{"id":9584,"date":"2026-02-02T14:53:24","date_gmt":"2026-02-02T06:53:24","guid":{"rendered":"https:\/\/www.packqc.com\/products\/syringe-liquid-leak-tester-iso-7886-1\/"},"modified":"2026-04-16T15:20:05","modified_gmt":"2026-04-16T07:20:05","slug":"syringe-liquid-leak-tester-iso-7886-1","status":"publish","type":"products","link":"https:\/\/www.packqc.com\/bs\/products\/syringe-liquid-leak-tester-iso-7886-1\/","title":{"rendered":"SPPT-01 Tester hermeti\u010dnosti injekcione \u0161price pod pozitivnim pritiskom"},"content":{"rendered":"<p>Osiguravanje integriteta jednokratnih \u0161prica je klju\u010dno za sigurnost pacijenata i kvalitetu proizvoda u proizvodnji lijekova i medicinskih ure\u0111aja. Me\u0111u najva\u017enijim procjenama je <strong data-start=\"593\" data-end=\"621\">test curenja teku\u0107ine iz \u0161price<\/strong>, posebno na kliznom \u010depu pod kompresijom. Ovaj test provjerava da li dolazi do curenja kada je kliza\u010d izlo\u017een i aksijalnim i radijalnim silama pod kontrolisanim uslovima. Cell Instruments nudi napredno rje\u0161enje za izvo\u0111enje ovog testa s precizno\u0161\u0107u i ponovljivo\u0161\u0107u\u2014<strong data-start=\"914\" data-end=\"972\">SPPT-01 tester hermeti\u010dnosti injekcione \u0161price pod pozitivnim pritiskom<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Tester curenja te\u010dnosti za \u0161price \u2013 ISO 7886-1<\/h2>\n\n\n\n<p>Za laboratorije i proizvo\u0111a\u010de koji \u017eele uskla\u0111enost sa ISO 7886-1 Aneksom D, <strong data-start=\"3251\" data-end=\"3305\">SPPT-01 Tester hermeti\u010dnosti injekcione \u0161price pod pozitivnim pritiskom<\/strong> od <strong data-start=\"3309\" data-end=\"3329\">Cell Instruments<\/strong> Pru\u017ea potpuno automatizirano i precizno rje\u0161enje za testiranje. Dizajnirano s <strong data-start=\"3403\" data-end=\"3428\">Sistem pod kontrolom PLC-a<\/strong> i <strong data-start=\"3433\" data-end=\"3465\">7-in\u010dni ekran osjetljiv na dodir<\/strong>, SPPT-01 nudi:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"3490\" data-end=\"3516\">Podesive brzine testiranja<\/strong> (1\u2013500 mm\/min)<\/li>\n\n\n\n<li><strong style=\"font-size: 16px;\" data-start=\"3534\" data-end=\"3563\">Visokoprecizno mjerenje<\/strong> (0,01 mm)<\/li>\n\n\n\n<li><strong style=\"font-size: 16px;\" data-start=\"3576\" data-end=\"3604\">Zamjenjivi rasvjetni tijela<\/strong> za razli\u010dite veli\u010dine \u0161prica<\/li>\n\n\n\n<li><strong style=\"font-size: 16px;\" data-start=\"3633\" data-end=\"3676\">Primjena bo\u010dne i silazne sile<\/strong> u jednoj integrisanoj platformi<\/li>\n\n\n\n<li><strong style=\"font-size: 16px;\" data-start=\"3706\" data-end=\"3729\">Za\u0161tita od preoptere\u0107enja<\/strong> i <strong style=\"font-size: 16px;\" data-start=\"3734\" data-end=\"3754\">automatski povratak<\/strong> za pobolj\u0161anu sigurnost<\/li>\n\n\n\n<li>Na brodu <strong style=\"font-size: 16px;\" data-start=\"3786\" data-end=\"3802\">mikroprinter<\/strong> za trenutno izvje\u0161tavanje o testu<\/li>\n<\/ul>\n\n\n\n<p>Ove zna\u010dajke osiguravaju dosljednost, ta\u010dnost i uskla\u0111enost sa globalnim regulatornim standardima poput <strong data-start=\"3928\" data-end=\"3942\">ISO 7886-1<\/strong>.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Glavni parametar<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td class=\"has-text-align-center\" data-align=\"center\"><strong>Load Cell<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\">200N (ili prema potrebi)<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\"><strong>Test Speed<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\">1~500 mm\/min<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\"><strong>Preciznost<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\">0.01mm<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\"><strong>Snaga<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\">110~220V<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">Primjene i relevantnost za industriju<\/h2>\n\n\n\n<p>Test curenja teku\u0107ine iz \u0161price odnosi se na proizvo\u0111a\u010de:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Intradermalne \u0161price<\/li>\n\n\n\n<li>Unaprijed napunjene \u0161price<\/li>\n\n\n\n<li>Medicinski sistemi za injektiranje<\/li>\n\n\n\n<li>Laboratorije za inspekciju kvaliteta i regulatorna ispitivanja<\/li>\n<\/ul>\n\n\n\n<p>Uklju\u010divanjem ovog testa u protokole kontrole kvaliteta, kompanije u <strong data-start=\"4253\" data-end=\"4271\">farmaceutski<\/strong>, <strong data-start=\"4273\" data-end=\"4291\">medicinski ure\u0111aj<\/strong>, i <strong data-start=\"4297\" data-end=\"4318\">sektori pakovanja<\/strong> mo\u017ee ispuniti me\u0111unarodne regulatorne zahtjeve i oja\u010dati pouzdanost proizvoda.