{"id":19640,"date":"2022-06-02T23:15:26","date_gmt":"2022-06-02T21:15:26","guid":{"rendered":"https:\/\/sw.fst.com\/magazine\/2025\/07\/bir-farmasotik-muhur-ne-yapabilmelidir\/"},"modified":"2025-07-30T17:49:47","modified_gmt":"2025-07-30T15:49:47","slug":"bir-farmasotik-muhur-ne-yapabilmelidir","status":"publish","type":"post","link":"https:\/\/sw.fst.com\/magazine\/tr\/2022\/06\/bir-farmasotik-muhur-ne-yapabilmelidir\/","title":{"rendered":"Bir farmas\u00f6tik m\u00fch\u00fcr ne yapabilmelidir?"},"content":{"rendered":"\n
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\"\"<\/figure>\n\n\n\n

\u00dcretim<\/h2>\n\n\n\n

SICAKLIKLAR VE BASIN\u00c7LAR<\/strong>\u00d6rne\u011fin organik sentez s\u0131ras\u0131nda y\u00fcksek s\u0131cakl\u0131klar ve bas\u0131n\u00e7lar meydana gelir. \u00c7ok d\u00fc\u015f\u00fck s\u0131cakl\u0131klar, a\u015f\u0131lar\u0131n veya proteinlerin \u00fcretimi s\u0131ras\u0131nda ve d\u00fc\u015f\u00fck s\u0131cakl\u0131klarda \u00e7ok esnek contalar gerektiren kan\u0131n ayr\u0131\u015ft\u0131r\u0131lmas\u0131 s\u0131ras\u0131nda ortaya \u00e7\u0131kabilir. <\/p>\n\n\n\n

CIP\/SIP D\u0130RENC\u0130<\/strong>S\u0131zd\u0131rmazl\u0131k malzemeleri, CIP\/SIPtemizlik maddeleri gibi agresif ortamlara dayanabilmelidir.<\/p>\n\n\n\n

TOZLU MEDYA<\/strong>Contalar\u0131n genellikle tablet preslerinde bulunangibi tozlu medyaya da dayanmas\u0131 gerekir.<\/p>\n\n\n\n

AGRES\u0130F K\u0130MY<\/strong>ASALLARKimyasal olarak \u00fcretilen aktif farmas\u00f6tik bile\u015fenlerin (API’ler) veya in vivo te\u015fhislerin (kontrast maddeleri ve biyobelirte\u00e7ler) \u00fcretiminde, contalar\u0131n dayanabilmesi gereken kimyasallar ve toksik maddeler kullan\u0131l\u0131r.<\/p>\n\n\n\n

UYGUNLUKLAR VE ONAYLAR<\/strong>Y\u00fcksek safl\u0131ktaki proses ortam\u0131yla do\u011frudan temas nedeniyle, contalar\u0131n ila\u00e7 end\u00fcstrisi i\u00e7in USP S\u0131n\u0131f VI ve FDA gibi \u00f6zel onaylara ve uygunluklara sahip olmas\u0131 gerekir.<\/p>\n\n\n\n

EKSTRAKTAB\u0130LLER<\/strong>Y\u00fcksek safl\u0131k gereklilikleri nedeniyle, ila\u00e7 \u00fcreticileri ekstrakte edilebilir madde \u00e7al\u0131\u015fmalar\u0131 yapmakla y\u00fck\u00fcml\u00fcd\u00fcr. Ekstrakte edilebilir maddeler, belirli ko\u015fullar alt\u0131nda (\u00f6rne\u011fin y\u00fcksek s\u0131cakl\u0131klarda veya farkl\u0131 \u00e7\u00f6z\u00fcc\u00fclerle temas halinde) bir ambalaj malzemesinden ekstrakte edilen ve \u00fcr\u00fcne ge\u00e7en kimyasal bile\u015fiklerdir. <\/p>\n\n\n\n

Y\u00dcKSEK S<\/strong>AFLIKLI \u00dcR\u00dcNLERLE DO\u011eRUDAN TEMAS\u0130la\u00e7 end\u00fcstrisinde ila\u00e7 sentezinin istenmeyen yan \u00fcr\u00fcnler \u00fcretmemesi veya herhangi bir yabanc\u0131 maddenin \u00fcr\u00fcne girmesine izin vermemesi gerekti\u011finden, proses ve \u00fcr\u00fcn i\u00e7in safl\u0131k gereksinimleri \u00f6zellikle y\u00fcksektir. Kontaminasyonu g\u00fcvenilir bir \u015fekilde \u00f6nleyen ve \u00fcr\u00fcnle herhangi bir endi\u015fe duymadan temas edebilen s\u0131zd\u0131rmazl\u0131k malzemeleri gereklidir. <\/p>\n\n\n\n

H\u0130JYEN\u0130K TASARIM<\/strong>S\u0131k\u0131 hijyen d\u00fczenlemeleri nedeniyle, contalar hijyenik tasar\u0131ma uygun olarak in\u015fa edilmelidir, b\u00f6ylece sistemlerin g\u00fcvenilir bir \u015fekilde temizlenebilirli\u011fi ve dolay\u0131s\u0131yla steril s\u00fcre\u00e7ler sa\u011flanabilir.<\/p>\n\n\n\n

