{"id":7087,"date":"2025-07-21T09:12:31","date_gmt":"2025-07-21T01:12:31","guid":{"rendered":"https:\/\/www.qualitester.com\/?page_id=7087"},"modified":"2025-07-21T09:12:31","modified_gmt":"2025-07-21T01:12:31","slug":"breaking-tester","status":"publish","type":"page","link":"https:\/\/www.qualitester.com\/cs\/applications\/breaking-tester\/","title":{"rendered":"Jak pou\u017e\u00edvat zku\u0161ebn\u00ed za\u0159\u00edzen\u00ed pro l\u00e1m\u00e1n\u00ed ampul\u00ed: ISO 9187"},"content":{"rendered":"

Jak pou\u017e\u00edvat p\u0159\u00edstroj na testov\u00e1n\u00ed l\u00e1mavosti ampul\u00ed
\nISO 9187<\/small><\/h1>\n
\n

Kontrola mechanick\u00e9 integrity ampul\u00ed m\u00e1 z\u00e1sadn\u00ed v\u00fdznam pro zaji\u0161t\u011bn\u00ed bezpe\u010dn\u00e9ho pod\u00e1v\u00e1n\u00ed l\u00e9\u010div, zejm\u00e9na u injek\u010dn\u00edch p\u0159\u00edpravk\u016f. Tento \u010dl\u00e1nek nab\u00edz\u00ed podrobn\u00e9ho a odborn\u00e9ho pr\u016fvodce na t\u00e9ma jak pou\u017e\u00edvat tester na l\u00e1m\u00e1n\u00ed ampul\u00ed<\/strong> pro ampule, v souladu s ISO 9187<\/strong><\/a> normy. D\u00e1le vysv\u011btluje \u00falohu s\u00edla ampule<\/strong> testov\u00e1n\u00ed a p\u0159edstavuje Zku\u0161ebn\u00ed stroj na m\u011b\u0159en\u00ed lomov\u00e9 s\u00edly<\/strong> jako nepostradateln\u00fd n\u00e1stroj v oblasti kontroly kvality ve farmaceutick\u00e9m pr\u016fmyslu. A\u0165 u\u017e jste technik kontroly kvality, pracovn\u00edk v oblasti regulace nebo vedouc\u00ed laborato\u0159e, tento \u010dl\u00e1nek v\u00e1m p\u0159in\u00e1\u0161\u00ed praktick\u00e9 informace, kter\u00e9 p\u0159\u00edmo podporuj\u00ed va\u0161e c\u00edle v oblasti dodr\u017eov\u00e1n\u00ed p\u0159edpis\u016f a integrity produkt\u016f.<\/p>\n

\n

Porozum\u011bn\u00ed pevnosti ampul\u00ed a zkou\u0161k\u00e1m pevnosti v rozlomen\u00ed ampul\u00ed<\/h2>\n

S\u00edla ampule<\/strong> ozna\u010duje odolnost ampule v\u016f\u010di vn\u011bj\u0161\u00edm mechanick\u00fdm sil\u00e1m a\u017e do okam\u017eiku, kdy se rozbije v m\u00edst\u011b, kter\u00e9 je pro tento \u00fa\u010del ur\u010deno. P\u0159esn\u00e9 stanoven\u00ed t\u00e9to rozb\u00edjec\u00ed s\u00edly je nezbytn\u00e9 pro zachov\u00e1n\u00ed bezpe\u010dnosti a pou\u017eitelnosti v\u00fdrobku. Nespr\u00e1vn\u00e9 hodnoty rozb\u00edjec\u00ed s\u00edly mohou v\u00e9st k:<\/p>\n

    \n
  • Rozbit\u00ed ampulky p\u0159i otev\u00edr\u00e1n\u00ed<\/li>\n
  • Zne\u010di\u0161t\u011bn\u00ed zp\u016fsoben\u00e9 nekontrolovan\u00fdm prasknut\u00edm<\/li>\n
  • Probl\u00e9my p\u0159i otev\u00edr\u00e1n\u00ed ze strany zdravotnick\u00e9ho person\u00e1lu<\/li>\n<\/ul>\n

    K posouzen\u00ed t\u00e9to vlastnosti se Zku\u0161ebn\u00ed stroj na m\u011b\u0159en\u00ed lomov\u00e9 s\u00edly<\/strong> hraje z\u00e1sadn\u00ed roli. Vyv\u00edj\u00ed tahovou s\u00edlu p\u0159i \u0159\u00edzen\u00e9 rychlosti a pod \u0159\u00edzen\u00fdm \u00fahlem, co\u017e umo\u017e\u0148uje spolehliv\u00e1 a reprodukovateln\u00e1 m\u011b\u0159en\u00ed.<\/p>\n

    \n

    Pro\u010d pou\u017e\u00edvat p\u0159\u00edstroj na m\u011b\u0159en\u00ed pevnosti v tahu ampul\u00ed?<\/h2>\n