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Va\u017enost testa curenja teku\u0107ine iz \u0161price<\/h2>\n\n\n\n<p>Test curenja teku\u0107ine iz \u0161price je neophodan za osiguranje kvaliteta u proizvodnji sterilnih hipodermijskih \u0161prica. \u0160prica koja curi predstavlja zna\u010dajne rizike, uklju\u010duju\u0107i kontaminaciju, neta\u010dno doziranje i kvar tokom primjene. Provo\u0111enjem kontroliranog <strong data-start=\"1288\" data-end=\"1316\">test curenja teku\u0107ine iz \u0161price<\/strong>, proizvo\u0111a\u010di mogu identificirati slabosti u dizajnu \u010depa klipa \u0161price i sprije\u010diti da neispravne jedinice dospiju na tr\u017ei\u0161te.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Metoda ispitivanja zasnovana na ISO 7886-1 Aneks D<\/h2>\n\n\n\n<p><a href=\"https:\/\/www.packqc.com\/bs\/product-category\/iso\/iso-7886-1\/\" target=\"_blank\" rel=\"noopener\"><strong data-start=\"1506\" data-end=\"1520\">ISO 7886-1<\/strong><\/a> je me\u0111unarodni standard za sterilne hipodermijske \u0161price za jednokratnu upotrebu. <strong data-start=\"1603\" data-end=\"1625\">Testiranje po ISO 7886-1<\/strong> Postupak osigurava mehani\u010dke i funkcionalne performanse \u0161price, uklju\u010duju\u0107i otpornost na curenje. Konkretno, <strong data-start=\"1746\" data-end=\"1768\">ISO 7886-1 Dodatak D<\/strong> iznosi <strong data-start=\"1782\" data-end=\"1865\">Metoda ispitivanja curenja teku\u0107ine kroz \u010dep klipa \u0161price pod kompresijom<\/strong>.<\/p>\n\n\n\n<p><strong data-start=\"1506\" data-end=\"1520\">ISO 7886-1<\/strong> je me\u0111unarodni standard za sterilne hipodermijske \u0161price za jednokratnu upotrebu. <strong data-start=\"1603\" data-end=\"1625\">Testiranje po ISO 7886-1<\/strong> Postupak osigurava mehani\u010dke i funkcionalne performanse \u0161price, uklju\u010duju\u0107i otpornost na curenje. Konkretno, <strong data-start=\"1746\" data-end=\"1768\">ISO 7886-1 Dodatak D<\/strong> iznosi <strong data-start=\"1782\" data-end=\"1865\">Metoda ispitivanja curenja teku\u0107ine kroz \u010dep klipa \u0161price pod kompresijom<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Principi ispitivanja iz ISO 7886-1 Aneksa D<\/h2>\n\n\n\n<p>Postupak u Prilogu D ima za cilj simulirati najgore uvjete kombiniranjem aksijalnih i radijalnih optere\u0107enja na klizni dio \u0161price:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u0160prica se prvo napuni sa <strong data-start=\"2076\" data-end=\"2095\">destilirana voda<\/strong> iznad svoje nominalne snage.<\/li>\n\n\n\n<li>Nakon istiskivanja zraka, volumen se pode\u0161ava na nominalni nivo.<\/li>\n\n\n\n<li>Mlaznica je zape\u010da\u0107ena pomo\u0107u <strong style=\"font-size: 16px;\" data-start=\"2223\" data-end=\"2252\">referentna konusna spojka<\/strong> u skladu sa ISO 80369-7 ili ekvivalentnim zaptivom.<\/li>\n\n\n\n<li>A <strong style=\"font-size: 16px;\" data-start=\"2311\" data-end=\"2329\">bo\u010dna sila<\/strong> (0,25 N do 3 N) primjenjuje se na klip da bi se izazvalo odstupanje.<\/li>\n\n\n\n<li><strong style=\"font-size: 16px;\" data-start=\"2396\" data-end=\"2414\">Osni pritisak<\/strong> generi\u0161e se u rasponu od 200\u2013300 kPa i odr\u017eava 30\u201335 sekundi.<\/li>\n\n\n\n<li>Bilo koji <strong style=\"font-size: 16px;\" data-start=\"2496\" data-end=\"2532\">Procurivanje pored kliznog \u010depa<\/strong> se pregleda vizuelno.<\/li>\n<\/ul>\n\n\n\n<p>Ova metodologija osigurava da \u010dep na klizni stabljici odr\u017eava \u010dvrsto brtvljenje pod pritiskom i bo\u010dnim naprezanjem, opona\u0161aju\u0107i stvarne uvjete koji bi mogli uzrokovati kvar.