{"id":6144,"date":"2026-09-20T18:39:24","date_gmt":"2026-09-20T15:39:24","guid":{"rendered":"https:\/\/aesinn.com\/muayene-periyodik-kontrol\/mekanik-ekipman-muayeneleri\/iso-14644-temiz-oda-standardi-partikul-siniflandirmasi-test-ve-sektorel-gereklilikler\/"},"modified":"2026-09-20T18:43:37","modified_gmt":"2026-09-20T15:43:37","slug":"iso-14644-temiz-oda-standardi-partikul-siniflandirmasi-test-ve-sektorel-gereklilikler","status":"publish","type":"page","link":"https:\/\/aesinn.com\/en\/muayene-periyodik-kontrol\/mekanik-ekipman-muayeneleri\/iso-14644-temiz-oda-standardi-partikul-siniflandirmasi-test-ve-sektorel-gereklilikler\/","title":{"rendered":"ISO 14644 Cleanroom Standard: Particle Classification, Testing and Industry Requirements"},"content":{"rendered":"<h2 class=\"wp-block-heading\">ISO 14644 Nedir ve Neden Gereklidir?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">ISO 14644, temiz oda (cleanroom) ve ili\u015fkili kontroll\u00fc ortamlar\u0131n havadaki partik\u00fcl konsantrasyonuna g\u00f6re s\u0131n\u0131fland\u0131r\u0131lmas\u0131, tasar\u0131m\u0131, i\u015fletilmesi ve do\u011frulanmas\u0131 i\u00e7in uluslararas\u0131 kabul g\u00f6rm\u00fc\u015f standart serisidir. Ama\u00e7, \u00fcretim veya ara\u015ft\u0131rma s\u00fcre\u00e7lerinde \u00fcr\u00fcn kalitesini ve s\u00fcre\u00e7 g\u00fcvenilirli\u011fini bozabilecek havadaki ask\u0131da partik\u00fcllerin (aerosollerin) belirli s\u0131n\u0131rlar i\u00e7inde tutulmas\u0131d\u0131r.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0130la\u00e7, medikal cihaz, yar\u0131 iletken ve benzeri hassas sekt\u00f6rlerde, mikroskobik bir partik\u00fcl dahi \u00fcr\u00fcn kusuruna, kontaminasyona veya s\u00fcre\u00e7 hatas\u0131na yol a\u00e7abilir. ISO 14644, bu kontaminasyon riskini \u00f6l\u00e7\u00fclebilir ve tekrarlanabilir kriterlere ba\u011flayarak farkl\u0131 tesisler ve \u00fclkeler aras\u0131nda ortak bir dil olu\u015fturur.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Bu sayfa, T\u00fcrk \u00fcretici ve ihracat\u00e7\u0131lar\u0131na y\u00f6nelik bir bilgilendirme amac\u0131 ta\u015f\u0131maktad\u0131r; standard\u0131n kavramsal \u00e7er\u00e7evesini \u00f6zetler, tesise \u00f6zg\u00fc bir uygunluk beyan\u0131 veya \u00f6l\u00e7\u00fcm sonucu niteli\u011fi ta\u015f\u0131maz.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n\n<li>Havadaki partik\u00fcl konsantrasyonunu \u00f6l\u00e7\u00fclebilir s\u0131n\u0131flara ba\u011flar<\/li>\n\n\n<li>Tesisler ve \u00fclkeler aras\u0131nda ortak bir kalite dili sa\u011flar<\/li>\n\n\n<li>Kontaminasyon kaynakl\u0131 \u00fcr\u00fcn ve s\u00fcre\u00e7 risklerini y\u00f6netilebilir k\u0131lar<\/li>\n\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Temiz Oda S\u0131n\u0131flar\u0131: ISO S\u0131n\u0131f 1&#8217;den 9&#8217;a Kadar<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">ISO 14644-1 standard\u0131, havan\u0131n temizli\u011fini dokuz s\u0131n\u0131fa ay\u0131r\u0131r: ISO S\u0131n\u0131f 1 en temiz ortam\u0131, ISO S\u0131n\u0131f 9 ise en y\u00fcksek partik\u00fcl konsantrasyonuna izin verilen ortam\u0131 temsil eder. S\u0131n\u0131f numaras\u0131 k\u00fc\u00e7\u00fcld\u00fck\u00e7e metrek\u00fcp ba\u015f\u0131na izin verilen partik\u00fcl say\u0131s\u0131 \u00fcstel olarak azal\u0131r.