NEDEN TES\u0130S \u0130ZLEME S\u0130STEM\u0130 GEREKL\u0130D\u0130R? <\/b><\/b><\/p>\n
Y\u00fck. Mak. M\u00fch. Bar\u0131\u015f D\u00d6KMEN<\/p>\n
\u00c7evresel izleme sistemi, \u00e7evrenin kalitesini izleyen s\u00fcre\u00e7tir. \u0130zleme sistemi yaz\u0131l\u0131m\u0131, gerekli herhangi bir parametrenin ger\u00e7ek zamanl\u0131 izlenmesine olanak tan\u0131r. Yaz\u0131l\u0131m, \u00e7izelgeler ve grafikler ve ayr\u0131ca alarm (E-posta, SMS, Telefon g\u00f6r\u00fc\u015fmesi) fonksiyonu sunabilir.<\/p>\n
\u0130zleme sistemleri, EU GMP Annex 1 Manufacture of Sterile Medicinal Products, FDA Sterile Drug <\/span>Products Produced by Aseptic Processing – Current Good Manufacturing Practice, ISO 14644-2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration dok\u00fcmanlar\u0131nda do\u011frudan yer almaktad\u0131r. Dok\u00fcmanlarda izleme sistemi ifadelerinin ge\u00e7ti\u011fi baz\u0131 maddeler a\u015fa\u011f\u0131da yer almaktad\u0131r.<\/p>\n EU GMP Annex 1 Manufacture of Sterile Medicinal Products <\/b><\/b><\/p>\n \u2018\u2019The use of appropriate technologies (e.g. Restricted Access Barriers Systems (RABS), isolators, robotic systems, rapid microbial testing and monitoring systems) should be considered to increase the protection of the product from potential extraneous sources of particulate and microbial contamination such as personnel, materials and the surrounding environment, and assist in the rapid detection of potential contaminants in the environment and product.\u2019\u2019 <\/i><\/i><\/p>\n \u201cUygun teknolojilerin kullan\u0131m\u0131 (\u00f6rne\u011fin, K\u0131s\u0131tl\u0131 Eri\u015fim Bariyer Sistemleri (RABS), izolat\u00f6rler, robotik sistemler, h\u0131zl\u0131 mikrobiyal test ve izleme sistemleri), \u00fcr\u00fcn\u00fcn, personel, malzemeler ve \u00e7evre gibi potansiyel yabanc\u0131 partik\u00fcl ve mikrobiyal kontaminasyon kaynaklar\u0131ndan korunmas\u0131n\u0131 art\u0131rmak ve \u00e7evredeki ve \u00fcr\u00fcndeki potansiyel kirleticilerin h\u0131zl\u0131 tespitine yard\u0131mc\u0131 olmak i\u00e7in d\u00fc\u015f\u00fcn\u00fclmelidir. ”<\/p>\n \u2018<\/i><\/span>\u2019Processes and monitoring systems for sterile product manufacture should be designed, commissioned, qualified and monitored by personnel with appropriate process, engineering and microbiological knowledge.\u2019\u2019 <\/i>www.analiztemizoda.com <\/span><\/p>\n \u201cSteril \u00fcr\u00fcn \u00fcretimi i\u00e7in prosesler ve izleme sistemleri uygun proses, m\u00fchendislik ve mikrobiyoloji bilgisine sahip personel taraf\u0131ndan tasarlanmal\u0131, devreye al\u0131nmal\u0131, kalifiye edilmeli ve izlenmelidir.\u201d<\/p>\n \u2018\u2019All non-conformities, such as sterility test failures, environmental monitoring excursions or deviations from established procedures should be investigated.