{"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\/sk\/standard\/astm-f2338\/","title":{"rendered":"ASTM F2338"},"content":{"rendered":"<p>V\u00fdznam normy ASTM F2338 v oblasti kvality obalov<\/p>\n\n\n\n<p>Obal sl\u00fa\u017ei ako prv\u00e1 bari\u00e9ra proti kontamin\u00e1cii. Aj mikroskopick\u00e9 netesnosti v tesneniach alebo materi\u00e1loch m\u00f4\u017eu umo\u017eni\u0165 vniknutie kysl\u00edka, vlhkosti alebo mikroorganizmov. V pr\u00edpade farmaceutick\u00fdch v\u00fdrobkov m\u00f4\u017ee jedin\u00e1 nezisten\u00e1 netesnos\u0165 ohrozi\u0165 bezpe\u010dnos\u0165 pacienta. Norma ASTM F2338 rie\u0161i tento probl\u00e9m t\u00fdm, \u017ee pon\u00faka <strong data-start=\"1180\" data-end=\"1237\">validovan\u00e1, nede\u0161trukt\u00edvna a opakovate\u013en\u00e1 testovacia met\u00f3da<\/strong> ktor\u00e9 presahuj\u00fa tradi\u010dn\u00e9 de\u0161trukt\u00edvne met\u00f3dy, ako je vnikanie farbiva alebo emisia bubl\u00edn.<\/p>\n\n\n\n<p>T\u00e1to norma je obzvl\u00e1\u0161\u0165 cenn\u00e1 pre <strong data-start=\"1370\" data-end=\"1411\">detekcia netesnost\u00ed farmaceutick\u00fdch obalov<\/strong>, kde regula\u010dn\u00e9 org\u00e1ny zd\u00f4raz\u0148uj\u00fa potrebu presn\u00fdch, neinvaz\u00edvnych met\u00f3d, ktor\u00e9 uchov\u00e1vaj\u00fa testovan\u00e9 vzorky na \u010fal\u0161ie pou\u017eitie alebo distrib\u00faciu.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Ako funguje met\u00f3da v\u00e1kuov\u00e9ho rozpadu<\/h2>\n\n\n\n<p>Met\u00f3da ASTM F2338 je zalo\u017een\u00e1 na presnom <strong data-start=\"1642\" data-end=\"1690\">monitorovanie tlaku v uzavretej sk\u00fa\u0161obnej komore<\/strong>. Tu je postup v jednoduchosti:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Obal sa umiestni do pevnej sk\u00fa\u0161obnej komory.<\/li>\n\n\n\n<li>Aplikuje sa v\u00e1kuum a komora sa izoluje od zdroja.<\/li>\n\n\n\n<li>Sn\u00edma\u010de tlaku s vysok\u00fdm rozl\u00ed\u0161en\u00edm meraj\u00fa ak\u00fdko\u013evek n\u00e1rast tlaku v priebehu \u010dasu.<\/li>\n\n\n\n<li>Zv\u00fd\u0161enie tlaku znamen\u00e1 \u00fanik plynu z obalu v d\u00f4sledku netesnosti.<\/li>\n<\/ul>\n\n\n\n<p>Na rozdiel od vizu\u00e1lnej kontroly alebo testovania farbivom je met\u00f3da v\u00e1kuov\u00e9ho rozkladu <strong data-start=\"2085\" data-end=\"2169\">kvantitat\u00edvne, citliv\u00e9 a nevy\u017eaduj\u00face zmenu alebo zni\u010denie obalu<\/strong>. Pri spr\u00e1vne kalibrovan\u00fdch syst\u00e9moch dok\u00e1\u017ee odhali\u0165 netesnosti a\u017e do ve\u013ekosti nieko\u013ek\u00fdch mikr\u00f3nov.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Aplik\u00e1cie nede\u0161trukt\u00edvnej detekcie \u00fanikov<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Detekcia \u00faniku farmaceutick\u00fdch obalov<\/h3>\n\n\n\n<p>V steriln\u00fdch farmaceutick\u00fdch obaloch, ako s\u00fa injek\u010dn\u00e9 liekovky, injek\u010dn\u00e9 strieka\u010dky alebo blistre, norma ASTM F2338 poskytuje z\u00e1ruku, \u017ee <strong data-start=\"2473\" data-end=\"2510\">celistvos\u0165 uz\u00e1veru kontajnera (CCI)<\/strong>. Zabr\u00e1nen\u00edm vstupu \u0161kodliv\u00fdch mikr\u00f3bov zohr\u00e1va t\u00e1to met\u00f3da d\u00f4le\u017eit\u00fa \u00falohu pri dodr\u017eiavan\u00ed pr\u00e1vnych predpisov.