332\/revisions"}],"predecessor-version":[{"id":20341,"href":"https:\/\/sw.fst.com\/magazine\/cs\/wp-json\/wp\/v2\/posts\/20332\/revisions\/20341"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sw.fst.com\/magazine\/cs\/wp-json\/wp\/v2\/media\/20336"}],"wp:attachment":[{"href":"https:\/\/sw.fst.com\/magazine\/cs\/wp-json\/wp\/v2\/media?parent=20332"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sw.fst.com\/magazine\/cs\/wp-json\/wp\/v2\/categories?post=20332"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sw.fst.com\/magazine\/cs\/wp-json\/wp\/v2\/tags?post=20332"},{"taxonomy":"powerkit_post_featured","embeddable":true,"href":"https:\/\/sw.fst.com\/magazine\/cs\/wp-json\/wp\/v2\/powerkit_post_featured?post=20332"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}