{"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\/ro\/products\/syringe-liquid-leak-tester-iso-7886-1\/","title":{"rendered":"SPPT-01 Tester de etan\u0219eitate cu presiune pozitiv\u0103 a seringii"},"content":{"rendered":"<p>Asigurarea integrit\u0103\u021bii seringilor de unic\u0103 folosin\u021b\u0103 este esen\u021bial\u0103 pentru siguran\u021ba pacien\u021bilor \u0219i calitatea produselor \u00een produc\u021bia farmaceutic\u0103 \u0219i a dispozitivelor medicale. Printre cele mai importante evalu\u0103ri se num\u0103r\u0103 <strong data-start=\"593\" data-end=\"621\">test de scurgere a lichidului din sering\u0103<\/strong>, \u00een special la nivelul dopului pistonului sub compresie. Acest test verific\u0103 dac\u0103 apar scurgeri atunci c\u00e2nd pistonul este supus unor for\u021be axiale \u0219i radiale \u00een condi\u021bii controlate. Cell Instruments ofer\u0103 o solu\u021bie avansat\u0103 pentru a efectua acest test cu precizie \u0219i repetabilitate.<strong data-start=\"914\" data-end=\"972\">Testerul de etan\u0219eitate cu presiune pozitiv\u0103 a seringii SPPT-01<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Tester de scurgere lichid sering\u0103 - ISO 7886-1<\/h2>\n\n\n\n<p>Pentru laboratoarele \u0219i produc\u0103torii care doresc s\u0103 se conformeze cu ISO 7886-1 anexa D <strong data-start=\"3251\" data-end=\"3305\">SPPT-01 Tester de etan\u0219eitate cu presiune pozitiv\u0103 a seringii<\/strong> de <strong data-start=\"3309\" data-end=\"3329\">Instrumente celulare<\/strong> ofer\u0103 o solu\u021bie de testare complet automatizat\u0103 \u0219i precis\u0103. Proiectat cu o <strong data-start=\"3403\" data-end=\"3428\">Sistem controlat de PLC<\/strong> \u015fi <strong data-start=\"3433\" data-end=\"3465\">Interfa\u021b\u0103 cu ecran tactil de 7 inchi<\/strong>, SPPT-01 ofer\u0103:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"3490\" data-end=\"3516\">Viteze de testare reglabile<\/strong> (1-500 mm\/min)<\/li>\n\n\n\n<li><strong style=\"font-size: 16px;\" data-start=\"3534\" data-end=\"3563\">M\u0103surare de mare acurate\u021be<\/strong> (0,01 mm)<\/li>\n\n\n\n<li><strong style=\"font-size: 16px;\" data-start=\"3576\" data-end=\"3604\">Corpuri interschimbabile<\/strong> pentru seringi de diferite dimensiuni<\/li>\n\n\n\n<li><strong style=\"font-size: 16px;\" data-start=\"3633\" data-end=\"3676\">Aplicarea for\u021bei laterale \u0219i descendente<\/strong> \u00eentr-o singur\u0103 platform\u0103 integrat\u0103<\/li>\n\n\n\n<li><strong style=\"font-size: 16px;\" data-start=\"3706\" data-end=\"3729\">Protectie la suprasarcina<\/strong> \u015fi <strong style=\"font-size: 16px;\" data-start=\"3734\" data-end=\"3754\">revenire automat\u0103<\/strong> pentru o siguran\u021b\u0103 sporit\u0103<\/li>\n\n\n\n<li>La bord <strong style=\"font-size: 16px;\" data-start=\"3786\" data-end=\"3802\">microimprimanta<\/strong> pentru raportarea imediat\u0103 a testelor<\/li>\n<\/ul>\n\n\n\n<p>Aceste caracteristici asigur\u0103 coeren\u021ba, acurate\u021bea \u0219i respectarea standardelor globale de reglementare, cum ar fi <strong data-start=\"3928\" data-end=\"3942\">ISO 7886-1<\/strong>.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Parametrul principal<\/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>Celul\u0103 de sarcin\u0103<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\">200N (sau dup\u0103 cum este necesar)<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\"><strong>Viteza de testare<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\">1~500mm\/min<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\"><strong>Precizie<\/strong><\/td><td class=\"has-text-align-center\" data-align=\"center\">0,01 mm<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\"><strong>Putere<\/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\">Aplica\u021bii \u0219i relevan\u021b\u0103 industrial\u0103<\/h2>\n\n\n\n<p>Testul de scurgere a lichidului din sering\u0103 se aplic\u0103 produc\u0103torilor de:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Seringi hipodermice<\/li>\n\n\n\n<li>Seringi preumplute<\/li>\n\n\n\n<li>Sisteme medicale de injec\u021bie<\/li>\n\n\n\n<li>Laboratoare de inspec\u021bie a calit\u0103\u021bii \u0219i de testare a reglement\u0103rilor<\/li>\n<\/ul>\n\n\n\n<p>Prin \u00eencorporarea acestui test \u00een protocoalele de control al calit\u0103\u021bii, companiile din <strong data-start=\"4253\" data-end=\"4271\">farmaceutice<\/strong>, <strong data-start=\"4273\" data-end=\"4291\">dispozitiv medical<\/strong>, \u0219i <strong data-start=\"4297\" data-end=\"4318\">sectoare de ambalare<\/strong> poate \u00eendeplini cerin\u021bele interna\u021bionale de reglementare \u0219i poate consolida fiabilitatea produsului.