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Zahtjevi za opremu za ispitivanje prema ISO 7886-1 Aneks D<\/h2>\n\n\n\n<p>Za precizno izvo\u0111enje testa curenja teku\u0107ine iz \u0161price potrebna je sljede\u0107a oprema:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Zaptivni ure\u0111aj za mlaznicu \u0161price.<\/li>\n\n\n\n<li>Priklju\u010dak za primjenu radijalnog optere\u0107enja na kliza\u010d.<\/li>\n\n\n\n<li>Ure\u0111aj za dovod tlaka do 200\u2013300 kPa.<\/li>\n\n\n\n<li>Destilirana voda (18\u00b0C do 28\u00b0C) za proces punjenja.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">FAQs<\/h2>\n\n\n\n<ol class=\"wp-block-list\">\n<li>\u010cemu slu\u017ei test curenja teku\u0107ine iz \u0161price?<br>Test curenja teku\u0107ine iz \u0161price procjenjuje odr\u017eava li kliza\u010d-\u010dep pravilno brtvljenje pod pritiskom, sprje\u010davaju\u0107i bilo kakvo curenje koje bi moglo ugroziti sterilitet ili to\u010dnost doziranja.<\/li>\n\n\n\n<li>Kako Cell Instruments\u2019 SPPT-01 izvodi test?<br>Tester SPPT-01 primjenjuje radijalnu i aksijalnu silu na kliza\u010d \u0161price dok je mlaznica zape\u010da\u0107ena, simuliraju\u0107i najgore uvjete kako bi se otkrilo bilo kakvo curenje pored \u010depa.<\/li>\n\n\n\n<li>Za\u0161to je ovaj test va\u017ean za kontrolu kvaliteta?<br>Osigurava da svaka \u0161prica isporu\u010duje lijek sigurno i precizno, sprje\u010davaju\u0107i kontaminaciju, gubitak doze ili neuspjeh injekcije.<\/li>\n\n\n\n<li>Mo\u017ee li se SPPT-01 koristiti za razli\u010dite veli\u010dine \u0161prica?<br>Da, SPPT-01 dolazi s vi\u0161e nosa\u010da koji omogu\u0107avaju prihvat \u0161irokog spektra vrsta i zapremina \u0161prica, \u010dime se pove\u0107ava njegova svestranost za razli\u010dite potrebe testiranja.<\/li>\n<\/ol>\n\n\n\n<p>Osiguravanje sposobnosti \u0161price da odr\u017ei zaptivenost bez curenja pod pritiskom je od su\u0161tinskog zna\u010daja za sigurnost i performanse. <strong data-start=\"4543\" data-end=\"4571\">test curenja teku\u0107ine iz \u0161price<\/strong>, kako je definirano u <strong data-start=\"4587\" data-end=\"4609\"><a href=\"https:\/\/www.iso.org\/standard\/64790.html\" target=\"_blank\" rel=\"noopener nofollow\">ISO 7886-1<\/a> Dodatak D<\/strong>, pru\u017ea standardiziranu i pouzdanu metodu za procjenu ove klju\u010dne osobine. Kori\u0161tenje preciznog i u potpunosti uskla\u0111enog instrumenta poput <strong data-start=\"4747\" data-end=\"4801\">SPPT-01 Tester hermeti\u010dnosti injekcione \u0161price pod pozitivnim pritiskom<\/strong> od <strong data-start=\"4807\" data-end=\"4827\">Cell Instruments<\/strong> Poma\u017ee proizvo\u0111a\u010dima da odr\u017ee standarde kvaliteta i za\u0161tite krajnje korisnike.<\/p>","protected":false},"excerpt":{"rendered":"<p>Osiguravanje integriteta jednokratnih \u0161prica je od klju\u010dne va\u017enosti za sigurnost pacijenata i kvalitetu proizvoda u proizvodnji farmaceutskih proizvoda i medicinskih ure\u0111aja. Me\u0111u najva\u017enijim ispitivanjima je test curenja teku\u0107ine iz \u0161price, posebno na \u010depu klipa pod kompresijom. Ovaj test provjerava da li dolazi do curenja kada je klip podvrgnut i aksijalnom i radijalnom [\u2026]<\/p>","protected":false},"featured_media":0,"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":""}}},"product-category":[484,438,593],"product-tag":[],"class_list":["post-9584","products","type-products","status-publish","hentry","product-category-leak-testing","product-category-medical-and-pharmaceutical-testing","product-category-syringe-testing"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.packqc.com\/bs\/wp-json\/wp\/v2\/products\/9584","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/bs\/wp-json\/wp\/v2\/products"}],"about":[{"href":"https:\/\/www.packqc.com\/bs\/wp-json\/wp\/v2\/types\/products"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/bs\/wp-json\/wp\/v2\/media?parent=9584"}],"wp:term":[{"taxonomy":"product-category","embeddable":true,"href":"https:\/\/www.packqc.com\/bs\/wp-json\/wp\/v2\/product-category?post=9584"},{"taxonomy":"product-tag","embeddable":true,"href":"https:\/\/www.packqc.com\/bs\/wp-json\/wp\/v2\/product-tag?post=9584"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}