{"id":1026,"date":"2020-02-13T10:30:38","date_gmt":"2020-02-12T23:30:38","guid":{"rendered":"http:\/\/paulyeatman.net.au\/?p=1026"},"modified":"2020-02-13T10:31:18","modified_gmt":"2020-02-12T23:31:18","slug":"question-regarding-sterile-filter-hold-time-validation","status":"publish","type":"post","link":"https:\/\/paulyeatman.net.au\/index.php\/2020\/02\/13\/question-regarding-sterile-filter-hold-time-validation\/","title":{"rendered":"Question regarding sterile filter hold time validation"},"content":{"rendered":"<h4 class=\"js-post-title post-title\"><a href=\"https:\/\/www.linkedin.com\/feed\/update\/urn:li:activity:6625891457616142336\" 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 id=\"ember1293\" class=\"ember-view\">How to validate maximum hold time for product sterile filter after autoclave sterilization? Any link to regulatory guidelines is much appreciated.<\/span>&#8220;<\/h4>\n<p><!--more--><\/p>\n<h4 class=\"js-post-body post-body\" tabindex=\"0\">My reply was this:<\/h4>\n<p class=\"mentions-texteditor__content\">&#8220;<span id=\"ember1649\" class=\"ember-view\">Hi Hany. I&#8217;ve sourced a couple of articles for you that may be of assistance: <\/span><\/p>\n<p class=\"mentions-texteditor__content\"><span id=\"ember1649\" class=\"ember-view\">1.\u00a0 <\/span><a href=\"https:\/\/paulyeatman.net.au\/wp-content\/uploads\/2020\/02\/defining-a-strategy-for-the-validation-and-qualification-of-sterile-filtration-processes-of-investigational-medicinal-compounds.pdf\">Defining a Strategy For The Validation and Qualification of Sterile Filtration Processes&#8230;<\/a><a id=\"ember1652\" class=\"feed-link ember-view\" tabindex=\"0\" href=\"https:\/\/www.pda.org\/docs\/default-source\/website-document-library\/chapters\/presentations\/metro\/defining-a-strategy-for-the-validation-and-qualification-of-sterile-filtration-processes-of-investigational-medicinal-compounds.pdf?sfvrsn=8\" target=\"_blank\" rel=\"noopener noreferrer\"><\/a><span id=\"ember1654\" class=\"ember-view\"> <\/span><\/p>\n<p class=\"mentions-texteditor__content\"><span id=\"ember1654\" class=\"ember-view\">2.\u00a0<\/span><a href=\"https:\/\/paulyeatman.net.au\/wp-content\/uploads\/2020\/02\/Regulatory-Trends-in-Manufacturing-of-Sterile-Medicinal-Products-by-Filtration-Michael-Payne-Biosafety-Technical-Consultant-Merck.pdf\">Regulatory Trends in Manufacturing of Sterile Medicinal Products by Filtration<\/a><span id=\"ember1659\" class=\"ember-view\"> <\/span><\/p>\n<p class=\"mentions-texteditor__content\"><span id=\"ember1659\" class=\"ember-view\">A nice list of FDA guidance\/regulations is included in <\/span><a href=\"https:\/\/paulyeatman.net.au\/wp-content\/uploads\/2020\/02\/Aseptic-Processing-of-Biological-Products-Current-Regulatory-Issues-Candace-Gomez-Broughton-PhD.pdf\">Aseptic Processing of Biological Products &#8211; Current Regulatory Issues<\/a><span id=\"ember1664\" class=\"ember-view\"> such as 21 <a href=\"https:\/\/www.govinfo.gov\/app\/details\/CFR-2011-title21-vol4\/CFR-2011-title21-vol4-sec211-113\" target=\"_blank\" rel=\"noopener\">CFR 211.113<\/a> and <a href=\"https:\/\/paulyeatman.net.au\/wp-content\/uploads\/2020\/02\/PDA-Technical-Report-No.-26-1997-final.pdf\">PDA Technical Report No. 26 (1997) final<\/a> (Sterilizing Filtration of Liquids)<\/span><\/p>\n<p class=\"mentions-texteditor__content\"><span id=\"ember1664\" class=\"ember-view\">Kind Regards Paul<\/span>&#8220;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Question posed on LinkedIn: &#8220;How to validate maximum hold time for product sterile filter after autoclave sterilization? Any link to regulatory guidelines is much appreciated.&#8220;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[21,5],"tags":[37,12,44,38],"class_list":["post-1026","post","type-post","status-publish","format-standard","hentry","category-advice-provided","category-documentation","tag-fda","tag-guidelines","tag-pics","tag-validation"],"_links":{"self":[{"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/1026","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=1026"}],"version-history":[{"count":1,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/1026\/revisions"}],"predecessor-version":[{"id":1031,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/1026\/revisions\/1031"}],"wp:attachment":[{"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/media?parent=1026"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/categories?post=1026"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/tags?post=1026"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}