{"id":133837,"date":"2025-09-30T10:29:13","date_gmt":"2025-09-30T08:29:13","guid":{"rendered":"https:\/\/obera.fr\/conseils\/farmatseudiatoostus-tolmu-ja-kokkupuute-kontrollimine-hpapi-kaalumise-ja-ulekande-ajal\/"},"modified":"2025-11-21T11:29:24","modified_gmt":"2025-11-21T09:29:24","slug":"farmatseudiatoostus-tolmu-ja-kokkupuute-kontrollimine-hpapi-kaalumise-ja-ulekande-ajal","status":"publish","type":"post","link":"https:\/\/obera.fr\/et\/farmaatsiatoostus\/farmatseudiatoostus-tolmu-ja-kokkupuute-kontrollimine-hpapi-kaalumise-ja-ulekande-ajal\/","title":{"rendered":"Farmatseudiat\u00f6\u00f6stus: Tolmu ja kokkupuute kontrollimine HPAPI kaalumise ja \u00fclekande ajal"},"content":{"rendered":"\n<p>HPAPI-de (Highly Potent Active Pharmaceutical Ingredients \u2013 k\u00f5rge aktiivsusega toimeained) kasv muudab p\u00f5hjalikult <strong>farmaatsiat\u00f6\u00f6stuse tootmistavasid<\/strong>. Need molekulid (ts\u00fctotoksilised, hormonaalsed, v\u00e4hivastased, viirusevastased) omavad k\u00f5rget terapeutilist aktiivsust, kuid ka <a href=\"https:\/\/obera.fr\/et\/meie-nouanne\/substances-cmr-risque-exposition-au-travail-quelle-reglementation-prevention\/\">olulist toksikoloogilist riski<\/a> t\u00f6\u00f6tajatele ja keskkonnale.<\/p>\n\n<h2 class=\"wp-block-heading\">V\u00e4ljakutsed ja praktilised probleemid<\/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>Pulbrite kaalumise ja \u00fclekandmise etapid on eriti kriitilised: isegi v\u00e4ikesed kogused v\u00f5ivad <strong>tekitada \u00f5hus kontsentratsioone<\/strong>, mis \u00fcletavad kutsealase kokkupuute piirnorme (OEL).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Halva kontrolli tagaj\u00e4rjed:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>operaatorite kokkupuude (hingamisteede haigused, s\u00fcsteemsed m\u00f5jud);<\/li>\n\n\n\n<li>teiste toodete v\u00f5i partiide ristsaastumine;<\/li>\n\n\n\n<li>kvaliteedik\u00f5rvalekalded, kuni partiide tagasikutsumiseni;<\/li>\n\n\n\n<li>peatamised v\u00f5i sanktsioonid GMP\/EHS mittevastavuse korral.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">HPAPI kaalumist\u00f6\u00f6kodade auditid n\u00e4itavad:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>resuspensioon t\u00fchjendamise, s\u00f5elumise v\u00f5i \u00fclekandmise ajal;<\/li>\n\n\n\n<li>lekked tihendite, lehtrite, klappide ja konteinerite juures;<\/li>\n\n\n\n<li>raske hooldus (filtrite ummistumine, pindade puhastamine), mis pikendab seisuaega;<\/li>\n\n\n\n<li>isoleerimisraskused partiide vahetamisel ja k\u00e4sitsi toimingutel.<\/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=\"farmaatsiat&#xF6;&#xF6;stus\" 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>Tavap\u00e4rased meetmed (lihtne \u00fcldventilatsioon v\u00f5i kaugp\u00fc\u00fcdmine) on ebapiisavad, et <strong>tagada osakeste taseme hoidmine<\/strong> vastavalt sihtm\u00e4rgiks seatud OEL-idele (&lt; 1 \u03bcg\/m3 v\u00f5i isegi &lt; 0,1 \u03bcg\/m3 vastavalt OEB-le).