{"id":134050,"date":"2025-09-30T10:29:13","date_gmt":"2025-09-30T08:29:13","guid":{"rendered":"https:\/\/obera.fr\/nase-rada\/industria-farmaceutica-controlul-pulberilor-si-expunerii-in-timpul-cantaririi-si-transferului-hpapi\/"},"modified":"2025-11-27T21:25:12","modified_gmt":"2025-11-27T19:25:12","slug":"industria-farmaceutica-controlul-pulberilor-si-expunerii-in-timpul-cantaririi-si-transferului-hpapi","status":"publish","type":"post","link":"https:\/\/obera.fr\/ro\/industria-farmaceutica\/industria-farmaceutica-controlul-pulberilor-si-expunerii-in-timpul-cantaririi-si-transferului-hpapi\/","title":{"rendered":"Industria farmaceutic\u0103: Controlul pulberilor \u0219i expunerii \u00een timpul c\u00e2nt\u0103ririi \u0219i transferului HPAPI"},"content":{"rendered":"\n<p>Cre\u0219terea HPAPI (Ingrediente Farmaceutice Active Foarte Puternice) transform\u0103 profund <strong>practicile de produc\u021bie farmaceutic\u0103<\/strong>. Aceste molecule (citotoxice, hormonale, anticanceroase, antivirale) prezint\u0103 o activitate terapeutic\u0103 ridicat\u0103, dar \u0219i un <a href=\"https:\/\/obera.fr\/ro\/sfatul-nostru\/substances-cmr-risque-exposition-au-travail-quelle-reglementation-prevention\/\">risc toxicologic semnificativ<\/a> pentru personal \u0219i mediu.<\/p>\n\n<h2 class=\"wp-block-heading\">Provoc\u0103ri \u0219i probleme pe teren<\/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>Etapele de c\u00e2nt\u0103rire \u0219i transfer al pulberilor sunt deosebit de critice: chiar \u0219i cantit\u0103\u021bi mici pot <strong>genera concentra\u021bii aeriene<\/strong> peste limitele de expunere profesional\u0103 (OEL).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Consecin\u021bele unui control deficitar:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>expunerea operatorilor (patologii respiratorii, efecte sistemice);<\/li>\n\n\n\n<li>contaminarea \u00eencruci\u0219at\u0103 a altor produse sau loturi;<\/li>\n\n\n\n<li>devia\u021bii de calitate, p\u00e2n\u0103 la rechem\u0103ri de loturi;<\/li>\n\n\n\n<li>opriri sau sanc\u021biuni \u00een caz de neconformitate GMP\/EHS.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Auditurile \u00een atelierele de c\u00e2nt\u0103rire HPAPI eviden\u021biaz\u0103:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>remise \u00een suspensie \u00een timpul desc\u0103rc\u0103rii, cernutului sau transferului;<\/li>\n\n\n\n<li>scurgeri la nivelul \u00eembin\u0103rilor, bunc\u0103relor, valvelor \u0219i containerelor;<\/li>\n\n\n\n<li>\u00eentre\u021binere grea (colmatarea filtrelor, cur\u0103\u021barea suprafe\u021belor) care prelunge\u0219te timpii de oprire;<\/li>\n\n\n\n<li>dificult\u0103\u021bi de izolare \u00een timpul schimb\u0103rilor de loturi \u0219i opera\u021biunilor 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 farmaceutic&#x103;\" 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>Mijloacele clasice (ventila\u021bie general\u0103 simpl\u0103 sau captare la distan\u021b\u0103) sunt insuficiente pentru a <strong>asigura men\u021binerea unui nivel de particule<\/strong> conform cu OEL-urile \u021bint\u0103 (&lt; 1 \u03bcg\/m3 sau chiar &lt; 0,1 \u03bcg\/m3 conform OEB).