{"id":1658,"date":"2021-06-29T07:00:02","date_gmt":"2021-06-29T01:30:02","guid":{"rendered":"https:\/\/www.kewaunee.in\/blog\/?p=1658"},"modified":"2024-07-15T12:30:18","modified_gmt":"2024-07-15T07:00:18","slug":"cleanroom-classification-requirements","status":"publish","type":"post","link":"https:\/\/www.kewaunee.in\/blog\/cleanroom-classification-requirements\/","title":{"rendered":"Cleanroom Classification &#038; Requirements"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row full_width=&#8221;stretch_row&#8221; equal_height=&#8221;yes&#8221; content_placement=&#8221;middle&#8221; css=&#8221;.vc_custom_1594037823219{margin-top: 0px !important;margin-bottom: 0px !important;padding-top: 40px !important;padding-bottom: 40px !important;}&#8221;][vc_column]<h1 class=\"boc_heading  al_left  \"  style=\"margin-bottom: 20px;margin-top: 0px;color: #333;\"><span>Cleanroom Classification Requirements<\/span><\/h1>[vc_column_text]A cleanroom is an environment typically used in different laboratories, where low level of environmental pollutants and a high level of sterility is required. It is a \u2018contained space\u2019 where arrangements are made to reduce the introduction, production, and storage of particles inside the room and to control other environmental factors such as temperature, humidity, and pressure.<\/p>\n<p>Depending on specific needs, cleanrooms have various levels of contaminants, such as airborne particles, dust particles, and chemical vapors, to be measured in the number of particles per meter. Cleanrooms are widely utilized in the following areas because they are sensitive to environmental contamination:<\/p>\n<ul>\n<li>Biotechnology labs<\/li>\n<li>Electronic assembly<\/li>\n<li>Semiconductor manufacturing<\/li>\n<li>Pharmaceutical labs<\/li>\n<li>Medical labs<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_column_text]<\/p>\n<h2 class=\"text123\" style=\"text-align: left; color: #ca2527; font-size: 22px;\">OBJECTIVE OF A CLEANROOM<\/h2>\n<p>[\/vc_column_text][vc_column_text]The main objective of a cleanroom is <em>\u201cto maintain a constant environment with controlled levels of airborne particles.\u201d<\/em><\/p>\n<p>This can be achieved by taking preventive measures so that contaminated particles and pollutants will not enter the contained spaces. External air entering the environment should be filtered and often kept at a positive pressure so that the unfiltered air will not be entered into the filtered environment.[\/vc_column_text][vc_column_text]<\/p>\n<h2 class=\"text123\" style=\"text-align: left; color: #ca2527; font-size: 22px;\">CLEANROOM CLASSIFICATIONS<\/h2>\n<p>[\/vc_column_text][vc_column_text]Cleaning chambers are classified according to the air quality based on the value of 0.5 mm or larger particles per cubic feet or meters consistent with\u00a0US Federal Standard 209 (A through D). They are\u00a0classified\u00a0consistent with\u00a0the amount\u00a0and size of particles that are permitted per volume of air.\u00a0The following is a table shows the various cleanroom classifications based on US Federal Standards:[\/vc_column_text][vc_column_text]<\/p>\n<div class=\"responsive_table_container\">\n<table class=\"fortuna_table\" style=\"height: 94px;\" width=\"953\">\n<tbody>\n<tr>\n<td rowspan=\"2\" width=\"104\"><strong>Class<\/strong><\/td>\n<td colspan=\"5\" width=\"491\"><strong>Maximum particles\/ft<sup>3<\/sup><\/strong><\/td>\n<td width=\"112\"><strong>ISO equivalent<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"113\"><strong>\u22650.1 \u00b5m<\/strong><\/td>\n<td width=\"104\"><strong>\u22650.2 \u00b5m<\/strong><\/td>\n<td width=\"94\"><strong>\u22650.3 \u00b5m<\/strong><\/td>\n<td