{"id":14957,"date":"2023-08-30T08:09:00","date_gmt":"2023-08-30T08:09:00","guid":{"rendered":"https:\/\/www.golighthouse.com\/en\/?post_type=knowledge-center&#038;p=14957"},"modified":"2023-08-08T15:45:48","modified_gmt":"2023-08-08T22:45:48","slug":"designing-cleanroom-aseptic-manufacturing-gmp-annex-1","status":"publish","type":"knowledge-center","link":"https:\/\/www.golighthouse.com\/en\/blog\/designing-cleanroom-aseptic-manufacturing-gmp-annex-1\/","title":{"rendered":"GMP Annex 1 In Action: Designing A Cleanroom for Aseptic Manufacturing"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"14957\" class=\"elementor elementor-14957\" data-elementor-post-type=\"knowledge-center\">\n\t\t\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-1b503c9 e-flex e-con-boxed e-con e-parent\" data-id=\"1b503c9\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dcd9602 elementor-widget elementor-widget-text-editor\" data-id=\"dcd9602\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">In 2022, GMP Annex 1 was revised to reflect the changing landscape of technology, discoveries, best practices, and needs. At the time of publication, this is the first and only, but far from the last, regulatory body to make a large update in several years. We do expect to see similar guidelines from the FDA soon; however, they have not published any yet.<\/span><\/p><p><span style=\"font-weight: 400;\">At this time, GMP Annex 1 remains an excellent resource for those designing or using a cleanroom. It outlines how to develop a cleanroom from a risk based approach centered on a Contamination Control Strategy (CCS) instead of designing a convenient cleanroom and later integrating contamination control.<\/span><\/p><p><span style=\"font-weight: 400;\">So let\u2019s break down some cleanroom design basics incorporating the recent updates to GMP Annex 1.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-f084d2a e-flex e-con-boxed e-con e-parent\" data-id=\"f084d2a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4987537 elementor-widget elementor-widget-heading\" data-id=\"4987537\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Conduct A Risk Assessment<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-3e47068 e-flex e-con-boxed e-con e-parent\" data-id=\"3e47068\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-56b9944 elementor-widget elementor-widget-text-editor\" data-id=\"56b9944\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">First and foremost, you need to conduct a risk assessment of your process and application. This risk assessment should cover:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">process inputs,<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">final product,<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">facility,<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">equipment,<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">specific processes,<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">operations,<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">historical monitoring data,<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">qualification data,<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">and other relevant information.<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">The goal of this risk assessment is to identify where your product is most susceptible to contamination, what contaminants are most dangerous, and where they are most likely to occur. GMP Annex 1 places an emphasis on relying on your most important resource: your personnel. Gather those who are most involved in your processes and glean from their collective knowledge to complete this risk assessment &#8211; and do not take any shortcuts. You should build your cleanroom around the information gathered here.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-cfaad77 e-flex e-con-boxed e-con e-parent\" data-id=\"cfaad77\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-52a5803 elementor-widget elementor-widget-heading\" data-id=\"52a5803\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Write Your Contamination Control Strategy\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-7abfee0 e-flex e-con-boxed e-con e-parent\" data-id=\"7abfee0\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f206a30 elementor-widget elementor-widget-text-editor\" data-id=\"f206a30\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Once you have your risk assessment, you should develop your Contamination Control Strategy (CCS). This is another very important aspect of GMP Annex 1. Instead of designing your cleanroom followed by your CCS, your CCS comes first. You should build around contamination control.<\/span><\/p><p><b>Your CCS and risk assessment dictate the strategy you take throughout the rest of your design according to GMP Annex 1.\u00a0<\/b><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-fc8e632 e-flex e-con-boxed e-con e-parent\" data-id=\"fc8e632\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a9d42f0 elementor-widget elementor-widget-heading\" data-id=\"a9d42f0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Integrate Automation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-228e9b2 e-flex e-con-boxed e-con e-parent\" data-id=\"228e9b2\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2e62ebb elementor-widget elementor-widget-text-editor\" data-id=\"2e62ebb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">As you move into truly designing your processes within your cleanroom, it is time to look at where you can automate. GMP Annex 1 places two levels of importance on automation: remove humans from cleanrooms in favor of automation wherever possible and automate computerized systems for data retention and collection.