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Testovanie integrity obalov potrav\u00edn a n\u00e1pojov<\/h3>\n\n\n\n<p>V pr\u00edpade v\u00e1kuovo balen\u00fdch potrav\u00edn, flexibiln\u00fdch vrec\u00fa\u0161ok alebo podnosov s vekom je zabezpe\u010denie hermetick\u00e9ho uzavretia nevyhnutn\u00e9 pre bezpe\u010dnos\u0165 v\u00fdrobku a pred\u013a\u017eenie jeho trvanlivosti. Norma ASTM F2338 pon\u00faka \u00fa\u010dinn\u00fd sp\u00f4sob testovania bez plytvania v\u00fdrobkom.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Balenie zdravotn\u00edckych pom\u00f4cok<\/h3>\n\n\n\n<p>Lek\u00e1rske z\u00e1sobn\u00edky, vreck\u00e1 a bari\u00e9rov\u00e9 obaly musia zosta\u0165 neporu\u0161en\u00e9 a\u017e do miesta pou\u017eitia. Nede\u0161trukt\u00edvna detekcia netesnost\u00ed zaru\u010duje, \u017ee tieto obaly sp\u013a\u0148aj\u00fa pr\u00edsne normy kvality.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">V\u00fdhody normy ASTM F2338 oproti in\u00fdm met\u00f3dam<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"3152\" data-end=\"3170\">Nede\u0161trukt\u00edvne<\/strong> - Vzorky zost\u00e1vaj\u00fa neporu\u0161en\u00e9 a m\u00f4\u017eu sa vr\u00e1ti\u0165 do v\u00fdroby.<\/li>\n\n\n\n<li><strong data-start=\"3234\" data-end=\"3254\">Vysoko citliv\u00e9<\/strong> - Odhal\u00ed men\u0161ie \u00faniky, ako dok\u00e1\u017eu identifikova\u0165 vizu\u00e1lne met\u00f3dy.<\/li>\n\n\n\n<li><strong data-start=\"3317\" data-end=\"3341\">Kvantitat\u00edvne v\u00fdsledky<\/strong> - Poskytuje merate\u013en\u00e9 \u00fadaje namiesto subjekt\u00edvneho vizu\u00e1lneho potvrdenia.<\/li>\n\n\n\n<li><strong data-start=\"3417\" data-end=\"3442\">Regula\u010dn\u00e1 akcept\u00e1cia<\/strong> - V\u0161eobecne uzn\u00e1van\u00fd farmaceutick\u00fdm priemyslom a priemyslom zdravotn\u00edckych pom\u00f4cok.<\/li>\n\n\n\n<li><strong data-start=\"3520\" data-end=\"3538\">N\u00e1kladovo efekt\u00edvne<\/strong> - Eliminuje materi\u00e1lov\u00fd odpad z de\u0161trukt\u00edvneho testovania.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">V\u00fdber spr\u00e1vneho zariadenia na testovanie pod\u013ea normy ASTM F2338<\/h2>\n\n\n\n<p>Implementova\u0165 <a href=\"https:\/\/www.astm.org\/f2338-09r20.html\" target=\"_blank\" rel=\"noopener nofollow\">ASTM F2338<\/a> s\u00fa potrebn\u00e9 presn\u00e9 pr\u00edstroje. Str\u00e1nka <strong data-start=\"3731\" data-end=\"3781\">MLT-01 <a href=\"https:\/\/www.packqc.com\/sk\/products\/mlt-01-vacuum-decay-leak-test-equipment\/\" target=\"_blank\" rel=\"noreferrer noopener\">Micro Leak Tester<\/a> od Cell Instruments<\/strong> je navrhnut\u00fd \u0161peci\u00e1lne pre <strong data-start=\"3811\" data-end=\"3835\">testovanie rozpadu vo v\u00e1kuu<\/strong>. V\u010faka vysokocitliv\u00fdm senzorom, prisp\u00f4sobite\u013en\u00fdm ve\u013ekostiam kom\u00f4r a u\u017e\u00edvate\u013esky pr\u00edvetiv\u00e9mu riadiacemu syst\u00e9mu PLC poskytuje MLT-01 spo\u013eahliv\u00e9 v\u00fdsledky pre \u0161irok\u00fa \u0161k\u00e1lu typov balen\u00ed.