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Importan\u021ba testului de scurgere a lichidului din sering\u0103<\/h2>\n\n\n\n<p>Testul de scurgere a lichidului din sering\u0103 este esen\u021bial pentru asigurarea calit\u0103\u021bii \u00een produc\u021bia de seringi hipodermice sterile. O sering\u0103 cu scurgeri prezint\u0103 riscuri semnificative, inclusiv contaminare, dozare inexact\u0103 \u0219i e\u0219ec \u00een timpul administr\u0103rii. Prin efectuarea unui test controlat <strong data-start=\"1288\" data-end=\"1316\">test de scurgere a lichidului din sering\u0103<\/strong>, produc\u0103torii pot identifica punctele slabe ale designului dopului pistonului seringii \u0219i pot preveni intrarea pe pia\u021b\u0103 a unit\u0103\u021bilor defecte.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Metoda de testare bazat\u0103 pe ISO 7886-1 anexa D<\/h2>\n\n\n\n<p><a href=\"https:\/\/www.packqc.com\/ro\/product-category\/iso\/iso-7886-1\/\" target=\"_blank\" rel=\"noopener\"><strong data-start=\"1506\" data-end=\"1520\">ISO 7886-1<\/strong><\/a> este standardul interna\u021bional pentru seringile hipodermice sterile de unic\u0103 folosin\u021b\u0103. Setul <strong data-start=\"1603\" data-end=\"1625\">Testarea ISO 7886-1<\/strong> asigur\u0103 performan\u021bele mecanice \u0219i func\u021bionale ale seringii, inclusiv rezisten\u021ba la scurgeri. Concret, <strong data-start=\"1746\" data-end=\"1768\">ISO 7886-1 Anexa D<\/strong> subliniaz\u0103 <strong data-start=\"1782\" data-end=\"1865\">metod\u0103 de testare a scurgerilor de lichid la nivelul dopului pistonului seringii sub compresie<\/strong>.<\/p>\n\n\n\n<p><strong data-start=\"1506\" data-end=\"1520\">ISO 7886-1<\/strong> este standardul interna\u021bional pentru seringile hipodermice sterile de unic\u0103 folosin\u021b\u0103. Setul <strong data-start=\"1603\" data-end=\"1625\">Testarea ISO 7886-1<\/strong> asigur\u0103 performan\u021bele mecanice \u0219i func\u021bionale ale seringii, inclusiv rezisten\u021ba la scurgeri. Concret, <strong data-start=\"1746\" data-end=\"1768\">ISO 7886-1 Anexa D<\/strong> subliniaz\u0103 <strong data-start=\"1782\" data-end=\"1865\">metod\u0103 de testare a scurgerilor de lichid la nivelul dopului pistonului seringii sub compresie<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Principii de testare din anexa D la ISO 7886-1<\/h2>\n\n\n\n<p>Procedura din anexa D vizeaz\u0103 simularea celor mai nefavorabile condi\u021bii prin combinarea sarcinilor axiale \u0219i radiale asupra pistonului seringii:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Seringa este mai \u00eent\u00e2i umplut\u0103 cu <strong data-start=\"2076\" data-end=\"2095\">ap\u0103 distilat\u0103<\/strong> peste capacitatea sa nominal\u0103.<\/li>\n\n\n\n<li>Dup\u0103 expulzarea aerului, volumul este ajustat la nivelul nominal.<\/li>\n\n\n\n<li>Duza este sigilat\u0103 cu ajutorul unui <strong style=\"font-size: 16px;\" data-start=\"2223\" data-end=\"2252\">racord conic de referin\u021b\u0103<\/strong> \u00een conformitate cu ISO 80369-7 sau un sigiliu echivalent.<\/li>\n\n\n\n<li>O <strong style=\"font-size: 16px;\" data-start=\"2311\" data-end=\"2329\">for\u021b\u0103 lateral\u0103<\/strong> (0,25 N p\u00e2n\u0103 la 3 N) este aplicat\u0103 pistonului pentru a induce deformarea.<\/li>\n\n\n\n<li><strong style=\"font-size: 16px;\" data-start=\"2396\" data-end=\"2414\">Presiune axial\u0103<\/strong> este generat\u0103 \u00een intervalul 200-300 kPa \u0219i men\u021binut\u0103 timp de 30-35 de secunde.<\/li>\n\n\n\n<li>Orice <strong style=\"font-size: 16px;\" data-start=\"2496\" data-end=\"2532\">scurgere dincolo de opritorul cu piston<\/strong> este examinat\u0103 vizual.