{"id":296,"date":"2022-09-24T06:27:41","date_gmt":"2022-09-24T06:27:41","guid":{"rendered":"https:\/\/www.kalibraceteplomeru.cz\/?page_id=296"},"modified":"2025-02-05T13:57:14","modified_gmt":"2025-02-05T13:57:14","slug":"sledovani-a-kontrola-teploty-pri-skladovani-a-preprave-leku","status":"publish","type":"page","link":"https:\/\/www.kalibraceteplomeru.cz\/?page_id=296","title":{"rendered":"Sledov\u00e1n\u00ed a kontrola teploty p\u0159i skladov\u00e1n\u00ed a p\u0159eprav\u011b l\u00e9k\u016f"},"content":{"rendered":"\n

Dokument DIS-15<\/strong>, verze 3 (S\u00daKL) – pokyn pro distributory a v\u00fdrobce l\u00e9\u010div. V dokumentu DIS-15 jsou uvedeny z\u00e1kladn\u00ed po\u017eadavky na zaji\u0161t\u011bn\u00ed, kontrolu a dokumentov\u00e1n\u00ed teploty p\u0159i skladov\u00e1n\u00ed a p\u0159eprav\u011b l\u00e9\u010div.<\/p>\n\n\n\n

<\/div>\n\n\n\n

Vybaven\u00ed skladov\u00fdch prostor m\u011b\u0159\u00edc\u00edm za\u0159\u00edzen\u00edm<\/strong><\/p>\n\n\n\n

V p\u0159\u00edpad\u011b skladov\u00e1n\u00ed l\u00e9\u010div v mraz\u00e1c\u00edch, lednic\u00edch a chlad\u00edc\u00edch boxech je nutn\u00e9 pravideln\u011b ov\u011b\u0159ovat rozlo\u017een\u00ed teplot v prostoru, tzv. teplotn\u00ed mapa. Opakovan\u00e9 ov\u011b\u0159en\u00ed se provede po p\u0159\u00edpadn\u00fdch rekonstrukc\u00edch m\u011bn\u00edc\u00edch vnit\u0159n\u00ed uspo\u0159\u00e1d\u00e1n\u00ed, po z\u00e1saz\u00edch do chlad\u00edc\u00edch \u010di klimatiza\u010dn\u00edch jednotek, kter\u00e9 mohou ovlivnit rozlo\u017een\u00ed teploty. Pomoc\u00ed teplotn\u00ed mapy se z\u00e1rove\u0148 ov\u011b\u0159\u00ed, \u017ee je l\u00e9\u010divo chr\u00e1n\u011bno p\u0159ed mrazem (s v\u00fdjimkou mraz\u00edc\u00edch za\u0159\u00edzen\u00ed). Tuto slu\u017ebu nab\u00edz\u00edme, zde je odkaz: ZDE<\/a><\/p>\n\n\n\n

Po ov\u011b\u0159en\u00ed teplotn\u00ed mapy se teplom\u011bry um\u00edst\u00ed na kritick\u00e1 m\u00edsta v prostory za\u0159\u00edzen\u00ed. <\/p>\n\n\n\n

V p\u0159\u00edpad\u011b, \u017ee jsou l\u00e9\u010diva skladov\u00e1na mimo chlad\u00edc\u00ed\/mraz\u00edc\u00ed za\u0159\u00edzen\u00ed, tak se teplom\u011bry um\u00edst\u00ed do m\u00edsta s p\u0159edpokl\u00e1danou nejvy\u0161\u0161\u00ed dosahovanou teplotou, a to na z\u00e1klad\u011b znalost\u00ed a zku\u0161enost\u00ed. Pokud si u\u017eivatel nen\u00ed jist, provede se ov\u011b\u0159en\u00ed rozlo\u017een\u00ed teplot v prostoru (teplotn\u00ed mapa).<\/p>\n\n\n\n

S rozm\u00edst\u011bn\u00edm teplom\u011br\u016f V\u00e1m r\u00e1di pom\u016f\u017eeme a v p\u0159\u00edpad\u011b zajist\u011bn\u00ed jistoty rozlo\u017een\u00ed, provedeme ov\u011b\u0159en\u00ed rozlo\u017een\u00ed teplot v prostoru.<\/p>\n\n\n\n