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">S\u0131n\u0131fland\u0131rma mant\u0131\u011f\u0131, belirli partik\u00fcl boyutu e\u015fiklerinde (0,1 \u00b5m ile 5 \u00b5m aras\u0131nda) metrek\u00fcp havada bulunabilecek azami partik\u00fcl say\u0131s\u0131na dayan\u0131r. Standart, her s\u0131n\u0131f i\u00e7in yaln\u0131zca anlaml\u0131 olan partik\u00fcl boyutlar\u0131n\u0131 dikkate al\u0131r; \u00e7ok temiz s\u0131n\u0131flarda k\u00fc\u00e7\u00fck boyutlu partik\u00fcller (\u00f6rne\u011fin 0,1-0,3 \u00b5m), daha az temiz s\u0131n\u0131flarda ise b\u00fcy\u00fck boyutlu partik\u00fcller \u00f6n plandad\u0131r.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Limit de\u011ferlerinin say\u0131sal kar\u015f\u0131l\u0131klar\u0131 standart taraf\u0131ndan tan\u0131mlanm\u0131\u015ft\u0131r ve her tesiste \u00f6l\u00e7\u00fcm ko\u015fullar\u0131na g\u00f6re yorumlanmas\u0131 gerekir. Kesin bir s\u0131n\u0131f atamas\u0131, ancak akredite bir laboratuvar\u0131n standarda uygun \u00f6l\u00e7\u00fcm\u00fcyle ve yetkili m\u00fchendis teknik de\u011ferlendirmesiyle yap\u0131labilir.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n\n<li>ISO S\u0131n\u0131f 1: en temiz ortam (en d\u00fc\u015f\u00fck partik\u00fcl say\u0131s\u0131)<\/li>\n\n\n<li>ISO S\u0131n\u0131f 5: hassas montaj ve steril s\u00fcre\u00e7lerde yayg\u0131n referans seviyesi<\/li>\n\n\n<li>ISO S\u0131n\u0131f 7-8: bir\u00e7ok kontroll\u00fc \u00fcretim alan\u0131 i\u00e7in tipik hedef<\/li>\n\n\n<li>ISO S\u0131n\u0131f 9: kontroll\u00fc ancak nispeten y\u00fcksek partik\u00fcl toleransl\u0131 ortam<\/li>\n\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">ISO 14644 Standart Ailesi<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">ISO 14644 tek bir belge de\u011fil, birbirini tamamlayan b\u00f6l\u00fcmlerden olu\u015fan bir seridir. Her b\u00f6l\u00fcm, temiz oda ya\u015fam d\u00f6ng\u00fcs\u00fcn\u00fcn farkl\u0131 bir a\u015famas\u0131n\u0131 ele al\u0131r; s\u0131n\u0131fland\u0131rma, s\u00fcrekli izleme, test y\u00f6ntemleri, tasar\u0131m ve ekipman uygunlu\u011fu bu serinin ana eksenleridir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Bu b\u00f6l\u00fcmler birlikte kullan\u0131ld\u0131\u011f\u0131nda, bir temiz odan\u0131n hem ilk devreye alma an\u0131nda hem de rutin i\u015fletme boyunca kontrol alt\u0131nda oldu\u011funu g\u00f6steren b\u00fct\u00fcnc\u00fcl bir \u00e7er\u00e7eve olu\u015fturur.