<\/li>\n<\/ul>\n\n\n\n<p>Aceast\u0103 metodologie asigur\u0103 c\u0103 opritorul cu piston men\u021bine o etan\u0219are etan\u0219\u0103 sub presiune \u0219i stres lateral, reproduc\u00e2nd condi\u021biile reale care ar putea provoca defec\u021biuni.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Cerin\u021be privind echipamentele pentru testarea ISO 7886-1 anexa D<\/h2>\n\n\n\n<p>Pentru a efectua cu exactitate testul de scurgere a lichidului din sering\u0103, este necesar urm\u0103torul echipament:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Un dispozitiv de etan\u0219are pentru duza seringii.<\/li>\n\n\n\n<li>Un dispozitiv de fixare pentru aplicarea for\u021bei radiale asupra pistonului.<\/li>\n\n\n\n<li>Un dispozitiv de presurizare pentru a ajunge la 200-300 kPa.<\/li>\n\n\n\n<li>Ap\u0103 distilat\u0103 (\u00eentre 18\u00b0C \u0219i 28\u00b0C) pentru procesul de umplere.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">\u00centreb\u0103ri frecvente<\/h2>\n\n\n\n<ol class=\"wp-block-list\">\n<li>Pentru ce este utilizat testul de scurgere a lichidului din sering\u0103?<br>Testul de scurgere a lichidului din sering\u0103 evalueaz\u0103 dac\u0103 opritorul pistonului men\u021bine o etan\u0219are corespunz\u0103toare sub compresie, prevenind orice scurgere care ar putea compromite sterilitatea sau precizia dozei.<\/li>\n\n\n\n<li>Cum efectueaz\u0103 testul Cell Instruments\u2019 SPPT-01?<br>Testerul SPPT-01 aplic\u0103 for\u021be radiale \u0219i axiale pistonului seringii \u00een timp ce duza este sigilat\u0103, simul\u00e2nd cele mai nefavorabile condi\u021bii pentru a identifica orice scurgere dincolo de dop.<\/li>\n\n\n\n<li>De ce este important acest test pentru controlul calit\u0103\u021bii?<br>Se asigur\u0103 c\u0103 fiecare sering\u0103 livreaz\u0103 medicamentul \u00een siguran\u021b\u0103 \u0219i cu precizie, prevenind contaminarea, pierderea dozei sau e\u0219ecurile de injectare.<\/li>\n\n\n\n<li>Poate fi utilizat SPPT-01 pentru seringi de dimensiuni diferite?<br>Da, SPPT-01 vine cu mai multe dispozitive de fixare pentru a g\u0103zdui o gam\u0103 larg\u0103 de tipuri \u0219i capacit\u0103\u021bi de seringi, sporindu-i versatilitatea pentru diferite nevoi de testare.<\/li>\n<\/ol>\n\n\n\n<p>Asigurarea capacit\u0103\u021bii unei seringi de a men\u021bine o etan\u0219are f\u0103r\u0103 scurgeri sub presiune este esen\u021bial\u0103 pentru siguran\u021b\u0103 \u0219i performan\u021b\u0103. Caracteristicile <strong data-start=\"4543\" data-end=\"4571\">test de scurgere a lichidului din sering\u0103<\/strong>, astfel cum sunt definite \u00een <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> Anexa D<\/strong>, ofer\u0103 o metod\u0103 standardizat\u0103 \u0219i fiabil\u0103 de evaluare a acestei propriet\u0103\u021bi critice. Utilizarea unui instrument precis \u0219i complet compatibil, cum ar fi <strong data-start=\"4747\" data-end=\"4801\">SPPT-01 Tester de etan\u0219eitate cu presiune pozitiv\u0103 a seringii<\/strong> din <strong data-start=\"4807\" data-end=\"4827\">Instrumente celulare<\/strong> ajut\u0103 produc\u0103torii s\u0103 men\u021bin\u0103 standardele de calitate \u0219i s\u0103 protejeze utilizatorii finali.<\/p>","protected":false},"excerpt":{"rendered":"<p>Ensuring the integrity of disposable syringes is critical for patient safety and product quality in pharmaceutical and medical device manufacturing. Among the most important assessments is the syringe liquid leak test, particularly at the plunger stopper under compression. This test verifies whether any leakage occurs when the plunger is subjected to both axial and radial [&hellip;]<\/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\/ro\/wp-json\/wp\/v2\/products\/9584","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/products"}],"about":[{"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/types\/products"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/media?parent=9584"}],"wp:term":[{"taxonomy":"product-category","embeddable":true,"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/product-category?post=9584"},{"taxonomy":"product-tag","embeddable":true,"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/product-tag?post=9584"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}