<\/span><\/p><p><span style=\"font-weight: 400;\">First, humans are a major source of contamination in cleanrooms, so removing them whenever you can greatly mitigates the risk of contamination. Automation is safer and more reliable than humans.<\/span><\/p><p><span style=\"font-weight: 400;\">Second, automation of computerized systems allows for predictable, repeatable processes and easily traceable data trails.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Thus, as you design your systems, look for places you can integrate automation.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-3620705 e-flex e-con-boxed e-con e-parent\" data-id=\"3620705\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4254c17 elementor-widget elementor-widget-heading\" data-id=\"4254c17\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Map Your Cleanroom<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-40a677b e-flex e-con-boxed e-con e-parent\" data-id=\"40a677b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1cfad91 elementor-widget elementor-widget-text-editor\" data-id=\"1cfad91\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Next, you need to map your cleanroom. Not every area in your cleanroom will demand the same level of cleanliness or attention, so create a list of spaces that you will need and begin to think about the flow.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-0d3cda7 e-flex e-con-boxed e-con e-parent\" data-id=\"0d3cda7\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-96dea61 elementor-widget elementor-widget-heading\" data-id=\"96dea61\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Critical Areas<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-e641ed9 e-flex e-con-boxed e-con e-parent\" data-id=\"e641ed9\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e239ab8 elementor-widget elementor-widget-text-editor\" data-id=\"e239ab8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">You will first need to identify the critical areas of your cleanroom for aseptic manufacturing. These are the Grade A areas, according to GMP Annex 1. This is where the sterilized product, containers, or closures are exposed to any environmental conditions, such as during aseptic filling.<\/span><\/p><p><span style=\"font-weight: 400;\">Grade A areas should be continuously monitored and are buffered by Grade B zones. (If you are more familiar with ISO classifications, the <\/span><a href=\"https:\/\/bluethundertechnologies.com\/cleanroom-classification-aseptic-processing\/\"><span style=\"font-weight: 400;\">FDA recommends<\/span><\/a><span style=\"font-weight: 400;\"> an ISO 5 or Class 100 designation).<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-804faa5 e-flex e-con-boxed e-con e-parent\" data-id=\"804faa5\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d634977 elementor-widget elementor-widget-heading\" data-id=\"d634977\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Buffer Areas<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-ea80b9d e-flex e-con-boxed e-con e-parent\" data-id=\"ea80b9d\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-74fd3bc elementor-widget elementor-widget-text-editor\" data-id=\"74fd3bc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Next, you have your buffer areas or Grade B zones. These are less crucial areas surrounding the critical zones designed to protect them and the product from the less restricted Grade C and D zones.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Grade B zones should also be continuously monitored and negative pressure. (The <\/span><a href=\"https:\/\/bluethundertechnologies.com\/cleanroom-classification-aseptic-processing\/\"><span style=\"font-weight: 400;\">FDA recommends<\/span><\/a><span style=\"font-weight: 400;\"> these zones are ISO 7 or Class 10,000).<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-5c5d520 e-flex e-con-boxed e-con e-parent\" data-id=\"5c5d520\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7bf54bb elementor-widget elementor-widget-heading\" data-id=\"7bf54bb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Design Your Flow<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-837b5fb e-flex e-con-boxed e-con e-parent\" data-id=\"837b5fb\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-71052c0 elementor-widget elementor-widget-text-editor\" data-id=\"71052c0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Once you have your general map of zones following your process, you need to design the general flow of your cleanroom. There are a few key components of your cleanroom in constant movement: air, personnel, equipment, and product.<\/span><\/p><p><span style=\"font-weight: 400;\">Your previous map should have lined out the general flow of your product, but let\u2019s take a look at the other elements.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-90b5c3c e-flex e-con-boxed e-con e-parent\" data-id=\"90b5c3c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1c13f4d elementor-widget elementor-widget-heading\" data-id=\"1c13f4d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Air Flow<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-e20ddf7 e-flex e-con-boxed e-con e-parent\" data-id=\"e20ddf7\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c4b8c6b elementor-widget elementor-widget-text-editor\" data-id=\"c4b8c6b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Your <\/span><a href=\"https:\/\/www.golighthouse.com\/en\/blog\/your-ultimate-guide-to-cleanroom-air-distribution-strategy-590\/\"><span style=\"font-weight: 400;\">air flow<\/span><\/a><span style=\"font-weight: 400;\"> is a very important part of your cleanroom strategy. There are two types of flow: laminar and turbulent. When air flow is turbulent, there is no predictable movement of particles through the air. Thus, we want to create laminar, or smooth, air flow throughout the cleanroom. This allows us to push the air through the <\/span><a href=\"https:\/\/www.golighthouse.com\/en\/blog\/4-cleanroom-particle-filtration-techniques-591\/\"><span style=\"font-weight: 400;\">air filtration system<\/span><\/a><span style=\"font-weight: 400;\"> and control the flow of particles away from critical areas.