{"id":133515,"date":"2025-09-30T10:29:13","date_gmt":"2025-09-30T08:29:13","guid":{"rendered":"https:\/\/obera.fr\/nase-rada\/farmaceuticky-priemysel-zvladnutie-prasnosti-a-expozicie-pocas-vazenia-a-prenosu-hpapi\/"},"modified":"2025-11-20T15:51:29","modified_gmt":"2025-11-20T13:51:29","slug":"farmaceuticky-priemysel-zvladnutie-prasnosti-a-expozicie-pocas-vazenia-a-prenosu-hpapi","status":"publish","type":"post","link":"https:\/\/obera.fr\/sk\/farmaceuticky-priemysel\/farmaceuticky-priemysel-zvladnutie-prasnosti-a-expozicie-pocas-vazenia-a-prenosu-hpapi\/","title":{"rendered":"Farmaceutick\u00fd priemysel: Zvl\u00e1dnutie pra\u0161nosti a expoz\u00edcie po\u010das v\u00e1\u017eenia a prenosu HPAPI"},"content":{"rendered":"\n<p>N\u00e1rast HPAPI (Highly Potent Active Pharmaceutical Ingredients \u2013 vysoko potentn\u00e9 akt\u00edvne farmaceutick\u00e9 zlo\u017eky) hlboko men\u00ed <strong>farmaceutick\u00e9 v\u00fdrobn\u00e9 postupy<\/strong>. Tieto molekuly (cytotoxick\u00e9, hormon\u00e1lne, protirakovinov\u00e9, antiv\u00edrusov\u00e9) vykazuj\u00fa vysok\u00fa terapeutick\u00fa aktivitu, ale aj <a href=\"https:\/\/obera.fr\/sk\/nasa-rada\/substances-cmr-risque-exposition-au-travail-quelle-reglementation-prevention\/\">v\u00fdznamn\u00e9 toxikologick\u00e9 riziko<\/a> pre person\u00e1l a \u017eivotn\u00e9 prostredie.<\/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\u00e1zy v\u00e1\u017eenia a prenosu pr\u00e1\u0161kov s\u00fa obzvl\u00e1\u0161\u0165 kritick\u00e9: aj mal\u00e9 mno\u017estv\u00e1 m\u00f4\u017eu <strong>generova\u0165 vzdu\u0161n\u00e9 koncentr\u00e1cie<\/strong> nad limity profesion\u00e1lnej expoz\u00edcie (OEL).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">D\u00f4sledky nedostato\u010dnej kontroly:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>expoz\u00edcia oper\u00e1torov (respira\u010dn\u00e9 patol\u00f3gie, syst\u00e9mov\u00e9 \u00fa\u010dinky);<\/li>\n\n\n\n<li>kr\u00ed\u017eov\u00e1 kontamin\u00e1cia in\u00fdch produktov alebo \u0161ar\u017e\u00ed;<\/li>\n\n\n\n<li>odch\u00fdlky kvality, a\u017e po stiahnutie \u0161ar\u017e\u00ed z obehu;<\/li>\n\n\n\n<li>zastavenie prev\u00e1dzky alebo sankcie v pr\u00edpade nezhody s GMP\/EHS.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Audity v prev\u00e1dzkach v\u00e1\u017eenia HPAPI poukazuj\u00fa na:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>op\u00e4tovn\u00e9 rozpt\u00fdlenie po\u010das vypr\u00e1zd\u0148ovania, preosievania alebo prenosu;<\/li>\n\n\n\n<li>\u00faniky na \u00farovni tesnen\u00ed, n\u00e1sypiek, ventilov a kontajnerov;<\/li>\n\n\n\n<li>n\u00e1ro\u010dn\u00e1 \u00fadr\u017eba (zan\u00e1\u0161anie filtrov, \u010distenie povrchov), ktor\u00e1 predl\u017euje prestoje;<\/li>\n\n\n\n<li>\u0165a\u017ekosti s izol\u00e1ciou po\u010das zmien \u0161ar\u017e\u00ed a manu\u00e1lnych oper\u00e1ci\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; priemysel\" 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 prostriedky (jednoduch\u00e9 v\u0161eobecn\u00e9 vetranie alebo dia\u013ekov\u00e9 ods\u00e1vanie) s\u00fa nedostato\u010dn\u00e9 na to, aby <strong>zaru\u010dili udr\u017eanie \u00farovne \u010dast\u00edc<\/strong> v s\u00falade s cie\u013eov\u00fdmi OEL (&lt; 1 \u03bcg\/m3 alebo dokonca &lt; 0,1 \u03bcg\/m3 v z\u00e1vislosti od OEB).