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n\n<li>ISO 14644-1: Partik\u00fcl konsantrasyonuna g\u00f6re hava temizli\u011fi s\u0131n\u0131fland\u0131rmas\u0131<\/li>\n\n\n<li>ISO 14644-2: \u0130zleme (monitoring) \u2014 s\u00fcrekli kontrol\u00fcn s\u00fcrd\u00fcr\u00fclmesi i\u00e7in g\u00f6zlem plan\u0131<\/li>\n\n\n<li>ISO 14644-3: Test y\u00f6ntemleri \u2014 performans\u0131 do\u011frulamak i\u00e7in standart \u00f6l\u00e7\u00fcm prosed\u00fcrleri<\/li>\n\n\n<li>ISO 14644-4: Tasar\u0131m, in\u015fa ve devreye alma k\u0131lavuzu<\/li>\n\n\n<li>ISO 14644-14: Ekipman uygunlu\u011funun partik\u00fcl sal\u0131m\u0131na g\u00f6re de\u011ferlendirilmesi<\/li>\n\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Temiz Odalarda Hangi Testler Yap\u0131l\u0131r?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Bir temiz odan\u0131n hedeflenen s\u0131n\u0131f\u0131 kar\u015f\u0131lad\u0131\u011f\u0131n\u0131n g\u00f6sterilmesi, tek bir \u00f6l\u00e7\u00fcmle de\u011fil, birbirini tamamlayan bir dizi testle m\u00fcmk\u00fcnd\u00fcr. Bu testler ISO 14644-3&#8217;te tan\u0131mlanan y\u00f6ntemlere dayan\u0131r ve tesisin havaland\u0131rma performans\u0131n\u0131, filtrasyon b\u00fct\u00fcnl\u00fc\u011f\u00fcn\u00fc ve kirlilikten ar\u0131nma kapasitesini bir b\u00fct\u00fcn olarak de\u011ferlendirir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Testlerin kapsam\u0131 ve s\u0131kl\u0131\u011f\u0131, odan\u0131n hedef s\u0131n\u0131f\u0131na, kullan\u0131m amac\u0131na ve ilgili sekt\u00f6rel gerekliliklere g\u00f6re de\u011fi\u015fir. \u00d6l\u00e7\u00fcm ekipman\u0131n\u0131n kalibrasyonu ve y\u00f6nteme uygunlu\u011fu, sonu\u00e7lar\u0131n g\u00fcvenilirli\u011fi i\u00e7in belirleyicidir.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n\n<li>Havadaki partik\u00fcl say\u0131m\u0131 (s\u0131n\u0131fland\u0131rman\u0131n temel \u00f6l\u00e7\u00fcm\u00fc)<\/li>\n\n\n<li>Hava debisi ve hava ak\u0131\u015f h\u0131z\u0131 \u00f6l\u00e7\u00fcm\u00fc<\/li>\n\n\n<li>HEPA\/ULPA filtre s\u0131zd\u0131rmazl\u0131k (b\u00fct\u00fcnl\u00fck) testi \u2014 DOP\/PAO aerosol y\u00f6ntemi<\/li>\n\n\n<li>Odalar aras\u0131 bas\u0131n\u00e7 fark\u0131 \u00f6l\u00e7\u00fcm\u00fc (pozitif\/negatif bas\u0131n\u00e7 kademesi)<\/li>\n\n\n<li>Geri kazan\u0131m (recovery) testi \u2014 kirlili\u011fin temizlenme s\u00fcresi<\/li>\n\n\n<li>Saatte hava de\u011fi\u015fim say\u0131s\u0131 (ACH) do\u011frulamas\u0131<\/li>\n\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">\u0130\u015fgal Durumlar\u0131: As-Built, At-Rest ve Operational<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">ISO 14644, bir temiz odan\u0131n \u00fc\u00e7 farkl\u0131 i\u015fgal (occupancy) durumunda de\u011ferlendirilebilece\u011fini tan\u0131mlar. Ayn\u0131 oda, bu durumlar\u0131n her birinde farkl\u0131 partik\u00fcl y\u00fck\u00fc g\u00f6sterebilir; bu nedenle s\u0131n\u0131f beyan\u0131 hangi durumda yap\u0131ld\u0131\u011f\u0131 belirtilerek anlam kazan\u0131r.