{"id":44160,"date":"2022-11-23T14:16:39","date_gmt":"2022-11-23T07:16:39","guid":{"rendered":"https:\/\/techmaster.com.vn\/?page_id=44160"},"modified":"2022-11-23T14:25:26","modified_gmt":"2022-11-23T07:25:26","slug":"choosing-the-most-suitable-particle-sample-point-locations","status":"publish","type":"page","link":"https:\/\/techmaster.com.vn\/en\/choosing-the-most-suitable-particle-sample-point-locations\/","title":{"rendered":"Choosing the Most Suitable Particle Sample Point Locations"},"content":{"rendered":"\n\t<section class=\"section\" id=\"section_1564135471\">\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\n\n<div class=\"row\"  id=\"row-172024842\">\n\n\n\t<div id=\"col-539510436\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\t<div id=\"text-2289597712\" class=\"text\">\n\t\t\n\n<h2 class=\"banner-title\" style=\"text-align: left;\">Application Note<\/h2>\n\t\t\n<style>\n#text-2289597712 {\n  font-size: 1.6rem;\n  line-height: 1.2;\n  color: rgb(255,255,255);\n}\n#text-2289597712 > * {\n  color: rgb(255,255,255);\n}\n<\/style>\n\t<\/div>\n\t\n\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-539510436 > .col-inner {\n  padding: 0px 0px 0px 40px;\n  margin: -12px 0px -55px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n<\/div>\n\n\t\t<\/div>\n\n\t\t\n<style>\n#section_1564135471 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n}\n#section_1564135471 .section-bg.bg-loaded {\n  background-image: url(https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/07\/banner-knowledge.jpeg);\n}\n#section_1564135471 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#section_1564135471 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n\t<\/section>\n\t\n\t<section class=\"section\" id=\"section_1098502924\">\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\n\n<div class=\"row\"  id=\"row-1364295651\">\n\n\n\t<div id=\"col-1788800517\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<h2><span data-text-color=\"alert\"><strong>Choosing the Most Suitable Particle Sample Point Locations<\/strong><\/span><\/h2>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1964908369\" class=\"col medium-3 small-12 large-3\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_1509673151\">\n\t\t\t\t\t\t\t\t<div class=\"img-inner dark\" >\n\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"322\" height=\"322\" src=\"https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/11\/Pharma-Top-10-W-Papers.png\" class=\"attachment-large size-large\" alt=\"Pharma Top 10 W Papers\" \/>\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_1509673151 {\n  width: 100%;\n}\n<\/style>\n\t<\/div>\n\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1757242399\" class=\"col medium-9 small-12 large-9\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<h3><span data-text-color=\"alert\"><em>Considerations for particle counter isokinetic probe placement to ensure effective cleanroom monitoring<\/em><\/span><\/h3>\n<p>The\u00a0<span data-text-color=\"alert\">Particle Measuring Systems (PMS)<\/span> environmental system designers are often asked how to choose clean room sampling points, whether it be performed in a pharmaceutical cleanroom or clean device (RABS, isolator, etc.).<\/p>\n<p>The answer is not always straightforward. There are several guidance documents that offer advice on what processes need to be monitored, along with advice on suitable distances from the process being monitored. The goal of this article is to identify the considerations, establish the most suitable location for monitoring a process, and build a scientific rationale for that decision.<\/p>\n<p><span data-text-color=\"alert\">Particle counting<\/span>\u00a0in\u00a0<span data-text-color=\"alert\">pharmaceutical applications<\/span>\u00a0can be clearly segregated into one of three categories:\u00a0<span data-text-color=\"alert\">certification<\/span>,\u00a0<span data-text-color=\"alert\">qualification<\/span>\u00a0and\u00a0<span data-text-color=\"alert\">monitoring<\/span>. Each category requires a different approach.<\/p>\n<p><b>Certification\u00a0<\/b>is measuring a cleanroom for a standard. The standard recognized worldwide is\u00a0<span data-text-color=\"alert\">ISO14644-1<\/span>, \u201cClassification of air cleanliness by particle concentration\u201d, which defines how a cleanroom performs and its ability to show uniformity across the entire space. This is done irrespective of the activities performed in it.<\/p>\n<p><b>Qualification\u00a0<\/b>is the process of analyzing risk assessment for the activities in the room. Qualification follows grid methodology testing methods. Particle counts are measured in both operational and at-rest states; however, the operational data is the most valid.<\/p>\n<p><b>Monitoring\u00a0<\/b>is the ongoing sampling of the cleanroom on a frequency relative to the degree of control required to prove management over risk to the finished product. The number of sample points and their location is determined by\u00a0<span data-text-color=\"alert\">risk assessment<\/span>, and the qualification and certification process.