{"id":1167,"date":"2020-07-03T14:19:46","date_gmt":"2020-07-03T03:19:46","guid":{"rendered":"http:\/\/paulyeatman.net.au\/?p=1167"},"modified":"2020-07-18T14:11:31","modified_gmt":"2020-07-18T03:11:31","slug":"questions-on-depyrogenation-and-viable-environmental-monitoring","status":"publish","type":"post","link":"https:\/\/paulyeatman.net.au\/index.php\/2020\/07\/03\/questions-on-depyrogenation-and-viable-environmental-monitoring\/","title":{"rendered":"Questions on Depyrogenation and Viable Environmental Monitoring"},"content":{"rendered":"<h4 class=\"js-post-title post-title\"><a href=\"https:\/\/www.linkedin.com\/feed\/update\/urn:li:activity:6674731358377648128\" target=\"_blank\" rel=\"noopener\"><strong>The Question posed on <\/strong><\/a><strong>LinkedIn:<\/strong><\/h4>\n<h4 class=\"js-post-title post-title\">&#8220;<span class=\"break-words\"><span dir=\"ltr\">Hi all, I need your support to find the answers of the following questions:<br \/>\n1. Using manual cleaning of glass vial before sterilization in dry oven in aseptic process for lyophilized product which means no depyrogenation , is it acceptable? and if yes, what is the requirement that should be provided to the inspector as evidence of no contamination (as documents \/ studies\/ gown).<br \/>\n2. Is it mandatory to conduct viable and non-viable monitoring in the ascetic process during the capping and crimping?<br \/>\nThanks in advance&#8230;<\/span><\/span>&#8220;<\/h4>\n<p><!--more--><\/p>\n<h4 class=\"js-post-body post-body\" tabindex=\"0\">My reply was this:<\/h4>\n<p id=\"ember1507\" class=\"feed-shared-main-content--highlighted-comment t-14 t-black t-normal feed-shared-main-content ember-view\" dir=\"ltr\">&#8220;<span id=\"ember1509\" class=\"ember-view\">Hi Ayat. <\/span><\/p>\n<p class=\"feed-shared-main-content--highlighted-comment t-14 t-black t-normal feed-shared-main-content ember-view\" dir=\"ltr\"><span id=\"ember1509\" class=\"ember-view\">1. Validating rinsing your vials with WFI could show an acceptable endotoxin\/pyrogen reduction. What auditors want to see is your processes are validated and capable of reducing the endotoxins by a certain log amount. Whether this is though cleaning followed by DHO, DHO only or WFI \u201cdilution\u201d. Ongoing data to show your in place systems are robust and operating under control is also needed. <\/span><\/p>\n<p class=\"feed-shared-main-content--highlighted-comment t-14 t-black t-normal feed-shared-main-content ember-view\" dir=\"ltr\"><span id=\"ember1509\" class=\"ember-view\">You might find this useful: <\/span><a id=\"ember1512\" class=\"feed-link ember-view\" tabindex=\"0\" href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/inspection-technical-guides\/bacterial-endotoxinspyrogens\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/inspection-technical-guides\/bacterial-endotoxinspyrogens<\/a><span id=\"ember1514\" class=\"ember-view\"> <\/span><\/p>\n<p class=\"feed-shared-main-content--highlighted-comment t-14 t-black t-normal feed-shared-main-content ember-view\" dir=\"ltr\"><span id=\"ember1514\" class=\"ember-view\">2. Your viable environmental monitoring program needs to show your clean rooms are operating within suitable defined parameters. This extends to all areas and activities so will include crimping and stoppering. Here I draw your alternation to <a href=\"https:\/\/picscheme.org\/en\/publications\" target=\"_blank\" rel=\"noopener\">PIC\/S PE009-14<\/a> and the <a href=\"https:\/\/www.iso.org\/standard\/53394.html\" target=\"_blank\" rel=\"noopener\">ISO 14644<\/a> series. As well as viable particles, non viable particles must not exceed stated levels. <\/span><\/p>\n<p class=\"feed-shared-main-content--highlighted-comment t-14 t-black t-normal feed-shared-main-content ember-view\" dir=\"ltr\"><span id=\"ember1514\" class=\"ember-view\">Kind regards Paul<\/span>&#8220;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Question posed on LinkedIn: &#8220;Hi all, I need your support to find the answers of the following questions: 1. Using manual cleaning of glass vial before sterilization in dry oven in aseptic process for lyophilized product which means no depyrogenation , is it acceptable? and if yes, what is the requirement that should be [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[21,3],"tags":[45,12,50,27,38,25],"class_list":["post-1167","post","type-post","status-publish","format-standard","hentry","category-advice-provided","category-testing","tag-gmp","tag-guidelines","tag-microbiology","tag-pyrogens","tag-validation","tag-vem"],"_links":{"self":[{"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/1167","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/comments?post=1167"}],"version-history":[{"count":2,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/1167\/revisions"}],"predecessor-version":[{"id":1174,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/1167\/revisions\/1174"}],"wp:attachment":[{"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/media?parent=1167"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/categories?post=1167"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/tags?post=1167"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}