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">&#8216;\u0130n\u015fa edilmi\u015f&#8217; (as-built) durum, tesisin tamamland\u0131\u011f\u0131 ancak ekipman\u0131n kurulu ve personelin mevcut olmad\u0131\u011f\u0131 a\u015famay\u0131; &#8216;dinlenme&#8217; (at-rest) durumu, havaland\u0131rma ve ekipman\u0131n \u00e7al\u0131\u015ft\u0131\u011f\u0131 ancak personelin bulunmad\u0131\u011f\u0131 a\u015famay\u0131; &#8216;i\u015fletme&#8217; (operational) durumu ise personelin rutin faaliyetlerini y\u00fcr\u00fctt\u00fc\u011f\u00fc ger\u00e7ek \u00fcretim ko\u015fullar\u0131n\u0131 ifade eder. En zorlu ve ger\u00e7ek\u00e7i de\u011ferlendirme genellikle i\u015fletme durumunda elde edilir.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n\n<li>As-built (in\u015fa edilmi\u015f): ekipman ve personel yok<\/li>\n\n\n<li>At-rest (dinlenme): sistemler \u00e7al\u0131\u015f\u0131r, personel yok<\/li>\n\n\n<li>Operational (i\u015fletme): normal \u00fcretim, personel \u00e7al\u0131\u015f\u0131r durumda<\/li>\n\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">ISO 14644 Hangi Sekt\u00f6rler \u0130\u00e7in Gereklidir?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Temiz oda kontrol\u00fc, havadaki partik\u00fcl veya mikrobiyal y\u00fck\u00fcn \u00fcr\u00fcn g\u00fcvenli\u011fini do\u011frudan etkiledi\u011fi t\u00fcm sekt\u00f6rler i\u00e7in kritik \u00f6nemdedir. Bu sekt\u00f6rlerin \u00e7o\u011funda, temiz oda performans\u0131n\u0131n belirli aral\u0131klarla do\u011frulanmas\u0131 yasal veya m\u00fc\u015fteri kaynakl\u0131 bir gerekliliktir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0130hracat yapan T\u00fcrk \u00fcreticileri a\u00e7\u0131s\u0131ndan, hedef pazarlar\u0131n (\u00f6zellikle AB) temiz oda beklentilerini kar\u015f\u0131lamak, pazara eri\u015fimin ve tedarik zinciri kabul\u00fcn\u00fcn \u00f6n ko\u015fulu olabilir.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n\n<li>\u0130la\u00e7 ve steril \u00fcr\u00fcn \u00fcretimi (GMP kapsam\u0131ndaki tesisler)<\/li>\n\n\n<li>Medikal cihaz ve implant \u00fcretimi<\/li>\n\n\n<li>G\u0131da ambalaj\u0131 ve hijyenik dolum hatlar\u0131<\/li>\n\n\n<li>Elektronik ve yar\u0131 iletken (semiconductor) \u00fcretimi<\/li>\n\n\n<li>Optik, hassas mekanik ve havac\u0131l\u0131k bile\u015fenleri<\/li>\n\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">GMP Annex 1 ile \u0130li\u015fki<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u0130la\u00e7 sekt\u00f6r\u00fcnde temiz oda gereklilikleri, AB GMP (\u0130yi \u00dcretim Uygulamalar\u0131) Annex 1 belgesiyle \u015fekillenir. Annex 1, steril \u00fcr\u00fcn \u00fcretimi i\u00e7in A, B, C ve D olarak adland\u0131r\u0131lan temizlik derecelerini (grade) tan\u0131mlar ve bu dereceleri partik\u00fcl limitleri a\u00e7\u0131s\u0131ndan ISO 14644-1 s\u0131n\u0131flar\u0131yla yak\u0131ndan ili\u015fkilendirir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u00d6rne\u011fin, en kritik steril i\u015flem b\u00f6lgeleri (Grade A) \u00e7ok y\u00fcksek bir temizlik seviyesi gerektirirken, \u00e7evreleyen b\u00f6lgeler kademeli olarak daha d\u00fc\u015f\u00fck derecelerle desteklenir. ISO 14644 bu ili\u015fki i\u00e7inde partik\u00fcl \u00f6l\u00e7\u00fcm\u00fc ve s\u0131n\u0131fland\u0131rma i\u00e7in teknik zemini sa\u011flar; Annex 1 ise farmas\u00f6tik ba\u011flamdaki ek mikrobiyolojik ve i\u015fletmesel beklentileri getirir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Bu iki \u00e7er\u00e7evenin birlikte yorumlanmas\u0131 uzmanl\u0131k gerektirir ve tesise \u00f6zg\u00fc de\u011ferlendirme yetkili m\u00fchendis teknik de\u011ferlendirmesi kapsam\u0131nda ele al\u0131nmal\u0131d\u0131r.