\u2019\u2019 <\/i><\/i><\/p>\n ”Sterilite testi ba\u015far\u0131s\u0131zl\u0131klar\u0131, \u00e7evresel izleme sapmalar\u0131 veya yerle\u015fik prosed\u00fcrlerden sapmalar gibi t\u00fcm uygunsuzluklar ara\u015ft\u0131r\u0131lmal\u0131d\u0131r.”<\/p>\n \u2018\u2019The site\u2019s environmental and process monitoring program forms part of the overall CCS and is used to monitor the controls designed to minimize the risk of microbial and particulate contamination.\u2019\u2019 <\/i><\/i><\/p>\n ”Alan\u0131n \u00e7evre ve proses izleme program\u0131, genel CCS’nin bir par\u00e7as\u0131n\u0131 olu\u015fturur ve mikrobiyal ve partik\u00fcl kontaminasyon riskini en aza indirecek \u015fekilde tasarlanm\u0131\u015f kontrolleri izlemek i\u00e7in kullan\u0131l\u0131r.”<\/p>\n \u2018\u2019Risk assessments should be performed in order to establish a comprehensive environmental monitoring program, i.e. sampling locations, frequency of monitoring, monitoring method used and incubation conditions (e.g. time, temperature(s), aerobic and\/or anaerobic conditions).\u2019\u2019 <\/i><\/i><\/p>\n \u201cNumune alma yerleri, izleme frekans\u0131, kullan\u0131lan izleme y\u00f6ntemi ve ink\u00fcbasyon ko\u015fullar\u0131 (\u00f6rn. zaman, s\u0131cakl\u0131k(lar), aerobik ve\/veya anaerobik ko\u015fullar) gibi kapsaml\u0131 bir \u00e7evresel izleme program\u0131 olu\u015fturmak i\u00e7in risk de\u011ferlendirmeleri yap\u0131lmal\u0131d\u0131r.\u201d<\/p>\n FDA Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice <\/b><\/b><\/p>\n \u2018\u2019An adequate aseptic processing facility monitoring program also will assess conformance with specified clean area classifications under dynamic conditions on a routine basis.\u2019\u2019 <\/i><\/i><\/p>\n \u201cYeterli bir aseptik i\u015fleme tesisi izleme program\u0131, dinamik ko\u015fullar alt\u0131nda rutin olarak belirlenmi\u015f temiz alan s\u0131n\u0131fland\u0131rmalar\u0131na uygunlu\u011fu da de\u011ferlendirecektir.\u201d<\/p>\n \u2018\u2019Regular monitoring should be performed during each production shift. We recommend conducting nonviable particle monitoring with a remote counting system.\u2019\u2019 <\/i><\/i><\/p>\n \u2018\u2019Her \u00fcretim vardiyas\u0131nda d\u00fczenli izleme yap\u0131lmal\u0131d\u0131r. Uzaktan bir say\u0131m sistemi ile cans\u0131z partik\u00fcl izlemesi yapman\u0131z\u0131 \u00f6neririz.”<\/p>\n \u2018\u2019A suitable facility monitoring system will rapidly detect atypical changes that can compromise the facility\u2019s environment.\u2019\u2019 <\/i><\/i><\/p>\n \u201cUygun bir tesis izleme sistemi, tesis ortam\u0131n\u0131 tehlikeye atabilecek atipik de\u011fi\u015fiklikleri h\u0131zla tespit edecektir.\u2019\u2019<\/p>\n \u2018\u2019In aseptic processing, one of the most important laboratory controls is the environmental monitoring program.