width=\"95\"><strong>\u22650.5 \u00b5m<\/strong><\/td>\n<td width=\"85\"><strong>\u22655 \u00b5m<\/strong><\/td>\n<td width=\"112\"><\/td>\n<\/tr>\n<tr>\n<td width=\"104\">1<\/td>\n<td width=\"113\">35<\/td>\n<td width=\"104\">7.5<\/td>\n<td width=\"94\">3<\/td>\n<td width=\"95\">1<\/td>\n<td width=\"85\">0.007<\/td>\n<td width=\"112\">ISO 3<\/td>\n<\/tr>\n<tr>\n<td width=\"104\">10<\/td>\n<td width=\"113\">350<\/td>\n<td width=\"104\">75<\/td>\n<td width=\"94\">30<\/td>\n<td width=\"95\">10<\/td>\n<td width=\"85\">0.07<\/td>\n<td width=\"112\">ISO 4<\/td>\n<\/tr>\n<tr>\n<td width=\"104\">100<\/td>\n<td width=\"113\">3,500<\/td>\n<td width=\"104\">750<\/td>\n<td width=\"94\">300<\/td>\n<td width=\"95\">100<\/td>\n<td width=\"85\">0.7<\/td>\n<td width=\"112\">ISO 5<\/td>\n<\/tr>\n<tr>\n<td width=\"104\">1,000<\/td>\n<td width=\"113\">35,000<\/td>\n<td width=\"104\">7,500<\/td>\n<td width=\"94\">3,000<\/td>\n<td width=\"95\">1,000<\/td>\n<td width=\"85\">7<\/td>\n<td width=\"112\">ISO 6<\/td>\n<\/tr>\n<tr>\n<td width=\"104\">10,000<\/td>\n<td width=\"113\">350,000<\/td>\n<td width=\"104\">75,000<\/td>\n<td width=\"94\">30,000<\/td>\n<td width=\"95\">10,000<\/td>\n<td width=\"85\">70<\/td>\n<td width=\"112\">ISO 7<\/td>\n<\/tr>\n<tr>\n<td width=\"104\">100,000<\/td>\n<td width=\"113\">3.5\u00d710<sup>6<\/sup><\/td>\n<td width=\"104\">750,000<\/td>\n<td width=\"94\">300,000<\/td>\n<td width=\"95\">100,000<\/td>\n<td width=\"85\">830<\/td>\n<td width=\"112\">ISO 8<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p>[\/vc_column_text][vc_row_inner][vc_column_inner][vc_column_text]The US federal standards were officially canceled in November 2001, with most switching to ISO-14644-1 and ISO 14698 standards that measure the number and size of particles that are permitted per cubic meter of air. The following is the table:[\/vc_column_text][vc_column_text]<\/p>\n<div class=\"responsive_table_container\">\n<table class=\"fortuna_table\" style=\"height: 94px;\" width=\"953\">\n<tbody>\n<tr>\n<td rowspan=\"2\" width=\"85\"><strong>Class<\/strong><\/td>\n<td colspan=\"6\" width=\"533\"><strong>Maximum particles\/m<sup>3 a<\/sup><\/strong><\/td>\n<td width=\"86\"><strong>FED STD 209E equivalent<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"112\"><strong>\u22650.1 \u00b5m<\/strong><\/td>\n<td width=\"93\"><strong>\u22650.2 \u00b5m<\/strong><\/td>\n<td width=\"93\"><strong>\u22650.3 \u00b5m<\/strong><\/td>\n<td width=\"94\"><strong>\u22650.5 \u00b5m<\/strong><\/td>\n<td width=\"75\"><strong>\u22651 \u00b5m<\/strong><\/td>\n<td width=\"65\"><strong>\u22655 \u00b5m<\/strong><\/td>\n<td width=\"86\"><\/td>\n<\/tr>\n<tr>\n<td width=\"85\">ISO 1<\/td>\n<td width=\"112\">10b<\/td>\n<td width=\"93\"><sup>d<\/sup><\/td>\n<td width=\"93\"><sup>d<\/sup><\/td>\n<td width=\"94\"><sup>d<\/sup><\/td>\n<td width=\"75\"><sup>d<\/sup><\/td>\n<td width=\"65\"><sup>d<\/sup><\/td>\n<td width=\"86\"><\/td>\n<\/tr>\n<tr>\n<td width=\"85\">ISO 2<\/td>\n<td width=\"112\">100<\/td>\n<td width=\"93\">24<sup>b<\/sup><\/td>\n<td width=\"93\">10<sup>b<\/sup><\/td>\n<td width=\"94\"><sup>d<\/sup><\/td>\n<td width=\"75\"><sup>d<\/sup><\/td>\n<td width=\"65\"><sup>e<\/sup><\/td>\n<td width=\"86\"><\/td>\n<\/tr>\n<tr>\n<td width=\"85\">ISO 3<\/td>\n<td width=\"112\">1,000<\/td>\n<td width=\"93\">237<\/td>\n<td width=\"93\">102<\/td>\n<td width=\"94\">35b<\/td>\n<td width=\"75\"><sup>d<\/sup><\/td>\n<td width=\"65\"><sup>e<\/sup><\/td>\n<td width=\"86\">Class 1<\/td>\n<\/tr>\n<tr>\n<td width=\"85\">ISO 4<\/td>\n<td width=\"112\">10,000<\/td>\n<td width=\"93\">2,370<\/td>\n<td width=\"93\">1,020<\/td>\n<td width=\"94\">352<\/td>\n<td width=\"75\">83<sup>b<\/sup><\/td>\n<td