{"id":43589,"date":"2022-11-17T15:15:27","date_gmt":"2022-11-17T08:15:27","guid":{"rendered":"https:\/\/techmaster.com.vn\/?page_id=43589"},"modified":"2022-11-17T15:15:27","modified_gmt":"2022-11-17T08:15:27","slug":"compressed-gas-microbial-monitoring-in-aseptic-manufacturing","status":"publish","type":"page","link":"https:\/\/techmaster.com.vn\/en\/compressed-gas-microbial-monitoring-in-aseptic-manufacturing\/","title":{"rendered":"Compressed Gas Microbial Monitoring in Aseptic Manufacturing"},"content":{"rendered":" \t<section class=\"section\" id=\"section_1405142356\">\n\t\t<div class=\"bg section-bg fill bg-fill  \" >\n\n\t\t\t\n\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t <div class=\"row\"  id=\"row-1499986977\"> \n\t<div id=\"col-1764290820\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t \t<div id=\"text-3414476726\" class=\"text\">\n\t\t\r\n<h2 class=\"banner-title\" style=\"text-align: left;\"><span style=\"font-size: 110%;\">Application Note<\/span><\/h2>\r\n\t\t\n<style>\n#text-3414476726 {\n  font-size: 1.6rem;\n  line-height: 1.2;\n  color: rgb(255,255,255);\n}\n#text-3414476726 > * {\n  color: rgb(255,255,255);\n}\n<\/style>\n\t<\/div>\n\t \t\t<\/div>\n\t\t\t\t\n<style>\n#col-1764290820 > .col-inner {\n  padding: 0px 0px 0px 40px;\n  margin: -12px 0px -55px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t <\/div> \t\t<\/div>\n\n\t\t\n<style>\n#section_1405142356 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n}\n#section_1405142356 .section-bg.bg-loaded {\n  background-image: url(https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/07\/banner-knowledge.jpeg);\n}\n#section_1405142356 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#section_1405142356 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n\t<\/section>\n\t \t<section class=\"section\" id=\"section_732092444\">\n\t\t<div class=\"bg section-bg fill bg-fill  bg-loaded\" >\n\n\t\t\t\n\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t <div class=\"row\"  id=\"row-1648512424\"> \n\t<div id=\"col-407996348\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\r\n<h2><span data-text-color=\"alert\">Compressed Gas Microbial Monitoring in Aseptic Manufacturing<\/span><\/h2>\r\n<h2><span data-text-color=\"alert\">Microbial Survival in Compressed Gases Under Fast Decompression to Normal Atmospheric Conditions<\/span><\/h2>\r\n<p>Compressed gas microbial monitoring in aseptic manufacturing presents particular challenges. The FDA guideline for the manufacturing of sterile products using aseptic processes specifically mentions that a compressed gas should be of appropriate purity (e.g., free from oil) and its microbiological and particle quality after filtration should be equal to or better than that of the air in the environment into which the gas is introduced.<\/p>\r\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t \n\t<div id=\"col-246875661\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t \t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_1542900326\">\n\t\t\t\t\t\t\t\t<div class=\"img-inner dark\" >\n\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"843\" height=\"313\" src=\"https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/11\/micro-compressed-gas-table-244.png\" class=\"attachment-large size-large\" alt=\"micro compressed gas table 244\" \/>\t\t\t\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n<style>\n#image_1542900326 {\n  width: 90%;\n}\n<\/style>\n\t<\/div>\n\t \t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t \n\t<div id=\"col-1233916547\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\r\n<p>Additional guidance on cleanroom or clean air monitoring and limits of particulate and microbial contaminants in the pharmaceutical industry is provided in\u00a0<span data-text-color=\"alert\">EU GMP Annex 1<\/span>\u00a020082 , and the USP chapter 11163 . A more specific reference is ISO 8573, a group of international standards relating to the quality (or purity) of compressed air. The standard consists of nine separate parts, with part 1 specifying the quality requirements of the compressed air4 and parts 2 \u2013 9 specifying the methods of testing for a range of contaminants. The test method for microbial monitoring of compressed gases is provided in ISO 8573-75 .<\/p>\r\n<p style=\"text-align: center;\"><strong>Interested in Learning More?<br \/>Complete the form to download the complete paper.<\/strong><\/p>\r\n<p>Looking for a microbial monitoring solution? Particle Measuring Systems (PMS) has a wide range of portable and remote microbial viable samplers including:<\/p>\r\n<ul>\r\n<li>MiniCapt Active Air Samplers available in a variety of\u00a0<span data-text-color=\"alert\">portable<\/span>\u00a0or\u00a0<span data-text-color=\"alert\">remote<\/span>\u00a0models\r\n<ul>\r\n<li>use with the\u00a0<span data-text-color=\"alert\">compressed gas kit<\/span><\/li>\r\n<\/ul>\r\n<\/li>\r\n<li>BioCapt Impactors available as a\u00a0<span data-text-color=\"alert\">single use solution<\/span>\u00a0or\u00a0<span data-text-color=\"alert\">stainless steel<\/span><\/li>\r\n<\/ul>\r\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t <\/div> \t\t<\/div>\n\n\t\t\n<style>\n#section_732092444 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n}\n#section_732092444 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#section_732092444 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n\t<\/section>\n\t ","protected":false},"excerpt":{"rendered":"","protected":false},"author":11,"featured_media":43591,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-blank.php","meta":{"footnotes":""},"class_list":["post-43589","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.8 (Yoast SEO v26.8) - 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