\u2019\u2019 <\/i><\/i><\/p>\n ”Aseptik i\u015flemede en \u00f6nemli laboratuvar kontrollerinden biri \u00e7evresel izleme program\u0131d\u0131r.”<\/p>\n \u2018\u2019Environmental monitoring data will provide information on the quality of the manufacturing environment.\u2019\u2019 <\/i>www.analiztemizoda.com <\/span><\/p>\n ”\u00c7evresel izleme verileri, \u00fcretim ortam\u0131n\u0131n kalitesi hakk\u0131nda bilgi sa\u011flayacakt\u0131r.”<\/p>\n \u2018\u2019Routine particle monitoring is useful in rapidly detecting significant deviations in air cleanliness from qualified processing norms (e.g., clean area classification).\u2019\u2019 <\/i><\/i><\/p>\n ”Rutin partik\u00fcl izleme, hava temizli\u011findeki, proses kalifikasyon normlar\u0131ndan (\u00f6rne\u011fin, temiz alan s\u0131n\u0131fland\u0131rmas\u0131) \u00f6nemli sapmalar\u0131n h\u0131zla tespit edilmesinde faydal\u0131d\u0131r.”<\/p>\n ISO 14644-2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration <\/b><\/b><\/p>\n Bu standart do\u011frudan izleme sistemleri \u00fczerinde bilgi sa\u011flar. Bu nedenle izleme sistemleri standard\u0131n bir\u00e7ok maddesinde yer almas\u0131na ra\u011fmen a\u015fa\u011f\u0131da birka\u00e7 \u00f6rnek verilmi\u015ftir.<\/p>\n \u2018\u2019This revision of ISO 14644-2 emphasizes the need to consider a monitoring strategy in addition to the initial or periodic execution of the classification of a cleanroom or clean zone in accordance with ISO 14644-1:2015, 5.1. The monitoring activity provides a continuing flow of data over time, thereby providing a more detailed view of the performance of the installation.\u2019\u2019 <\/i><\/i><\/p>\n \u2018\u2019ISO 14644-2’nin bu revizyonu, ISO 14644-1:2015, 5.1 ile uyumlu \u015fekilde, bir temiz oda veya temiz alan s\u0131n\u0131fland\u0131rmas\u0131n\u0131n ilk veya periyodik olarak y\u00fcr\u00fct\u00fclmesine ek olarak bir izleme stratejisinin dikkate al\u0131nmas\u0131 ihtiyac\u0131n\u0131 vurgulamaktad\u0131r. \u0130zleme faaliyeti, zaman i\u00e7inde s\u00fcrekli bir veri ak\u0131\u015f\u0131 sa\u011flayarak, kurulumun performans\u0131n\u0131n daha ayr\u0131nt\u0131l\u0131 bir g\u00f6r\u00fcn\u00fcm\u00fcn\u00fc sa\u011flar.\u2019\u2019<\/p>\n \u2018\u2019This part of ISO 14644 specifies minimum requirements for a monitoring plan for cleanroom or clean zone performance related to air cleanliness by particle concentration, based upon parameters that measure or affect airborne particle concentration.\u2019\u2019 <\/i><\/i><\/p>\n “ISO 14644’\u00fcn bu b\u00f6l\u00fcm\u00fc, havadaki partik\u00fcl konsantrasyonunu \u00f6l\u00e7en veya etkileyen parametrelere dayal\u0131 olarak, partik\u00fcl konsantrasyonuna g\u00f6re hava temizli\u011fi ile ilgili, temiz oda veya temiz alan performans\u0131na dair bir izleme plan\u0131 i\u00e7in minimum gereksinimleri belirtir.”