{"id":133963,"date":"2025-09-30T10:29:13","date_gmt":"2025-09-30T08:29:13","guid":{"rendered":"https:\/\/obera.fr\/nase-rada\/farmaceuticky-prumysl-zvladnuti-prasnosti-a-expozice-pri-vazeni-a-prenosu-hpapi\/"},"modified":"2025-11-25T20:10:25","modified_gmt":"2025-11-25T18:10:25","slug":"farmaceuticky-prumysl-zvladnuti-prasnosti-a-expozice-pri-vazeni-a-prenosu-hpapi","status":"publish","type":"post","link":"https:\/\/obera.fr\/cs\/farmaceuticky-prumysl\/farmaceuticky-prumysl-zvladnuti-prasnosti-a-expozice-pri-vazeni-a-prenosu-hpapi\/","title":{"rendered":"Farmaceutick\u00fd pr\u016fmysl: Zvl\u00e1dnut\u00ed pra\u0161nosti a expozice p\u0159i v\u00e1\u017een\u00ed a p\u0159enosu HPAPI"},"content":{"rendered":"\n<p>N\u00e1r\u016fst HPAPI (Highly Potent Active Pharmaceutical Ingredients \u2013 vysoce \u00fa\u010dinn\u00e9 farmaceutick\u00e9 \u00fa\u010dinn\u00e9 l\u00e1tky) hluboce m\u011bn\u00ed<strong> postupy farmaceutick\u00e9 v\u00fdroby<\/strong>. Tyto molekuly (cytotoxick\u00e9, hormon\u00e1ln\u00ed, protin\u00e1dorov\u00e9, antivirov\u00e9) vykazuj\u00ed vysokou terapeutickou aktivitu, ale tak\u00e9 <a href=\"https:\/\/obera.fr\/cs\/nase-rady\/substances-cmr-risque-exposition-au-travail-quelle-reglementation-prevention\/\">v\u00fdznamn\u00e9 toxikologick\u00e9 riziko<\/a> pro person\u00e1l a \u017eivotn\u00ed prost\u0159ed\u00ed.<\/p>\n\n<h2 class=\"wp-block-heading\">V\u00fdzvy a probl\u00e9my v praxi<\/h2>\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<p>F\u00e1ze v\u00e1\u017een\u00ed a p\u0159enosu pr\u00e1\u0161k\u016f jsou obzvl\u00e1\u0161t\u011b kritick\u00e9: i mal\u00e1 mno\u017estv\u00ed mohou <strong>generovat koncentrace ve vzduchu<\/strong> nad limity expozice na pracovi\u0161ti (OEL).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">D\u016fsledky nedostate\u010dn\u00e9 kontroly:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>expozice oper\u00e1tor\u016f (respira\u010dn\u00ed patologie, syst\u00e9mov\u00e9 \u00fa\u010dinky);<\/li>\n\n\n\n<li>k\u0159\u00ed\u017eov\u00e1 kontaminace jin\u00fdch produkt\u016f nebo \u0161ar\u017e\u00ed;<\/li>\n\n\n\n<li>odchylky kvality, a\u017e po stahov\u00e1n\u00ed \u0161ar\u017e\u00ed;<\/li>\n\n\n\n<li>zastaven\u00ed provozu nebo sankce v p\u0159\u00edpad\u011b neshody s GMP\/EHS.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Audity v provozech v\u00e1\u017een\u00ed HPAPI odhaluj\u00ed:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>op\u011btovn\u00e9 rozpt\u00fdlen\u00ed p\u0159i vyprazd\u0148ov\u00e1n\u00ed, pros\u00e9v\u00e1n\u00ed nebo p\u0159enosu;<\/li>\n\n\n\n<li>\u00faniky v oblasti t\u011bsn\u011bn\u00ed, n\u00e1sypek, ventil\u016f a kontejner\u016f;<\/li>\n\n\n\n<li>n\u00e1ro\u010dn\u00e1 \u00fadr\u017eba (ucp\u00e1v\u00e1n\u00ed filtr\u016f, \u010di\u0161t\u011bn\u00ed povrch\u016f), kter\u00e1 prodlu\u017euje prostoje;<\/li>\n\n\n\n<li>pot\u00ed\u017ee s izolac\u00ed b\u011bhem zm\u011bn \u0161ar\u017e\u00ed a manu\u00e1ln\u00edch operac\u00ed.