{"id":6940,"date":"2025-07-15T11:21:17","date_gmt":"2025-07-15T03:21:17","guid":{"rendered":"https:\/\/www.qualitester.com\/?page_id=6940"},"modified":"2025-09-30T10:21:19","modified_gmt":"2025-09-30T02:21:19","slug":"syringe-leak-testing","status":"publish","type":"page","link":"https:\/\/www.qualitester.com\/ro\/applications\/syringe-leak-testing\/","title":{"rendered":"Metoda de testare a scurgerilor cu seringa"},"content":{"rendered":"<h1 style=\"text-align: center;\" data-start=\"370\" data-end=\"882\">Metoda de testare a scurgerilor cu seringa<br \/>\n<small>ISO 7886-1 ISO 8537<\/small><\/h1>\n<hr \/>\n<p><strong data-start=\"318\" data-end=\"342\">Testarea scurgerilor seringii<\/strong> este o procedur\u0103 critic\u0103 care asigur\u0103 integritatea, siguran\u021ba \u0219i performan\u021ba seringilor utilizate \u00een aplica\u021bii medicale \u0219i farmaceutice. Conform <a href=\"https:\/\/www.qualitester.com\/ro\/standards\/iso-7886-1\/\"><em data-start=\"493\" data-end=\"505\">ISO 7886-1<\/em> <\/a>\u0219i<a href=\"https:\/\/www.qualitester.com\/ro\/categorie-produs\/iso\/iso-8537\/\"> <em data-start=\"510\" data-end=\"520\">ISO 8537<\/em><\/a>, testarea scurgerilor de aer \u0219i a separ\u0103rii pistonului este obligatorie pentru seringile sterile de unic\u0103 folosin\u021b\u0103, inclusiv pentru seringile de insulin\u0103. Acest ghid v\u0103 va \u00eendruma prin proceduri standardizate, cerin\u021be privind aparatura \u0219i informa\u021bii esen\u021biale privind testarea pentru a ajuta profesioni\u0219tii \u0219i echipele QC s\u0103 ob\u021bin\u0103 conformitatea \u0219i fiabilitatea produselor.<\/p>\n<hr \/>\n<h2><img fetchpriority=\"high\" decoding=\"async\" class=\"wp-image-6951 alignright\" src=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/07\/syringe-leak-testing-300x300.webp\" alt=\"testarea etan\u0219eit\u0103\u021bii seringii\" width=\"240\" height=\"240\" srcset=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/07\/syringe-leak-testing-300x300.webp 300w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/07\/syringe-leak-testing-150x150.webp 150w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/07\/syringe-leak-testing-12x12.webp 12w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/07\/syringe-leak-testing-100x100.webp 100w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/07\/syringe-leak-testing.webp 334w\" sizes=\"(max-width: 240px) 100vw, 240px\" \/>Importan\u021ba test\u0103rii scurgerilor de sering\u0103<\/h2>\n<p data-start=\"880\" data-end=\"1247\">Scurgerile din seringi pot duce la e\u0219ecul administr\u0103rii medicamentelor, riscuri de contaminare sau r\u0103nirea utilizatorului. Ca urmare, <em data-start=\"993\" data-end=\"1015\">testarea etan\u0219eit\u0103\u021bii seringii<\/em> este o parte esen\u021bial\u0103 a asigur\u0103rii calit\u0103\u021bii \u00een produc\u021bia de dispozitive medicale. Aceste teste nu numai c\u0103 valideaz\u0103 etan\u0219area structural\u0103, dar confirm\u0103 \u0219i faptul c\u0103 <em data-start=\"1174\" data-end=\"1191\">Dop de piston<\/em> men\u021bine o conexiune etan\u0219\u0103 sub presiunea vidului.