<\/p>\n\n<h2 class=\"wp-block-heading\">Limitele practicilor tradi\u021bionale<\/h2>\n\n<h3 class=\"wp-block-heading\">Unele unit\u0103\u021bi continu\u0103 s\u0103 se bazeze pe:<\/h3>\n\n<ul class=\"wp-block-list\">\n<li>ventila\u021bie prin dilu\u021bie (HVAC) f\u0103r\u0103 captare direct\u0103;<\/li>\n\n\n\n<li>hote deschise sau cabine simple cu filtre colmatate sau prost pozi\u021bionate;<\/li>\n\n\n\n<li>filtre netestate regulat, sau chiar de clas\u0103 inferioar\u0103 H13.<\/li>\n<\/ul>\n\n<p>Aceste solu\u021bii nu permit atingerea OEL-urilor sc\u0103zute \u0219i <strong>expun operatorii \u00een timpul fazelor dinamice<\/strong> (deschiderea butoiului, c\u00e2nt\u0103rirea, transferul).<\/p>\n\n<h2 class=\"wp-block-heading\">Solu\u021bia 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\">Captare la surs\u0103, proximitate maxim\u0103<\/h3>\n\n\n\n<p>Unul dintre principiile de baz\u0103 ale <strong>controlului contamin\u0103rii<\/strong> este captarea prafului imediat la emisie. Faptul c\u0103 EpurBox BRS poate fi pozi\u021bionat foarte aproape de punctul de c\u00e2nt\u0103rire (sau de bunc\u0103r) limiteaz\u0103 remisele \u00een suspensie, reduce dispersia \u00een atelier \u0219i scade sarcina pe celelalte <strong>sisteme de ventila\u021bie<\/strong>. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Flexibilitate pentru utilizare multi-produs sau pilot<\/h3>\n\n\n\n<p>\u00cen site-urile care utilizeaz\u0103 mai multe molecule sau \u00een faza de dezvoltare\/pilot, poate fi nepractic s\u0103 <strong>instalezi un sistem fix<\/strong> pentru fiecare punct de c\u00e2nt\u0103rire. EpurBox BRS permite o utilizare \u201ela cerere\u201d: este adus c\u00e2nd opera\u021biunea este \u00een curs, apoi mutat. Acest lucru limiteaz\u0103 <strong>investi\u021biile fixe,<\/strong> cre\u0219te agilitatea \u0219i reduce zonele de risc.  <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Securizarea interven\u021biilor manuale<\/h3>\n\n\n\n<p>\u00cen timpul sarcinilor manuale, cum ar fi deschiderea butoaielor, dozarea sau transferul prin p\u00e2lnie, EpurBox BRS poate fi plasat astfel \u00eenc\u00e2t s\u0103 <strong>capteze fluxurile de praf<\/strong> emise \u00een timpul acestor manipul\u0103ri, reduc\u00e2nd expunerea punctual\u0103 a operatorului.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Conformitate ATEX \u00een medii cu praf combustibil<\/h3>\n\n\n\n<p>Certificat ATEX, EpurBox BRS este potrivit \u00een zonele clasificate (ex. zona 22 pentru prafuri). Acest lucru permite <a href=\"https:\/\/obera.fr\/ro\/industria-farmaceutica\/\">site-urilor farmaceutice<\/a> care <strong>manipuleaz\u0103 pulberi<\/strong> posibil combustibile (excipienti organici, zaharuri, lactoz\u0103 etc.) s\u0103-l utilizeze f\u0103r\u0103 a compromite zonarea de siguran\u021b\u0103. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Facilitatea de calificare \u0219i exploatare<\/h3>\n\n\n\n<p>\u00cen caz de necesitate de schimbare a filtrului, carcasa poate fi izolat\u0103\/depresurizat\u0103, limit\u00e2nd emisiile.<\/p>\n\n\n\n<p>Carcasa permite <strong>documentarea performan\u021belor sale<\/strong> (debite, presiuni, eficien\u021b\u0103 filtrare) \u00een cadrul IQ\/OQ\/PQ.<\/p>\n\n\n\n<p>Monitorizarea presiunii diferen\u021biale, alarmele \u0219i \u00eentre\u021binerea planificat\u0103 asigur\u0103 o exploatare controlat\u0103.