<\/p>\n\n\n\n<p>Spolo\u010dnosti zaoberaj\u00face sa <strong data-start=\"4034\" data-end=\"4111\">zis\u0165ovanie netesnosti farmaceutick\u00fdch obalov alebo testovanie neporu\u0161enosti obalov potrav\u00edn<\/strong> vyu\u017eijete schopnos\u0165 pr\u00edstroja odhali\u0165 nepatrn\u00e9 \u00faniky pri zachovan\u00ed produktivity. Integr\u00e1ciou tak\u00e9hoto modern\u00e9ho zariadenia v\u00fdrobcovia posil\u0148uj\u00fa zabezpe\u010denie kvality a dodr\u017eiavanie medzin\u00e1rodn\u00fdch noriem.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Kontaktujte n\u00e1s Z\u00edskajte rie\u0161enie na testovanie pod\u013ea normy 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> poskytuje spo\u013eahliv\u00fd a overen\u00fd pr\u00edstup k <strong data-start=\"4897\" data-end=\"4931\">nede\u0161trukt\u00edvna detekcia \u00faniku<\/strong> na balenie. Pou\u017eit\u00edm met\u00f3dy v\u00e1kuov\u00e9ho rozkladu v\u00fdrobcovia zabezpe\u010duj\u00fa, \u017ee <strong data-start=\"5007\" data-end=\"5053\">farmaceutick\u00e9, zdravotn\u00edcke a potravinov\u00e9 obaly<\/strong> zosta\u0165 v bezpe\u010d\u00ed a neporu\u0161en\u00e9 po\u010das cel\u00e9ho \u017eivotn\u00e9ho cyklu. V\u010faka pokro\u010dil\u00fdm rie\u0161eniam, ako je napr. <strong data-start=\"5141\" data-end=\"5186\">Cell Instruments MLT-01 Mikro tester netesnost\u00ed<\/strong>, m\u00f4\u017eu spolo\u010dnosti dosiahnu\u0165 konzistentn\u00e9, citliv\u00e9 a efekt\u00edvne <strong data-start=\"5247\" data-end=\"5278\">testovanie integrity obalu<\/strong> v s\u00falade s glob\u00e1lnymi normami kvality.<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Importance of ASTM F2338 in Packaging Quality Packaging serves as the first barrier against contamination. Even microscopic leaks in seals or materials can allow the ingress of oxygen, moisture, or microorganisms. For pharmaceutical products, a single undetected leak may compromise patient safety. ASTM F2338 addresses this issue by offering a validated, nondestructive, and repeatable test [&hellip;]<\/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\/sk\/wp-json\/wp\/v2\/standard\/9857","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/standard"}],"about":[{"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/types\/standard"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/media\/7869"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/media?parent=9857"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/standard-category?post=9857"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}