{"id":10293,"date":"2026-04-20T17:05:13","date_gmt":"2026-04-20T09:05:13","guid":{"rendered":"https:\/\/www.packqc.com\/?post_type=standard&#038;p=10293"},"modified":"2026-04-20T17:08:43","modified_gmt":"2026-04-20T09:08:43","slug":"iso-9187","status":"publish","type":"standard","link":"https:\/\/www.packqc.com\/ro\/standard\/iso-9187\/","title":{"rendered":"ISO 9187"},"content":{"rendered":"<h2 class=\"wp-block-heading\">\u00cen\u021belegerea ISO 9187 \u00een ambalarea produselor farmaceutice<\/h2>\n\n\n\n<p><strong>ISO 9187<\/strong> define\u0219te cerin\u021bele critice de performan\u021b\u0103 pentru fiolele de sticl\u0103 utilizate \u00een produsele farmaceutice injectabile. Aceasta se concentreaz\u0103 pe asigurarea <strong>durabilitate chimic\u0103, fiabilitate mecanic\u0103 \u0219i siguran\u021ba utilizatorului<\/strong> \u00een timpul deschiderii \u0219i administr\u0103rii medicamentelor.<\/p>\n\n\n\n<p>Produc\u0103torii \u0219i echipele de control al calit\u0103\u021bii se bazeaz\u0103 pe ISO 9187 pentru a standardiza procedurile de testare, a reduce variabilitatea \u0219i a garanta performan\u021ba constant\u0103 a produselor. Standardul se aliniaz\u0103 \u00eendeaproape cu alte cadre precum ISO 4802 \u0219i ISO 7500-1, form\u00e2nd un ecosistem robust de conformitate.<\/p>\n\n\n\n<p>Domeniile cheie de testare includ:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Rezisten\u021ba hidrolitic\u0103 a suprafe\u021belor de sticl\u0103<\/strong><\/li>\n\n\n\n<li><strong>Calitatea recoacerii \u0219i controlul tensiunilor reziduale<\/strong><\/li>\n\n\n\n<li><strong>For\u021ba de rupere \u0219i comportamentul la fractur\u0103<\/strong><\/li>\n<\/ul>\n\n\n\n<p>Ace\u0219ti parametri afecteaz\u0103 \u00een mod direct stabilitatea medicamentelor \u0219i siguran\u021ba pacien\u021bilor, f\u0103c\u00e2nd ca conformitatea s\u0103 nu fie negociabil\u0103 \u00een industriile reglementate.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">ISO 9187-1:2010 Cerin\u021be pentru testarea fiolelor de sticl\u0103<\/h2>\n\n\n\n<p>Prima parte a ISO 9187 stabile\u0219te cerin\u021be generale pentru fiolele pentru produse injectabile, concentr\u00e2ndu-se pe integritatea performan\u021bei.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Cerin\u021be tehnice esen\u021biale<\/h3>\n\n\n\n<p><strong>Rezisten\u021b\u0103 hidrolitic\u0103<\/strong><br>Ampulele trebuie s\u0103 \u00eendeplineasc\u0103 <strong>Cerin\u021be pentru clasa HC1<\/strong> atunci c\u00e2nd sunt testate conform protocoalelor ISO 4802. Acest lucru asigur\u0103 o eliberare minim\u0103 de alcali de pe suprafa\u021ba intern\u0103, protej\u00e2nd formul\u0103rile de medicamente.<\/p>\n\n\n\n<p><strong>Calitatea recoacerii<\/strong><br>Tensiunea rezidual\u0103 trebuie s\u0103 r\u0103m\u00e2n\u0103 sub <strong>50 nm\/mm \u00eent\u00e2rziere optic\u0103<\/strong>, prevenind ruperea spontan\u0103 sau instabilitatea structural\u0103.<\/p>\n\n\n\n<p><strong>For\u021ba de rupere<\/strong><br>Fiola trebuie s\u0103 se rup\u0103 \u00eentr-un interval de for\u021b\u0103 definit, asigur\u00e2nd:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Deschidere manual\u0103 sigur\u0103<\/li>\n\n\n\n<li>Fractur\u0103 curat\u0103 f\u0103r\u0103 fragmente de sticl\u0103<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Principiul de testare<\/h3>\n\n\n\n<p>Testul for\u021bei de rupere a fiolei determin\u0103 for\u021ba necesar\u0103 pentru a separa tija de corp. Configura\u021bia testului necesit\u0103:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>O ma\u0219in\u0103 de testare la trac\u021biune conform\u0103 cu ISO 7500-1<\/li>\n\n\n\n<li>Vitez\u0103 controlat\u0103 (de obicei <strong>10 mm\/min<\/strong>)<\/li>\n\n\n\n<li>M\u0103surarea for\u021bei p\u00e2n\u0103 la <strong>200 N<\/strong><\/li>\n<\/ul>\n\n\n\n<p>For\u021ba este aplicat\u0103 perpendicular pe axa fiolei pentru a simula condi\u021biile reale de deschidere.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">ISO 9187-2:2010 \u0219i fiole One-Point-Cut<\/h2>\n\n\n\n<p>ISO 9187-2 extinde cerin\u021bele la <strong>Fiole OPC (cu t\u0103iere \u00eentr-un singur punct)<\/strong>, care prezint\u0103 un punct de rupere predefinit.