{"id":924,"date":"2021-07-09T13:22:42","date_gmt":"2021-07-09T13:22:42","guid":{"rendered":"https:\/\/www.analiztemizoda.com\/?post_type=product&#038;p=924"},"modified":"2021-07-28T07:46:26","modified_gmt":"2021-07-28T07:46:26","slug":"biotrak-9510","status":"publish","type":"product","link":"https:\/\/www.analiztemizoda.com\/en\/product\/biotrak-9510\/","title":{"rendered":"Biotrak 9510 +"},"content":{"rendered":"<p><span style=\"color: #0000ff;\"><a style=\"color: #0000ff;\" href=\"https:\/\/www.analiztemizoda.com\/wp-content\/uploads\/2021\/07\/BioTrak-FAQ_A4_5001727_WEB.pdf\">\u00dcr\u00fcn bro\u015f\u00fcr\u00fc<\/a><\/span><\/p>\n<p>BioTrak\u00ae Ger\u00e7ek Zamanl\u0131 Canl\u0131 Partik\u00fcl Sayac\u0131 (biyofloresan partik\u00fcl dedekt\u00f6r\u00fc) ile aseptik prosesinizi ger\u00e7ekten izole edin.\u00a0Uygulanabilir hava testi i\u00e7in alternatif ve h\u0131zl\u0131 bir mikrobiyolojik y\u00f6ntem (ARMM), farmas\u00f6tik \u00e7evresel izleme i\u00e7in eksiksiz bir \u00e7\u00f6z\u00fcm sunmak i\u00e7in canl\u0131 par\u00e7ac\u0131k say\u0131m\u0131n\u0131 (biyofloresan par\u00e7ac\u0131k say\u0131m\u0131 (BFPC) olarak da adland\u0131r\u0131l\u0131r) \u00f6rnek yakalama \u00f6zelli\u011fi ve ISO uyumlu toplam par\u00e7ac\u0131k say\u0131m\u0131 ile birle\u015ftirir.\u00a0Canl\u0131 ve at\u0131l par\u00e7ac\u0131klar aras\u0131ndaki \u00fcst\u00fcn ayr\u0131m, g\u00fcvenilir canl\u0131 par\u00e7ac\u0131k verileri sa\u011flar.\u00a0Zamanla test edilmi\u015f jelatin filtre teknolojisi, sonraki tan\u0131mlama i\u00e7in \u00f6rneklenen mikroorganizmalar\u0131 verimli bir \u015fekilde yakalar.<\/p>\n<p>TSI\u00a0<a href=\"https:\/\/tsi.com\/products\/cleanroom-particle-counters\/cleanroom-monitoring-systems\/facility-monitoring-system\/\" target=\"_blank\" rel=\"noopener\">FMS Yaz\u0131l\u0131m\u0131<\/a>\u00a0ile birle\u015ftirildi\u011finde,\u00a0\u00e7evresel izleme (EM) m\u00fcdahalelerini ortadan kald\u0131rarak riski azaltmak ve daha iyi s\u00fcre\u00e7 anlay\u0131\u015f\u0131 ile kaliteyi art\u0131rmak i\u00e7in aseptik s\u00fcre\u00e7lerin s\u00fcrekli izlenmesi i\u00e7in kullan\u0131labilir.\u00a021 CFR Part 11 \u00f6zellikli FMS Yaz\u0131l\u0131m\u0131 ile otomatik veri toplama, en y\u00fcksek d\u00fczeyde veri b\u00fct\u00fcnl\u00fc\u011f\u00fc sa\u011flar.<\/p>\n<p>Aseptik s\u00fcre\u00e7lerin izlenmesinin \u00f6tesinde, ba\u011f\u0131ms\u0131z bir ara\u00e7 olarak da de\u011fer sa\u011flayabilir.\u00a0Bu uygulamalar aras\u0131nda rutin periyodik testler, EM ara\u015ft\u0131rmalar\u0131 s\u0131ras\u0131nda kontaminasyon kaynaklar\u0131n\u0131n h\u0131zla belirlenmesi, odan\u0131n derhal serbest b\u0131rak\u0131lmas\u0131na izin vermek i\u00e7in veri toplanmas\u0131 ve iyile\u015ftirilmi\u015f risk de\u011ferlendirmeleri i\u00e7in riskin tan\u0131mlanmas\u0131na ve azalt\u0131lmas\u0131na yard\u0131mc\u0131 olunmas\u0131 yer al\u0131r.