<\/p>\n<p data-start=\"1249\" data-end=\"1274\"><strong data-start=\"1249\" data-end=\"1274\">Standarde la care se face referire:<\/strong><\/p>\n<ul>\n<li data-start=\"1277\" data-end=\"1336\"><a href=\"https:\/\/www.iso.org\/standard\/64790.html\" target=\"_blank\" rel=\"noopener nofollow\"><strong data-start=\"1277\" data-end=\"1291\">ISO 7886-1<\/strong><\/a>: Seringi hipodermice sterile de unic\u0103 folosin\u021b\u0103.<\/li>\n<li data-start=\"1339\" data-end=\"1397\"><a href=\"https:\/\/www.iso.org\/standard\/60510.html\" target=\"_blank\" rel=\"noopener nofollow\"><strong data-start=\"1339\" data-end=\"1351\">ISO 8537<\/strong><\/a>: Seringi pentru insulin\u0103 cu sau f\u0103r\u0103 ac.<\/li>\n<\/ul>\n<p data-start=\"1401\" data-end=\"1548\">Aceste standarde definesc <strong data-start=\"1428\" data-end=\"1468\">scurgere de aer pe l\u00e2ng\u0103 opritorul pistonului<\/strong> \u0219i <strong data-start=\"1473\" data-end=\"1519\">separarea dopului de piston<\/strong> ca dou\u0103 criterii cheie de e\u0219ec.<\/p>\n<hr \/>\n<h2 data-start=\"1401\" data-end=\"1548\">Testarea func\u021bionalit\u0103\u021bii seringii \u0219i scurgerea de aer pentru opritorul pistonului<\/h2>\n<p><em data-start=\"1625\" data-end=\"1656\">Testarea func\u021bionalit\u0103\u021bii seringii<\/em>, concentr\u00e2ndu-se \u00een special pe <em data-start=\"1683\" data-end=\"1716\">scurgere de aer pentru obturatorul cu piston<\/em>, asigur\u0103 men\u021binerea integrit\u0103\u021bii vidului seringii \u00een timpul aspira\u021biei. Aceast\u0103 sec\u021biune prezint\u0103 procedurile standardizate bazate pe orient\u0103rile ISO \u0219i recomand\u0103 instrumente fiabile pentru a efectua testul cu acurate\u021be.<\/p>\n<h3>Echipament necesar<\/h3>\n<p data-start=\"1953\" data-end=\"2034\">Pentru a efectua o testare fiabil\u0103 a scurgerilor seringii, sunt necesare urm\u0103toarele componente:<\/p>\n<ul>\n<li data-start=\"2038\" data-end=\"2164\"><strong data-start=\"2038\" data-end=\"2072\">Generator de vid \u0219i manometru<\/strong>: Pentru crearea \u0219i monitorizarea condi\u021biilor de vid p\u00e2n\u0103 la <strong data-start=\"2126\" data-end=\"2136\">88 kPa<\/strong> sub presiunea atmosferic\u0103.<\/li>\n<li data-start=\"2167\" data-end=\"2235\"><strong data-start=\"2167\" data-end=\"2183\">Sistem de prindere<\/strong>: Pentru a fixa pistonul \u00een pozi\u021bia sa de volum nominal.<\/li>\n<li data-start=\"2238\" data-end=\"2317\"><strong data-start=\"2238\" data-end=\"2291\">Racord conic feminin (ISO 80369-7 sau ISO 594-1)<\/strong>: Pentru conexiune standard.<\/li>\n<li data-start=\"2320\" data-end=\"2390\"><strong data-start=\"2320\" data-end=\"2358\">Ap\u0103 distilat\u0103 (ISO 3696 grad 3)<\/strong>: La 18-28 \u00b0C ca mediu de testare.<\/li>\n<li data-start=\"2393\" data-end=\"2465\"><strong data-start=\"2393\" data-end=\"2408\">Capcan\u0103 pentru sticle<\/strong>: Pentru a preveni contaminarea sau refluxul \u00een timpul aspira\u021biei.<\/li>\n<\/ul>\n<h3>Procedura de testare pas cu pas<\/h3>\n<ol>\n<li data-start=\"2506\" data-end=\"2578\"><strong data-start=\"2506\" data-end=\"2522\">Umple\u021bi seringa<\/strong>: Trage\u021bi ap\u0103 p\u00e2n\u0103 la cel pu\u021bin <strong data-start=\"2550\" data-end=\"2577\">25% de capacitate nominal\u0103<\/strong>.