    A Zku\u0161ebn\u00ed stroj na m\u011b\u0159en\u00ed lomov\u00e9 s\u00edly<\/strong> zaji\u0161\u0165uje p\u0159esn\u00e1 a standardizovan\u00e1 m\u011b\u0159en\u00ed lomov\u00e9 s\u00edly pot\u0159ebn\u00e9 k odd\u011blen\u00ed stopky ampule od jej\u00edho t\u011bla. Podle ISO 9187-1:2010<\/strong>, bod 6 \u2013 jedn\u00e1 se o p\u0159edepsan\u00fd postup pro posouzen\u00ed mechanick\u00e9 integrity ampule. Mezi hlavn\u00ed v\u00fdhody pat\u0159\u00ed:<\/p>\n

      \n
    • Dodr\u017eov\u00e1n\u00ed ISO 7500-1<\/strong> pro stroje na zkou\u0161en\u00ed tahem<\/li>\n
    • Rozsah s\u00edly a\u017e 200 N p\u0159i zku\u0161ebn\u00ed rychlosti 10 mm\/min<\/li>\n
    • Minim\u00e1ln\u00ed vliv obsluhy<\/li>\n
    • Schopnost rozli\u0161it \u010dist\u00fd lom od lomu s poru\u0161en\u00edm materi\u00e1lu<\/li>\n<\/ul>\n

      Spole\u010dnost Cell Instruments doporu\u010duje BST-01 Tester pro poru\u0161en\u00ed ampul\u00ed<\/strong> jako spolehliv\u00e9 \u0159e\u0161en\u00ed t\u011bchto zkou\u0161ek, kter\u00e9 spl\u0148uje p\u0159\u00edslu\u0161n\u00e9 normy.<\/p>\n

      \n

      Krok za krokem: Jak pou\u017e\u00edvat tester na l\u00e1m\u00e1n\u00ed ampul\u00ed<\/h2>\n

      Abyste zajistili p\u0159esn\u00e9 a p\u0159edpis\u016fm vyhovuj\u00edc\u00ed v\u00fdsledky test\u016f, postupujte podle n\u00e1sleduj\u00edc\u00edch podrobn\u00fdch pokyn\u016f:<\/p>\n

      1. P\u0159ipravte si vybaven\u00ed<\/strong><\/h3>\n

      Ujist\u011bte se, \u017ee zku\u0161ebn\u00ed za\u0159\u00edzen\u00ed pro zkou\u0161ku pevnosti v tahu spl\u0148uje po\u017eadavky normy ISO 7500-1:<\/p>\n

        \n
      • Kalibrov\u00e1no pro rozsah s\u00edly 200 N<\/li>\n
      • \u0158\u00edzen\u00fd pohyb p\u0159i 10 mm\/min<\/strong><\/li>\n
      • P\u0159\u00edslu\u0161enstv\u00ed ur\u010den\u00e9 k p\u016fsoben\u00ed s\u00edly na 90\u00b0<\/strong> pod\u00e9l osy ampule<\/li>\n<\/ul>\n

        Pou\u017eijte tester, jako je nap\u0159\u00edklad Cell Instruments BST-01<\/strong>, kter\u00fd je vybaven ergonomick\u00fdm up\u00ednac\u00edm syst\u00e9mem a digit\u00e1ln\u00edm ovl\u00e1d\u00e1n\u00edm zaji\u0161\u0165uj\u00edc\u00edm p\u0159esnost.<\/p>\n

        2. \u00daprava vzork\u016f<\/strong><\/h3>\n

        Podle ISO 9187-1, odd\u00edl 6.3.2<\/strong>:<\/p>\n

          \n
        • Ampule skladujte p\u0159i teplot\u011b 20 \u00b1 5 \u00b0C<\/strong> nejm\u00e9n\u011b 24 hodin p\u0159ed proveden\u00edm testu.<\/li>\n
        • N\u00e1hodn\u00fd v\u00fdb\u011br ampul\u00ed na z\u00e1klad\u011b ISO 2859-1, \u00farove\u0148 kontroly S-4<\/strong>.<\/li>\n<\/ul>\n

          3. Nastaven\u00ed parametr\u016f testu<\/strong><\/h3>\n

          Nastavte tester n\u00e1sleduj\u00edc\u00edm zp\u016fsobem:<\/p>\n

            \n
          • Nastavte p\u016fsoben\u00ed s\u00edly na 10 mm\/min<\/strong><\/li>\n
          • Nasm\u011brujte ampulku tak, aby p\u0159edem stanoven\u00fd bod zlomu<\/strong> (nap\u0159. keramick\u00fd krou\u017eek) je um\u00edst\u011bn uprost\u0159ed mezi kovov\u00fdmi ty\u010demi<\/li>\n
          • Je t\u0159eba vyvinout s\u00edlu kolm\u00fd<\/strong> pod\u00e9l osy ampule<\/li>\n<\/ul>\n

            4. Prove\u010fte test<\/strong><\/h3>\n
              \n
            • Upevn\u011bte ampulku tak, aby jej\u00ed z\u00fa\u017een\u00ed bylo sev\u0159eno mezi dv\u011bma kovov\u00fdmi \u010delistmi<\/li>\n
            • Spus\u0165te stroj; ten bude automaticky vyv\u00edjet tahovou s\u00edlu, dokud se ampule nerozbije<\/li>\n
            • Zaznamenat hodnota lomov\u00e9 s\u00edly<\/strong> a sledujte kvalitu zlomu (\u010dist\u00fd zlom vs. rozt\u0159\u00ed\u0161t\u011bn\u00fd)\n