{"id":1215,"date":"2022-10-05T12:26:45","date_gmt":"2022-10-05T12:26:45","guid":{"rendered":"http:\/\/masacare.com.tr\/?page_id=1215"},"modified":"2022-10-20T05:56:49","modified_gmt":"2022-10-20T05:56:49","slug":"clean-room","status":"publish","type":"page","link":"http:\/\/masacare.com.tr\/tr\/clean-room\/","title":{"rendered":"Temiz oda"},"content":{"rendered":"<div data-colibri-id=\"1215-c1\" class=\"style-1724 style-local-1215-c1 position-relative\">\n  <!---->\n  <div data-colibri-component=\"section\" data-colibri-id=\"1215-c2\" id=\"reusable-sections\" class=\"h-section h-section-global-spacing d-flex align-items-lg-center align-items-md-center align-items-center style-1725 style-local-1215-c2 position-relative\">\n    <!---->\n    <!---->\n    <div class=\"h-section-grid-container h-section-fluid-container\">\n      <!---->\n      <div data-colibri-id=\"1215-c3\" class=\"h-row-container gutters-row-lg-0 gutters-row-md-0 gutters-row-2 gutters-row-v-lg-0 gutters-row-v-md-0 gutters-row-v-2 style-1726 style-local-1215-c3 position-relative\">\n        <!---->\n        <div class=\"h-row justify-content-lg-center justify-content-md-center justify-content-center align-items-lg-stretch align-items-md-stretch align-items-stretch gutters-col-lg-0 gutters-col-md-0 gutters-col-2 gutters-col-v-lg-0 gutters-col-v-md-0 gutters-col-v-2\">\n          <!---->\n          <div class=\"h-column h-column-container d-flex h-col-lg-auto h-col-md-auto h-col-auto style-1727-outer style-local-1215-c4-outer\">\n            <div data-colibri-id=\"1215-c4\" class=\"d-flex h-flex-basis h-column__inner h-px-lg-0 h-px-md-0 h-px-0 v-inner-lg-0 v-inner-md-0 v-inner-0 style-1727 style-local-1215-c4 position-relative\">\n              <!---->\n              <!---->\n              <div class=\"w-100 h-y-container h-column__content h-column__v-align flex-basis-100 align-self-lg-start align-self-md-start align-self-start\">\n                <!---->\n                <div data-colibri-id=\"1215-c5\" class=\"h-global-transition-all h-heading style-1728 style-local-1215-c5 position-relative h-element\">\n                  <!---->\n                  <div class=\"h-heading__outer style-1728 style-local-1215-c5\">\n                    <!---->\n                    <!---->\n                    <h2 class=\"\">Temiz Oda Do\u011frulamas\u0131<\/h2>\n                  <\/div>\n                <\/div>\n                <div data-colibri-id=\"1215-c6\" class=\"h-text h-text-component style-1729 style-local-1215-c6 position-relative h-element\">\n                  <!---->\n                  <!---->\n                  <div class=\"\">\n                    <p>Temiz oda do\u011frulamas\u0131, kontroll\u00fc bir ortam\u0131n s\u00fcre\u00e7 gereksinimlerine ve ISO 14644-1:2015 gibi ge\u00e7erli d\u00fczenleyici y\u00f6nergelere uygun olarak performans g\u00f6sterip g\u00f6stermedi\u011fini belirlemek i\u00e7in bir dizi test ger\u00e7ekle\u015ftirerek sa\u011flan\u0131r.