<\/div>\n\n\n\n

Po\u017eadavky na m\u011b\u0159\u00edc\u00ed za\u0159\u00edzen\u00ed pro sledov\u00e1n\u00ed teploty skladov\u00e1n\u00ed termolabiln\u00edch l\u00e9\u010div<\/strong><\/p>\n\n\n\n

    \n
  1. Pokud jsou m\u011b\u0159idla teploty nap\u00e1jena elektrick\u00fdm proudem, je t\u0159eba zajistit proveden\u00ed p\u0159edem schv\u00e1len\u00e9ho postupu pro p\u0159\u00edpad v\u00fdpadku proudu.<\/li>\n\n\n\n
  2. U teplom\u011br\u016f mus\u00ed b\u00fdt zaji\u0161t\u011bna funkce alarmu, resp. mus\u00ed b\u00fdt funk\u010dn\u00ed za\u0159\u00edzen\u00ed pro hl\u00e1\u0161en\u00ed p\u0159ekro\u010den\u00ed mez\u00edch hodnot teploty.<\/li>\n\n\n\n
  3. Je t\u0159eba zajistit bezokladn\u00e9 p\u0159edem schv\u00e1len\u00e9 postupy v p\u0159\u00edpad\u011b, \u017ee dojde k signalizaci odchylky od stanoven\u00e9ho teplotn\u00edho rozmez\u00ed (alarmu).<\/li>\n\n\n\n
  4. Mus\u00ed se prov\u00e1d\u011bt pravideln\u00e1 kontrola spr\u00e1vn\u00e9 funkce alarmu.<\/li>\n<\/ol>\n\n\n\n
    <\/div>\n\n\n\n

    Kalibrace m\u011b\u0159idel pro sleddov\u00e1n\u00ed skladovac\u00edch podm\u00ednek<\/strong><\/p>\n\n\n\n

      \n
    1. \u010casov\u00fd interval od rekalibrace teplom\u011br\u016f se stanov\u00ed na z\u00e1klad\u011b posouzen\u00ed rizik a spolehlivosti a podle jejich kontrukce a technick\u00e9ho stavu m\u011b\u0159idla, p\u0159i\u010dem\u017e doba mezi dv\u011bmi, po sob\u011b jdouc\u00edmi kalibracemi, by nem\u011bla b\u00fdt del\u0161\u00ed ne\u017e 24 m\u011bs\u00edc\u016f<\/strong>, s v\u00fdjimkou za\u0159\u00edzen\u00ed pro monitorov\u00e1n\u00ed teploty b\u011bhem p\u0159epravy, kde by nem\u011bl b\u00fdt interval del\u0161\u00ed ne\u017e 12 m\u011bs\u00edc\u016f.<\/li>\n\n\n\n
    2. Pokud je teplota m\u011b\u0159ena m\u011b\u0159\u00edc\u00edmi syst\u00e9my, je t\u0159eba zajistit kalibraci nebo konfirmaci teplotn\u00edch \u010didel ve vazb\u011b na pou\u017e\u00edvanou vyhodnocovac\u00ed a registra\u010dn\u00ed jednotku (tzv. m\u011b\u0159\u00edc\u00ed \u0159etezec).<\/li>\n\n\n\n
    3. Je-li zji\u0161t\u011bna nespr\u00e1vn\u00e1 funkce teplom\u011bru nebo m\u011b\u0159\u00edc\u00edho syst\u00e9mu, je t\u0159eba v\u017edy posoudit vliv na v\u00fdsledky m\u011b\u0159en\u00ed a n\u00e1sledn\u00fd vliv na dodr\u017een\u00ed p\u0159edepsan\u00e9 teploty skladov\u00e1n\u00ed nebo p\u0159epravy uskute\u010d\u0148ovan\u00e9 p\u0159ed t\u00edmto zji\u0161t\u011bn\u00edm a mo\u017en\u00e9 riziko pro jakost skladovan\u00fdch nebo p\u0159epravovan\u00fdch l\u00e9\u010div.<\/li>\n\n\n\n
    4. V r\u00e1mci kalibrace by m\u011bla b\u00fdt zji\u0161t\u011bna, mimo jin\u00e9, tak\u00e9 chyba m\u011b\u0159idla (zjist\u00edte z kalibra\u010dn\u00edho listu).<\/li>\n\n\n\n
    5. Pro sledov\u00e1n\u00ed teploty skladov\u00e1n\u00ed termolabiln\u00edch l\u00e9\u010div by pou\u017eit\u00e9 teploty nem\u011bly vykazovat v\u011bt\u0161\u00ed chybu ne\u017e 0,5 \u00b0C.<\/li>\n\n\n\n
    6. Pro sledov\u00e1n\u00ed teplotn\u00edch podm\u00ednek jin\u00fdch ne\u017e v mraz\u00edc\u00edch a chlad\u00edc\u00edh za\u0159\u00edzen\u00edch by pou\u017eit\u00e9 teplom\u011bry nem\u011bly vykazovat vyt\u0161\u00ed chybu ne\u017e 1,0 \u00b0C.<\/li>\n<\/ol>\n\n\n\n
      <\/div>\n\n\n\n

