{"id":2453,"date":"2018-04-10T12:33:15","date_gmt":"2018-04-10T10:33:15","guid":{"rendered":"https:\/\/fedegari.com\/?p=2453"},"modified":"2022-12-07T09:41:45","modified_gmt":"2022-12-07T08:41:45","slug":"fedegari-receives-fda-inspectors","status":"publish","type":"post","link":"https:\/\/fedegari.com\/en\/fedegari-receives-fda-inspectors\/","title":{"rendered":"FEDEGARI RECEIVES FDA INSPECTORS"},"content":{"rendered":"

[vc_row full_width=”stretch_row_content_no_spaces” equal_height=”yes” content_placement=”middle” css=”.vc_custom_1551448839631{background-color: #eaedf2 !important;}”][vc_column width=”1\/2″ css=”.vc_custom_1554287557430{background-image: url(https:\/\/fedegari.com\/wp-content\/uploads\/2019\/04\/news8b.jpg?id=2461) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}” offset=”vc_hidden-xs”][\/vc_column][vc_column width=”1\/2″][vc_row_inner css=”.vc_custom_1551447616941{padding-right: 30px !important;padding-left: 30px !important;}”][vc_column_inner width=”1\/6″][\/vc_column_inner][vc_column_inner width=”2\/3″][vc_empty_space height=”60px”][vc_column_text]<\/p>\n

HOME<\/a> <\/i><\/b><\/span><\/span>\u00a0NEWS<\/span><\/a><\/b><\/span><\/p>\n

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FEDEGARI RECEIVES FDA INSPECTORS FOR A TRAINING ON CHEMICAL BIO-DECONTAMINATION<\/strong><\/h1>\n

[\/vc_column_text][vc_empty_space height=”45px”][vc_column_text css_animation=”fadeIn”]Fedegari US Tech Center provided training on chemical bio-decontaminations for\u00a0 FDA inspectors<\/p>\n

It was a great pleasure to receive the\u00a0FDA\u00a0(Food and Drugs Administration<\/a>) inspectors for a Seminar on chemical\u00a0bio-decontamination<\/a>\u00a0with hydrogen peroxide last March at\u00a0Fedegari Tech Center<\/a>, Sellersville, PA (USA).[\/vc_column_text][vc_empty_space height=”60px”][\/vc_column_inner][vc_column_inner width=”1\/6″][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner offset=”vc_hidden-lg vc_hidden-md vc_hidden-sm”][vc_single_image image=”2240″ img_size=”full”][\/vc_column_inner][\/vc_row_inner][vc_empty_space height=”20px”][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” equal_height=”yes” css=”.vc_custom_1551448777969{margin-top: 60px !important;margin-bottom: 60px !important;}” el_id=”content”][vc_column width=”1\/2″][vc_column_text css_animation=”fadeIn”]Fedegari Training & Education team (represented by Serena Ambrosini and Maria Luisa Bernuzzi) was proud to work with\u00a0Jim Agalloco<\/a>, the internationally recognized expert on aseptic manufacturing, and\u00a0Mesa Labs<\/a>\u00a0to share experiences about processes and applications.<\/p>\n

The one-day training entitled \u201cINSIGHTS IN CHEMICAL BIO-DECONTAMINATION: Design, applications and validation of H2O2 processes\u201d was specially developed for the US FDA inspectors.<\/p>\n

During the training, the FDA inspectors could learn more about process development and they had the opportunity to explore the technology of Fedegari systems and bio-decontamination units (FCDV). In addition, the team was able to better understand the use of biological indicators and Fedegari BI Evaluation Resistometer (BIER).<\/p>\n

It was a great opportunity to exchange ideas and case studies between Fedegari, FDA and Mesa Labs.[\/vc_column_text][vc_empty_space][vc_single_image image=”2457″ img_size=”full”][\/vc_column][vc_column width=”1\/2″][vc_row_inner][vc_column_inner][vc_empty_space height=”60px”][\/vc_column_inner][\/vc_row_inner][vc_column_text]Jim Agalloco<\/a>\u00a0is Fedegari long-term partner and senior advisor<\/p>\n

The training program:<\/strong><\/p>\n

INSIGHTS IN CHEMICAL BIO-DECONTAMINATION:<\/em>
\nDesign, applications and validation of H2O2 processes<\/em><\/p>\n

Vaporized H2O2 processes (J. Agalloco)<\/em>
\nProcess description and challenges<\/em><\/p>\n

Biological Indicators (K. McCauley)<\/em><\/p>\n

Process development and PQ (J. Agalloco)<\/em>
\nValidation activities<\/em><\/p>\n

BI Evaluation Resistometer (M. L. Bernuzzi)<\/em>
\nFedegari prototype<\/em><\/p>\n

Fedegari system demonstration (S. Ambrosini)<\/em>
\nDesign features<\/em>
\nLoad and process examples<\/em><\/p>\n

Process milestones (M. L. Bernuzzi)<\/em>
\nControl, reproducibility, robustness, safety<\/em>[\/vc_column_text][vc_empty_space][vc_single_image image=”2459″ img_size=”full”][\/vc_column][\/vc_row][vc_row][vc_column][vc_empty_space height=”60px”][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” equal_height=”yes” css=”.vc_custom_1551450117939{background-color: #eaedf2 !important;}”][vc_column][vc_row_inner css=”.vc_custom_1552902064695{background-color: #c4161c !important;}”][vc_column_inner][vc_empty_space height=”20px”][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"

Fedegari US Tech Center provided training on chemical …<\/p>\n","protected":false},"author":17,"featured_media":2541,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[153],"tags":[154],"class_list":["post-2453","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en","tag-news-en"],"yoast_head":"\nFEDEGARI RECEIVES FDA INSPECTORS - Fedegari - Innovative solutions for clean and sterile processes<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/fedegari.com\/en\/fedegari-receives-fda-inspectors\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FEDEGARI RECEIVES FDA INSPECTORS - Fedegari - Innovative solutions for clean and sterile processes\" \/>\n<meta property=\"og:description\" content=\"Fedegari US Tech Center provided training on chemical ...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/fedegari.com\/en\/fedegari-receives-fda-inspectors\/\" \/>\n<meta property=\"og:site_name\" content=\"Fedegari - 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