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n\n<li>Annex 1 dereceleri (A-D) partik\u00fcl limitleri a\u00e7\u0131s\u0131ndan ISO s\u0131n\u0131flar\u0131yla e\u015fle\u015ftirilir<\/li>\n\n\n<li>Grade A: en kritik steril i\u015flem b\u00f6lgesi<\/li>\n\n\n<li>Annex 1, ISO 14644&#8217;e ek mikrobiyolojik ve i\u015fletmesel gereklilikler getirir<\/li>\n\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Bilgilendirme Notu ve AES&#8217;in Kapsam\u0131<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">AES, T\u00dcRKAK taraf\u0131ndan yaln\u0131zca &#8220;6.1 Elektrik Tesisat\u0131&#8221; kapsam\u0131nda akredite A tipi muayene kurulu\u015fudur. ISO 14644 temiz oda s\u0131n\u0131fland\u0131rmas\u0131, AES&#8217;in akreditasyon kapsam\u0131 d\u0131\u015f\u0131nda bir konudur ve bu sayfa yaln\u0131zca genel fark\u0131ndal\u0131k olu\u015fturmak i\u00e7in haz\u0131rlanm\u0131\u015ft\u0131r.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">AES bu kapsamda akredite muayene\/belgelendirme kurulu\u015fu DE\u011e\u0130LD\u0130R; ISO 14644 temiz oda s\u0131n\u0131fland\u0131rma belgesi\/sertifikas\u0131 d\u00fczenlemez.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Bu i\u00e7erik bilgilendirme ama\u00e7l\u0131d\u0131r ve yetkili m\u00fchendis teknik de\u011ferlendirmesi \u00e7er\u00e7evesindedir. Tesisinizin temiz oda gereksinimlerine ili\u015fkin ba\u011flay\u0131c\u0131 bir de\u011ferlendirme i\u00e7in ilgili kapsamda akredite bir kurulu\u015fa ba\u015fvurulmas\u0131 gerekir.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n\n<li>AES akreditasyon kapsam\u0131: yaln\u0131zca 6.1 Elektrik Tesisat\u0131<\/li>\n\n\n<li>ISO 14644 s\u0131n\u0131fland\u0131rma belgesi\/sertifikas\u0131 AES taraf\u0131ndan d\u00fczenlenmez<\/li>\n\n\n<li>\u0130\u00e7erik bilgilendirme ama\u00e7l\u0131d\u0131r; ba\u011flay\u0131c\u0131 de\u011ferlendirme de\u011fildir<\/li>\n\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Related Services<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n\n<li><a href=\"https:\/\/aesinn.com\/en\/muayene-periyodik-kontrol\/mekanik-ekipman-muayeneleri\/basincli-kaplar-ve-tesisatlar-periyodik-testleri\/\">Periodic Testing of Pressure Vessels and Installations<\/a><\/li>\n\n\n<li><a href=\"https:\/\/aesinn.com\/en\/muayene-periyodik-kontrol\/mekanik-ekipman-muayeneleri\/api-510-570-653-statik-ekipman-muayene-kodlari-basincli-kap-proses-boru-hatti-ve-depolama-tanki\/\">API 510 \/ 570 \/ 653 Statik Ekipman Muayene Kodlar\u0131<\/a><\/li>\n\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Frequently Asked Questions<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">ISO 14644-1&#8217;de ka\u00e7 temiz oda s\u0131n\u0131f\u0131 vard\u0131r?