\u00a0Ba\u011f\u0131ms\u0131z uygulamalar i\u00e7in Veri B\u00fct\u00fcnl\u00fc\u011f\u00fc Moduna yerle\u015ftirilerek ve birlikte verilen TSI\u00a0<a href=\"https:\/\/tsi.com\/product-accessories\/trakpro-lite-secure-download-software-tpl-s90\/\" target=\"_blank\" rel=\"noopener\">TrakPro&#x2122; Lite G\u00fcvenli Yaz\u0131l\u0131m\u0131<\/a>\u00a0ile birlikte kullan\u0131larak geli\u015fmi\u015f veri b\u00fct\u00fcnl\u00fc\u011f\u00fc elde edilebilir\u00a0\u00a0, Veri B\u00fct\u00fcnl\u00fc\u011f\u00fc Modu, GMP kullan\u0131c\u0131lar\u0131n\u0131n zorlu d\u00fczenleyici gereksinimlerini kar\u015f\u0131lamak i\u00e7in ALCOA+ ilkelerine g\u00f6re tasarlanm\u0131\u015ft\u0131r. TSI ta\u015f\u0131nabilir par\u00e7ac\u0131k sayma aletleri.\u00a0<a href=\"https:\/\/tsi.com\/focus\/cc-data-integrity\/\" target=\"_blank\" rel=\"noopener\">Daha fazla bilgi edinin &gt;<\/a><\/p>\n<h3>\u0130ZLEME \u0130\u00c7\u0130N BU ALTERNAT\u0130F VE HIZLI M\u0130KROB\u0130YOLOJ\u0130K Y\u00d6NTEM\u0130N (ARRM) KULLANILMASINDAN YARARLANAB\u0130LECEK UYGULAMALAR \u015eUNLARI \u0130\u00c7ER\u0130R:<\/h3>\n<ul>\n<li>Aseptik ortamlar\u0131n s\u00fcrekli otomatik izlenmesi<\/li>\n<li>Destek ortamlar\u0131nda s\u00fcrekli otomatik izleme<\/li>\n<li>Geli\u015ftirilmi\u015f k\u00f6k neden ara\u015ft\u0131rmalar\u0131<\/li>\n<li>Oda serbest b\u0131rakma<\/li>\n<li>Risk azaltma<\/li>\n<\/ul>\n<h3>\u00d6ZELL\u0130KLER VE FAYDALAR<\/h3>\n<ul>\n<li>Havadaki canl\u0131 par\u00e7ac\u0131klar\u0131n ger\u00e7ek zamanl\u0131 tespiti\n<ul>\n<li>Tam otomatik s\u00fcre\u00e7 \u2013 medya veya manuel i\u015fleme yok<\/li>\n<\/ul>\n<\/li>\n<li>Hem toplam hem de canl\u0131 par\u00e7ac\u0131klar\u0131n e\u015fzamanl\u0131 tespiti\n<ul>\n<li>ISO 21501-4&#8217;\u00fcn t\u00fcm gerekliliklerine uygundur<\/li>\n<li>1 CFM (28.3 L\/dk) numune ak\u0131\u015f h\u0131z\u0131<\/li>\n<li>Numune alan\u0131nda yaln\u0131zca tek bir izokinetik prob gerektirir<\/li>\n<\/ul>\n<\/li>\n<li>Hat i\u00e7i partik\u00fcl toplama filtresi<\/li>\n<li>Otomatik s\u00fcrekli izleme i\u00e7in ba\u011f\u0131ms\u0131z bir cihaz olarak veya FMS ile tamamen entegre olarak kullan\u0131labilir<\/li>\n<li>Sezgisel simge odakl\u0131 dokunmatik ekran Grafik Kullan\u0131c\u0131 Aray\u00fcz\u00fc<\/li>\n<li>Paslanmaz \u00e7elik muhafaza ve HEPA filtreli egzoz<\/li>\n<\/ul>\n<h3>DAHA FAZLA B\u0130LG\u0130 ED\u0130N<\/h3>\n<ul>\n<li>Video \u2014\u00a0<a href=\"https:\/\/player.vimeo.com\/video\/70651395\" target=\"_blank\" rel=\"noopener\">BioTrak ile Tan\u0131\u015f\u0131n<\/a><\/li>\n<li>Uygulama Notlar\u0131\u00a0<i>\u00a0\u00a0<\/i>\n<ul>\n<li><a href=\"https:\/\/tsi.com\/getmedia\/3b3fae93-2801-418b-85f7-89da3788a841\/CC-123_BioTrak_Root_Cause_Guidance_US-web_1\" target=\"_blank\" rel=\"noopener\">K\u00f6k Neden Ara\u015ft\u0131rma Rehberi (CC-123)<\/a><\/li>\n<li><a href=\"https:\/\/tsi.com\/getmedia\/ba667d47-4ed8-4a38-a4be-bf62f912561a\/CC-124_BioTrak_Evaluation_Guidance_5001467_US_web_1\" target=\"_blank\" rel=\"noopener\">De\u011ferlendirme K\u0131lavuzu (CC-124)<\/a><\/li>\n<li><a