{"id":133850,"date":"2025-09-30T10:29:13","date_gmt":"2025-09-30T08:29:13","guid":{"rendered":"https:\/\/obera.fr\/nase-rada\/industri-farmaceutike-kontrollimi-i-pluhurimit-dhe-ekspozimit-gjate-peshimit-dhe-transferimit-te-hpapi-ve\/"},"modified":"2025-11-21T11:29:40","modified_gmt":"2025-11-21T09:29:40","slug":"industri-farmaceutike-kontrollimi-i-pluhurimit-dhe-ekspozimit-gjate-peshimit-dhe-transferimit-te-hpapi-ve","status":"publish","type":"post","link":"https:\/\/obera.fr\/sq\/industria-farmaceutike\/industri-farmaceutike-kontrollimi-i-pluhurimit-dhe-ekspozimit-gjate-peshimit-dhe-transferimit-te-hpapi-ve\/","title":{"rendered":"Industri farmaceutike: Kontrollimi i pluhurimit dhe ekspozimit gjat\u00eb peshimit dhe transferimit t\u00eb HPAPI-ve"},"content":{"rendered":"\n<p>Rritja e HPAPI-ve (Highly Potent Active Pharmaceutical Ingredients \u2013 p\u00ebrb\u00ebr\u00ebs farmaceutik\u00eb aktiv\u00eb shum\u00eb t\u00eb fuqish\u00ebm) transformon thell\u00ebsisht <strong>praktikat e prodhimit farmaceutik<\/strong>. K\u00ebto molekula (citotoksike, hormonale, antikanceroze, antivirale) paraqesin nj\u00eb aktivitet terapeutik t\u00eb lart\u00eb, por edhe nj\u00eb <a href=\"https:\/\/obera.fr\/sq\/keshilla-jone-sq\/substances-cmr-risque-exposition-au-travail-quelle-reglementation-prevention\/\">rrezik t\u00eb r\u00ebnd\u00ebsish\u00ebm toksikologjik<\/a> p\u00ebr personelin dhe mjedisin.<\/p>\n\n<h2 class=\"wp-block-heading\">Sfidat dhe problematikat n\u00eb terren<\/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>Fazat e peshimit dhe transferimit t\u00eb pluhurave jan\u00eb ve\u00e7an\u00ebrisht kritike: edhe sasi t\u00eb vogla mund t\u00eb <strong>gjenerojn\u00eb p\u00ebrqendrime ajrore<\/strong> p\u00ebrtej kufijve t\u00eb ekspozimit profesional (OEL).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Pasojat e nj\u00eb kontrolli t\u00eb dob\u00ebt:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ekspozimi i operator\u00ebve (patologji respiratore, efekte sistemike);<\/li>\n\n\n\n<li>kontaminim i kryq\u00ebzuar i produkteve ose loteve t\u00eb tjera;<\/li>\n\n\n\n<li>devijime t\u00eb cil\u00ebsis\u00eb, deri n\u00eb t\u00ebrheqje t\u00eb loteve;<\/li>\n\n\n\n<li>nd\u00ebrprerje ose sanksione n\u00eb rast mos-konformiteti me GMP\/EHS.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Auditimet n\u00eb pun\u00ebtorit\u00eb e peshimit t\u00eb HPAPI-ve nxjerrin n\u00eb pah:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>rishp\u00ebrndarje gjat\u00eb shkarkimit, sitjes ose transferimit;<\/li>\n\n\n\n<li>rrjedhje n\u00eb nivelin e guarnicioneve, hinkave, valvulave dhe kontejner\u00ebve;<\/li>\n\n\n\n<li>mir\u00ebmbajtje e r\u00ebnd\u00eb (bllokim filtrash, pastrim sip\u00ebrfaqesh) q\u00eb zgjat koh\u00ebn e nd\u00ebrprerjes;<\/li>\n\n\n\n<li>v\u00ebshtir\u00ebsi n\u00eb izolim gjat\u00eb ndryshimeve t\u00eb loteve dhe operacioneve manuale.<\/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=\"industria farmaceutike\" 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>Mjetet klasike (ventilim i thjesht\u00eb i p\u00ebrgjithsh\u00ebm ose kapje n\u00eb distanc\u00eb) jan\u00eb t\u00eb pamjaftueshme p\u00ebr t\u00eb <strong>garantuar mbajtjen e nj\u00eb niveli grimcash <\/strong>n\u00eb p\u00ebrputhje me OEL-t\u00eb e synuara (&lt; 1 \u03bcg\/m3 ose &lt; 0,1 \u03bcg\/m3 sipas OEB).