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">ISO 14644-1, havan\u0131n temizli\u011fini ISO S\u0131n\u0131f 1&#8217;den ISO S\u0131n\u0131f 9&#8217;a kadar dokuz s\u0131n\u0131fa ay\u0131r\u0131r. S\u0131n\u0131f 1 en temiz ortam\u0131, S\u0131n\u0131f 9 ise en y\u00fcksek partik\u00fcl konsantrasyonuna izin verilen ortam\u0131 temsil eder.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Temiz oda s\u0131n\u0131fland\u0131rmas\u0131nda hangi partik\u00fcl boyutlar\u0131 \u00f6l\u00e7\u00fcl\u00fcr?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Standart, s\u0131n\u0131fland\u0131rma amac\u0131yla 0,1 \u00b5m ile 5 \u00b5m aras\u0131ndaki e\u015fik partik\u00fcl boyutlar\u0131n\u0131 dikkate al\u0131r. Her ISO s\u0131n\u0131f\u0131 i\u00e7in yaln\u0131zca anlaml\u0131 olan boyutlar de\u011ferlendirilir; \u00e7ok temiz s\u0131n\u0131flarda k\u00fc\u00e7\u00fck partik\u00fcller, daha az temiz s\u0131n\u0131flarda b\u00fcy\u00fck partik\u00fcller belirleyicidir.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">As-built, at-rest ve operational durumlar\u0131 aras\u0131ndaki fark nedir?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">As-built durumu ekipman ve personelin bulunmad\u0131\u011f\u0131 tamamlanm\u0131\u015f tesisi; at-rest durumu sistemlerin \u00e7al\u0131\u015ft\u0131\u011f\u0131 ancak personelin olmad\u0131\u011f\u0131 a\u015famay\u0131; operational durumu ise personelin rutin faaliyet y\u00fcr\u00fctt\u00fc\u011f\u00fc ger\u00e7ek \u00fcretim ko\u015fullar\u0131n\u0131 ifade eder. S\u0131n\u0131f beyan\u0131, hangi durumda yap\u0131ld\u0131\u011f\u0131 belirtilerek anlam kazan\u0131r.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Temiz odada hangi testler yap\u0131l\u0131r?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Ba\u015fl\u0131ca testler aras\u0131nda havadaki partik\u00fcl say\u0131m\u0131, hava debisi ve h\u0131z \u00f6l\u00e7\u00fcm\u00fc, HEPA\/ULPA filtre s\u0131zd\u0131rmazl\u0131k testi (DOP\/PAO), odalar aras\u0131 bas\u0131n\u00e7 fark\u0131, geri kazan\u0131m (recovery) testi ve saatte hava de\u011fi\u015fim say\u0131s\u0131 (ACH) do\u011frulamas\u0131 yer al\u0131r.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">ISO 14644 ile GMP Annex 1 aras\u0131ndaki ili\u015fki nedir?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">GMP Annex 1, steril \u00fcretim i\u00e7in A-D temizlik derecelerini tan\u0131mlar ve bunlar\u0131 partik\u00fcl limitleri a\u00e7\u0131s\u0131ndan ISO 14644-1 s\u0131n\u0131flar\u0131yla ili\u015fkilendirir. ISO 14644 partik\u00fcl \u00f6l\u00e7\u00fcm\u00fc i\u00e7in teknik zemini sa\u011flarken, Annex 1 farmas\u00f6tik ba\u011flamdaki ek mikrobiyolojik ve i\u015fletmesel gereklilikleri getirir.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">AES temiz oda s\u0131n\u0131fland\u0131rma belgesi d\u00fczenler mi?