{"id":7180,"date":"2026-11-10T13:51:42","date_gmt":"2026-11-10T13:51:42","guid":{"rendered":"https:\/\/www.waters.com\/blog\/?p=7180"},"modified":"2026-11-10T13:51:43","modified_gmt":"2026-11-10T13:51:43","slug":"beyond-the-sop-rethinking-consistency-in-endotoxin-testing","status":"publish","type":"post","link":"https:\/\/www.waters.com\/blog\/beyond-the-sop-rethinking-consistency-in-endotoxin-testing\/","title":{"rendered":"Beyond the SOP: Rethinking Consistency in Endotoxin Testing"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\">What if simpler sample preparation could help make endotoxin testing more consistent\u2014without compromising throughput?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/event.on24.com\/wcc\/r\/5459610\/70604EDC67CB81E558599D29940A80DA?partnerref=BlogPost\">In a recent webinar<\/a>, Guillaume Mignard from Waters and Paola Vigilanza, PhD, and Luca Di Bello from bioM\u00e9rieux demonstrated how to simplify endotoxin testing by combining ready-to-use assay plates with automated sample preparation. The webinar explored assay simplification, standardized preparation and traceable execution.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">You&#8217;ll also see assay performance data, review the required Andrew+ Robot and <a href=\"https:\/\/www.waters.com\/nextgen\/global\/products\/laboratory-automation-and-equipment\/onelab-software.html\">OneLab Software<\/a> workflow configuration, and explore practical considerations for implementing the approach in a QC laboratory.<\/p>\n\n\n<style>.wp-block-kadence-spacer.kt-block-spacer-7180_754aab-f7 .kt-block-spacer{height:60px;}.wp-block-kadence-spacer.kt-block-spacer-7180_754aab-f7 .kt-divider{border-top-width:1px;height:1px;border-top-color:#eee;width:80%;border-top-style:solid;}<\/style>\n<div class=\"wp-block-kadence-spacer aligncenter kt-block-spacer-7180_754aab-f7\"><div class=\"kt-block-spacer kt-block-spacer-halign-center\"><hr class=\"kt-divider\"\/><\/div><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Where variability enters the workflow<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">A valid standard curve is essential, but it does not demonstrate that all operator-dependent variability has disappeared.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Even when analysts follow the same written procedure and use the same reagents, plates, and samples, small differences in manual execution may still introduce variability. Differences in pipetting technique, timing, and handling can contribute to variation in coefficients of variation and standard-curve parameters, including slope and y-intercept.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Standard-curve preparation makes this distinction particularly tangible. Reconstituting endotoxins, preparing serial dilutions, and transferring standards introduce successive handling steps, alongside preparation of negative controls and positive product controls (PPCs). Each is another opportunity for variation. Because curve performance helps determine assay validity, a failure can lead to repeat testing across the plate\u2014with consequences for analyst time, instrument availability, and investigation workload.<\/p>\n\n\n<style>.wp-block-kadence-spacer.kt-block-spacer-7180_381b25-99 .kt-block-spacer{height:60px;}.wp-block-kadence-spacer.kt-block-spacer-7180_381b25-99 .kt-divider{border-top-width:1px;height:1px;border-top-color:#eee;width:80%;border-top-style:solid;}<\/style>\n<div class=\"wp-block-kadence-spacer aligncenter kt-block-spacer-7180_381b25-99\"><div class=\"kt-block-spacer kt-block-spacer-halign-center\"><hr class=\"kt-divider\"\/><\/div><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">When manual work becomes a capacity constraint<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">These analytical vulnerabilities need to be managed within a busy laboratory. Samples can arrive together while analysts manage other priorities, and repetitive pipetting requires sustained attention. An interruption may make it difficult to establish which transfers have already been completed. Increasing demand therefore creates a personnel-capacity challenge as well as a throughput challenge\u2014the lab needs appropriately trained analysts available to perform the work. Intensive pipetting can also add an ergonomic burden.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The webinar\u2019s opening audience poll reflected this combination of concerns, bringing together operator variability, manual workflows, data integrity, and capacity. Rather than treating them as separate problems, the discussion asks where the workflow itself can be redesigned. The aim is not simply to move existing manual tasks onto an automated platform, but to remove avoidable complexity first.