href=\"https:\/\/tsi.com\/getmedia\/1e9bde0b-f6db-471b-8aa0-3a8d57772f07\/BioTrak_Facility_Monitoring_Systems_US_CC-105-web_1\" target=\"_blank\" rel=\"noopener\">Tesis \u0130zleme Sistemleri (CC-105)<\/a><\/li>\n<\/ul>\n<\/li>\n<li><i><\/i>Beyaz ka\u011f\u0131tlar\n<ul>\n<li><a href=\"https:\/\/tsi.com\/getmedia\/cf829f4f-416b-42f3-8f08-90be100cba95\/White-Paper_Root-Cause-Investigation_US_5002610_RevA\" target=\"_blank\" rel=\"noopener\">Kesin K\u00f6k Neden Ara\u015ft\u0131rmas\u0131 i\u00e7in Ger\u00e7ek Zamanl\u0131 Canl\u0131 Par\u00e7ac\u0131k Tespiti<\/a><br \/>\nKaynak: TSI<\/li>\n<li><a href=\"https:\/\/tsi.com\/getmedia\/ff8b2754-ae91-498f-a9b5-b9a6819870fe\/BioTrak%20Return%20on%20Investment%20Paper_US_1?ext=.pdf\" target=\"_blank\" rel=\"noopener\">\u200bBioTrak Ger\u00e7ek Zamanl\u0131 Canl\u0131 Par\u00e7ac\u0131k Sayac\u0131 Doldurma-Biti\u015f&#8217;te S\u00fcrekli Ortam \u0130zleme: Yat\u0131r\u0131m Getirisi<\/a><br \/>\nKaynak: TSI<\/li>\n<\/ul>\n<\/li>\n<li>Ba\u015fl\u0131ca end\u00fcstri yay\u0131n \u00f6zellikleri\n<ul>\n<li><a href=\"https:\/\/journal.pda.org\/content\/early\/2021\/01\/15\/pdajpst.2020.012419?utm_source=tsi-website&amp;utm_medium=biotrak-pg-content&amp;utm_campaign=biotrak&amp;utm_content=biotrak-pemm-jan2021\" target=\"_blank\" rel=\"noopener\">Biyo-floresan Partik\u00fcl Saya\u00e7lar\u0131 \u00dczerine Bir Tart\u0131\u015fma: S\u00fcrecin \u00d6zeti ve \u00c7evresel \u0130zleme Y\u00f6ntemleri \u00c7al\u0131\u015fma Grubu FDA Geli\u015fen Teknoloji Ekibi ile Toplant\u0131<\/a><br \/>\nKaynak: PDA Journal of Pharmaceutical Science and Technology<\/li>\n<li><a href=\"http:\/\/journal.pda.org\/content\/73\/2\/121.abstract\" target=\"_blank\" rel=\"noopener\">Aseptik \u00dcretimde Proses Anlama ve Azalt\u0131lm\u0131\u015f M\u00fcdahaleler i\u00e7in S\u00fcrekli Mikrobiyolojik \u00c7evresel \u0130zleme<\/a><br \/>\nKaynak: PDA Journal of Pharmaceutical Science and Technology<\/li>\n<li><a href=\"https:\/\/journal.pda.org\/content\/early\/2019\/12\/13\/pdajpst.2019.009969\" target=\"_blank\" rel=\"noopener\">\u00c7evresel \u0130zleme Ara\u015ft\u0131rmalar\u0131nda Biyo-Floresan Par\u00e7ac\u0131k Say\u0131m\u0131n\u0131n Pratik Uygulamalar\u0131.<\/a><br \/>\nKaynak: PDA Farmas\u00f6tik Bilim ve Teknoloji Dergisi<\/li>\n<li><a title=\"Ger\u00e7ek Zamanl\u0131 Uygulanabilir Par\u00e7ac\u0131k \u0130zleme: Nas\u0131l \u00c7al\u0131\u015f\u0131r? Nas\u0131l Yard\u0131mc\u0131 Olabilir?\" href=\"https:\/\/www.pharmaceuticalonline.com\/doc\/real-time-viable-particle-monitoring-how-does-it-work-how-can-it-help-0001?vm_tId=2045890&amp;user=6c1c6778-9ed8-4c70-b761-8c894264be1c&amp;utm_source=et_6214180&amp;utm_medium=email&amp;utm_campaign=PHARM_01-23-2018&amp;utm_term=6c1c6778-9ed8-4c70-b761-8c894264be1c&amp;utm_content=Real-Time%20Viable%20Particle%20Monitoring%3a%20How%20Does%20It%20Work%3f%20How%20Can%20It%20Help%3f\" target=\"_blank\" rel=\"noopener\">Ger\u00e7ek Zamanl\u0131 Uygulanabilir Par\u00e7ac\u0131k \u0130zleme: Nas\u0131l \u00c7al\u0131\u015f\u0131r?\u00a0Nas\u0131l Yard\u0131mc\u0131 Olabilir?