<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/industrie-pharmaceutique-1024x1024.webp\" alt=\"farmaceutick&#xFD; pr&#x16F;mysl\" class=\"wp-image-129371\" srcset=\"https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/industrie-pharmaceutique-1024x1024.webp 1024w, https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/industrie-pharmaceutique-300x300.webp 300w, https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/industrie-pharmaceutique-150x150.webp 150w, https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/industrie-pharmaceutique-768x768.webp 768w, https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/industrie-pharmaceutique.webp 1080w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n<\/div>\n<\/div>\n\n<p>Klasick\u00e9 prost\u0159edky (jednoduch\u00e9 celkov\u00e9 v\u011btr\u00e1n\u00ed nebo vzd\u00e1len\u00e9 ods\u00e1v\u00e1n\u00ed) jsou nedostate\u010dn\u00e9 pro <strong>zaji\u0161t\u011bn\u00ed udr\u017een\u00ed \u00farovn\u011b \u010d\u00e1stic<\/strong> v souladu s c\u00edlov\u00fdmi OEL (&lt; 1 \u03bcg\/m3 nebo dokonce &lt; 0,1 \u03bcg\/m3 podle OEB).<\/p>\n\n<h2 class=\"wp-block-heading\">Limity tradi\u010dn\u00edch postup\u016f<\/h2>\n\n<h3 class=\"wp-block-heading\">N\u011bkter\u00e9 jednotky se st\u00e1le spol\u00e9haj\u00ed na:<\/h3>\n\n<ul class=\"wp-block-list\">\n<li>v\u011btr\u00e1n\u00ed \u0159ed\u011bn\u00edm (HVAC) bez p\u0159\u00edm\u00e9ho ods\u00e1v\u00e1n\u00ed;<\/li>\n\n\n\n<li>otev\u0159en\u00e9 digesto\u0159e nebo jednoduch\u00e9 kabiny s ucpan\u00fdmi nebo \u0161patn\u011b um\u00edst\u011bn\u00fdmi filtry;<\/li>\n\n\n\n<li>filtry, kter\u00e9 nejsou pravideln\u011b testov\u00e1ny, nebo dokonce ni\u017e\u0161\u00ed t\u0159\u00eddy ne\u017e H13.<\/li>\n<\/ul>\n\n<p>Tato \u0159e\u0161en\u00ed neumo\u017e\u0148uj\u00ed dos\u00e1hnout n\u00edzk\u00fdch OEL a <strong>vystavuj\u00ed oper\u00e1tory b\u011bhem dynamick\u00fdch f\u00e1z\u00ed<\/strong> (otev\u00edr\u00e1n\u00ed sud\u016f, v\u00e1\u017een\u00ed, p\u0159enos).<\/p>\n\n<h2 class=\"wp-block-heading\">\u0158e\u0161en\u00ed OberA: ePURBOX BRS (ATEX)<\/h2>\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<h3 class=\"wp-block-heading\">Ods\u00e1v\u00e1n\u00ed u zdroje, maxim\u00e1ln\u00ed bl\u00edzkost<\/h3>\n\n\n\n<p>Jedn\u00edm ze z\u00e1kladn\u00edch princip\u016f <strong>kontroly kontaminace<\/strong> je zachycen\u00ed prachu ihned po jeho uvoln\u011bn\u00ed. Skute\u010dnost, \u017ee EpurBox BRS m\u016f\u017ee b\u00fdt um\u00edst\u011bn velmi bl\u00edzko m\u00edsta v\u00e1\u017een\u00ed (nebo n\u00e1sypky), omezuje op\u011btovn\u00e9 rozpt\u00fdlen\u00ed, sni\u017euje rozptyl v d\u00edln\u011b a sni\u017euje zat\u00ed\u017een\u00ed ostatn\u00edch <strong>ventila\u010dn\u00edch syst\u00e9m\u016f<\/strong>. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Flexibilita pro v\u00edcepou\u017eit\u00ed nebo pilotn\u00ed projekty<\/h3>\n\n\n\n<p>V provozech, kter\u00e9 pou\u017e\u00edvaj\u00ed v\u00edce molekul nebo jsou ve f\u00e1zi v\u00fdvoje \/ pilotn\u00edho projektu, m\u016f\u017ee b\u00fdt nepraktick\u00e9 <strong>instalovat pevn\u00fd syst\u00e9m<\/strong> pro ka\u017ed\u00e9 v\u00e1\u017eic\u00ed m\u00edsto. EpurBox BRS umo\u017e\u0148uje pou\u017eit\u00ed \u201ena vy\u017e\u00e1d\u00e1n\u00ed\u201c: p\u0159iveze se, kdy\u017e prob\u00edh\u00e1 operace, a pot\u00e9 se p\u0159esune. To omezuje <strong>fixn\u00ed investice,<\/strong> zvy\u0161uje agilitu a sni\u017euje rizikov\u00e9 z\u00f3ny.  <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Zabezpe\u010den\u00ed manu\u00e1ln\u00edch z\u00e1sah\u016f<\/h3>\n\n\n\n<p>B\u011bhem manu\u00e1ln\u00edch \u00fakol\u016f, jako je otev\u00edr\u00e1n\u00ed sud\u016f, d\u00e1vkov\u00e1n\u00ed nebo p\u0159enos pomoc\u00ed trycht\u00fd\u0159e, m\u016f\u017ee b\u00fdt EpurBox BRS um\u00edst\u011bn tak, aby <strong>zachyt\u00e1val proudy prachu<\/strong> uvoln\u011bn\u00e9 b\u011bhem t\u011bchto manipulac\u00ed, \u010d\u00edm\u017e se sni\u017euje okam\u017eit\u00e1 expozice oper\u00e1tora.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Shoda s ATEX v prost\u0159ed\u00ed s ho\u0159lav\u00fdm prachem<\/h3>\n\n\n\n<p>Certifikovan\u00fd ATEX, EpurBox BRS je vhodn\u00fd do klasifikovan\u00fdch z\u00f3n (nap\u0159. z\u00f3na 22 pro prach). To umo\u017e\u0148uje <a href=\"https:\/\/obera.fr\/cs\/farmaceuticky-prumysl\/\">farmaceutick\u00fdm provoz\u016fm<\/a>, kter\u00e9 <strong>manipuluj\u00ed s potenci\u00e1ln\u011b ho\u0159lav\u00fdmi pr\u00e1\u0161ky<\/strong> (organick\u00e9 excipienty, cukry, lakt\u00f3za atd.), pou\u017e\u00edvat jej bez ohro\u017een\u00ed jejich bezpe\u010dnostn\u00edho z\u00f3nov\u00e1n\u00ed. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Snadn\u00e1 kvalifikace a provoz<\/h3>\n\n\n\n<p>V p\u0159\u00edpad\u011b nutnosti v\u00fdm\u011bny filtru lze sk\u0159\u00ed\u0148 izolovat \/ sn\u00ed\u017eit tlak, \u010d\u00edm\u017e se omez\u00ed \u00faniky.<\/p>\n\n\n\n<p>Sk\u0159\u00ed\u0148 umo\u017e\u0148uje <strong>dokumentovat sv\u00e9 parametry<\/strong> (pr\u016ftoky, tlaky, \u00fa\u010dinnost filtrace) v r\u00e1mci IQ\/OQ\/PQ.<\/p>\n\n\n\n<p>Monitorov\u00e1n\u00ed diferen\u010dn\u00edho tlaku, alarmy a pl\u00e1novan\u00e1 \u00fadr\u017eba zaji\u0161\u0165uj\u00ed kontrolovan\u00fd provoz.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/visuel-epurbox-brs-1024x1024.png\" alt=\"vizu&#xE1;l epurbox brs\" class=\"wp-image-129394\" srcset=\"https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/visuel-epurbox-brs-1024x1024.png 1024w, https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/visuel-epurbox-brs-300x300.png 300w, https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/visuel-epurbox-brs-150x150.png 150w, https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/visuel-epurbox-brs-768x768.png 768w, https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/visuel-epurbox-brs.png 1200w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n<\/div>\n<\/div>\n\n<h2 class=\"wp-block-heading\">Sc\u00e9n\u00e1\u0159 implementace: typick\u00fd p\u0159\u00edpad pou\u017eit\u00ed<\/h2>\n\n<h3 class=\"wp-block-heading\">Uve\u010fme si konkr\u00e9tn\u00ed p\u0159\u00edklad:<\/h3>\n\n<ul class=\"wp-block-list\">\n<li>Farmaceutick\u00fd provoz mus\u00ed v\u00e1\u017eit HPAPI s OEB = 4 (c\u00edlov\u00e1 OEL ~ 1 \u03bcg\/m3) v pilotn\u00ed laborato\u0159i. <\/li>\n\n\n\n<li>EpurBox BRS je um\u00edst\u011bn vedle v\u00e1hy, s ramenem nebo <strong>sac\u00ed tryskou sm\u011b\u0159uj\u00edc\u00ed k v\u00e1\u017eic\u00ed z\u00f3n\u011b<\/strong>. <\/li>\n\n\n\n<li>Stroj pracuje, pr\u00e1\u0161ky se