<\/li>\n<li data-start=\"2582\" data-end=\"2659\"><strong data-start=\"2582\" data-end=\"2596\">Set Volum<\/strong>: Trage\u021bi plonjorul p\u00e2n\u0103 la linia gradat\u0103 nominal\u0103 \u0219i fixa\u021bi-l bine.<\/li>\n<li data-start=\"2663\" data-end=\"2763\"><strong data-start=\"2663\" data-end=\"2682\">Conecta\u021bi fitingul<\/strong>: Ata\u0219a\u021bi duza la un racord conic feminin \u00een conformitate cu standardele ISO.<\/li>\n<li data-start=\"2767\" data-end=\"2833\"><strong data-start=\"2767\" data-end=\"2786\">Generarea vidului<\/strong>: Aplica\u021bi un vid controlat pentru a ajunge la <strong data-start=\"2821\" data-end=\"2832\">-88 kPa<\/strong>.<\/li>\n<li data-start=\"2837\" data-end=\"2857\"><strong data-start=\"2837\" data-end=\"2856\">Inspec\u021bia scurgerilor<\/strong>:\n<ul>\n<li data-start=\"2863\" data-end=\"2924\">Inspecta\u021bi vizual pentru <strong data-start=\"2884\" data-end=\"2899\">bule de aer<\/strong> \u00een jurul garniturii pistonului.<\/li>\n<li data-start=\"2930\" data-end=\"2985\">\u00cenregistra\u021bi <strong data-start=\"2941\" data-end=\"2962\">citirea manometrului<\/strong> scade dup\u0103 60 de secunde.<\/li>\n<\/ul>\n<\/li>\n<li data-start=\"2989\" data-end=\"3066\"><strong data-start=\"2989\" data-end=\"3014\">Verificarea opritorului pistonului<\/strong>: Inspecta\u021bi pentru <strong data-start=\"3028\" data-end=\"3042\">separare<\/strong> de la arborele pistonului.<\/li>\n<\/ol>\n<p data-start=\"3068\" data-end=\"3163\">\u00cen cazul \u00een care orice <strong data-start=\"3075\" data-end=\"3090\">scurgeri de aer<\/strong> sau <strong data-start=\"3094\" data-end=\"3108\">deta\u0219are<\/strong> este observat\u0103, seringa nu trece testul de func\u021bionalitate.<\/p>\n<hr \/>\n<h2 data-start=\"3068\" data-end=\"3163\">Cerin\u021be de raportare<\/h2>\n<p data-start=\"3197\" data-end=\"3264\">\u00cen conformitate cu ISO 7886-1 \u0219i ISO 8537, raportul de testare trebuie s\u0103 includ\u0103:<\/p>\n<ul>\n<li data-start=\"3268\" data-end=\"3304\">Identitatea seringii \u0219i volumul nominal.<\/li>\n<li data-start=\"3307\" data-end=\"3323\">Data test\u0103rii.<\/li>\n<li data-start=\"3326\" data-end=\"3358\">Rezultatele observ\u0103rii scurgerilor de aer.<\/li>\n<li data-start=\"3361\" data-end=\"3402\">Rezultatul deta\u0219\u0103rii dopului pistonului.<\/li>\n<li data-start=\"3405\" data-end=\"3447\">Modificarea presiunii \u00een vid \u00een timpul testului.<\/li>\n<\/ul>\n<hr \/>\n<h2>De ce s\u0103 alege\u021bi <a href=\"https:\/\/www.qualitester.com\/ro\/\">Instrumente celulare<\/a> SLT-02 pentru testarea scurgerilor seringii<\/h2>\n<figure id=\"attachment_6946\" aria-describedby=\"caption-attachment-6946\" style=\"width: 300px\" class=\"wp-caption alignright\"><a href=\"https:\/\/www.qualitester.com\/ro\/?s=slt-02\"><img decoding=\"async\" class=\"wp-image-6946 size-medium\" src=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/07\/SLT-02-Syringe-Air-Leakage-Tester-300x300.webp\" alt=\"tester de contrac\u021bie termic\u0103\" width=\"300\" height=\"300\" srcset=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/07\/SLT-02-Syringe-Air-Leakage-Tester-300x300.webp 300w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/07\/SLT-02-Syringe-Air-Leakage-Tester-150x150.webp 150w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/07\/SLT-02-Syringe-Air-Leakage-Tester-12x12.webp 