{"id":9857,"date":"2026-02-24T15:11:45","date_gmt":"2026-02-24T07:11:45","guid":{"rendered":"https:\/\/www.packqc.com\/standard\/astm-f2338-2\/"},"modified":"2026-04-16T09:53:23","modified_gmt":"2026-04-16T01:53:23","slug":"astm-f2338","status":"publish","type":"standard","link":"https:\/\/www.packqc.com\/ro\/standard\/astm-f2338\/","title":{"rendered":"ASTM F2338"},"content":{"rendered":"<p>Importan\u021ba ASTM F2338 \u00een calitatea ambalajelor<\/p>\n\n\n\n<p>Ambalajul serve\u0219te drept prima barier\u0103 \u00eempotriva contamin\u0103rii. Chiar \u0219i scurgeri microscopice \u00een sigilii sau materiale pot permite p\u0103trunderea oxigenului, umidit\u0103\u021bii sau microorganismelor. Pentru produsele farmaceutice, o singur\u0103 scurgere nedetectat\u0103 poate compromite siguran\u021ba pacientului. ASTM F2338 abordeaz\u0103 aceast\u0103 problem\u0103 prin oferirea unei <strong data-start=\"1180\" data-end=\"1237\">metod\u0103 de testare validat\u0103, nedistructiv\u0103 \u0219i repetabil\u0103<\/strong> care merge dincolo de metodele distructive tradi\u021bionale, cum ar fi p\u0103trunderea colorantului sau emisia de bule.<\/p>\n\n\n\n<p>Acest standard este deosebit de valoros pentru <strong data-start=\"1370\" data-end=\"1411\">detectarea scurgerilor de ambalaje farmaceutice<\/strong>, unde organismele de reglementare subliniaz\u0103 necesitatea unor metode precise, neinvazive, care s\u0103 p\u0103streze probele testate pentru utilizare sau distribu\u021bie ulterioar\u0103.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Cum func\u021bioneaz\u0103 metoda descompunerii \u00een vid<\/h2>\n\n\n\n<p>Metoda ASTM F2338 se bazeaz\u0103 pe precizie <strong data-start=\"1642\" data-end=\"1690\">monitorizarea presiunii \u00eentr-o camer\u0103 de testare etan\u0219\u0103<\/strong>. Iat\u0103 procesul \u00een termeni simpli:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Pachetul este plasat \u00eentr-o camer\u0103 de testare rigid\u0103.<\/li>\n\n\n\n<li>Se aplic\u0103 un vid, iar camera este izolat\u0103 de surs\u0103.<\/li>\n\n\n\n<li>Traductoarele de presiune de \u00eenalt\u0103 rezolu\u021bie m\u0103soar\u0103 orice cre\u0219tere a presiunii \u00een timp.<\/li>\n\n\n\n<li>O cre\u0219tere a presiunii indic\u0103 o scurgere de gaz din ambalaj.<\/li>\n<\/ul>\n\n\n\n<p>Spre deosebire de inspec\u021bia vizual\u0103 sau testarea cu vopsea, metoda de descompunere \u00een vid este <strong data-start=\"2085\" data-end=\"2169\">cantitative, sensibile \u0219i nu necesit\u0103 modificarea sau distrugerea ambalajului<\/strong>. Cu sisteme calibrate corespunz\u0103tor, acesta poate detecta scurgeri de p\u00e2n\u0103 la doar c\u00e2\u021biva microni \u00een dimensiune.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Aplica\u021bii ale detect\u0103rii nedistructive a scurgerilor<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Detectarea scurgerilor de ambalaje farmaceutice<\/h3>\n\n\n\n<p>\u00cen ambalaje farmaceutice sterile, cum ar fi fiole, seringi sau blistere, ASTM F2338 asigur\u0103 <strong data-start=\"2473\" data-end=\"2510\">integritatea \u00eenchiderii recipientului (CCI)<\/strong>. Prin prevenirea p\u0103trunderii microbilor d\u0103un\u0103tori, metoda joac\u0103 un rol esen\u021bial \u00een respectarea reglement\u0103rilor.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Testarea integrit\u0103\u021bii ambalajelor pentru alimente \u0219i b\u0103uturi<\/h3>\n\n\n\n<p>Pentru alimentele ambalate \u00een vid, pungi flexibile sau t\u0103vi cu capac, asigurarea unei etan\u0219eit\u0103\u021bi ermetice este esen\u021bial\u0103 pentru siguran\u021ba produsului \u0219i prelungirea duratei de valabilitate. ASTM F2338 ofer\u0103 o modalitate eficient\u0103 de testare f\u0103r\u0103 a risipi produsul.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Ambalare Dispozitive Medicale<\/h3>\n\n\n\n<p>T\u0103vile medicale, pungile \u0219i ambalajele cu barier\u0103 trebuie s\u0103 r\u0103m\u00e2n\u0103 intacte p\u00e2n\u0103 la punctul de utilizare. Detectarea nedistructiv\u0103 a scurgerilor asigur\u0103 conformitatea acestor ambalaje cu standardele stricte de calitate.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Avantajele ASTM F2338 fa\u021b\u0103 de alte metode<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"3152\" data-end=\"3170\">Nondestructiv<\/strong> - E\u0219antioanele r\u0103m\u00e2n intacte \u0219i pot fi returnate la produc\u021bie.