<\/p>\n\n<h2 class=\"wp-block-heading\">Kufizimet e praktikave tradicionale<\/h2>\n\n<h3 class=\"wp-block-heading\">Disa nj\u00ebsi vazhdojn\u00eb t\u00eb mb\u00ebshteten n\u00eb:<\/h3>\n\n<ul class=\"wp-block-list\">\n<li>ventilim me hollim (HVAC) pa kapje direkte;<\/li>\n\n\n\n<li>kabineta t\u00eb hapura ose kabina t\u00eb thjeshta me filtra t\u00eb bllokuar ose t\u00eb pozicionuar gabim;<\/li>\n\n\n\n<li>filtra t\u00eb patestuar rregullisht, madje edhe t\u00eb klas\u00ebs m\u00eb t\u00eb ul\u00ebt se H13.<\/li>\n<\/ul>\n\n<p>K\u00ebto zgjidhje nuk lejojn\u00eb arritjen e OEL-ve t\u00eb ul\u00ebta, dhe <strong>ekspozojn\u00eb operator\u00ebt gjat\u00eb fazave dinamike<\/strong> (hapje fu\u00e7ie, peshim, transferim).<\/p>\n\n<h2 class=\"wp-block-heading\">Zgjidhja 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\">Kapje n\u00eb burim, af\u00ebrsi maksimale<\/h3>\n\n\n\n<p>Nj\u00eb nga parimet baz\u00eb t\u00eb <strong>kontrollit t\u00eb kontaminimit <\/strong>\u00ebsht\u00eb kapja e pluhurave q\u00eb n\u00eb momentin e emetimit t\u00eb tyre. Fakti q\u00eb EpurBox BRS mund t\u00eb pozicionohet shum\u00eb af\u00ebr pik\u00ebs s\u00eb peshimit (ose hink\u00ebs) kufizon rishp\u00ebrndarjen, zvog\u00eblon shp\u00ebrndarjen n\u00eb punishte, dhe zvog\u00eblon ngarkes\u00ebn n\u00eb <strong>sistemet e tjera t\u00eb ventilimit<\/strong>. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Fleksibilitet p\u00ebr p\u00ebrdorim me shum\u00eb produkte ose pilot<\/h3>\n\n\n\n<p>N\u00eb vendet q\u00eb p\u00ebrdorin disa molekula ose jan\u00eb n\u00eb faz\u00eb zhvillimi \/ pilot, mund t\u00eb jet\u00eb e papraktikueshme t\u00eb <strong>instalohet nj\u00eb sistem fiks<\/strong> p\u00ebr \u00e7do pik\u00eb peshimi. EpurBox BRS lejon nj\u00eb p\u00ebrdorim \u201csipas k\u00ebrkes\u00ebs\u201d: e sjellim kur operacioni \u00ebsht\u00eb n\u00eb zhvillim, pastaj e zhvendosim. Kjo kufizon <strong>investimet fikse,<\/strong> rrit shkatht\u00ebsin\u00eb dhe zvog\u00eblon zonat e rrezikut.  <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Sigurimi i nd\u00ebrhyrjeve manuale<\/h3>\n\n\n\n<p>Gjat\u00eb detyrave manuale si hapja e fu\u00e7ive, dozimi ose transferimi me hink\u00eb, EpurBox BRS mund t\u00eb vendoset n\u00eb m\u00ebnyr\u00eb q\u00eb t\u00eb <strong>kap\u00eb flukset e pluhurave<\/strong> t\u00eb emetuara gjat\u00eb k\u00ebtyre manipulimeve, duke reduktuar ekspozimin e p\u00ebrkohsh\u00ebm t\u00eb operatorit.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Konformitet ATEX n\u00eb mjedise me pluhura t\u00eb djegsh\u00ebm<\/h3>\n\n\n\n<p>Certifikuar ATEX, EpurBox BRS \u00ebsht\u00eb i p\u00ebrshtatsh\u00ebm n\u00eb zonat e klasifikuara (p.sh. zona 22 p\u00ebr pluhurat). Kjo u mund\u00ebson <a href=\"https:\/\/obera.fr\/sq\/industria-farmaceutike\/\">vendeve farmaceutike<\/a> q\u00eb <strong>manipulojn\u00eb pluhura<\/strong> potencialisht t\u00eb djegsh\u00ebm (ekscipient\u00eb organik\u00eb, sheqerna, laktoz\u00eb, etj.) ta p\u00ebrdorin at\u00eb pa kompromentuar zonimin e tyre t\u00eb siguris\u00eb. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Leht\u00ebsi kualifikimi dhe shfryt\u00ebzimi<\/h3>\n\n\n\n<p>N\u00eb rast nevoje p\u00ebr ndryshim filtri, kutia mund t\u00eb izolohet \/ de-presurizohet, duke kufizuar shkarkimet.<\/p>\n\n\n\n<p>Kutia lejon t\u00eb <strong>dokumentoj\u00eb performancat e saj <\/strong>(rrjedhat, presionet, efikasitetin e filtrimit) n\u00eb kuad\u00ebr t\u00eb IQ\/OQ\/PQ.<\/p>\n\n\n\n<p>Monitorimi i presionit diferencial, alarmet dhe mir\u00ebmbajtja e planifikuar sigurojn\u00eb nj\u00eb shfryt\u00ebzim t\u00eb kontrolluar.