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Criterii de performan\u021b\u0103 suplimentare<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Precizia pozi\u021bion\u0103rii punctului de rupere (\u00b11 mm)<\/strong><\/li>\n\n\n\n<li><strong>Stabilitate termic\u0103 \u00een timpul steriliz\u0103rii (expunere la 120\u00b0C)<\/strong><\/li>\n\n\n\n<li><strong>Rezisten\u021b\u0103 la procesele de cur\u0103\u021bare \u0219i manipulare<\/strong><\/li>\n<\/ul>\n\n\n\n<p>Aceste criterii asigur\u0103 o rezisten\u021b\u0103 constant\u0103 la rupere \u0219i previn defectarea accidental\u0103 \u00een timpul logisticii sau utiliz\u0103rii.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Prezentare general\u0103 a metodelor de testare a fiolelor de sticl\u0103<\/h2>\n\n\n\n<p>Eficace <strong>testarea fiolelor de sticl\u0103<\/strong> combin\u0103 analiza mecanic\u0103 \u0219i chimic\u0103 pentru a valida conformitatea.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Metode de testare de baz\u0103<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Testarea rezisten\u021bei hidrolitice<\/strong> (durabilitate chimic\u0103)<\/li>\n\n\n\n<li><strong>Testul for\u021bei de rupere a fiolei<\/strong> (rezisten\u021b\u0103 mecanic\u0103)<\/li>\n\n\n\n<li><strong>Analiza vizual\u0103 \u0219i de stres<\/strong> (calitatea recoacerii)<\/li>\n<\/ul>\n\n\n\n<p>Fiecare metod\u0103 contribuie la o evaluare complet\u0103 a performan\u021bei fiolelor.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Test de for\u021b\u0103 de rupere a fiolei \u0219i test de flexie \u00een 3 puncte<\/h2>\n\n\n\n<p>The <strong>testul for\u021bei de rupere a fiolei<\/strong> r\u0103m\u00e2ne metoda principal\u0103 definit\u0103 \u00een ISO 9187. Aceasta evalueaz\u0103 simultan capacitatea de utilizare \u0219i siguran\u021ba.<\/p>\n\n\n\n<p>\u00cen unele scenarii de cercetare \u0219i dezvoltare, o <strong>Test de flexiune \u00een 3 puncte<\/strong> ofer\u0103 informa\u021bii suplimentare privind distribu\u021bia rezisten\u021bei sticlei \u0219i mecanica fracturii. De\u0219i nu este obligatorie \u00een ISO 9187, aceasta sus\u021bine:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Optimizarea materialelor<\/li>\n\n\n\n<li>Analiza defec\u021biunilor<\/li>\n\n\n\n<li>Studii comparative \u00eentre tipurile de sticl\u0103<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">De ce este important\u0103 for\u021ba de rupere<\/h3>\n\n\n\n<p><strong>For\u021b\u0103 prea mare:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Deschidere dificil\u0103<\/li>\n\n\n\n<li>Risc de r\u0103nire a utilizatorului<\/li>\n<\/ul>\n\n\n\n<p><strong>For\u021b\u0103 prea mic\u0103:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Rupere prematur\u0103<\/li>\n\n\n\n<li>Avarii de transport<\/li>\n<\/ul>\n\n\n\n<p>O gam\u0103 controlat\u0103 asigur\u0103 o performan\u021b\u0103 optim\u0103.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Echipament recomandat<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.packqc.com\/ro\/products\/bst-01-glass-ampoule-break-force-tester\/\" data-type=\"products\" data-id=\"9545\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Tester de for\u021b\u0103 de rupere cu fiole BST-01<\/strong><br><\/a>Ofer\u0103 m\u0103sur\u0103tori precise \u0219i repetabile ale for\u021bei de rupere cu control programabil al vitezei \u0219i protec\u021bie de siguran\u021b\u0103. Ideal pentru testarea conformit\u0103\u021bii ISO 9187 \u00een laboratoarele QC \u0219i liniile de produc\u021bie.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Test de rezisten\u021b\u0103 hidrolitic\u0103 a fiolelor \u0219i siguran\u021ba materialelor<\/h2>\n\n\n\n<p>The <strong>test de rezisten\u021b\u0103 hidrolitic\u0103 a fiolei<\/strong> evalueaz\u0103 durabilitatea chimic\u0103 a sticlei \u00een condi\u021bii apoase.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Principiul de testare<\/h3>\n\n\n\n<p>Probele de sticl\u0103 sunt zdrobite \u00een particule de dimensiuni controlate \u0219i expuse la ap\u0103 purificat\u0103. Solu\u021bia extras\u0103 este analizat\u0103 pentru con\u021binutul de alcalii.