<\/li>\n\n\n\n<li><strong data-start=\"3234\" data-end=\"3254\">Extrem de sensibil<\/strong> - Detecteaz\u0103 scurgeri mai mici dec\u00e2t pot identifica metodele vizuale.<\/li>\n\n\n\n<li><strong data-start=\"3317\" data-end=\"3341\">Rezultate cantitative<\/strong> - Ofer\u0103 date m\u0103surabile mai degrab\u0103 dec\u00e2t o confirmare vizual\u0103 subiectiv\u0103.<\/li>\n\n\n\n<li><strong data-start=\"3417\" data-end=\"3442\">Acceptarea reglement\u0103rilor<\/strong> - Recunoscut pe scar\u0103 larg\u0103 de industria farmaceutic\u0103 \u0219i a dispozitivelor medicale.<\/li>\n\n\n\n<li><strong data-start=\"3520\" data-end=\"3538\">Cost-eficient<\/strong> - Elimin\u0103 risipa de material din testele distructive.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Alegerea echipamentului potrivit pentru testarea ASTM F2338<\/h2>\n\n\n\n<p>Pentru a pune \u00een aplicare <a href=\"https:\/\/www.astm.org\/f2338-09r20.html\" target=\"_blank\" rel=\"noopener nofollow\">ASTM F2338<\/a> \u00een mod eficient, sunt necesare instrumente de precizie. Caracteristicile <strong data-start=\"3731\" data-end=\"3781\">MLT-01 <a href=\"https:\/\/www.packqc.com\/ro\/products\/mlt-01-vacuum-decay-leak-test-equipment\/\" target=\"_blank\" rel=\"noreferrer noopener\">Micro tester de scurgeri<\/a> de la Cell Instruments<\/strong> este conceput special pentru <strong data-start=\"3811\" data-end=\"3835\">teste de descompunere \u00een vid<\/strong>. Cu senzorii s\u0103i de \u00eenalt\u0103 sensibilitate, dimensiunile camerelor personalizabile \u0219i sistemul de control PLC u\u0219or de utilizat, MLT-01 ofer\u0103 rezultate fiabile pentru o gam\u0103 larg\u0103 de tipuri de ambalaje.<\/p>\n\n\n\n<p>Societ\u0103\u021bi angajate \u00een <strong data-start=\"4034\" data-end=\"4111\">detectarea scurgerilor din ambalajele farmaceutice sau testarea integrit\u0103\u021bii ambalajelor alimentare<\/strong> vor beneficia de capacitatea instrumentului de a detecta scurgeri minuscule, men\u021bin\u00e2nd \u00een acela\u0219i timp productivitatea. Prin integrarea unor astfel de echipamente avansate, produc\u0103torii consolideaz\u0103 asigurarea calit\u0103\u021bii \u0219i conformitatea cu standardele interna\u021bionale.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Contacta\u021bi-ne Ob\u021bine\u021bi solu\u021bia de testare ASTM F2338 <\/h2>\n\n\n\n<p><a href=\"https:\/\/store.astm.org\/f2338-24.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">ASTM F2338<\/a> ofer\u0103 o abordare fiabil\u0103, validat\u0103 pentru <strong data-start=\"4897\" data-end=\"4931\">detectarea nedistructiv\u0103 a scurgerilor<\/strong> pentru ambalare. Prin utilizarea metodei de descompunere \u00een vid, produc\u0103torii se asigur\u0103 c\u0103 <strong data-start=\"5007\" data-end=\"5053\">ambalaje farmaceutice, medicale \u0219i alimentare<\/strong> s\u0103 r\u0103m\u00e2n\u0103 sigure \u0219i intacte pe tot parcursul ciclului lor de via\u021b\u0103. Cu solu\u021bii avansate, cum ar fi <strong data-start=\"5141\" data-end=\"5186\">Cell Instruments MLT-01 Micro Tester de scurgere<\/strong>, companiile pot ob\u021bine informa\u021bii coerente, sensibile \u0219i eficiente <strong data-start=\"5247\" data-end=\"5278\">testarea integrit\u0103\u021bii ambalajului<\/strong> \u00een conformitate cu standardele globale de calitate.<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Importan\u021ba ASTM F2338 \u00een calitatea ambalajelor Ambalajele servesc drept prima barier\u0103 \u00eempotriva contamin\u0103rii. Chiar \u0219i scurgeri microscopice \u00een sigilii sau materiale pot permite p\u0103trunderea oxigenului, umidit\u0103\u021bii sau microorganismelor. Pentru produsele farmaceutice, o singur\u0103 scurgere nedetectat\u0103 poate compromite siguran\u021ba pacien\u021bilor. ASTM F2338 abordeaz\u0103 aceast\u0103 problem\u0103 prin oferirea unui test validat, nedistructiv \u0219i repetabil [...]<\/p>","protected":false},"featured_media":7869,"parent":0,"template":"","meta":{"_acf_changed":true,"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":"","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":[611],"class_list":["post-9857","standard","type-standard","status-publish","has-post-thumbnail","hentry","standard-category-astm"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/standard\/9857","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\/7869"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/media?parent=9857"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/standard-category?post=9857"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}