width=\"65\"><sup>e<\/sup><\/td>\n<td width=\"86\">Class 10<\/td>\n<\/tr>\n<tr>\n<td width=\"85\">ISO 5<\/td>\n<td width=\"112\">100,000<\/td>\n<td width=\"93\">23,700<\/td>\n<td width=\"93\">10,200<\/td>\n<td width=\"94\">3,520<\/td>\n<td width=\"75\">832<\/td>\n<td width=\"65\"><sup>d,e,f<\/sup><\/td>\n<td width=\"86\">Class 100<\/td>\n<\/tr>\n<tr>\n<td width=\"85\">ISO 6<\/td>\n<td width=\"112\">1,000,000<\/td>\n<td width=\"93\">2,3700<\/td>\n<td width=\"93\">1,02000<\/td>\n<td width=\"94\">35200<\/td>\n<td width=\"75\">8320<\/td>\n<td width=\"65\"><sup>293<\/sup><\/td>\n<td width=\"86\">Class 1000<\/td>\n<\/tr>\n<tr>\n<td width=\"85\">ISO 7<\/td>\n<td width=\"112\"><\/td>\n<td width=\"93\"><\/td>\n<td width=\"93\"><\/td>\n<td width=\"94\">3,52000<\/td>\n<td width=\"75\">83200<\/td>\n<td width=\"65\"><sup>2930<\/sup><\/td>\n<td width=\"86\">Class 10000<\/td>\n<\/tr>\n<tr>\n<td width=\"85\">ISO 8<\/td>\n<td width=\"112\"><\/td>\n<td width=\"93\"><\/td>\n<td width=\"93\"><\/td>\n<td width=\"94\">3520000<\/td>\n<td width=\"75\">832000<\/td>\n<td width=\"65\"><sup>29300<\/sup><\/td>\n<td width=\"86\">Class 100000<\/td>\n<\/tr>\n<tr>\n<td width=\"85\">ISO 9<\/td>\n<td width=\"112\"><\/td>\n<td width=\"93\"><\/td>\n<td width=\"93\"><\/td>\n<td width=\"94\">35200000<\/td>\n<td width=\"75\">8320000<\/td>\n<td width=\"65\"><sup>293000<\/sup><\/td>\n<td width=\"86\">Class 1000000<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p>[\/vc_column_text][vc_column_text]<\/p>\n<h2 class=\"text123\" style=\"text-align: left; color: #ca2527; font-size: 22px;\">AIR HANDLING AND VENTILATION<\/h2>\n<p>[\/vc_column_text][vc_column_text]For contamination control, both Air Handling and Ventilation are important.<\/p>\n<ul>\n<li>The size of the particle-like 0.3 microns and larger (ISO Class 2-9) are controlled by High Efficiency Particulate Air (HEPA) filter.<\/li>\n<li>For smaller particles (ISO Class 1) Ultra Low Particulate Air (ULPA) filters are used.<\/li>\n<\/ul>\n<p>Depending upon the ISO class desired, airflow type, airflow velocity, and air changes are determined by always keeping positive pressure in the cleanroom.[\/vc_column_text][vc_column_text]<\/p>\n<h2 class=\"text123\" style=\"text-align: left; color: #ca2527; font-size: 22px;\">CLEANROOM REQUIREMENTS<\/h2>\n<p>[\/vc_column_text][vc_column_text]Following is some of the Cleanroom requirements related to ISO Standards.<\/p>\n<ul>\n<li><strong>ISO 5-<\/strong> A Cleanroom must have less than 3520 particles&gt;0.5 micron per cubic meter and 250-300 HEPA filtered air changes per hour.<\/li>\n<li><strong>ISO 6-<\/strong> A Cleanroom must have less than 35200 particles&gt;0.5 micron per cubic meter and 180 HEPA filtered air changes per hour.<\/li>\n<li><strong>ISO 7-<\/strong> A Cleanroom must have less than 352000 particles&gt;0.5 micron per cubic meter and 60 HEPA filtered air changes per hour.<\/li>\n<li><strong>ISO 8-<\/strong> A Cleanroom must have less than 35200000 particles&gt;0.5 micron per cubic meter and 20 HEPA filtered air changes per hour.<\/li>\n<\/ul>\n<p>Various laboratories require cleanrooms and sterile environments to perform their experiments and to produce their products. Following are the three important requirements defined in the <strong>Good Manufacturing Practices (GMP)<\/strong> of a cleanroom:<\/p>\n<ol>\n<li>The internal surfaces of the cleanroom and the equipment should be smooth and impervious.<\/li>\n<li>The control and quality of air through the cleanroom; controlled temperature and humidity.<\/li>\n<li>The way the cleanroom is operated and maintained.