<\/p>\n\n<h2 class=\"wp-block-heading\">Traditsiooniliste praktikate piirangud<\/h2>\n\n<h3 class=\"wp-block-heading\">M\u00f5ned \u00fcksused tuginevad endiselt:<\/h3>\n\n<ul class=\"wp-block-list\">\n<li>lahjendusega ventilatsioonile (HVAC) ilma otsese p\u00fc\u00fcdmiseta;<\/li>\n\n\n\n<li>avatud t\u00f5mbekapid v\u00f5i lihtsad kabiinid ummistunud v\u00f5i valesti paigutatud filtritega;<\/li>\n\n\n\n<li>regulaarselt testimata filtrid v\u00f5i isegi madalama klassiga kui H13.<\/li>\n<\/ul>\n\n<p>Need lahendused ei v\u00f5imalda saavutada madalaid OEL-e ja <strong>seavad operaatorid ohtu d\u00fcnaamiliste faaside ajal<\/strong> (t\u00fcnni avamine, kaalumine, \u00fclekandmine).<\/p>\n\n<h2 class=\"wp-block-heading\">OberA lahendus: 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\">P\u00fc\u00fcdmine tekkekohas, maksimaalne l\u00e4hedus<\/h3>\n\n\n\n<p>\u00dcks <strong>saastekontrolli<\/strong> p\u00f5hiprintsiipe on tolmu p\u00fc\u00fcdmine kohe selle tekkimisel. EpurBox BRS-i v\u00f5imalus paigutada see v\u00e4ga l\u00e4hedale kaalumispunktile (v\u00f5i lehtrile) piirab resuspensiooni, v\u00e4hendab hajumist t\u00f6\u00f6kojas ja v\u00e4hendab koormust teistele <strong>ventilatsioonis\u00fcsteemidele<\/strong>. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Paindlikkus mitme toote v\u00f5i pilootprojekti jaoks<\/h3>\n\n\n\n<p>Tehastes, kus kasutatakse mitut molekuli v\u00f5i arendus-\/pilootfaasis, v\u00f5ib olla ebapraktiline <strong>paigaldada p\u00fcsis\u00fcsteem<\/strong> igasse kaalumispunkti. EpurBox BRS v\u00f5imaldab kasutamist &#8220;vastavalt vajadusele&#8221;: seda tuuakse, kui toiming on k\u00e4imas, seej\u00e4rel liigutatakse. See piirab <strong>p\u00fcsiinvesteeringuid,<\/strong> suurendab paindlikkust ja v\u00e4hendab riskipiirkondi.  <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">K\u00e4sitsi sekkumiste turvalisus<\/h3>\n\n\n\n<p>K\u00e4sitsi toimingute ajal, nagu t\u00fcnnide avamine, doseerimine v\u00f5i lehtriga \u00fclekandmine, saab EpurBox BRS-i paigutada nii, et see <strong>p\u00fc\u00fcab kinni tolmuvood<\/strong>, mis tekivad nende toimingute ajal, v\u00e4hendades operaatori ajutist kokkupuudet.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">ATEX-i vastavus p\u00f5levtolmuga keskkondades<\/h3>\n\n\n\n<p>ATEX-sertifikaadiga EpurBox BRS sobib klassifitseeritud tsoonidesse (nt tsoon 22 tolmu jaoks). See v\u00f5imaldab <a href=\"https:\/\/obera.fr\/et\/farmaatsiatoostus\/\">farmaatsiatehaste<\/a>, mis <strong>k\u00e4itlevad<\/strong> potentsiaalselt p\u00f5levaid pulbreid (orgaanilised abiained, suhkrud, laktoos jne), kasutada seda ilma ohutustsooni ohtu seadmata. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Lihtne kvalifitseerimine ja kasutamine<\/h3>\n\n\n\n<p>Filtri vahetamise vajaduse korral saab korpuse isoleerida\/r\u00f5hu alt vabastada, piirates heitmeid.<\/p>\n\n\n\n<p>Korpus v\u00f5imaldab <strong>dokumenteerida oma j\u00f5udlust<\/strong> (vooluhulgad, r\u00f5hud, filtreerimise t\u00f5husus) IQ\/OQ\/PQ raames.<\/p>\n\n\n\n<p>R\u00f5huvahe j\u00e4lgimine, h\u00e4ired ja planeeritud hooldus tagavad kontrollitud t\u00f6\u00f6.