<\/a><br \/>\nKaynak: Farmas\u00f6tik \u00c7evrimi\u00e7i<\/li>\n<li><a href=\"http:\/\/www.biophorum.com\/a-clear-path-to-implementing-alternative-and-rapid-microbiological-methods\/\" target=\"_blank\" rel=\"noopener\">Alternatif ve H\u0131zl\u0131 Mikrobiyolojik Y\u00f6ntemleri Uygulamak \u0130\u00e7in A\u00e7\u0131k Bir Yol.\u00a0<\/a><br \/>\nKaynak: BioPhorum<\/li>\n<\/ul>\n<\/li>\n<li>Web semineri\n<ul>\n<li><a title=\"USP 1223: Yakla\u015fan De\u011fi\u015fiklikler ve Geli\u015fen Teknolojiler\" href=\"https:\/\/vimeo.com\/120729164\" target=\"_blank\" rel=\"noopener\">BioTrak Ger\u00e7ek Zamanl\u0131 Canl\u0131 Par\u00e7ac\u0131k Sayac\u0131 Kullan\u0131larak G\u00fcvenilir K\u00f6k Neden Ara\u015ft\u0131rmalar\u0131<\/a><br \/>\nKaynak: TSI<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h3>YAZILIMI \u0130ND\u0130R<\/h3>\n<p>Uygun yaz\u0131l\u0131m\u0131 ve\/veya donan\u0131m yaz\u0131l\u0131m\u0131n\u0131 indirmek i\u00e7in l\u00fctfen\u00a0\u00a0<a href=\"https:\/\/tsi.com\/support\/tsi-software-and-firmware\/\" target=\"_blank\" rel=\"noopener\">Yaz\u0131l\u0131m\/Firmware Sihirbaz\u0131n\u0131 kullan\u0131n\u00a0<\/a><a title=\"Yaz\u0131l\u0131m\/Firmware Se\u00e7ici\" href=\"http:\/\/www.tsi.com\/SoftwareDownloads\/\" target=\"_blank\" rel=\"noopener\">.<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Aseptik m\u00fcdahaleleri azaltmak, k\u00f6k neden ara\u015ft\u0131rmalar\u0131n\u0131 iyile\u015ftirmek ve s\u00fcre\u00e7 bilgisini art\u0131rmak i\u00e7in farmas\u00f6tik \u00fcretim ortamlar\u0131nda ger\u00e7ek zamanl\u0131 toplam ve canl\u0131 partik\u00fcl say\u0131m\u0131 sa\u011flar.<\/p>","protected":false},"featured_media":925,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[],"product_cat":[36],"product_tag":[],"class_list":["post-924","product","type-product","status-publish","has-post-thumbnail","product_cat-gercek-zamanli-canli-partikul-olcum-cihazi","first","instock","shipping-taxable","product-type-simple"],"_links":{"self":[{"href":"https:\/\/www.analiztemizoda.com\/en\/wp-json\/wp\/v2\/product\/924","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.analiztemizoda.com\/en\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/www.analiztemizoda.com\/en\/wp-json\/wp\/v2\/types\/product"}],"replies":[{"embeddable":true,"href":"https:\/\/www.analiztemizoda.com\/en\/wp-json\/wp\/v2\/comments?post=924"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.analiztemizoda.com\/en\/wp-json\/wp\/v2\/media\/925"}],"wp:attachment":[{"href":"https:\/\/www.analiztemizoda.com\/en\/wp-json\/wp\/v2\/media?parent=924"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/www.analiztemizoda.com\/en\/wp-json\/wp\/v2\/product_brand?post=924"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/www.analiztemizoda.com\/en\/wp-json\/wp\/v2\/product_cat?post=924"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/www.analiztemizoda.com\/en\/wp-json\/wp\/v2\/product_tag?post=924"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}