      Ulo\u017een\u00ed l\u00e9\u010div ve skladu a dodr\u017eov\u00e1n\u00ed skladovac\u00edch podm\u00ednek<\/strong><\/p>\n\n\n\n

        \n
      1. Mus\u00ed b\u00fdt zpracov\u00e1ny seznamy l\u00e9\u010div pro jednotliv\u00e9 skladovac\u00ed re\u017eimy a jsou k dispozici v m\u00edstrnosti p\u0159\u00edjmu nebo je zaji\u0161t\u011bna identifikace skladovac\u00edho re\u017eimu l\u00e9\u010diva p\u0159i p\u0159\u00edjmu pomoc\u00ed polo\u017eek v programu pro skladov\u00e9 hospod\u00e1\u0159stv\u00ed \u0159\u00edzen\u00e9 po\u010d\u00edta\u010dem.<\/li>\n\n\n\n
      2. L\u00e9\u010diva se nesm\u00ed ukl\u00e1dat p\u0159\u00edmo na podlahu, v t\u011bsn\u00e9 bl\u00edzkosti topn\u00fdch t\u011bles a na m\u00edstech vystaven\u00fdch slune\u010dn\u00edmu z\u00e1\u0159en\u00ed, u mraz\u00edc\u00edch a chlad\u00edc\u00edch za\u0159\u00edzen\u00ed, t\u011bsn\u011b vedle st\u011bn,v bl\u00edzkosti mraz\u00edc\u00edch desek, mraz\u00edc\u00edch vlo\u017eek nebo chlad\u00edc\u00edch jednotek a tak\u00e9 na m\u00edstech, kter\u00e1 jsou, na z\u00e1klad\u011b teplotn\u00ed mapy, ozna\u010dena jako nevhodn\u00e1.<\/li>\n\n\n\n
      3. Po\u017eaduje se, aby teplota skladov\u00e1n\u00ed l\u00e9\u010div\u00fdch p\u0159\u00edpravk\u016f byla v rozmez\u00ed dan\u00e9m rozhodnut\u00edm o registraci, v p\u0159\u00edpad\u011b l\u00e9\u010div\u00fdch\/pomocn\u00fdch l\u00e1tek v rozmez\u00ed stanoven\u00e9m v\u00fdrobcem l\u00e9\u010div\u00e9\/pomocn\u00e9 l\u00e1tky.<\/li>\n<\/ol>\n\n\n\n
        <\/div>\n\n\n\n

        Sledov\u00e1n\u00ed a kontrola teploty skladov\u00e1n\u00ed l\u00e9\u010div v\u010detn\u011b veden\u00ed a uchov\u00e1n\u00ed z\u00e1znam\u016f<\/strong><\/p>\n\n\n\n

