{"id":1434,"date":"2024-11-18T15:06:54","date_gmt":"2024-11-18T08:06:54","guid":{"rendered":"https:\/\/gerahitech.vn\/?p=1434"},"modified":"2024-11-18T15:15:04","modified_gmt":"2024-11-18T08:15:04","slug":"giai-thich-phan-loai-phong-sach","status":"publish","type":"post","link":"https:\/\/giaiphapdokiemchatluong.vn\/en\/giai-thich-phan-loai-phong-sach\/","title":{"rendered":"Cleanroom Classifications Explained"},"content":{"rendered":"<p><\/p>\n<p style=\"margin-top: 0in; background: white; text-align: justify;\"><span style=\"font-size: 14pt;\"><em><span style=\"font-family: 'Arial',sans-serif; color: #54595f;\">A cleanroom classification basically tells you how clean a cleanroom is. While we typically consider cleanrooms to use HEPA filters and multiple layers of protection, cleanrooms can really be any room where precautions are taken to ensure that the product stays clean from contaminants.<\/span><\/em><\/span><\/p>\n<p style=\"margin-top: 0in; background: white; text-align: justify;\"><span style=\"font-size: 14pt;\"><em><span style=\"font-family: 'Arial',sans-serif; color: #54595f;\">But if that\u2019s the case, then what makes one cleanroom stand above the other? That\u2019s where cleanroom classifications come into play.<\/span><\/em><\/span><\/p>\n<pre><span style=\"font-size: 18pt; color: #0000ff; font-family: arial, helvetica, sans-serif;\"><strong>Who Sets Cleanroom Classifications?<\/strong><\/span><\/pre>\n<p style=\"text-align: justify;\"><span style=\"font-size: 14pt;\">Cleanroom classifications are set by the\u00a0<a href=\"https:\/\/www.iso.org\/about-us.html\"><strong>International Organization for Standardization (ISO)<\/strong><\/a>. They are an independent, non-governmental agency dedicated to providing world standards in a variety of industries. ISO offers international standards, but there is an additional standard for companies wanting a USA certification.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 14pt;\">The Federal Standard 209 (FS 209) is an American classification that was established in 1963 by the\u00a0<a href=\"https:\/\/www.iest.org\/\"><strong>Institute of Environmental Sciences and Technology<\/strong><\/a>\u00a0(IEST). Similar to ISO, there are a number of classifications available through the IEST \u2013 ranging from FS209A through FS209E. The most recent update was FS209E establishing the maximum number of particles present if a room is to be officially classified as a cleanroom.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 14pt;\">Whether you choose to go with the FS 209 classifications or the ISO classification, FS 209 E and ISO 14644-1 reflect the same measurements to classify a cleanroom at certain levels. While being classified with either is a good idea (and, often, required), we typically side with ISO as the international aspect allows for more flexibility.<\/span><\/p>\n<pre><span style=\"font-size: 18pt; font-family: arial, helvetica, sans-serif; color: #0000ff;\"><strong>What Are Cleanroom Classifications?<\/strong><\/span><\/pre>\n<p style=\"text-align: justify;\"><span style=\"font-size: 14pt;\">Since we typically use the ISO standard, today we\u2019ll be talking about how these classifications work.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 14pt;\">There are 9 ISO classifications of cleanrooms:<\/span><\/p>\n<ul style=\"text-align: justify;\">\n<li><span style=\"font-size: 14pt;\">ISO 1<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">ISO 2<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">ISO 3 (FS 209 E class 1 equivalent)<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">ISO 4 (FS 209 E class 10 equivalent)<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">ISO 5 (FS 209 E class 100 equivalent)<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">ISO 6 (FS 209 E class 1,000 equivalent)<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">ISO 7 (FS 209 E class 10,000 equivalent)<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">ISO 8 (FS 209 E class 100,000 equivalent)<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">ISO 9 (room air)<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><span style=\"font-size: 14pt;\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-1437\" src=\"https:\/\/gerahitech.vn\/wp-content\/uploads\/2024\/11\/Picture1.png\" alt=\"\" width=\"624\" height=\"484\" srcset=\"https:\/\/giaiphapdokiemchatluong.vn\/wp-content\/uploads\/2024\/11\/Picture1.png 624w, https:\/\/giaiphapdokiemchatluong.vn\/wp-content\/uploads\/2024\/11\/Picture1-300x233.png 300w\" sizes=\"auto, (max-width: 624px) 100vw, 624px\" \/><\/span><\/p>\n<p style=\"margin-top: 0in; background: white; text-align: justify;\"><span style=\"font-family: Arial, sans-serif; color: #54595f; font-size: 14pt;\">If you want to be the cleanest cleanroom, you\u2019ll need an ISO 1 classification. To attain this classification, you\u2019ll need to prove a known sample that has 10 or fewer particles measuring 0.1 microns and only 2 or fewer particles at 0.2 microns.<\/span><\/p>\n<p style=\"margin-top: 0in; background: white; text-align: justify;\"><span style=\"font-family: Arial, sans-serif; color: #54595f; font-size: 14pt;\">From there, the scale allows for more and larger particles. ISO 9 is considered normal room air. These rooms have a known sampling with 35,200,000 or fewer particles measuring 0.5 microns, 8,320,000 or fewer particles measuring 1 micron, and 293,000 or fewer particles measuring 5 microns.<\/span><\/p>\n<p style=\"margin-top: 0in; background: white; text-align: justify;\"><span style=\"font-family: Arial, sans-serif; color: #54595f; font-size: 14pt;\">Basically, there are a lot of particles and they can be pretty big!