12w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/07\/SLT-02-Syringe-Air-Leakage-Tester-100x100.webp 100w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/07\/SLT-02-Syringe-Air-Leakage-Tester.webp 600w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/a><figcaption id=\"caption-attachment-6946\" class=\"wp-caption-text\">Sering\u0103 de testare a scurgerilor de aer<\/figcaption><\/figure>\n<p data-start=\"3518\" data-end=\"3721\">Pentru laboratoarele \u0219i produc\u0103torii care doresc s\u0103 \u00ee\u0219i eficientizeze procesul de testare cu <strong data-start=\"3594\" data-end=\"3612\">\u00eenalt\u0103 precizie<\/strong>, a <strong data-start=\"3618\" data-end=\"3665\">Cell Instruments SLT-02 Tester de scurgere a seringii<\/strong> ofer\u0103 o solu\u021bie conform\u0103, automatizat\u0103, care simplific\u0103:<\/p>\n<ul>\n<li data-start=\"3725\" data-end=\"3750\"><strong data-start=\"3725\" data-end=\"3750\">Detectarea scurgerilor de aer<\/strong><\/li>\n<li data-start=\"3753\" data-end=\"3782\"><strong data-start=\"3753\" data-end=\"3782\">Testarea reten\u021biei dopului<\/strong><\/li>\n<li data-start=\"3785\" data-end=\"3829\"><strong data-start=\"3785\" data-end=\"3829\">Controlul vidului cu manometru integrat<\/strong><\/li>\n<li data-start=\"3832\" data-end=\"3872\"><strong data-start=\"3832\" data-end=\"3872\">\u00cenregistrarea datelor \u0219i generarea de rapoarte<\/strong><\/li>\n<\/ul>\n<p data-start=\"3874\" data-end=\"4081\"><strong data-start=\"3874\" data-end=\"3884\">SLT-02<\/strong> \u00eendepline\u0219te pe deplin cerin\u021bele aparatelor descrise \u00een ISO 7886-1 \u0219i ISO 8537. Cu interfe\u021be personalizabile \u0219i un sistem modular de prindere, este ideal pentru laboratoarele de cercetare \u0219i dezvoltare, departamentele QC \u0219i liniile de produc\u021bie.<\/p>\n<hr \/>\n<h2 data-start=\"3874\" data-end=\"4081\">\u00cembun\u0103t\u0103\u021birea calit\u0103\u021bii seringilor prin testarea corespunz\u0103toare<\/h2>\n<p data-start=\"4258\" data-end=\"4556\">corespunz\u0103toare <em data-start=\"4265\" data-end=\"4287\">testarea etan\u0219eit\u0103\u021bii seringii<\/em> nu numai c\u0103 \u00eendepline\u0219te a\u0219tept\u0103rile de reglementare, dar asigur\u0103 siguran\u021ba pacien\u021bilor \u0219i credibilitatea m\u0103rcii. Implementarea unor practici de testare corecte, ghidate de standarde precum <strong data-start=\"4442\" data-end=\"4456\">ISO 7886-1<\/strong> \u0219i <strong data-start=\"4461\" data-end=\"4473\">ISO 8537<\/strong>, ajut\u0103 produc\u0103torii s\u0103 detecteze din timp defectele de fabrica\u021bie \u0219i s\u0103 reduc\u0103 rechem\u0103rile costisitoare.<\/p>\n<p data-start=\"4558\" data-end=\"4833\">Pentru profesioni\u0219tii din <strong data-start=\"4583\" data-end=\"4601\">farmaceutice<\/strong>, <strong data-start=\"4603\" data-end=\"4621\">dispozitiv medical<\/strong>, \u0219i <strong data-start=\"4627\" data-end=\"4651\">ambalaje de diagnosticare<\/strong> procesele robuste de testare nu sunt negociabile. Pe m\u0103sur\u0103 ce complexitatea dispozitivelor cre\u0219te, cre\u0219te \u0219i nevoia de <em data-start=\"4762\" data-end=\"4789\">instrumenta\u021bie de precizie<\/em> \u0219i <strong data-start=\"4794\" data-end=\"4832\">metodologii standardizate de testare<\/strong>.