          \n
        1. Podm\u00ednky skladov\u00e1n\u00ed se denn\u011b kontroluj\u00ed a vedou se o tom z\u00e1znamy.<\/li>\n\n\n\n
        2. U termolabiln\u00edch l\u00e9\u010div se po\u0159izuj\u00ed z\u00e1znamy teplot kontinu\u00e1ln\u011b pomoc\u00ed vhodn\u00e9ho za\u0159\u00edzen\u00ed.<\/li>\n\n\n\n
        3. U l\u00e9\u010div skladovan\u00fdch ze teplotn\u00edch podm\u00ednek jin\u00fdch ne\u017e v mraz\u00edc\u00edch a chlad\u00edc\u00edch za\u0159\u00edzen\u00ed je mo\u017eno po\u0159izovat z\u00e1znamy teplot i manu\u00e1ln\u011b, minim\u00e1ln\u011b jednou denn\u011b, a to v dob\u011b, kdy je o\u010dek\u00e1v\u00e1no, \u017ee teplota skladov\u00e1n\u00ed bude nejm\u00e9n\u011b p\u0159\u00edzniv\u00e1.<\/li>\n\n\n\n
        4. Z\u00e1znamy teplot na elektronick\u00fdch m\u00e9di\u00edch se z\u00e1lohuj\u00ed (pokud se z\u00e1rove\u0148 neukl\u00e1daj\u00ed jako v\u00fdtisk).<\/li>\n<\/ol>\n\n\n\n
          <\/div>\n\n\n\n

          P\u00edsemn\u00fd postup pro kontrolu teploty a pro opat\u0159en\u00ed p\u0159i odchylk\u00e1ch teploty<\/strong><\/p>\n\n\n\n

          Sou\u010d\u00e1st\u00ed t\u011bchto opat\u0159en\u00ed je i posouzen\u00ed mo\u017en\u00e9ho vlivu na jakost l\u00e9\u010diva a posouzen\u00ed m\u00edry rizika dal\u0161\u00ed distribuce l\u00e9\u010diva. V p\u0159\u00edpad\u011b jak\u00fdchkoliv pochybnost\u00ed je nezbytn\u00e9 vy\u017e\u00e1dat vyj\u00e1d\u0159en\u00ed dr\u017eitele rozhodnut\u00ed o registraci (v p\u0159\u00edpad\u011b distribuce l\u00e9\u010div\u00fdch\/pomocn\u00fdch l\u00e1tek v\u00fdrobce l\u00e9\u010div\u00e9\/pomocn\u00e9 l\u00e1tky). Za realizaci tohoto postupu odpov\u00edd\u00e1 kvalifikovan\u00e1 osoba distributora.<\/p>\n\n\n\n

          \n

          R\u00e1di V\u00e1m s nastaven\u00edm syst\u00e9mu sou\u010dinnosti s t\u00edmto na\u0159\u00edzen\u00ed pom\u016f\u017eeme.<\/p>\n<\/blockquote>\n","protected":false},"excerpt":{"rendered":"

          Dokument DIS-15, verze 3 (S\u00daKL) – pokyn pro distributory a v\u00fdrobce l\u00e9\u010div. V dokumentu DIS-15 jsou uvedeny z\u00e1kladn\u00ed po\u017eadavky na zaji\u0161t\u011bn\u00ed, kontrolu a dokumentov\u00e1n\u00ed teploty p\u0159i skladov\u00e1n\u00ed a p\u0159eprav\u011b l\u00e9\u010div. Vybaven\u00ed skladov\u00fdch prostor m\u011b\u0159\u00edc\u00edm za\u0159\u00edzen\u00edm V p\u0159\u00edpad\u011b skladov\u00e1n\u00ed l\u00e9\u010div v mraz\u00e1c\u00edch, lednic\u00edch a chlad\u00edc\u00edch boxech je nutn\u00e9 pravideln\u011b ov\u011b\u0159ovat rozlo\u017een\u00ed teplot v prostoru, tzv. teplotn\u00ed […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-296","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.kalibraceteplomeru.cz\/index.php?rest_route=\/wp\/v2\/pages\/296","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.kalibraceteplomeru.cz\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.kalibraceteplomeru.cz\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.kalibraceteplomeru.cz\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.kalibraceteplomeru.cz\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=296"}],"version-history":[{"count":5,"href":"https:\/\/www.kalibraceteplomeru.cz\/index.php?rest_route=\/wp\/v2\/pages\/296\/revisions"}],"predecessor-version":[{"id":446,"href":"https:\/\/www.kalibraceteplomeru.cz\/index.php?rest_route=\/wp\/v2\/pages\/296\/revisions\/446"}],"wp:attachment":[{"href":"https:\/\/www.kalibraceteplomeru.cz\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=296"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}