<\/p>\n Neden Tesis \u0130zleme Sistemi? <\/b><\/b><\/p>\n Bir\u00e7ok tesis, partik\u00fcl \u00f6l\u00e7\u00fcmlerini ve di\u011fer \u00e7evresel parametreleri izlemek i\u00e7in tesis izleme sistemleri kurmay\u0131 tercih eder.<\/p>\n Kullan\u0131mda izleme sistemi kurman\u0131n birden fazla faydas\u0131 vard\u0131r. Ancak, bir i\u015fletmeye sa\u011flanan faydalar her zaman tam olarak anla\u015f\u0131lamaz.<\/p>\n Faydalar:<\/p>\n + At\u0131\u011fa giden \u00fcr\u00fcn miktar\u0131n\u0131n azalmas\u0131<\/p>\n + Geli\u015ftirilmi\u015f verim<\/p>\n + \u0130yile\u015ftirilmi\u015f kalite<\/p>\n + Artan kar <\/span>www.analiztemizoda.com<\/p>\n Tesis izleme sistemini sadece d\u00fczenleyici dok\u00fcmanlarda belirtildi\u011fi i\u00e7in kurmay\u0131 ve kullanmay\u0131 se\u00e7enler, \u015fans verilmesi durumunda ilk sermaye ve bak\u0131m maliyetleri pahal\u0131 g\u00f6z\u00fckt\u00fc\u011f\u00fc i\u00e7in bunu tercih etmeyebilirler.<\/p>\n Analiz gerektirecek veri miktar\u0131, uzun zaman gerektiren k\u00f6k neden ara\u015ft\u0131rmalar\u0131na yol a\u00e7an uyar\u0131lar ve eylem gerektiren sapmalar g\u00f6z korkutucu olabilir. Ayr\u0131ca buna, bak\u0131m, kalibrasyon ve do\u011frulama i\u015flemleri nedeniyle olu\u015fan i\u015f y\u00fck\u00fc de ilave olur.<\/p>\n Bir tesis izleme sistemini evde kulland\u0131\u011f\u0131n\u0131z buzdolab\u0131 ya da derin dondurucu gibi d\u00fc\u015f\u00fcn\u00fcn. Bu cihazlar verimli bir \u015fekilde i\u00e7 s\u0131cakl\u0131\u011f\u0131 izleyerek depolanan malzemelerin korunmas\u0131n\u0131 sa\u011flarlar. Yanl\u0131\u015f s\u0131cakl\u0131kta depolanan yiyecekler, insan sa\u011fl\u0131\u011f\u0131 i\u00e7in potansiyel olarak tehlikelidir. Bu yiyecekler m\u00fcdahale edilmezse zamanla bozulmaya ba\u015flar ve sonunda at\u0131lmas\u0131 gerekir. Serin tutulmas\u0131 gereken yiyecek donarsa, yenmez hale gelebilir ve at\u0131k haline gelir. Sonu\u00e7ta enerji bo\u015fa harcanm\u0131\u015f olur.<\/p>\n Buzdolab\u0131n\u0131n veya derin dondurucunun dahili s\u0131cakl\u0131\u011f\u0131n s\u00fcrekli izlenmesi yiyeceklerin bozulmas\u0131 ve insanlar\u0131n yemekten zehirlenmesi risklerini azalt\u0131r. Verimli s\u0131cakl\u0131k izleme enerji tasarrufu sa\u011flar, g\u0131da kalitesini korur ve tasarruf sa\u011flarken at\u0131k miktar\u0131n\u0131 azalt\u0131r. Ayn\u0131 \u015fekilde, bir \u00fcretim prosesini \u00e7evreleyen ortam\u0131 s\u00fcrekli izlemek \u00fcr\u00fcn kalitesi i\u00e7in kritik oldu\u011fundan mant\u0131kl\u0131d\u0131r.<\/p>\n Ya\u015famdan Bir \u00d6rnek <\/b><\/span>www.analiztemizoda.com<\/p>\n Y\u00f6netmelikler Neden \u0130zleme Sisteminin Kurulmas\u0131n\u0131 Bekliyor? <\/b><\/b><\/p>\n K\u0131sa cevap: Risk azalt\u0131lmas\u0131 ve iyi bir i\u015f anlay\u0131\u015f\u0131 i\u00e7in <\/b><\/b><\/p>\n Bir tesis izleme sistemi, tehlike tespit olas\u0131l\u0131\u011f\u0131n\u0131 art\u0131r\u0131r ve bu \u015fekilde riskte azalmaya yol