{"id":6318,"date":"2024-08-01T16:58:55","date_gmt":"2024-08-01T08:58:55","guid":{"rendered":"https:\/\/www.thy-precision.com\/what-is-an-iso-8-cleanroom-principles-requirements\/"},"modified":"2025-07-23T16:15:50","modified_gmt":"2025-07-23T08:15:50","slug":"what-is-an-iso-8-cleanroom-principles-requirements","status":"publish","type":"post","link":"https:\/\/www.thy-precision.com\/de\/what-is-an-iso-8-cleanroom-principles-requirements\/","title":{"rendered":"What is an ISO 8 Cleanroom? Principles Requirements"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Even the smallest particle of dust can have a devastating impact when it comes to manufacturing sensitive medical devices and pharmaceuticals. That&#8217;s why these industries rely on cleanrooms.  <\/p>\n\n<p class=\"wp-block-paragraph\">Cleanrooms are designed to have a low level of airborne particles to protect products from contamination during the manufacturing and packaging process. They are certified to meet the standards of the International Organization for Standardization (ISO) <a href=\"https:\/\/www.iso.org\/standard\/53394.html\" target=\"_blank\" rel=\"noreferrer noopener\">14644-1<\/a>, which outlines classifications for cleanrooms ISO 1 to ISO 9.  <\/p>\n\n<p class=\"wp-block-paragraph\">Many manufacturers opt for an ISO 8 cleanroom, the second lowest classification, because it offers cleanliness and is cost-efficient. <\/p>\n\n<p class=\"wp-block-paragraph\">So, what exactly defines an ISO 8 cleanroom? <\/p>\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_85 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.thy-precision.com\/de\/what-is-an-iso-8-cleanroom-principles-requirements\/#What_is_an_ISO_8_Cleanroom\" >What is an ISO 8 Cleanroom?<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.thy-precision.com\/de\/what-is-an-iso-8-cleanroom-principles-requirements\/#Common_Applications_of_an_ISO_8_Classroom\" >Common Applications of an ISO 8 Classroom<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.thy-precision.com\/de\/what-is-an-iso-8-cleanroom-principles-requirements\/#ISO_14644-1_Cleanroom_Classifications\" >ISO 14644-1 Cleanroom Classifications<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.thy-precision.com\/de\/what-is-an-iso-8-cleanroom-principles-requirements\/#ISO_8_Cleanroom_vs_Federal_Standard_209E\" >ISO 8 Cleanroom v.s. Federal Standard 209E<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.thy-precision.com\/de\/what-is-an-iso-8-cleanroom-principles-requirements\/#Key_ISO_8_Cleanroom_Environmental_Parameters_to_Control\" >Key ISO 8 Cleanroom Environmental Parameters to Control<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.thy-precision.com\/de\/what-is-an-iso-8-cleanroom-principles-requirements\/#1_HEPA_Filtration\" >1. HEPA Filtration<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.thy-precision.com\/de\/what-is-an-iso-8-cleanroom-principles-requirements\/#2_Air_Changes_Per_Hour_ACH\" >2. Air Changes Per Hour (ACH)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.thy-precision.com\/de\/what-is-an-iso-8-cleanroom-principles-requirements\/#3_Airflow_Patterns\" >3. Airflow Patterns<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.thy-precision.com\/de\/what-is-an-iso-8-cleanroom-principles-requirements\/#4_Air_Pressure_Management\" >4. Air Pressure Management<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.thy-precision.com\/de\/what-is-an-iso-8-cleanroom-principles-requirements\/#5_Temperature_and_Humidity_Control\" >5. Temperature and Humidity Control<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.thy-precision.com\/de\/what-is-an-iso-8-cleanroom-principles-requirements\/#6_Static_Control_Measures\" >6. Static Control Measures<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.thy-precision.com\/de\/what-is-an-iso-8-cleanroom-principles-requirements\/#7_Lighting_and_Noise_Levels\" >7. Lighting and Noise