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Importan\u021b\u0103<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Previne <strong>Modific\u0103ri ale pH-ului \u00een formul\u0103rile de medicamente<\/strong><\/li>\n\n\n\n<li>Asigur\u0103 pe termen lung <strong>stabilitate chimic\u0103<\/strong><\/li>\n\n\n\n<li>\u00cendepline\u0219te cerin\u021bele pharmacopeial \u0219i ISO<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Echipament recomandat<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.packqc.com\/ro\/products\/sale-glass-grain-hydrolytic-resistance-tester\/\" target=\"_blank\" data-type=\"products\" data-id=\"9565\" rel=\"noreferrer noopener\"><strong>GHR-01A Tester de rezisten\u021b\u0103 hidrolitic\u0103 pentru cereale de sticl\u0103<\/strong><br><\/a>Automatizeaz\u0103 zdrobirea \u0219i cernerea, asigur\u00e2nd o preg\u0103tire consecvent\u0103 a probelor \u0219i \u00eembun\u0103t\u0103\u021bind repetabilitatea testelor, sporind \u00een acela\u0219i timp siguran\u021ba operatorului.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Implementare practic\u0103 pentru controlul calit\u0103\u021bii<\/h2>\n\n\n\n<p>Pentru a implementa pe deplin ISO 9187, laboratoarele ar trebui:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Utilizare <strong>sisteme calibrate de testare la trac\u021biune<\/strong><\/li>\n\n\n\n<li>Men\u021bine\u021bi <strong>condi\u021bii de mediu controlate (20 \u00b1 5\u00b0C)<\/strong><\/li>\n\n\n\n<li>Urma\u021bi <strong>metode statistice de e\u0219antionare (ISO 2859-1)<\/strong><\/li>\n\n\n\n<li>Documenta\u021bi toate rezultatele pentru trasabilitate<\/li>\n<\/ul>\n\n\n\n<p><strong>Coeren\u021ba procedurilor de testare are un impact direct asupra conformit\u0103\u021bii \u0219i preg\u0103tirii pentru audit.<\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u00centreb\u0103ri frecvente<\/h2>\n\n\n\n<p><strong>1. Pentru ce este utilizat \u00een principal ISO 9187?<\/strong><br>Acesta define\u0219te cerin\u021bele de testare \u0219i calitate pentru fiolele de sticl\u0103 utilizate \u00een produsele farmaceutice injectabile.<\/p>\n\n\n\n<p><strong>2. De ce este important\u0103 rezisten\u021ba hidrolitic\u0103?<\/strong><br>Se asigur\u0103 c\u0103 sticla nu elibereaz\u0103 substan\u021be nocive care ar putea modifica compozi\u021bia medicamentului.<\/p>\n\n\n\n<p><strong>3. Cum se m\u0103soar\u0103 for\u021ba de rupere a fiolei?<\/strong><br>Folosind o ma\u0219in\u0103 de testare la trac\u021biune care aplic\u0103 o for\u021b\u0103 controlat\u0103 p\u00e2n\u0103 c\u00e2nd fiola se sparge.<\/p>\n\n\n\n<p><strong>4. Care este diferen\u021ba dintre <a href=\"https:\/\/www.iso.org\/standard\/55920.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">ISO 9187-1<\/a> \u015fi <a href=\"https:\/\/www.iso.org\/standard\/55921.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">ISO 9187-2<\/a>?<\/strong><br>Partea 1 acoper\u0103 fiolele generale, \u00een timp ce partea 2 se concentreaz\u0103 pe fiolele OPC cu puncte de rupere predefinite.<\/p>\n\n\n\n<p><strong>5. Poate echipamentul automatizat s\u0103 \u00eembun\u0103t\u0103\u021beasc\u0103 conformitatea?<\/strong><br>Da, sistemele precum BST-01 \u0219i GHR-01A \u00eembun\u0103t\u0103\u021besc repetabilitatea, precizia \u0219i eficien\u021ba testelor.<\/p>","protected":false},"excerpt":{"rendered":"<p>ISO 9187 stabile\u0219te cerin\u021be standardizate pentru fiolele de sticl\u0103, concentr\u00e2ndu-se pe rezisten\u021ba hidrolitic\u0103, calitatea recoacerii \u0219i for\u021ba de rupere.<\/p>","protected":false},"featured_media":10294,"parent":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}}},"standard-category":[612],"class_list":["post-10293","standard","type-standard","status-publish","has-post-thumbnail","hentry","standard-category-iso"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/standard\/10293","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/standard"}],"about":[{"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/types\/standard"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/media\/10294"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/media?parent=10293"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/standard-category?post=10293"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}