a\u00e7ar. E\u011fer \u00e7ok say\u0131da hava kaynakl\u0131 partik\u00fcl steril \u00fcr\u00fcnlere girerse, \u00fcr\u00fcn kalitesi etkilenir ve hasta g\u00fcvenli\u011fi tehlikeye at\u0131lm\u0131\u015f olur. Yaln\u0131zca, s\u0131k veri toplamak i\u00e7in do\u011fru \u015fekilde konumland\u0131r\u0131lm\u0131\u015f izleme problar\u0131 ile partik\u00fclleri tespit etme \u015fans\u0131 olur. E\u011fer kritik i\u015flem konumuna yak\u0131n partik\u00fcl izleme problar\u0131 yoksa prosese giren par\u00e7ac\u0131klar\u0131 tespit etme \u015fans\u0131 s\u0131f\u0131rd\u0131r.<\/p>\n Kritik verileri bilgiye d\u00f6n\u00fc\u015ft\u00fcrmek \u00e7ok \u00f6nemlidir. (ger\u00e7ek zamanl\u0131 veriler, sunum, raporlar ve alarm bildirimleri) Bu \u015fekilde \u00fcretim s\u00fcreci hakk\u0131nda daha iyi bir anlay\u0131\u015fa ve daha fazla bilgiye sahip olunur. Artan bilgi, s\u00fcre\u00e7 kontrolden \u00e7\u0131kmaya ba\u015flad\u0131\u011f\u0131 anda \u00e7ok ge\u00e7 olmadan sorunu tan\u0131mlamaya yarar. Bu, hasta g\u00fcvenli\u011fini tehlikeye atmadan, daha az ayr\u0131lm\u0131\u015f \u00fcr\u00fcn, daha az at\u0131\u011fa giden \u00fcr\u00fcn ve \u00fcretim <\/span>s\u0131ras\u0131nda daha az kesinti anlam\u0131na gelir.<\/p>\n \u015eekil \u2013 Tesis \u0130zleme Sisteminin Amac\u0131 (Veri \u2013 Bilgi \u2013 Faydal\u0131 Bilgi) www.analiztemizoda.com <\/span><\/p>\n \u0130zleme, \u0130yi Bir \u0130\u015f Anlay\u0131\u015f\u0131 Sa\u011flar <\/b><\/b><\/p>\n G\u00fcn\u00fcm\u00fczde, izleme sistemleri halihaz\u0131rda enerji tasarrufu giri\u015fimlerini desteklemek i\u00e7in kullan\u0131l\u0131yor. Hava de\u011fi\u015fim oranlar\u0131n\u0131 ve hava h\u0131zlar\u0131n\u0131, \u00e7evresel ko\u015fullar\u0131n riske edilmedi\u011fini bilerek g\u00fcvenli bir bi\u00e7imde d\u00fc\u015f\u00fcrebilmek \u00f6nemli enerji tasarrufu sa\u011flar.<\/p>\n Bir tesiste s\u00fcrekli partik\u00fcl izleme, partik\u00fcl konsantrasyon limitlerinden sapman\u0131n ger\u00e7ekle\u015fti\u011fi zaman\u0131 tam olarak bilmeye yarar ve kullan\u0131c\u0131lar an\u0131nda uyar\u0131l\u0131r. Bu, zaman isteyen k\u00f6k neden ara\u015ft\u0131rmalar\u0131n\u0131 destekler ve ayr\u0131lan seriyi (batch) en aza indirerek \u00f6nemli miktarda tasarruf sa\u011flar.<\/p>\n Lazer ile uyar\u0131lan floresan partik\u00fcl say\u0131m\u0131 gibi alternatif mikrobiyolojik y\u00f6ntemlerinin (AMM’ler) ortaya \u00e7\u0131kmas\u0131, prosesi \u00e7evreleyen havan\u0131n mikrobiyolojik kalitesini de an\u0131nda anlayabilmek gibi bir se\u00e7ene\u011fin oldu\u011fu anlam\u0131na gelir. Bu gibi geli\u015fmeler ilerleyen zamanda, muhtemelen m\u00fcdahalesiz \u00fcretimi ve Ger\u00e7ek Zamanl\u0131 Serbest B\u0131rakma Testini (RTRT) sa\u011flayacakt\u0131r.