{"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 class=\"wp-block-paragraph\">V\u00fdznam normy ASTM F2338 v oblasti kvality obalov<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>V\u00fdznam normy ASTM F2338 pre kvalitu obalov Obal sl\u00fa\u017ei ako prv\u00e1 bari\u00e9ra proti kontamin\u00e1cii. Aj mikroskopick\u00e9 netesnosti v tesneniach alebo materi\u00e1loch m\u00f4\u017eu sp\u00f4sobi\u0165 vniknutie kysl\u00edka, vlhkosti alebo mikroorganizmov. V pr\u00edpade farmaceutick\u00fdch v\u00fdrobkov m\u00f4\u017ee u\u017e 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 validovan\u00fa, nedestrukt\u00edvnu a opakovate\u013en\u00fa sk\u00fa\u0161ku [\u2026]<\/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}]}}