<\/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=\"pamje 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\">Skenari i implementimit: rast p\u00ebrdorimi tipik<\/h2>\n\n<h3 class=\"wp-block-heading\">Le t\u00eb marrim nj\u00eb shembull konkret:<\/h3>\n\n<ul class=\"wp-block-list\">\n<li>Nj\u00eb vend farmaceutik duhet t\u00eb peshoj\u00eb nj\u00eb HPAPI me OEB = 4 (OEL i synuar ~ 1 \u03bcg\/m3) n\u00eb nj\u00eb laborator pilot. <\/li>\n\n\n\n<li>EpurBox BRS pozicionohet pran\u00eb peshores, me nj\u00eb krah ose nj\u00eb <strong>gryk\u00eb thith\u00ebse t\u00eb drejtuar drejt zon\u00ebs s\u00eb peshimit<\/strong>. <\/li>\n\n\n\n<li>Makina funksionon, pluhurat shp\u00ebtojn\u00eb leht\u00ebsisht gjat\u00eb depozitimit ose transferimit: EpurBox thith lokalisht, duke kthyer ajrin e filtruar drejt punishtes ose drejt nj\u00eb evakuimi t\u00eb dedikuar. <\/li>\n\n\n\n<li>Gjat\u00eb operacionit, presioni diferencial monitorohet: n\u00ebse filtri bllokohet, nj\u00eb alarm aktivizohet p\u00ebr ndryshim \/ pastrim. <\/li>\n\n\n\n<li>Pas p\u00ebrdorimit, EpurBox mund t\u00eb zhvendoset n\u00eb nj\u00eb linj\u00eb tjet\u00ebr ose t\u00eb ruhet n\u00eb gatishm\u00ebri.<\/li>\n<\/ul>\n\n<p>Me k\u00ebt\u00eb pajisje, <strong>punishtja shmang instalimin e kabinetave fikse<\/strong> rreth \u00e7do posti, dhe disponon nj\u00eb mjet izolimi mobil performant.<\/p>\n\n<p>P\u00ebr t\u00eb zbuluar produktet tona dhe p\u00ebr t\u00eb imagjinuar s\u00eb bashku ZGJIDHJEN e p\u00ebrshtatshme p\u00ebr hap\u00ebsirat tuaja, kontaktoni ekipet tona. Ne ju shoq\u00ebrojm\u00eb n\u00eb zgjedhjen e <strong>pajisjeve m\u00eb t\u00eb p\u00ebrshtatshme<\/strong> p\u00ebr kufizimet dhe objektivat tuaja. <\/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\/sq\/contact\/\">Na kontaktoni<\/a><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>P\u00ebrhapja e HPAPI-ve (Highly Potent Active Pharmaceutical Ingredients \u2013 P\u00ebrb\u00ebr\u00ebs Farmaceutik\u00eb Aktiv\u00eb Shum\u00eb Potent\u00eb) transformon thell\u00ebsisht praktikat e prodhimit farmaceutik.<\/p>\n","protected":false},"author":13,"featured_media":83732,"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":[874],"tags":[875],"class_list":["post-133850","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-industria-farmaceutike","tag-kutite-mobile","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\/sq\/wp-json\/wp\/v2\/posts\/133850","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/obera.fr\/sq\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/obera.fr\/sq\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/obera.fr\/sq\/wp-json\/wp\/v2\/users\/13"}],"replies":[{"embeddable":true,"href":"https:\/\/obera.fr\/sq\/wp-json\/wp\/v2\/comments?post=133850"}],"version-history":[{"count":2,"href":"https:\/\/obera.fr\/sq\/wp-json\/wp\/v2\/posts\/133850\/revisions"}],"predecessor-version":[{"id":133852,"href":"https:\/\/obera.fr\/sq\/wp-json\/wp\/v2\/posts\/133850\/revisions\/133852"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/obera.fr\/sq\/wp-json\/wp\/v2\/media\/83732"}],"wp:attachment":[{"href":"https:\/\/obera.fr\/sq\/wp-json\/wp\/v2\/media?parent=133850"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/obera.fr\/sq\/wp-json\/wp\/v2\/categories?post=133850"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/obera.fr\/sq\/wp-json\/wp\/v2\/tags?post=133850"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}