<\/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=\"epurbox brs visuaal\" 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\">Juurutamise stsenaarium: t\u00fc\u00fcpiline kasutusjuhtum<\/h2>\n\n<h3 class=\"wp-block-heading\">V\u00f5tame konkreetse n\u00e4ite:<\/h3>\n\n<ul class=\"wp-block-list\">\n<li>Farmaatsiatehas peab kaaluma HPAPI-d OEB = 4 (siht-OEL ~ 1 \u03bcg\/m3) pilootlaboris. <\/li>\n\n\n\n<li>EpurBox BRS on paigutatud kaalu k\u00f5rvale, koos k\u00e4e v\u00f5i <strong>imemisotsikuga, mis on suunatud kaalumisalale<\/strong>. <\/li>\n\n\n\n<li>Masin t\u00f6\u00f6tab, pulbrid p\u00e4\u00e4sevad kergelt v\u00e4lja laadimise v\u00f5i \u00fclekandmise ajal: EpurBox imeb kohalikult, suunates filtreeritud \u00f5hu tagasi t\u00f6\u00f6kotta v\u00f5i spetsiaalsesse v\u00e4ljat\u00f5mbesse. <\/li>\n\n\n\n<li>T\u00f6\u00f6 ajal j\u00e4lgitakse r\u00f5huvahet: kui filter ummistub, k\u00e4ivitub vahetamise\/puhastamise hoiatus. <\/li>\n\n\n\n<li>P\u00e4rast kasutamist saab EpurBox-i liigutada teisele liinile v\u00f5i hoiustada ootere\u017eiimis.<\/li>\n<\/ul>\n\n<p>Selle seadmega <strong>v\u00e4ldib t\u00f6\u00f6koda p\u00fcsit\u00f5mbekapide paigaldamist<\/strong> iga t\u00f6\u00f6koha \u00fcmber ja omab t\u00f5husat mobiilset isoleerimisvahendit.<\/p>\n\n<p>Meie toodete avastamiseks ja teie ruumidele sobiva lahenduse leidmiseks v\u00f5tke \u00fchendust meie meeskonnaga. Aitame teil valida <strong>seadmed<\/strong>, mis sobivad k\u00f5ige paremini teie piirangute ja eesm\u00e4rkidega. <\/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\/et\/contact\/\">V\u00f5tke meiega \u00fchendust<\/a><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>HPAPI (v\u00e4ga tugevad aktiivsed farmatseutilised koostisosad) t\u00f5us muudab s\u00fcgavalt farmaatsiatootmise praktikaid.<\/p>\n","protected":false},"author":13,"featured_media":83738,"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":[868],"tags":[869],"class_list":["post-133837","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-farmaatsiatoostus","tag-mobiilsed-pjedestaalid","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\/et\/wp-json\/wp\/v2\/posts\/133837","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/obera.fr\/et\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/obera.fr\/et\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/obera.fr\/et\/wp-json\/wp\/v2\/users\/13"}],"replies":[{"embeddable":true,"href":"https:\/\/obera.fr\/et\/wp-json\/wp\/v2\/comments?post=133837"}],"version-history":[{"count":2,"href":"https:\/\/obera.fr\/et\/wp-json\/wp\/v2\/posts\/133837\/revisions"}],"predecessor-version":[{"id":133841,"href":"https:\/\/obera.fr\/et\/wp-json\/wp\/v2\/posts\/133837\/revisions\/133841"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/obera.fr\/et\/wp-json\/wp\/v2\/media\/83738"}],"wp:attachment":[{"href":"https:\/\/obera.fr\/et\/wp-json\/wp\/v2\/media?parent=133837"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/obera.fr\/et\/wp-json\/wp\/v2\/categories?post=133837"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/obera.fr\/et\/wp-json\/wp\/v2\/tags?post=133837"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}