Levels<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/www.thy-precision.com\/de\/what-is-an-iso-8-cleanroom-principles-requirements\/#8_Personnel_Control\" >8. Personnel Control<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/www.thy-precision.com\/de\/what-is-an-iso-8-cleanroom-principles-requirements\/#Types_of_ISO_8_Cleanroom\" >Types of ISO 8 Cleanroom<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/www.thy-precision.com\/de\/what-is-an-iso-8-cleanroom-principles-requirements\/#%E2%97%8F_Modular_Cleanrooms\" >\u25cf Modular Cleanrooms<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/www.thy-precision.com\/de\/what-is-an-iso-8-cleanroom-principles-requirements\/#%E2%97%8F_Stick-Built_Cleanrooms\" >\u25cf Stick-Built Cleanrooms<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-17\" href=\"https:\/\/www.thy-precision.com\/de\/what-is-an-iso-8-cleanroom-principles-requirements\/#%E2%97%8F_Softwall_Cleanrooms\" >\u25cf Softwall Cleanrooms<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-18\" href=\"https:\/\/www.thy-precision.com\/de\/what-is-an-iso-8-cleanroom-principles-requirements\/#The_Basic_ISO_8_Cleanroom_Gowning_Procedures\" >The Basic ISO 8 Cleanroom Gowning Procedures<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-19\" href=\"https:\/\/www.thy-precision.com\/de\/what-is-an-iso-8-cleanroom-principles-requirements\/#%E2%97%8F_Shoe_Covers\" >\u25cf Shoe Covers<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-20\" href=\"https:\/\/www.thy-precision.com\/de\/what-is-an-iso-8-cleanroom-principles-requirements\/#%E2%97%8F_Head_Coverings\" >\u25cf Head Coverings<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-21\" href=\"https:\/\/www.thy-precision.com\/de\/what-is-an-iso-8-cleanroom-principles-requirements\/#%E2%97%8F_Jackets_or_Coveralls\" >\u25cf Jackets or Coveralls<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-22\" href=\"https:\/\/www.thy-precision.com\/de\/what-is-an-iso-8-cleanroom-principles-requirements\/#%E2%97%8F_Gown_Rooms_and_Airlocks\" >\u25cf Gown Rooms and Airlocks<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-23\" href=\"https:\/\/www.thy-precision.com\/de\/what-is-an-iso-8-cleanroom-principles-requirements\/#%E2%97%8F_Others\" >\u25cf Others<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-24\" href=\"https:\/\/www.thy-precision.com\/de\/what-is-an-iso-8-cleanroom-principles-requirements\/#Cleanroom_Solutions_for_Medical_Devices_THY_Precision_Leads_the_Way\" >Cleanroom Solutions for Medical Devices: THY Precision Leads the Way<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_an_ISO_8_Cleanroom\"><\/span><strong>What is an ISO 8 Cleanroom?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n<figure class=\"wp-block-image size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1000\" height=\"550\" src=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/08\/ISO8-03-jpg.webp\" alt=\"What is an ISO 8 clean room? A corner of ISO 8 clean room in THY Precision \" class=\"wp-image-5904\" srcset=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/08\/ISO8-03-jpg.webp 1000w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/08\/ISO8-03-300x165.webp 300w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/08\/ISO8-03-768x422.webp 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n<p class=\"wp-block-paragraph\">The ISO, an independent, non-governmental organization, acts as a global benchmark for cleanroom classifications across industries. It also establishes <a href=\"https:\/\/www.thy-precision.com\/de\/iso-standards-for-medical-devices-the-meaning-of-iso-13485\/\" target=\"_blank\" rel=\"noreferrer noopener\">ISO standards for medical devices<\/a>.  <\/p>\n\n<p class=\"wp-block-paragraph\">An ISO 8 cleanroom guarantees a controlled environment with a maximum allowable particle concentration of 3,520,000 particles per cubic meter that are 0.5 micrometers or larger. <\/p>\n\n<p class=\"wp-block-paragraph\">High-efficiency particulate air (HEPA) filters, which remove at least 99.97% of airborne particles that are 0.3 micrometers or larger, maintain the air purity standards in ISO 8 Cleanrooms. This level of filtration ensures the quality and safety of products.  <\/p>\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Common_Applications_of_an_ISO_8_Classroom\"><\/span><strong>Common Applications of an ISO 8 Classroom<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p class=\"wp-block-paragraph\">ISO 8 cleanrooms are used in many different industries to create a sterile environment, including: <\/p>\n\n<ul class=\"wp-block-list\">\n<li><strong>Pharmaceutical manufacturing:<\/strong> Preventing contamination during the production of sterile drugs, active pharmaceutical ingredients, and certain medical devices. <\/li>\n\n\n\n<li><a href=\"https:\/\/www.thy-precision.com\/de\/contract-medical-device-manufacturer-what-you-need-to-know\/\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Medical device manufacturing<\/strong><\/a><strong>: <\/strong> Protecting medical implants, surgical instruments, and other sensitive devices during assembly and packaging. <\/li>\n\n\n\n<li><strong>Electronics manufacturing:<\/strong> Ensuring the quality and reliability of semiconductors, microchips, and other electronic components. <\/li>\n\n\n\n<li><strong>Optics manufacturing:<\/strong> Maintaining the precision and accuracy of lenses, mirrors, and other optical components. <\/li>\n\n\n\n<li><strong>Food processing: <\/strong>Minimizing the risk of foodborne illness and cross-contamination. <\/li>\n\n\n\n<li><strong>Aerospace manufacturing: <\/strong>Protecting aerospace components and instruments during assembly, testing, and calibration. <\/li>\n\n\n\n<li><strong>Research laboratories: <\/strong>Providing a controlled environment for sensitive experiments and research, particularly in microbiology and biotechnology. <\/li>\n<\/ul>\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"ISO_14644-1_Cleanroom_Classifications\"><\/span><strong>ISO 14644-1 Cleanroom Classifications<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p class=\"wp-block-paragraph\">Here&#8217;s a table of the maximum number of particles allowed per cubic meter of air for each cleanroom classification, from the cleanest (ISO 1) to the least clean (ISO 9):<\/p>\n\n<table style=\"border-collapse: collapse; width: 100%;\" border=\"1\">\n  <thead>\n    <tr>\n      <th style=\"padding: 8px; text-align: left;\">ISO Class<\/th>\n<th style=\"padding: 8px; text-align: left;\">Maximum Particles per Cubic Meter (\u2265 0.5\u00b5m)<\/th>\n    <\/tr>\n  <\/thead>\n  <tbody>\n    <tr><td style=\"padding: 8px;\">ISO 1<\/td><td style=\"padding: 8px;\">a<\/td><\/tr>\n    <tr><td style=\"padding: 8px;\">ISO 2<\/td><td style=\"padding: 8px;\">a<\/td><\/tr>\n    <tr><td style=\"padding: 8px;\">ISO 3<\/td><td style=\"padding: 8px;\">35<\/td><\/tr>\n    <tr><td style=\"padding: 8px;\">ISO 4<\/td><td style=\"padding: 8px;\">352<\/td><\/tr>\n    <tr><td style=\"padding: 8px;\">ISO 5<\/td><td style=\"padding: 8px;\">3,520<\/td><\/tr>\n    <tr><td style=\"padding: 8px;\">ISO 6<\/td><td style=\"padding: 8px;\">35,200<\/td><\/tr>\n    <tr><td style=\"padding: 8px;\">ISO 7<\/td><td style=\"padding: 8px;\">352,000<\/td><\/tr>\n    <tr><td style=\"padding: 8px;\">ISO 8<\/td><td style=\"padding: 8px;\">3,520,000<\/td><\/tr>\n    <tr><td style=\"padding: 8px;\">ISO 9<\/td><td style=\"padding: 8px;\">35,200,000<\/td><\/tr>\n    <tr>\n      <td colspan=\"2\" style=\"padding: 8px;\">\n        <strong>Note<\/strong><br\/>a. Sampling and statistical limitations for particles in low concentrations make classification inappropriate. \n      <\/td>\n    <\/tr>\n  <\/tbody>\n<\/table>\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"ISO_8_Cleanroom_vs_Federal_Standard_209E\"><\/span><strong>ISO 8 Cleanroom v.s. Federal Standard 209E<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n<p class=\"wp-block-paragraph\">Before the global adoption of ISO 14644-1, the United States used Federal Standard 209E to classify cleanrooms. This standard is similar to ISO 14644-1, but uses different terminology and measurements.  <\/p>\n\n<p class=\"wp-block-paragraph\">In 2001, ISO 14644-1 officially replaced Federal Standard 209E to align with international practices for easier global trade and collaboration. <\/p>\n\n<table style=\"border-collapse: collapse; width: 100%;\" border=\"1\">\n  <thead>\n    <tr>\n       <th style=\"padding: 8px; text-align: left;\">\nISO Class\n<\/th>\n<th style=\"padding: 8px; text-align: left;\">\nFederal Standard 209E\n<small>(Equivalent at 0.5 microns)<\/small>\n<\/th>\n<th style=\"padding: 8px; text-align: left;\">\nMaximum Particles per Cubic Meter<br\/><small>(\u2265 0.5\u00b5m)<\/small><br\/><\/th> \n    <\/tr>\n  <\/thead>\n  <tbody>\n    <tr><td style=\"padding: 8px;\">ISO 1<\/td><td style=\"padding: 8px;\"><\/td><td style=\"padding: 8px;\">a<\/td><\/tr>\n    <tr><td style=\"padding: 8px;\">ISO 2<\/td><td style=\"padding: 8px;\"><\/td><td style=\"padding: 8px;\">a<\/td><\/tr>\n    <tr><td style=\"padding: 8px;\">ISO 3<\/td><td style=\"padding: 8px;\">Class 1<\/td><td style=\"padding: 8px;\">35<\/td><\/tr>\n    <tr><td style=\"padding: 8px;\">ISO 4<\/td><td style=\"padding: 8px;\">Class 10<\/td><td style=\"padding: 8px;\">352<\/td><\/tr>\n    <tr><td style=\"padding: 8px;\">ISO 5<\/td><td style=\"padding: 8px;\">Class 100<\/td><td style=\"padding: 8px;\">3,520<\/td><\/tr>\n    <tr><td style=\"padding: 8px;\">ISO 6<\/td><td style=\"padding: 8px;\">Class 1,000<\/td><td style=\"padding: 8px;\">35,200<\/td><\/tr>\n    <tr><td style=\"padding: 8px;\">ISO 7<\/td><td style=\"padding: 8px;\">Class 10,000<\/td><td style=\"padding: 8px;\">352,000<\/td><\/tr>\n    <tr><td style=\"padding: 8px;\">ISO 8<\/td><td style=\"padding: 8px;\">Class 100,000<\/td><td style=\"padding: 8px;\">3,520,000<\/td><\/tr>\n    <tr><td style=\"padding: 8px;\">ISO 9<\/td><td style=\"padding: 8px;\"><\/td><td style=\"padding: 8px;\">35,200,000<\/td><\/tr>\n    <tr>\n      <td colspan=\"3\" style=\"padding: 8px;\">\n        <strong>Note<\/strong><br\/>a. Sampling and statistical limitations for particles in low concentrations make classification inappropriate. \n      <\/td>\n    <\/tr>\n  <\/tbody>\n<\/table>\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Key_ISO_8_Cleanroom_Environmental_Parameters_to_Control\"><\/span><strong>Key ISO 8 Cleanroom Environmental Parameters to Control<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n<p class=\"wp-block-paragraph\">These environmental parameters need to be controlled in order to ensure the level of cleanliness in ISO 8 cleanrooms: <\/p>\n\n<h3 class=\"wp-block-heading post_list_h3\"><span class=\"ez-toc-section\" id=\"1_HEPA_Filtration\"><\/span><strong>1. HEPA Filtration<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p class=\"post_list_p wp-block-paragraph\">HEPA filters need to show a minimum efficiency of <strong>99.97% <\/strong>at capturing particles 0.3 microns or larger in size. Regular testing and replacing HEPA filters help maintain their performance. <\/p>\n\n<h3 class=\"wp-block-heading post_list_h3\"><span class=\"ez-toc-section\" id=\"2_Air_Changes_Per_Hour_ACH\"><\/span><strong>2. Air Changes Per Hour (ACH)<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p class=\"post_list_p wp-block-paragraph\">This refers to the number of times the air in a cleanroom is replaced with filtered air. For ISO 8 cleanrooms, a minimum of <strong>20 air changes per hour<\/strong> is recommended to effectively dilute and remove airborne contaminants. <\/p>\n\n<h3 class=\"wp-block-heading post_list_h3\"><span class=\"ez-toc-section\" id=\"3_Airflow_Patterns\"><\/span><strong>3. Airflow Patterns<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p class=\"post_list_p wp-block-paragraph\">ISO 8 cleanrooms use <strong>non-unidirectional