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Most cleanrooms use a low-level return system combined with positive or negative pressure to control air flow. This means the air supply is along the ceiling and the returns are along the floor. This helps create laminar flow and can control temperature, too.<\/span><\/p><p><span style=\"font-weight: 400;\">The air is cycled through a strategic use of filters, mainly ULPA and HEPA filters, before re-entering the room. This is perhaps the most important part of the design of your cleanroom. We recommend exploring the air filtration strategy documents we have in our free <\/span><a href=\"https:\/\/www.golighthouse.com\/en\/knowledge-center\/\"><span style=\"font-weight: 400;\">Knowledge Center<\/span><\/a><span style=\"font-weight: 400;\"> for a more comprehensive look at designing an air filtration strategy.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-df41b1d e-flex e-con-boxed e-con e-parent\" data-id=\"df41b1d\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4ceb766 elementor-widget elementor-widget-heading\" data-id=\"4ceb766\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Personnel and Equipment Flow<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-78e1e3b e-flex e-con-boxed e-con e-parent\" data-id=\"78e1e3b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-04ee408 elementor-widget elementor-widget-text-editor\" data-id=\"04ee408\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The next items that will consistently flow throughout your cleanroom are the personnel and equipment. Both of these can create particles as they move. Thus, track where they will be moving in your cleanroom and plan those spots as hot spots for potential contamination. Identify if there will be extra movement in critical areas and design ways to avoid contamination there.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-f0edcde e-flex e-con-boxed e-con e-parent\" data-id=\"f0edcde\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-54aac32 elementor-widget elementor-widget-heading\" data-id=\"54aac32\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Choose Materials Used<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-ded9751 e-flex e-con-boxed e-con e-parent\" data-id=\"ded9751\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a26e2c1 elementor-widget elementor-widget-text-editor\" data-id=\"a26e2c1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Whenever choosing any sort of material used in your cleanroom (or in items that enter your cleanroom), you need to consider the following:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Is it porous?<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Is it difficult to clean or sanitize?<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Does it shed particles?<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">If the answer to any of the above is yes, then you need a different material. If it is going to be present in the cleanroom, it needs to be non-porous, easily cleaned and sanitized, and non-shedding.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-c6c49ee e-flex e-con-boxed e-con e-parent\" data-id=\"c6c49ee\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fa09ad4 elementor-widget elementor-widget-heading\" data-id=\"fa09ad4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Choose Your Environmental Monitoring System\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-27362bf e-flex e-con-boxed e-con e-parent\" data-id=\"27362bf\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7630ed8 elementor-widget elementor-widget-text-editor\" data-id=\"7630ed8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Now you get to choose your Environmental Monitoring System (EMS). This system should:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Meet all the criteria of your CCS.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Make your life easier.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Offer real-time monitoring.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Be of high quality.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Have self diagnostics.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Provide multiple integration options.<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">The good news is that this is actually the easiest part, because all you have to do is bring your CCS, risk assessment, and application to our experts here at LWS and we\u2019ll do the rest for you.<\/span><\/p><p><a href=\"https:\/\/www.golighthouse.com\/en\/real-time-monitoring-systems\/\"><span style=\"font-weight: 400;\">Start by exploring our EMS options today.<\/span><\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"featured_media":15079,"template":"","kc_format":[63],"kc_topics":[67,122,68,69],"class_list":["post-14957","knowledge-center","type-knowledge-center","status-publish","has-post-thumbnail","hentry","kc_format-blog","kc_topics-best-practices","kc_topics-best-practices-guidelines","kc_topics-cleaning-wipedown","kc_topics-cleanroom-gowning"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.2) - 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