<\/p>\n\n<h2 class=\"wp-block-heading\">Limity tradi\u010dn\u00fdch postupov<\/h2>\n\n<h3 class=\"wp-block-heading\">Niektor\u00e9 jednotky sa na\u010falej spoliehaj\u00fa na:<\/h3>\n\n<ul class=\"wp-block-list\">\n<li>vetranie rieden\u00edm (HVAC) bez priameho ods\u00e1vania;<\/li>\n\n\n\n<li>otvoren\u00e9 digestory alebo jednoduch\u00e9 kab\u00edny so zanesen\u00fdmi alebo nespr\u00e1vne umiestnen\u00fdmi filtrami;<\/li>\n\n\n\n<li>filtre, ktor\u00e9 nie s\u00fa pravidelne testovan\u00e9, alebo s\u00fa dokonca ni\u017e\u0161ej triedy ako H13.<\/li>\n<\/ul>\n\n<p>Tieto rie\u0161enia neumo\u017e\u0148uj\u00fa dosiahnu\u0165 n\u00edzke OEL a <strong>vystavuj\u00fa oper\u00e1torov po\u010das dynamick\u00fdch f\u00e1z<\/strong> (otv\u00e1ranie sudov, v\u00e1\u017eenie, prenos).<\/p>\n\n<h2 class=\"wp-block-heading\">Rie\u0161enie 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\u00e1vanie pri zdroji, maxim\u00e1lna bl\u00edzkos\u0165<\/h3>\n\n\n\n<p>Jedn\u00fdm zo z\u00e1kladn\u00fdch princ\u00edpov <strong>kontroly kontamin\u00e1cie<\/strong> je zachyt\u00e1va\u0165 prach hne\u010f pri jeho vzniku. Skuto\u010dnos\u0165, \u017ee EpurBox BRS m\u00f4\u017ee by\u0165 umiestnen\u00fd ve\u013emi bl\u00edzko miesta v\u00e1\u017eenia (alebo n\u00e1sypky), obmedzuje op\u00e4tovn\u00e9 rozpt\u00fdlenie, zni\u017euje rozptyl v dielni a zni\u017euje za\u0165a\u017eenie ostatn\u00fdch <strong>ventila\u010dn\u00fdch syst\u00e9mov<\/strong>. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Flexibilita pre viacproduktov\u00e9 alebo pilotn\u00e9 pou\u017eitie<\/h3>\n\n\n\n<p>Na pracovisk\u00e1ch, ktor\u00e9 pou\u017e\u00edvaj\u00fa viacero molek\u00fal alebo s\u00fa vo f\u00e1ze v\u00fdvoja \/ pilotnej prev\u00e1dzky, m\u00f4\u017ee by\u0165 nepraktick\u00e9 <strong>in\u0161talova\u0165 pevn\u00fd syst\u00e9m<\/strong> pre ka\u017ed\u00e9 miesto v\u00e1\u017eenia. EpurBox BRS umo\u017e\u0148uje pou\u017eitie \u201ena po\u017eiadanie\u201c: prinesie sa, ke\u010f prebieha oper\u00e1cia, a potom sa premiestni. To obmedzuje <strong>fixn\u00e9 invest\u00edcie<\/strong>, zvy\u0161uje agilitu a zni\u017euje rizikov\u00e9 z\u00f3ny.  <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Zabezpe\u010denie manu\u00e1lnych z\u00e1sahov<\/h3>\n\n\n\n<p>Po\u010das manu\u00e1lnych \u00faloh, ako je otv\u00e1ranie sudov, d\u00e1vkovanie alebo prenos lievikom, m\u00f4\u017ee by\u0165 EpurBox BRS umiestnen\u00fd tak, aby <strong>zachyt\u00e1val pr\u00fad prachu<\/strong> uvo\u013enen\u00fd po\u010das t\u00fdchto manipul\u00e1ci\u00ed, \u010d\u00edm sa zni\u017euje bodov\u00e1 expoz\u00edcia oper\u00e1tora.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">S\u00falad s ATEX v prostrediach s hor\u013eav\u00fdm prachom<\/h3>\n\n\n\n<p>Certifikovan\u00fd ATEX, EpurBox BRS je vhodn\u00fd do klasifikovan\u00fdch z\u00f3n (napr. z\u00f3na 22 pre prach). To umo\u017e\u0148uje <a href=\"https:\/\/obera.fr\/sk\/farmaceuticky-priemysel\/\">farmaceutick\u00fdm prev\u00e1dzkam<\/a>, ktor\u00e9 <strong>manipuluj\u00fa s potenci\u00e1lne hor\u013eav\u00fdmi pr\u00e1\u0161kami<\/strong> (organick\u00e9 excipienty, cukry, lakt\u00f3za at\u010f.), pou\u017e\u00edva\u0165 ho bez ohrozenia ich bezpe\u010dnostn\u00e9ho z\u00f3novania. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Jednoduch\u00e1 kvalifik\u00e1cia a prev\u00e1dzka<\/h3>\n\n\n\n<p>V pr\u00edpade potreby v\u00fdmeny filtra m\u00f4\u017ee by\u0165 skri\u0148a izolovan\u00e1 \/ dekomprimovan\u00e1, \u010d\u00edm sa obmedzuj\u00fa emisie.<\/p>\n\n\n\n<p>Skri\u0148a umo\u017e\u0148uje <strong>dokumentova\u0165 jej v\u00fdkon<\/strong> (prietoky, tlaky, \u00fa\u010dinnos\u0165 filtr\u00e1cie) v r\u00e1mci IQ\/OQ\/PQ.