{"id":35920,"date":"2022-07-22T11:53:21","date_gmt":"2022-07-22T04:53:21","guid":{"rendered":"https:\/\/techmaster.com.vn\/?page_id=35920"},"modified":"2022-07-22T13:21:07","modified_gmt":"2022-07-22T06:21:07","slug":"usp-1788-2022-revision-overview-faq","status":"publish","type":"page","link":"https:\/\/techmaster.com.vn\/en\/usp-1788-2022-revision-overview-faq\/","title":{"rendered":"USP 1788 2022 Revision Overview FAQ"},"content":{"rendered":" \t<section class=\"section\" id=\"section_208964117\">\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 <div class=\"row\"  id=\"row-1049179084\"> \n\t<div id=\"col-1237263127\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t \t<div id=\"text-3344203584\" class=\"text\">\n\t\t\r\n<h1>Application Note<\/h1>\r\n\t\t\n<style>\n#text-3344203584 {\n  font-size: 1.6rem;\n  line-height: 1.2;\n  color: rgb(255,255,255);\n}\n#text-3344203584 > * {\n  color: rgb(255,255,255);\n}\n<\/style>\n\t<\/div>\n\t \t\t<\/div>\n\t\t\t\t\n<style>\n#col-1237263127 > .col-inner {\n  padding: 0px 0px 0px 40px;\n  margin: 0px 0px -55px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t <\/div> \t\t<\/div>\n\n\t\t\n<style>\n#section_208964117 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n}\n#section_208964117 .section-bg.bg-loaded {\n  background-image: url(https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/07\/banner-knowledge.jpeg);\n}\n#section_208964117 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#section_208964117 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n\t<\/section>\n\t \t<section class=\"section\" id=\"section_755988048\">\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 <div class=\"row\"  id=\"row-325106376\"> \n\t<div id=\"col-454969060\" 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\r\n<h1>USP 1788 2022 Revision Overview FAQ<\/h1>\r\n<p>In May 2021, a revision to USP 1788 Methods for Determination of Subvisible Particulate Matter was published in order to provide clarification and support of the information given in chapters USP &lt;788&gt; Particulate Matter in Injections, USP &lt;789&gt; Particulate Matter in Ophthalmic Solutions, and USP &lt;787&gt; Sub-visible Particulate Matter in Therapeutic Protein Injections. While the previous version of USP &lt;1788&gt; only covered the testing requirements for Optical Light Obscuration testing and Microscope testing, the revision expands the scope of testing requirements to include newly viable technologies such as Flow Imaging and new therapeutic protein solutions. Particle Measuring Systems\u2019(PMS) APSS-2000 testing system still fully complies with the requirements for use in the testing of solutions in the Normative Chapters and revised General Chapters.<\/p>\r\n<p>In light of these revisions, Particle Measuring Systems is sharing some insight about the requirements and discussing how this may affect the APSS-2000 testing system. PMS has provided\u00a0<span data-text-color=\"alert\">a Methods Review<\/span>\u00a0of the USP &lt;1788&gt; Revisions. PMS also has\u00a0<span data-text-color=\"alert\">an on-demand webinar<\/span>\u00a0that discusses meeting the USP &lt;729&gt;, USP &lt;788&gt;, and USP &lt;1788&gt; regulatory requirements and\u00a0<span data-text-color=\"alert\">an article<\/span>\u00a0comparing USP &lt;788&gt; and USP &lt;1788&gt;.<\/p>\r\n<p>This FAQ paper is a follow up to the webinar, \u201c<span data-text-color=\"alert\">USP 1788 2022 Revision Overview<\/span>\u201d presented by Mark Hallworth and Rick Duskey that looks at the holistic view of finished product contaminants, and how they should be investigated. Many thoughtful questions were asked about the USP &lt;1788&gt; revision and troubleshooting the APSS-2000 system. Questions submitted during and after the webinar are answered by Mark Hallworth, below. If you have any additional queries for our experts,\u00a0<span data-text-color=\"alert\">submit them directly here<\/span>.<\/p>\r\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-454969060 > .col-inner {\n  padding: 0px 0px 0px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t \n\t<div id=\"col-2100930138\" 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 \t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_403457374\">\n\t\t\t\t\t\t\t\t<div class=\"img-inner dark\" >\n\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"380\" height=\"400\" src=\"https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/07\/APSS-2000.png\" class=\"attachment-large size-large\" alt=\"USP 788 Particulate Matter in Injections\" \/>\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_403457374 {\n  width: 100%;\n}\n<\/style>\n\t<\/div>\n\t \t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t <\/div> \t\t<\/div>\n\n\t\t\n<style>\n#section_755988048 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n  background-color: rgb(255,255,255);\n}\n#section_755988048 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#section_755988048 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n\t<\/section>\n\t ","protected":false},"excerpt":{"rendered":"","protected":false},"author":11,"featured_media":35814,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-blank.php","meta":{"footnotes":""},"class_list":["post-35920","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) - 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