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Hay\u0131r. AES yaln\u0131zca 6.1 Elektrik Tesisat\u0131 kapsam\u0131nda akreditedir; ISO 14644 temiz oda s\u0131n\u0131fland\u0131rma belgesi\/sertifikas\u0131 d\u00fczenlemez. Bu sayfadaki i\u00e7erik bilgilendirme ama\u00e7l\u0131d\u0131r ve yetkili m\u00fchendis teknik de\u011ferlendirmesi \u00e7er\u00e7evesindedir.<\/p>","protected":false},"excerpt":{"rendered":"<p>ISO 14644 serisi, temiz oda ve kontroll\u00fc ortamlar\u0131n hava kalitesini partik\u00fcl konsantrasyonuna g\u00f6re s\u0131n\u0131fland\u0131r\u0131r, izler ve test eder. Bu bilgilendirme sayfas\u0131 standard\u0131n kapsam\u0131n\u0131, s\u0131n\u0131flar\u0131n\u0131 ve test parametrelerini \u00fcretici ve ihracat\u00e7\u0131lar i\u00e7in a\u00e7\u0131klar.<\/p>","protected":false},"author":1,"featured_media":6148,"parent":4099,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_kad_blocks_custom_css":"","_kad_blocks_head_custom_js":"","_kad_blocks_body_custom_js":"","_kad_blocks_footer_custom_js":"","_kadence_starter_templates_imported_post":false,"_kad_post_transparent":"","_kad_post_title":"","_kad_post_layout":"","_kad_post_sidebar_id":"","_kad_post_content_style":"","_kad_post_vertical_padding":"","_kad_post_feature":"","_kad_post_feature_position":"","_kad_post_header":false,"_kad_post_footer":false,"_kad_post_classname":"","slim_seo":{"title":"What is the ISO 14644 Cleanroom Standard? | Information","description":"AES information guide on ISO 14644 cleanroom classification (ISO Class 1-9), particle limits, test methods and industry requirements."},"_pplb_hide_from_list":false,"footnotes":""},"class_list":["post-6144","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"taxonomy_info":[],"featured_image_src_large":["https:\/\/aesinn.com\/wp-content\/uploads\/iso14644-aes-kart-1024x1024.png",1024,1024,true],"author_info":{"display_name":"Emre Metin","author_link":"https:\/\/aesinn.com\/en\/author\/yonetim\/"},"comment_info":"","_hostinger_reach_plugin_has_subscription_block":false,"_hostinger_reach_plugin_is_elementor":false,"_links":{"self":[{"href":"https:\/\/aesinn.com\/en\/wp-json\/wp\/v2\/pages\/6144","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/aesinn.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/aesinn.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/aesinn.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/aesinn.com\/en\/wp-json\/wp\/v2\/comments?post=6144"}],"version-history":[{"count":2,"href":"https:\/\/aesinn.com\/en\/wp-json\/wp\/v2\/pages\/6144\/revisions"}],"predecessor-version":[{"id":6153,"href":"https:\/\/aesinn.com\/en\/wp-json\/wp\/v2\/pages\/6144\/revisions\/6153"}],"up":[{"embeddable":true,"href":"https:\/\/aesinn.com\/en\/wp-json\/wp\/v2\/pages\/4099"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/aesinn.com\/en\/wp-json\/wp\/v2\/media\/6148"}],"wp:attachment":[{"href":"https:\/\/aesinn.com\/en\/wp-json\/wp\/v2\/media?parent=6144"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}