<\/p>\n Gelece\u011fin ak\u0131ll\u0131 fabrikalar\u0131, verilerin birden \u00e7ok platform aras\u0131nda sorunsuz bir \u015fekilde payla\u015f\u0131ld\u0131\u011f\u0131 tamamen birlikte \u00e7al\u0131\u015fabilir sistemlere sahip olacak. Tesis izleme sistemi verilerinin payla\u015f\u0131lmas\u0131 ve merkezile\u015ftirilmesi, bu veriyi karar vermeye yard\u0131mc\u0131 olan b\u00fct\u00fcnsel bir bilgiye d\u00f6n\u00fc\u015ft\u00fcr\u00fcr. Bu b\u00fct\u00fcnsel bilgi sayesinde, bir sapman\u0131n muhtemel oldu\u011funu \u00f6ng\u00f6r\u00fclebilir ve proaktif ad\u0131mlar\u0131n at\u0131lmas\u0131n\u0131 sa\u011flanarak, verimin olumlu y\u00f6nde etkilenmesinin yan\u0131nda \u00fcretim maliyetlerinden \u00f6nemli \u00f6l\u00e7\u00fcde tasarruf sa\u011flan\u0131r.<\/p>\n REFERANSLAR: <\/b><\/b><\/p>\n 1. EU GMP Annex 1 Manufacture of Sterile Medicinal Products<\/p>\n 2. FDA Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice<\/p>\n 3. ISO 14644-2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration<\/p>","protected":false},"excerpt":{"rendered":" NEDEN TES\u0130S \u0130ZLEME S\u0130STEM\u0130 GEREKL\u0130D\u0130R? Y\u00fck. Mak. M\u00fch. Bar\u0131\u015f D\u00d6KMEN \u0130zleme Sistemi Nedir? \u00c7evresel izleme sistemi, \u00e7evrenin kalitesini izleyen s\u00fcre\u00e7tir. \u0130zleme sistemi yaz\u0131l\u0131m\u0131, gerekli herhangi bir parametrenin ger\u00e7ek zamanl\u0131 izlenmesine olanak tan\u0131r. Yaz\u0131l\u0131m, \u00e7izelgeler ve grafikler ve ayr\u0131ca alarm (E-posta, SMS, Telefon g\u00f6r\u00fc\u015fmesi) fonksiyonu sunabilir. \u0130zleme Sistemi Hangi Standartlarda \/ K\u0131lavuz Dok\u00fcmanlarda Ge\u00e7iyor? \u0130zleme sistemleri, […]\n","protected":false},"author":2,"featured_media":1872,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-1882","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/www.analiztemizoda.com\/en\/wp-json\/wp\/v2\/posts\/1882","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.analiztemizoda.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.analiztemizoda.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.analiztemizoda.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.analiztemizoda.com\/en\/wp-json\/wp\/v2\/comments?post=1882"}],"version-history":[{"count":2,"href":"https:\/\/www.analiztemizoda.com\/en\/wp-json\/wp\/v2\/posts\/1882\/revisions"}],"predecessor-version":[{"id":2009,"href":"https:\/\/www.analiztemizoda.com\/en\/wp-json\/wp\/v2\/posts\/1882\/revisions\/2009"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.analiztemizoda.com\/en\/wp-json\/wp\/v2\/media\/1872"}],"wp:attachment":[{"href":"https:\/\/www.analiztemizoda.com\/en\/wp-json\/wp\/v2\/media?parent=1882"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.analiztemizoda.com\/en\/wp-json\/wp\/v2\/categories?post=1882"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.analiztemizoda.com\/en\/wp-json\/wp\/v2\/tags?post=1882"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}