<\/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=\"vizual 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\">Scenariu de implementare: caz de utilizare tipic<\/h2>\n\n<h3 class=\"wp-block-heading\">S\u0103 lu\u0103m un exemplu concret:<\/h3>\n\n<ul class=\"wp-block-list\">\n<li>Un site farmaceutic trebuie s\u0103 c\u00e2nt\u0103reasc\u0103 un HPAPI cu OEB = 4 (\u021bint\u0103 OEL ~ 1 \u03bcg\/m3) \u00eentr-un laborator pilot. <\/li>\n\n\n\n<li>EpurBox BRS este pozi\u021bionat l\u00e2ng\u0103 balan\u021b\u0103, cu un bra\u021b sau o <strong>duz\u0103 de aspira\u021bie \u00eendreptat\u0103 spre zona de c\u00e2nt\u0103rire<\/strong>. <\/li>\n\n\n\n<li>Ma\u0219ina func\u021bioneaz\u0103, pulberile scap\u0103 u\u0219or \u00een timpul depunerii sau transferului: EpurBox aspir\u0103 local, trimi\u021b\u00e2nd aerul filtrat \u00eenapoi \u00een atelier sau c\u0103tre o evacuare dedicat\u0103. <\/li>\n\n\n\n<li>\u00cen timpul opera\u021biunii, presiunea diferen\u021bial\u0103 este monitorizat\u0103: dac\u0103 filtrul se colmateaz\u0103, se declan\u0219eaz\u0103 o alert\u0103 pentru schimbare\/cur\u0103\u021bare. <\/li>\n\n\n\n<li>Dup\u0103 utilizare, EpurBox poate fi mutat pe o alt\u0103 linie sau depozitat \u00een standby.<\/li>\n<\/ul>\n\n<p>Cu acest dispozitiv, <strong>atelierul evit\u0103 instalarea de hote fixe<\/strong> \u00een jurul fiec\u0103rui post \u0219i dispune de un instrument de izolare mobil performant.<\/p>\n\n<p>Pentru a descoperi produsele noastre \u0219i a imagina \u00eempreun\u0103 SOLU\u021aIA adaptat\u0103 spa\u021biilor dumneavoastr\u0103, contacta\u021bi echipele noastre. V\u0103 \u00eenso\u021bim \u00een alegerea <strong>dispozitivelor cele mai potrivite<\/strong> pentru constr\u00e2ngerile \u0219i obiectivele dumneavoastr\u0103. <\/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\/ro\/contact\/\">Contacta\u021bi-ne<\/a><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Cre\u0219terea utiliz\u0103rii HPAPI (Highly Potent Active Pharmaceutical Ingredients \u2013 ingrediente active farmaceutice foarte puternice) transform\u0103 profund practicile de produc\u021bie farmaceutic\u0103.<\/p>\n","protected":false},"author":13,"featured_media":83748,"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":[896],"tags":[897],"class_list":["post-134050","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-industria-farmaceutica","tag-piedestaluri-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\/ro\/wp-json\/wp\/v2\/posts\/134050","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/obera.fr\/ro\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/obera.fr\/ro\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/obera.fr\/ro\/wp-json\/wp\/v2\/users\/13"}],"replies":[{"embeddable":true,"href":"https:\/\/obera.fr\/ro\/wp-json\/wp\/v2\/comments?post=134050"}],"version-history":[{"count":1,"href":"https:\/\/obera.fr\/ro\/wp-json\/wp\/v2\/posts\/134050\/revisions"}],"predecessor-version":[{"id":134053,"href":"https:\/\/obera.fr\/ro\/wp-json\/wp\/v2\/posts\/134050\/revisions\/134053"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/obera.fr\/ro\/wp-json\/wp\/v2\/media\/83748"}],"wp:attachment":[{"href":"https:\/\/obera.fr\/ro\/wp-json\/wp\/v2\/media?parent=134050"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/obera.fr\/ro\/wp-json\/wp\/v2\/categories?post=134050"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/obera.fr\/ro\/wp-json\/wp\/v2\/tags?post=134050"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}