<\/span><\/p>\n<p style=\"margin-top: 0in; background: white; text-align: justify;\"><span style=\"font-family: Arial, sans-serif; color: #54595f; font-size: 14pt;\">Your classification really depends on what you\u2019re producing and how sterile the environment needs to be. But once you determine what classification is required for your industry and production, there are steps you can take to certify your cleanroom and conduct regular maintenance.<\/span><\/p>\n<pre style=\"text-align: justify;\"><span style=\"font-size: 18pt; color: #0000ff;\"><b><span style=\"line-height: 107%; font-family: Arial, sans-serif;\">How Can You Certify Your Cleanroom Classification?<\/span><\/b><\/span><\/pre>\n<p style=\"text-align: justify;\"><span style=\"font-size: 14pt;\">If you\u2019re ready to get your cleanroom classification, there are a few steps you can follow.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 14pt;\"><strong>1. Determine your cleanroom size and the number of areas that need to have their particles measured.<\/strong><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 14pt;\">Depending on the size of your cleanroom and entry and exit locations, you will need to measure your cleanroom\u2019s particle size and count in different areas. Your particle counter can help with this determination.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 14pt;\"><strong>2. Determine what level of cleanliness you need for your desired classification.<\/strong><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 14pt;\">This will help you figure out what size and concentration of particles you need to achieve to secure your classification. Make sure your particle counter can correctly and accurately measure particles in the size and concentration you need.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 14pt;\"><strong>3. Measure the required areas.<\/strong><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 14pt;\">When going through your annual or semi-annual testing to verify your cleanroom classification, we recommend conducting 4 tests. While the Non-Viable Particle Counting is the one that will determine how clean your cleanroom is, all 4 tests give you valuable information for your classification and general cleanroom maintenance. The tests are:<\/span><\/p>\n<ul style=\"text-align: justify;\">\n<li><span style=\"font-size: 14pt;\">Airflow Volume\/Velocity Readings: This test makes sure the airflow is in the correct amount and direction.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">HEPA Filter Integrity Testing: While not required by ISO standards, this test is often required by other organizations such as the FDA. This test makes sure there are no leaks in your HEPA filter.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Non-Viable Particle Counting: In this process, this is the most important test, as it tells you how many particles are in a certain area as well as what size they are. This is the test that will determine your classifications.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Room Pressurization Testing: This test verifies the desired room pressure is correct.<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><span style=\"font-size: 14pt;\"><strong>4. Take the averages.<\/strong><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 14pt;\">Average the number and size of particles in each location. Then take your location averages and find their average, so you have the overall average size and number of particles for the cleanroom.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 14pt;\"><strong>5. Find your cleanroom classification!<\/strong><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 14pt;\">Use a particle counter that will automatically find the Upper Confidence Limit to determine where your statistically significant particle size and number. Then determine which ISO classification you fall under<\/span><\/p>\n<pre><span style=\"font-size: 18pt; color: #0000ff; font-family: arial, helvetica, sans-serif;\"><strong>Let Us Help You Keep Your Cleanroom Clean!<\/strong><\/span><\/pre>\n<p style=\"margin-top: 0in; background: white; text-align: justify;\"><span style=\"font-family: Arial, sans-serif; color: #54595f; font-size: 14pt;\">What industry are you in? How clean does your cleanroom need to be? What\u2019s your ideal cleanroom classification?<\/span><\/p>\n<p style=\"margin-top: 0in; background: white; text-align: justify;\"><span style=\"font-family: Arial, sans-serif; color: #54595f; font-size: 14pt;\">Whatever your ideal is, we know we can get you there.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 14pt;\"><img decoding=\"async\" id=\"image-hover-icon\" style=\"position: absolute; width: 25px; height: 25px; cursor: pointer; left: 279.444px; top: 927.889px; display: none; opacity: 0.7;\" src=\"chrome-extension:\/\/opimdenmabjbacmheeebgjckapkmedkp\/src\/public\/images\/128px.png\" \/><\/span><\/p>\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>A cleanroom classification basically tells you how clean a cleanroom is. While we typically consider cleanrooms to use HEPA filters &#8230;<\/p>\n","protected":false},"author":1,"featured_media":1435,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[40],"tags":[44,43],"class_list":["post-1434","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-tin-tuc-san-pham-kien-thuc","tag-cleanroom","tag-phong-sach"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Cleanroom Classifications Explained<\/title>\n<meta name=\"description\" content=\"Ph\u00e2n lo\u1ea1i ph\u00f2ng s\u1ea1ch v\u1ec1 c\u01a1 b\u1ea3n cho bi\u1ebft m\u1ee9c \u0111\u1ed9 s\u1ea1ch c\u1ee7a ph\u00f2ng s\u1ea1ch. 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