\n \u00f6zel bir test program\u0131 olu\u015fturmak i\u00e7in ihtiya\u00e7lar\u0131n\u0131z\u0131 de\u011ferlendirerek sizinle birlikte \u00e7al\u0131\u015facakt\u0131r. En uygun temiz oda do\u011frulama testlerini belirlemek i\u00e7in a\u015fa\u011f\u0131daki gibi fakt\u00f6rleri g\u00f6z \u00f6n\u00fcnde bulunduraca\u011f\u0131z: ISO standard\u0131 veya GMP k\u0131lavuz gereksinimleri Do\u011frulama s\u0131kl\u0131\u011f\u0131\nY\u0131ll\u0131k ve ara testler dahil olmak \u00fczere gereksinimler URS'niz, risk de\u011ferlendirme ve izleme plan\u0131n\u0131z<\/p>\n                    <p>Testler ayr\u0131ca a\u015fa\u011f\u0131dakiler de dahil olmak \u00fczere hangi temiz oda ya\u015fam d\u00f6ng\u00fcs\u00fc a\u015famas\u0131n\u0131n kalifikasyon gerektirdi\u011fine ba\u011fl\u0131 olacakt\u0131r:<\/p>\n                    <ul>\n                      <li>Kurulum Kalifikasyonu (IQ) \u2013 kullan\u0131c\u0131 ve tasar\u0131m gereksinimlerini kar\u015f\u0131lama<\/li>\n                      <li>Operasyonel Kalifikasyon (OQ) \u2013 tan\u0131mlanm\u0131\u015f ko\u015fullar dahilinde faaliyet g\u00f6sterme<\/li>\n                      <li>Performans Kalifikasyonu (PQ) \u2013 \u00e7al\u0131\u015f\u0131r durumda&nbsp;<\/li>\n                    <\/ul>\n                    <p>\n                      <br>\n                    <\/p>\n                    <p>Temiz oda do\u011frulama belgelerimiz ayr\u0131nt\u0131l\u0131 ve denetlenebilir. Test g\u00fcn\u00fcnde bir ara rapor alacaks\u0131n\u0131z ve hemen ard\u0131ndan tam rapor gelecek. Raporlama, gereksinimlerinizi kar\u015f\u0131lamak i\u00e7in ISO standartlar\u0131 ve GMP y\u00f6nergeleri ile uyumludur.\n gereksinimleri ve MHRA gibi herhangi bir atanm\u0131\u015f d\u00fczenleyici kurumun gereksinimleri.<\/p>\n                  <\/div>\n                <\/div>\n              <\/div>\n            <\/div>\n          <\/div>\n          <div class=\"h-column h-column-container d-flex h-col-lg-auto h-col-md-auto h-col-auto style-1734-outer style-local-1215-c7-outer\">\n            <div data-colibri-id=\"1215-c7\" class=\"d-flex h-flex-basis h-column__inner h-ui-empty-state-container h-px-lg-0 h-px-md-0 h-px-0 v-inner-lg-0 v-inner-md-0 v-inner-0 style-1734 style-local-1215-c7 position-relative\">\n              <!---->\n              <!---->\n              <div class=\"w-100 h-y-container h-column__content h-column__v-align flex-basis-100\">\n                <!---->\n              <\/div>\n            <\/div>\n          <\/div>\n        <\/div>\n      <\/div>\n    <\/div>\n  <\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Clean Room Validation Cleanroom validation is provided by conducting a series of tests to qualify if a controlled environment is performing in accordance with process requirements and the applicable regulatory guidelines, such as ISO 14644-1:2015 Our team will work with you, assessing your needs to build a custom testing schedule. To determine the most appropriate [&hellip;]<\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-templates\/full-width-page.php","meta":{"footnotes":""},"class_list":["post-1215","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"http:\/\/masacare.com.tr\/tr\/wp-json\/wp\/v2\/pages\/1215","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/masacare.com.tr\/tr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"http:\/\/masacare.com.tr\/tr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"http:\/\/masacare.com.tr\/tr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/masacare.com.tr\/tr\/wp-json\/wp\/v2\/comments?post=1215"}],"version-history":[{"count":4,"href":"http:\/\/masacare.com.tr\/tr\/wp-json\/wp\/v2\/pages\/1215\/revisions"}],"predecessor-version":[{"id":1488,"href":"http:\/\/masacare.com.tr\/tr\/wp-json\/wp\/v2\/pages\/1215\/revisions\/1488"}],"wp:attachment":[{"href":"http:\/\/masacare.com.tr\/tr\/wp-json\/wp\/v2\/media?parent=1215"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}