<\/p>\n\n\n\n<p>Monitorovanie diferen\u010dn\u00e9ho tlaku, alarmy a pl\u00e1novan\u00e1 \u00fadr\u017eba zabezpe\u010duj\u00fa kontrolovan\u00fa prev\u00e1dzku.<\/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\">Scen\u00e1r implement\u00e1cie: typick\u00fd pr\u00edpad pou\u017eitia<\/h2>\n\n<h3 class=\"wp-block-heading\">Uve\u010fme si konkr\u00e9tny pr\u00edklad:<\/h3>\n\n<ul class=\"wp-block-list\">\n<li>Farmaceutick\u00e1 prev\u00e1dzka mus\u00ed v\u00e1\u017ei\u0165 HPAPI s OEB = 4 (cie\u013eov\u00e9 OEL ~ 1 \u03bcg\/m3) v pilotnom laborat\u00f3riu. <\/li>\n\n\n\n<li>EpurBox BRS je umiestnen\u00fd ved\u013ea v\u00e1hy, s ramenom alebo <strong>ods\u00e1vacou d\u00fdzou smeruj\u00facou k v\u00e1\u017eiacej z\u00f3ne<\/strong>. <\/li>\n\n\n\n<li>Stroj pracuje, pr\u00e1\u0161ky mierne unikaj\u00fa po\u010das ukladania alebo prenosu: EpurBox ods\u00e1va lok\u00e1lne a vracia filtrovan\u00fd vzduch do dielne alebo do vyhraden\u00e9ho odvodu. <\/li>\n\n\n\n<li>Po\u010das prev\u00e1dzky sa monitoruje diferen\u010dn\u00fd tlak: ak sa filter zanesie, spust\u00ed sa alarm na v\u00fdmenu \/ \u010distenie. <\/li>\n\n\n\n<li>Po pou\u017eit\u00ed m\u00f4\u017ee by\u0165 EpurBox premiestnen\u00fd na in\u00fa linku alebo uskladnen\u00fd v pohotovostnom re\u017eime.<\/li>\n<\/ul>\n\n<p>S t\u00fdmto zariaden\u00edm sa <strong>diel\u0148a vyhne in\u0161tal\u00e1cii pevn\u00fdch digestorov<\/strong> okolo ka\u017ed\u00e9ho pracoviska a m\u00e1 k dispoz\u00edcii v\u00fdkonn\u00fd mobiln\u00fd izola\u010dn\u00fd n\u00e1stroj.<\/p>\n\n<p>Ak chcete objavi\u0165 na\u0161e produkty a spolo\u010dne si predstavi\u0165 RIE\u0160ENIE prisp\u00f4soben\u00e9 va\u0161im priestorom, kontaktujte na\u0161e t\u00edmy. Pom\u00f4\u017eeme v\u00e1m s v\u00fdberom <strong>najvhodnej\u0161\u00edch zariaden\u00ed<\/strong> pre va\u0161e po\u017eiadavky a ciele. <\/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\/sk\/contact\/\">Kontaktujte n\u00e1s<\/a><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>N\u00e1rast HPAPI (Highly Potent Active Pharmaceutical Ingredients \u2013 vysoko \u00fa\u010dinn\u00e9 akt\u00edvne farmaceutick\u00e9 zlo\u017eky) hlboko men\u00ed postupy farmaceutickej v\u00fdroby.<\/p>\n","protected":false},"author":13,"featured_media":83749,"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":[807],"tags":[808],"class_list":["post-133515","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-farmaceuticky-priemysel","tag-mobilne-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\/sk\/wp-json\/wp\/v2\/posts\/133515","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/obera.fr\/sk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/obera.fr\/sk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/obera.fr\/sk\/wp-json\/wp\/v2\/users\/13"}],"replies":[{"embeddable":true,"href":"https:\/\/obera.fr\/sk\/wp-json\/wp\/v2\/comments?post=133515"}],"version-history":[{"count":3,"href":"https:\/\/obera.fr\/sk\/wp-json\/wp\/v2\/posts\/133515\/revisions"}],"predecessor-version":[{"id":133538,"href":"https:\/\/obera.fr\/sk\/wp-json\/wp\/v2\/posts\/133515\/revisions\/133538"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/obera.fr\/sk\/wp-json\/wp\/v2\/media\/83749"}],"wp:attachment":[{"href":"https:\/\/obera.fr\/sk\/wp-json\/wp\/v2\/media?parent=133515"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/obera.fr\/sk\/wp-json\/wp\/v2\/categories?post=133515"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/obera.fr\/sk\/wp-json\/wp\/v2\/tags?post=133515"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}