or mixed airflow patterns<\/strong>. Low wall air returns directs contaminants away from work areas and towards the filters. <\/p>\n\n<h3 class=\"wp-block-heading post_list_h3\"><span class=\"ez-toc-section\" id=\"4_Air_Pressure_Management\"><\/span><strong>4. Air Pressure Management<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p class=\"post_list_p wp-block-paragraph\">By keeping a higher pressure inside the cleanroom than outside, unfiltered air can flow outwards when doors are opened. <\/p>\n\n<h3 class=\"wp-block-heading post_list_h3\"><span class=\"ez-toc-section\" id=\"5_Temperature_and_Humidity_Control\"><\/span><strong>5. Temperature and Humidity Control<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p class=\"post_list_p wp-block-paragraph\">Stable temperature and humidity levels ensure product stability and prevent microorganisms from growing. The temperature should typically stay between 64\u00b0F to 72\u00b0F, with a 40% and 60% humidity level. <\/p>\n\n<h3 class=\"wp-block-heading post_list_h3\"><span class=\"ez-toc-section\" id=\"6_Static_Control_Measures\"><\/span><strong>6. Static Control Measures<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p class=\"post_list_p wp-block-paragraph\">Static electricity can attract and hold unwanted particles. Anti-static flooring, ionizers, and grounding straps mitigate the risk in ISO 8 cleanrooms, especially in <a href=\"https:\/\/www.thy-precision.com\/de\/micro-electronics\/\" target=\"_blank\" rel=\"noreferrer noopener\">electronics manufacturing<\/a>. <\/p>\n\n<h3 class=\"wp-block-heading post_list_h3\"><span class=\"ez-toc-section\" id=\"7_Lighting_and_Noise_Levels\"><\/span><strong>7. Lighting and Noise Levels<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p class=\"post_list_p wp-block-paragraph\">Lighting and noise can severely disrupt manufacturing processes. Cleanroom lighting should be bright, glare-free, and energy-efficient. Noise levels should also be minimized.   <\/p>\n\n<h3 class=\"wp-block-heading post_list_h3\"><span class=\"ez-toc-section\" id=\"8_Personnel_Control\"><\/span><strong>8. Personnel Control<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p class=\"post_list_p wp-block-paragraph\">People are actually the biggest source of contamination in cleanrooms. Limiting the number of personnel inside, enforcing strict gowning protocols, and providing training on cleanroom practices are key to maintaining an effective cleanroom.  <\/p>\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Types_of_ISO_8_Cleanroom\"><\/span><strong>Types of ISO 8 Cleanroom<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"1000\" height=\"550\" src=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/08\/ISO8-04-jpg.webp\" alt=\"Types of ISO 8 Cleanroom. Another corner of ISO 8 clean room in THY Precision \" class=\"wp-image-5907\" srcset=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/08\/ISO8-04-jpg.webp 1000w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/08\/ISO8-04-300x165.webp 300w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/08\/ISO8-04-768x422.webp 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n<p class=\"wp-block-paragraph\">Depending on your application, space, and budget, there are<strong> three main types of ISO 8 cleanrooms<\/strong> to choose from: <\/p>\n\n<h3 class=\"wp-block-heading post_list_h3\"><span class=\"ez-toc-section\" id=\"%E2%97%8F_Modular_Cleanrooms\"><\/span>\u25cf <strong>Modular Cleanrooms<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p class=\"post_list_p wp-block-paragraph\">Modular cleanrooms are a popular option because of their flexibility and cost-effectiveness. They are built with prefabricated panels and easily-assemblable components so they can be installed, expanded, or reconfigured with ease.  <\/p>\n\n<p class=\"post_list_p wp-block-paragraph\">They\u2019re great for manufacturers that need an adaptable and affordable cleanroom solution, particularly those with changing needs or temporary installations. The pharmaceutical and medical industries often use modular cleanrooms.  <\/p>\n\n<h3 class=\"wp-block-heading post_list_h3\"><span class=\"ez-toc-section\" id=\"%E2%97%8F_Stick-Built_Cleanrooms\"><\/span>\u25cf <strong>Stick-Built Cleanrooms<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p class=\"post_list_p wp-block-paragraph\">Stick-built cleanrooms are a more permanent solution for larger facilities. They are built on-site using traditional materials like drywall, steel studs, and epoxy paint.  <\/p>\n\n<p class=\"post_list_p wp-block-paragraph\">Large facilities, such as those in the semiconductor and aerospace industries, prefer this type of cleanroom because they can customize designs to fit their needs. However, stick-built cleanrooms are more expensive and time-consuming to build.  <\/p>\n\n<h3 class=\"wp-block-heading post_list_h3\"><span class=\"ez-toc-section\" id=\"%E2%97%8F_Softwall_Cleanrooms\"><\/span><strong>\u25cf Softwall Cleanrooms<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p class=\"post_list_p wp-block-paragraph\">Softwall cleanrooms use transparent vinyl curtains or panels to create a controlled environment. Their lightweight and flexible construction makes them a budget-friendly and portable option. <\/p>\n\n<p class=\"post_list_p wp-block-paragraph\">Applications that need frequent access and visibility, like food packaging lines, use softwall cleanrooms to quickly establish clean zones without disrupting workflow. Yet, because of their structure, there\u2019s a higher risk of air leakage and contamination.  <\/p>\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"The_Basic_ISO_8_Cleanroom_Gowning_Procedures\"><\/span><strong>The Basic ISO 8 Cleanroom Gowning Procedures<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"1000\" height=\"550\" src=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/08\/ISO8-05-jpg.webp\" alt=\"The Basic ISO 8 Cleanroom Gowning Procedures\" class=\"wp-image-5910\" srcset=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/08\/ISO8-05-jpg.webp 1000w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/08\/ISO8-05-300x165.webp 300w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/08\/ISO8-05-768x422.webp 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n<p class=\"wp-block-paragraph\">Skin flakes, hair, and clothing fibers can all compromise product quality and safety. Proper gowning procedures prevent contamination:  <\/p>\n\n<h3 class=\"wp-block-heading post_list_h3\"><span class=\"ez-toc-section\" id=\"%E2%97%8F_Shoe_Covers\"><\/span>\u25cf <strong>Shoe Covers<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p class=\"post_list_p wp-block-paragraph\">Anyone entering an ISO 8 cleanroom must put on non-shedding shoe covers to prevent dirt and debris from being tracked inside.<\/p>\n\n<h3 class=\"wp-block-heading post_list_h3\"><span class=\"ez-toc-section\" id=\"%E2%97%8F_Head_Coverings\"><\/span><strong>\u25cf Head Coverings<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p class=\"post_list_p wp-block-paragraph\">Hair is a huge contamination source in cleanrooms. Personnel should wear a lint-free hairnet or a hood to cover their hair completely. <\/p>\n\n<h3 class=\"wp-block-heading post_list_h3\"><span class=\"ez-toc-section\" id=\"%E2%97%8F_Jackets_or_Coveralls\"><\/span>\u25cf <strong>Jackets or Coveralls<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p class=\"post_list_p wp-block-paragraph\">Jackets or coveralls cover regular clothing to stop lint, dust, and dander from entering the cleanroom. <\/p>\n\n<h3 class=\"wp-block-heading post_list_h3\"><span class=\"ez-toc-section\" id=\"%E2%97%8F_Gown_Rooms_and_Airlocks\"><\/span>\u25cf <strong>Gown Rooms and Airlocks<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p class=\"post_list_p wp-block-paragraph\">Gowning procedures are often done in a separate gown room or airlock. These areas are buffer zones between the outside environment and the cleanroom.  <\/p>\n\n<p class=\"post_list_p wp-block-paragraph\">It&#8217;s also important to follow a specific gowning order to prevent cross-contamination. This ensures that cleaner items are not contaminated by dirtier ones. <\/p>\n\n<h3 class=\"wp-block-heading post_list_h3\"><span class=\"ez-toc-section\" id=\"%E2%97%8F_Others\"><\/span>\u25cf <strong>Others<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p class=\"post_list_p wp-block-paragraph\">Some cleanroom protocols require personnel to wear gloves to prevent oil transfers from the hand to products. Face masks are sometimes required to prevent saliva and respiratory droplets. <\/p>\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Cleanroom_Solutions_for_Medical_Devices_THY_Precision_Leads_the_Way\"><\/span><strong>Cleanroom Solutions for Medical Devices: THY Precision Leads the Way<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"1000\" height=\"550\" src=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/08\/ISO8-02-jpg.webp\" alt=\"Cleanroom Solutions for Medical Devices. Another corner of ISO 8 clean room in THY Precision \" class=\"wp-image-5916\" srcset=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/08\/ISO8-02-jpg.webp 1000w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/08\/ISO8-02-300x165.webp 300w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/08\/ISO8-02-768x422.webp 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n<p class=\"wp-block-paragraph\">THY Precision understands your need for pristine and reliable cleanrooms. Our state-of-the-art facilities include a 13,000 sq.  umfasst. ISO 8 cleanroom dedicated for injection molding, a 7,500 sq. umfasst. ISO 7 cleanroom assembly line, and a 54,000 sq. ft. climate-controlled injection molding area.  <\/p>\n\n<p class=\"wp-block-paragraph\">We ensure that every step of the manufacturing process is precise, accurate, and consistent. Our <a href=\"https:\/\/www.thy-precision.com\/de\/iso-standards-for-medical-devices-the-meaning-of-iso-13485\/\" target=\"_blank\" rel=\"noreferrer noopener\">ISO 13485 certification<\/a> also reflects our commitment to the highest quality management standards for medical devices. <\/p>\n\n<p class=\"wp-block-paragraph\">Whether you need expert assistance with medical device manufacturing or cleanroom services, THY Precision is here for you \u2014 <a href=\"https:\/\/www.thy-precision.com\/de\/contact\/\" target=\"_blank\" rel=\"noreferrer noopener\">Contact us today<\/a>. <\/p>\n\n<p class=\"wp-block-paragraph\">Related articles: <br\/><a href=\"https:\/\/www.thy-precision.com\/de\/precision-injection-molding-basics-and-design-considerations\/\" target=\"_blank\" rel=\"noreferrer noopener\">Precision Injection Molding Basics and Design Considerations<\/a><br\/><a href=\"https:\/\/www.thy-precision.com\/de\/essential-design-guidelines-for-precision-injection-molding\/\" target=\"_blank\" rel=\"noreferrer noopener\">Essential Design Guidelines for Precision Injection Molding<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Even the smallest particle of dust can have a devastating impact when it comes to manufacturing sensitive medical devices and pharmaceuticals. That&#8217;s why these industries rely on cleanrooms. Cleanrooms are designed to have a low level of airborne particles to protect products from contamination during the manufacturing and packaging process. They are certified to meet [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":5914,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[44],"tags":[],"class_list":["post-6318","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>What is an ISO 8 Cleanroom? Principles Requirements<\/title>\n<meta name=\"description\" content=\"ISO 8 cleanroom ensures a controlled environment with max 3,520,000 particles\/m\u00b3. 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