<\/p>\n\n\n<style>.wp-block-kadence-spacer.kt-block-spacer-7180_598947-26 .kt-block-spacer{height:60px;}.wp-block-kadence-spacer.kt-block-spacer-7180_598947-26 .kt-divider{border-top-width:1px;height:1px;border-top-color:#eee;width:80%;border-top-style:solid;}<\/style>\n<div class=\"wp-block-kadence-spacer aligncenter kt-block-spacer-7180_598947-26\"><div class=\"kt-block-spacer kt-block-spacer-halign-center\"><hr class=\"kt-divider\"\/><\/div><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Simplify before automating<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The assay provides the starting point. Recombinant Factor C (rFC) detects the endotoxin without relying on horseshoe-crab blood. The endotoxin activates rFC, which cleaves a fluorogenic substrate; the resulting fluorescence is quantified against a standard curve. This changes the reagent approach, but careful preparation and sample suitability remain important.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">bioM\u00e9rieux ENDONEXT ENDOZYME\u00ae II GO ready-to-use plates simplify preparation through preloaded, lyophilized standard-curve material and PPCs. This reduces the manual control-standard handling associated with conventional workflows. It also changes the question that need to be asked about automation. Instead of reproducing every dilution and transfer, which remaining steps would benefit most from controlled execution?<\/p>\n\n\n<style>.wp-block-kadence-spacer.kt-block-spacer-7180_7c26c9-60 .kt-block-spacer{height:60px;}.wp-block-kadence-spacer.kt-block-spacer-7180_7c26c9-60 .kt-divider{border-top-width:1px;height:1px;border-top-color:#eee;width:80%;border-top-style:solid;}<\/style>\n<div class=\"wp-block-kadence-spacer aligncenter kt-block-spacer-7180_7c26c9-60\"><div class=\"kt-block-spacer kt-block-spacer-halign-center\"><hr class=\"kt-divider\"\/><\/div><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Standardize preparation with automation<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Within the Waters OneLab Software ecosystem, <a href=\"https:\/\/www.waters.com\/nextgen\/global\/products\/laboratory-automation-and-equipment\/andrew-plus-pipetting-robot.html\">the Andrew+ Robot<\/a> automates the plate-preparation steps that remain after assay simplification. Simplification removes steps and automation controls their execution, helping make repetitive liquid handling less dependent on individual technique and timing while retaining multi-well testing.<\/p>\n\n\n<style>.wp-block-kadence-spacer.kt-block-spacer-7180_72725f-af .kt-block-spacer{height:60px;}.wp-block-kadence-spacer.kt-block-spacer-7180_72725f-af .kt-divider{border-top-width:1px;height:1px;border-top-color:#eee;width:80%;border-top-style:solid;}<\/style>\n<div class=\"wp-block-kadence-spacer aligncenter kt-block-spacer-7180_72725f-af\"><div class=\"kt-block-spacer kt-block-spacer-halign-center\"><hr class=\"kt-divider\"\/><\/div><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Build traceability into every run<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">In QC, reproducibility requires evidence of how a workflow was executed. OneLab Software links protocol execution to experiment reports, timestamps, device logs, audit trails, and sample-position information, alongside electronic signature workflows.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Together, these records make preparation activities traceable and support laboratories during audits with a clear account of workflow execution.<\/p>\n\n\n<style>.wp-block-kadence-spacer.kt-block-spacer-7180_219b76-a5 .kt-block-spacer{height:60px;}.wp-block-kadence-spacer.kt-block-spacer-7180_219b76-a5 .kt-divider{border-top-width:1px;height:1px;border-top-color:#eee;width:80%;border-top-style:solid;}<\/style>\n<div class=\"wp-block-kadence-spacer aligncenter kt-block-spacer-7180_219b76-a5\"><div class=\"kt-block-spacer kt-block-spacer-halign-center\"><hr class=\"kt-divider\"\/><\/div><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">The next step toward more consistent endotoxin testing<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Choosing a BET workflow means considering method suitability, applicable requirements, and running costs together. This assessment helps you target automation where it can strengthen preparation control and improve consistency.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Where could simplifying preparation make the greatest difference in your lab? Considering assay preparation, liquid handling and documentation together helps identify where controlled execution can add value. Scientific expertise remains central to deciding how those changes can support more consistent routine testing.<\/p>\n\n\n<style>.wp-block-kadence-spacer.kt-block-spacer-7180_df5445-98 .kt-block-spacer{height:60px;}.wp-block-kadence-spacer.kt-block-spacer-7180_df5445-98 .kt-divider{border-top-width:1px;height:1px;border-top-color:#eee;width:80%;border-top-style:solid;}<\/style>\n<div class=\"wp-block-kadence-spacer aligncenter kt-block-spacer-7180_df5445-98\"><div class=\"kt-block-spacer kt-block-spacer-halign-center\"><hr class=\"kt-divider\"\/><\/div><\/div>\n\n\n\n<h2 class=\"wp-block-heading\"><strong><a href=\"https:\/\/event.on24.com\/wcc\/r\/5459610\/70604EDC67CB81E558599D29940A80DA?partnerref=BlogPost\"><span style=\"text-decoration: underline;\">Watch the webinar<\/span><\/a> <\/strong>to see the workflow in action.