m\u00edrn\u011b uvol\u0148uj\u00ed p\u0159i ukl\u00e1d\u00e1n\u00ed nebo p\u0159enosu: EpurBox lok\u00e1ln\u011b ods\u00e1v\u00e1 a vrac\u00ed filtrovan\u00fd vzduch zp\u011bt do d\u00edlny nebo do vyhrazen\u00e9ho odvodu. <\/li>\n\n\n\n<li>B\u011bhem provozu je monitorov\u00e1n diferen\u010dn\u00ed tlak: pokud se filtr ucpe, spust\u00ed se alarm pro v\u00fdm\u011bnu \/ \u010di\u0161t\u011bn\u00ed. <\/li>\n\n\n\n<li>Po pou\u017eit\u00ed lze EpurBox p\u0159esunout na jinou linku nebo ulo\u017eit do pohotovostn\u00edho re\u017eimu.<\/li>\n<\/ul>\n\n<p>S t\u00edmto za\u0159\u00edzen\u00edm se <strong>d\u00edlna vyhne instalaci pevn\u00fdch digesto\u0159\u00ed<\/strong> kolem ka\u017ed\u00e9ho pracovi\u0161t\u011b a m\u00e1 k dispozici v\u00fdkonn\u00fd mobiln\u00ed n\u00e1stroj pro izolaci.<\/p>\n\n<p>Chcete-li objevit na\u0161e produkty a spole\u010dn\u011b si p\u0159edstavit TO NEJLEP\u0160\u00cd \u0159e\u0161en\u00ed p\u0159izp\u016fsoben\u00e9 va\u0161im prostor\u00e1m, kontaktujte na\u0161e t\u00fdmy. Pom\u016f\u017eeme v\u00e1m s v\u00fdb\u011brem <strong>nejvhodn\u011bj\u0161\u00edch za\u0159\u00edzen\u00ed<\/strong> pro va\u0161e po\u017eadavky a c\u00edle. <\/p>\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-a89b3969 wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/obera.fr\/cs\/contact\/\">Kontaktujte n\u00e1s<\/a><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>N\u00e1r\u016fst v\u00fdznamu HPAPI (vysoce \u00fa\u010dinn\u00e9 farmaceutick\u00e9 substance) z\u00e1sadn\u011b m\u011bn\u00ed postupy farmaceutick\u00e9 v\u00fdroby.<\/p>\n","protected":false},"author":13,"featured_media":83734,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_seopress_robots_primary_cat":"none","_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":"","footnotes":""},"categories":[878],"tags":[879],"class_list":["post-133963","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-farmaceuticky-prumysl","tag-mobilni-podstavce","generate-columns","tablet-grid-50","mobile-grid-100","grid-parent","grid-50","no-featured-image-padding","resize-featured-image"],"acf":[],"_links":{"self":[{"href":"https:\/\/obera.fr\/cs\/wp-json\/wp\/v2\/posts\/133963","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/obera.fr\/cs\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/obera.fr\/cs\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/obera.fr\/cs\/wp-json\/wp\/v2\/users\/13"}],"replies":[{"embeddable":true,"href":"https:\/\/obera.fr\/cs\/wp-json\/wp\/v2\/comments?post=133963"}],"version-history":[{"count":1,"href":"https:\/\/obera.fr\/cs\/wp-json\/wp\/v2\/posts\/133963\/revisions"}],"predecessor-version":[{"id":133964,"href":"https:\/\/obera.fr\/cs\/wp-json\/wp\/v2\/posts\/133963\/revisions\/133964"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/obera.fr\/cs\/wp-json\/wp\/v2\/media\/83734"}],"wp:attachment":[{"href":"https:\/\/obera.fr\/cs\/wp-json\/wp\/v2\/media?parent=133963"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/obera.fr\/cs\/wp-json\/wp\/v2\/categories?post=133963"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/obera.fr\/cs\/wp-json\/wp\/v2\/tags?post=133963"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}