<\/li>\n<\/ol>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row][vc_column][\/vc_column][vc_column][\/vc_column][\/vc_row][vc_row][vc_column][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row full_width=&#8221;stretch_row&#8221; equal_height=&#8221;yes&#8221; content_placement=&#8221;middle&#8221; css=&#8221;.vc_custom_1594037823219{margin-top: 0px !important;margin-bottom: 0px !important;padding-top: 40px !important;padding-bottom: 40px !important;}&#8221;][vc_column][vc_column_text]A cleanroom is an environment typically used in different laboratories, where low level of environmental pollutants and a high level of sterility is required. It is a \u2018contained space\u2019 where arrangements are made to reduce the introduction, production, and storage of particles inside the room and to control<\/p>\n<div class=\"h10\"><\/div>\n<p><a class=\"more-link1\" href=\"https:\/\/www.kewaunee.in\/blog\/cleanroom-classification-requirements\/\">Read more<\/a><\/p>\n","protected":false},"author":2,"featured_media":1659,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[1,66,65,103,61,22,64],"tags":[154,151,152,153,18],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.8 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Cleanroom Classification Requirements - Kewaunee Blogs<\/title>\n<meta name=\"description\" content=\"A cleanroom is an environment typically used in different laboratories, where low level of environmental pollutants and a high level of sterility is required.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kewaunee.in\/blog\/cleanroom-classification-requirements\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Cleanroom Classification Requirements - Kewaunee Blogs\" \/>\n<meta property=\"og:description\" content=\"A cleanroom is an environment typically used in different laboratories, where low level of environmental pollutants and a high level of sterility is required.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kewaunee.in\/blog\/cleanroom-classification-requirements\/\" \/>\n<meta property=\"article:published_time\" content=\"2021-06-29T01:30:02+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-07-15T07:00:18+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kewaunee.in\/blog\/wp-content\/uploads\/2021\/06\/3-Featured-Image.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1071\" \/>\n\t<meta property=\"og:image:height\" content=\"643\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Kewaunee International Group\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Kewaunee International Group\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.kewaunee.in\/blog\/cleanroom-classification-requirements\/\",\"url\":\"https:\/\/www.kewaunee.in\/blog\/cleanroom-classification-requirements\/\",\"name\":\"Cleanroom Classification Requirements - Kewaunee Blogs\",\"isPartOf\":{\"@id\":\"https:\/\/www.kewaunee.in\/blog\/#website\"},\"datePublished\":\"2021-06-29T01:30:02+00:00\",\"dateModified\":\"2024-07-15T07:00:18+00:00\",\"author\":{\"@id\":\"https:\/\/www.kewaunee.in\/blog\/#\/schema\/person\/8984b794f6a03b8701a044f24c072f1a\"},\"description\":\"A cleanroom is an environment typically used in different laboratories, where low level of environmental pollutants and a high level of sterility is required.\",\"breadcrumb\":{\"@id\":\"https:\/\/www.kewaunee.in\/blog\/cleanroom-classification-requirements\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.kewaunee.in\/blog\/cleanroom-classification-requirements\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.kewaunee.in\/blog\/cleanroom-classification-requirements\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.kewaunee.in\/blog\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Cleanroom Classification &#038; 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