<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>What if simpler sample preparation could help make endotoxin testing more consistent\u2014without compromising throughput? In a recent webinar, Guillaume Mignard from Waters and Paola Vigilanza, PhD, and Luca Di Bello from bioM\u00e9rieux demonstrated how to simplify endotoxin testing by combining ready-to-use assay plates with automated sample preparation. The webinar explored assay simplification, standardized preparation and&#8230;<\/p>\n","protected":false},"author":139,"featured_media":7181,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_kad_blocks_custom_css":"","_kad_blocks_head_custom_js":"","_kad_blocks_body_custom_js":"","_kad_blocks_footer_custom_js":"","_kad_post_transparent":"","_kad_post_title":"","_kad_post_layout":"","_kad_post_sidebar_id":"","_kad_post_content_style":"","_kad_post_vertical_padding":"","_kad_post_feature":"","_kad_post_feature_position":"","_kad_post_header":false,"_kad_post_footer":false,"_kad_post_classname":"","footnotes":""},"categories":[22],"tags":[763,791,64,764,624],"class_list":["post-7180","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-technology","tag-andrew-robot","tag-endotoxins","tag-lc-ms","tag-onelab-software","tag-quality-control"],"acf":[],"taxonomy_info":{"category":[{"value":22,"label":"Technology"}],"post_tag":[{"value":763,"label":"Andrew+ Robot"},{"value":791,"label":"endotoxins"},{"value":64,"label":"LC-MS"},{"value":764,"label":"OneLab Software"},{"value":624,"label":"quality control"}]},"featured_image_src_large":["https:\/\/www.waters.com\/blog\/wp-content\/uploads\/andrew-plus-beauty_medium-1920px-transparent-background.jpg",600,400,false],"author_info":{"display_name":"Waters Staff","author_link":"https:\/\/www.waters.com\/blog\/author\/waters_staff\/"},"comment_info":"","category_info":[{"term_id":22,"name":"Technology","slug":"technology","term_group":0,"term_taxonomy_id":22,"taxonomy":"category","description":"Our expertise drives innovation, development, and\u00a0application of informatics and software that continue to enable leading pharmaceutical, environmental, food &amp; beverage and chemical materials organizations to accelerate decision-making, improve laboratory effectiveness, and get products to market faster.","parent":0,"count":131,"filter":"raw","term_order":"0","cat_ID":22,"category_count":131,"category_description":"Our expertise drives innovation, development, and\u00a0application of informatics and software that continue to enable leading pharmaceutical, environmental, food &amp; beverage and chemical materials organizations to accelerate decision-making, improve laboratory effectiveness, and get products to market faster.","cat_name":"Technology","category_nicename":"technology","category_parent":0}],"tag_info":[{"term_id":763,"name":"Andrew+ Robot","slug":"andrew-robot","term_group":0,"term_taxonomy_id":763,"taxonomy":"post_tag","description":"","parent":0,"count":9,"filter":"raw","term_order":"0"},{"term_id":791,"name":"endotoxins","slug":"endotoxins","term_group":0,"term_taxonomy_id":791,"taxonomy":"post_tag","description":"","parent":0,"count":1,"filter":"raw","term_order":"0"},{"term_id":64,"name":"LC-MS","slug":"lc-ms","term_group":0,"term_taxonomy_id":64,"taxonomy":"post_tag","description":"","parent":0,"count":39,"filter":"raw","term_order":"0"},{"term_id":764,"name":"OneLab Software","slug":"onelab-software","term_group":0,"term_taxonomy_id":764,"taxonomy":"post_tag","description":"","parent":0,"count":6,"filter":"raw","term_order":"0"},{"term_id":624,"name":"quality control","slug":"quality-control","term_group":0,"term_taxonomy_id":624,"taxonomy":"post_tag","description":"","parent":0,"count":5,"filter":"raw","term_order":"0"}],"_links":{"self":[{"href":"https:\/\/www.waters.com\/blog\/wp-json\/wp\/v2\/posts\/7180","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.waters.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.waters.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.waters.com\/blog\/wp-json\/wp\/v2\/users\/139"}],"replies":[{"embeddable":true,"href":"https:\/\/www.waters.com\/blog\/wp-json\/wp\/v2\/comments?post=7180"}],"version-history":[{"count":1,"href":"https:\/\/www.waters.com\/blog\/wp-json\/wp\/v2\/posts\/7180\/revisions"}],"predecessor-version":[{"id":7182,"href":"https:\/\/www.waters.com\/blog\/wp-json\/wp\/v2\/posts\/7180\/revisions\/7182"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.waters.com\/blog\/wp-json\/wp\/v2\/media\/7181"}],"wp:attachment":[{"href":"https:\/\/www.waters.com\/blog\/wp-json\/wp\/v2\/media?parent=7180"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.waters.com\/blog\/wp-json\/wp\/v2\/categories?post=7180"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.waters.com\/blog\/wp-json\/wp\/v2\/tags?post=7180"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}