<\/p>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-324085013\" class=\"col medium-8 small-12 large-8\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<h3><span data-text-color=\"alert\">Certification<\/span><\/h3>\n<p>As mentioned above, cleanroom certification is based on ISO14644-1, \u201cClassification of air cleanliness by particle concentration\u201d standards. The specifics of the assessment may vary slightly for FDA or\u00a0<span data-text-color=\"alert\">EU GMP regulations<\/span>, but the underlying methodology is standard.<\/p>\n<p>Certification demonstrates that the entire area meets a specific ISO classification by particle concentration. That is, irrespective of the final use of the room, the design and implementation of the filtration system are considered. The international standard means that a cleanroom tested to meet compliance for ISO 5 standards will meet that standard independent of geography and regulatory aspects (i.e.: FDA or EU GMP). This provides a universal standard to show that a cleanroom level has been established.<\/p>\n<p>There are many different resources to prove ISO compliance and this paper will not cover these in depth. However, using the example of a classic filling machine (Grade A\/ISO5) within a Grade B (ISO7) background area, the basic rules of testing can be demonstrated.<\/p>\n<h2 style=\"text-align: center;\"><span data-text-color=\"alert\"><strong>Please help us understand your needs and download the complete paper by completing the form on the right.<\/strong><\/span><\/h2>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-786245090\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_2091278073\">\n\t\t\t\t\t\t\t\t<div class=\"img-inner dark\" >\n\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"400\" height=\"267\" src=\"https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/11\/200207-PMS_Argonaut-2-probe-SM-400x267-1.jpeg\" class=\"attachment-large size-large\" alt=\"200207 PMS Argonaut 2 probe SM\" \/>\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_2091278073 {\n  width: 100%;\n}\n<\/style>\n\t<\/div>\n\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1733714219\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<h3><span data-text-color=\"alert\">Cleanroom monitors<\/span><\/h3>\n<p>Particle Measuring Systems\u2019 cleanroom viable non viable cleanoom monitoring instruments, include:<\/p>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-666981091\" class=\"col medium-3 small-12 large-3\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_34074052\">\n\t\t\t\t\t\t\t\t<div class=\"img-inner dark\" >\n\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"400\" height=\"306\" src=\"https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/11\/MiniCapt-Mobile-with-BioCapt-Single-Use-400x306-1.jpeg\" class=\"attachment-large size-large\" alt=\"\" \/>\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_34074052 {\n  width: 100%;\n}\n<\/style>\n\t<\/div>\n\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-5535568\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<h4>Active Air Samplers<\/h4>\n<ul>\n<li><span data-text-color=\"alert\">MiniCapt mobile active air sampler<\/span><\/li>\n<li><span data-text-color=\"alert\">MiniCapt Remote<\/span>\u00a0microbial air sampler<\/li>\n<li><span data-text-color=\"alert\">BioCapt Single Use<\/span>\u00a0microbial impactors<\/li>\n<\/ul>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1897845936\" class=\"col medium-5 small-12 large-5\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1487972746\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<h3><span data-text-color=\"alert\">Particle Counters<\/span><\/h3>\n<ul>\n<li><span data-text-color=\"alert\">IsoAir Pro-Plus Remote Particle Counter (with built-in pump)\u00a0<\/span><\/li>\n<li><span data-text-color=\"alert\">Airnet\u00ae II Particle Sensor<\/span><\/li>\n<li><span data-text-color=\"alert\">Lasair Pro Portable Particle Counter<\/span>\n<ul>\n<li><span data-text-color=\"alert\">DataAnalyst<\/span>\u00a0interactive software can even step the user through the certification process.<\/li>\n<\/ul>\n<\/li>\n<li><span data-text-color=\"alert\">HandiLaz Mini II<\/span>\u00a0handheld particle counter<\/li>\n<\/ul>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1256356280\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_1333700393\">\n\t\t\t\t\t\t\t\t<div class=\"img-inner dark\" >\n\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"338\" height=\"173\" 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100%;\n}\n<\/style>\n\t<\/section>\n\t\n\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":11,"featured_media":44168,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-blank.php","meta":{"footnotes":""},"class_list":["post-44160","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) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Choosing the Most Suitable Particle Sample Point Locations - Techmaster Electronics JSC<\/title>\n<meta name=\"description\" content=\"Choosing the Most Suitable Particle Sample Point Locations Considerations for particle counter isokinetic probe placement to ensure effective cleanroom monitoring\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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