<\/p>\n<hr \/>\n<h2 data-start=\"4558\" data-end=\"4833\">Concluzie<\/h2>\n<p data-start=\"4855\" data-end=\"5219\">Integritatea seringilor medicale se bazeaz\u0103 pe rigurozitate <strong data-start=\"4908\" data-end=\"4932\">testarea etan\u0219eit\u0103\u021bii seringii<\/strong> proceduri. Aderarea la ISO 7886-1 \u0219i ISO 8537 asigur\u0103 siguran\u021ba, coeren\u021ba \u0219i conformitatea cu reglement\u0103rile. \u00cencorporarea <strong data-start=\"5055\" data-end=\"5085\"><a href=\"https:\/\/www.qualitester.com\/ro\/?s=slt-02\">SLT-02<\/a> Tester de scurgere sering\u0103<\/strong> de la <strong data-start=\"5091\" data-end=\"5111\">Instrumente celulare<\/strong> \u00een fluxul dvs. de lucru va spori acurate\u021bea test\u0103rii, va reduce erorile manuale \u0219i va promova standarde ridicate ale produselor.<\/p>\n<p data-start=\"5221\" data-end=\"5438\">Fie c\u0103 sunte\u021bi un <strong data-start=\"5238\" data-end=\"5255\">Tehnician QC<\/strong>, <strong data-start=\"5257\" data-end=\"5273\">Inginer R&amp;D<\/strong>, sau <strong data-start=\"5278\" data-end=\"5300\">auditor de conformitate<\/strong>, \u00een\u021belegerea \u0219i executarea eficient\u0103 a protocoalelor de testare a scurgerilor din seringi este esen\u021bial\u0103 pentru furnizarea de produse medicale sigure \u0219i func\u021bionale.<\/p>","protected":false},"excerpt":{"rendered":"<p>Metoda de testare a scurgerilor seringilor ISO 7886-1 ISO 8537 Testarea scurgerilor seringilor este o procedur\u0103 critic\u0103 care asigur\u0103 integritatea, siguran\u021ba \u0219i performan\u021ba seringilor utilizate \u00een aplica\u021bii medicale \u0219i farmaceutice. \u00cen conformitate cu ISO 7886-1 \u0219i ISO 8537, testarea scurgerilor de aer \u0219i a separ\u0103rii pistonului este obligatorie pentru seringile sterile de unic\u0103 folosin\u021b\u0103, inclusiv seringile de insulin\u0103. Acest ghid ...<\/p>\n<p class=\"read-more\"> <a class=\"\" href=\"https:\/\/www.qualitester.com\/ro\/applications\/syringe-leak-testing\/\"> <span class=\"screen-reader-text\">Metoda de testare a scurgerilor cu seringa<\/span> Cite\u0219te mai mult \"<\/a><\/p>","protected":false},"author":3,"featured_media":0,"parent":6794,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"default","site-content-layout":"default","ast-global-header-display":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","footnotes":""},"class_list":["post-6940","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.qualitester.com\/ro\/wp-json\/wp\/v2\/pages\/6940","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.qualitester.com\/ro\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.qualitester.com\/ro\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.qualitester.com\/ro\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.qualitester.com\/ro\/wp-json\/wp\/v2\/comments?post=6940"}],"version-history":[{"count":0,"href":"https:\/\/www.qualitester.com\/ro\/wp-json\/wp\/v2\/pages\/6940\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.qualitester.com\/ro\/wp-json\/wp\/v2\/pages\/6794"}],"wp:attachment":[{"href":"https:\/\/www.qualitester.com\/ro\/wp-json\/wp\/v2\/media?parent=6940"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}