SAF SU (WFI VE DI SU)<\/strong>Hem WFI su (enjeksiyonluk su, demineralize ultra saf su) hem de DI su (tamamen demineralize su) elastomer malzemelerden \u00e7ok b\u00fcy\u00fck taleplerde bulunur. Uzun s\u00fcreli kullan\u0131mda bu ortamlara dayan\u0131kl\u0131 s\u0131zd\u0131rmazl\u0131k malzemeleri kullan\u0131lmal\u0131d\u0131r. <\/p>\n<\/div><\/div>\n\n

<\/div>\n\n
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\"\"<\/figure>\n\n\n\n

Kalite kontrol ve paketleme<\/h2>\n\n\n\n

\u0130ZLENEB\u0130L\u0130RL\u0130K<\/strong>Bir partinin safl\u0131\u011f\u0131n\u0131 garanti alt\u0131na almak i\u00e7in, s\u00fcre\u00e7lerin belgelendirilmesine \u00f6zellikle dikkat edilir. Bu nedenle m\u00fch\u00fcrler, \u00fcr\u00fcn tan\u0131m\u0131, tasar\u0131m\u0131, boyutlar\u0131, elastomer malzemesi, \u00fcretim tarihi ve seri numaras\u0131 hakk\u0131nda bilgi almak i\u00e7in kullan\u0131labilen lazer i\u015faretleme gibi g\u00fcvenlik etiketlemesi gerektirir. Bu, m\u00fch\u00fcrlerin g\u00fcvenilir bir \u015fekilde izlenebilirli\u011fini sa\u011flar. <\/p>\n<\/div><\/div>\n\n

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\"\"<\/figure>\n\n\n\n

Y\u00fcksek safl\u0131kta son \u00fcr\u00fcn<\/h2>\n\n\n\n

LEACHABLES .<\/strong>..… bir \u00fcr\u00fcn\u00fcn kullan\u0131m \u00f6mr\u00fc boyunca normal \u00e7evre ko\u015fullar\u0131 alt\u0131nda ambalaj malzemelerinden, kaplamalardan vb. a\u00e7\u0131\u011fa \u00e7\u0131kan kimyasal bile\u015fiklerdir. Bu nedenle ila\u00e7 \u00fcreticileri bu konuda kapsaml\u0131 \u00e7al\u0131\u015fmalar yapmakla y\u00fck\u00fcml\u00fcd\u00fcr. Bu, elastomerik bir kar\u0131\u015f\u0131m\u0131n zararl\u0131 bile\u015fenlerinin depolama s\u0131ras\u0131nda ambalaj malzemelerinden sal\u0131nmamas\u0131n\u0131 ve \u00fcr\u00fcne ge\u00e7memesini sa\u011flamak i\u00e7indir. <\/p>\n<\/div><\/div>\n

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\r\n \r\n <\/i>\r\n <\/a>\r\n <\/span>\r\n<\/div><\/div>","protected":false},"excerpt":{"rendered":"

\u00dcretim SICAKLIKLAR VE BASIN\u00c7LAR\u00d6rne\u011fin organik sentez s\u0131ras\u0131nda y\u00fcksek s\u0131cakl\u0131klar ve bas\u0131n\u00e7lar meydana gelir. \u00c7ok d\u00fc\u015f\u00fck s\u0131cakl\u0131klar, a\u015f\u0131lar\u0131n veya proteinlerin \u00fcretimi s\u0131ras\u0131nda ve d\u00fc\u015f\u00fck s\u0131cakl\u0131klarda \u00e7ok esnek contalar gerektiren kan\u0131n ayr\u0131\u015ft\u0131r\u0131lmas\u0131…<\/p>\n","protected":false},"author":3,"featured_media":19642,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[1339],"tags":[1509],"powerkit_post_featured":[],"class_list":["post-19640","post","type-post","status-publish","format-standard","has-post-thumbnail","category-teknoloji-ve-yenilikler","tag-baski-03_2022-tr"],"_links":{"self":[{"href":"https:\/\/sw.fst.com\/magazine\/tr\/wp-json\/wp\/v2\/posts\/19640","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sw.fst.com\/magazine\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/sw.fst.com\/magazine\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/sw.fst.com\/magazine\/tr\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/sw.fst.com\/magazine\/tr\/wp-json\/wp\/v2\/comments?post=19640"}],"version-history":[{"count":1,"href":"https:\/\/sw.fst.com\/magazine\/tr\/wp-json\/wp\/v2\/posts\/19640\/revisions"}],"predecessor-version":[{"id":19646,"href":"https:\/\/sw.fst.com\/magazine\/tr\/wp-json\/wp\/v2\/posts\/19640\/revisions\/19646"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sw.fst.com\/magazine\/tr\/wp-json\/wp\/v2\/media\/19642"}],"wp:attachment":[{"href":"https:\/\/sw.fst.com\/magazine\/tr\/wp-json\/wp\/v2\/media?parent=19640"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sw.fst.com\/magazine\/tr\/wp-json\/wp\/v2\/categories?post=19640"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sw.fst.com\/magazine\/tr\/wp-json\/wp\/v2\/tags?post=19640"},{"taxonomy":"powerkit_post_featured","embeddable":true,"href":"https:\/\/sw.fst.com\/magazine\/tr\/wp-json\/wp\/v2\/powerkit_post_featured?post=19640"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}