In order to make process technology know-how available, the Pharma Service at OYSTAR H\u00fcttlin is holding a series of seminars. The series began with the seminar entitled “Statistical Design Space Development – From DoE To Granules”. Twenty attendees acquired theoretical knowledge on Design of Experiment (DoE) and subsequently had the opportunity to put this know-how immediately into practice in OYSTAR H\u00fcttlin’s own laboratory, where the participants themselves performed and analyzed granulation trials.<\/p>\n
The goal of the seminar instructors was to assist the participants in dealing skillfully with the latest methods of Design of Experiment. Pascal Wehrl\u00e9, professor at the University of Strasbourg, thus first of all familiarized the participants with the basic concept of “Quality by Design” for quality assurance during the product and process design phase. Prof. Wehrl\u00e9 then rounded off the subject with a talk on the theory of Design of Experiment. Marcus Kn\u00f6ll, head of Pharma Service at OYSTAR H\u00fcttlin, used FMEA to provide a detailed overview of the influencing factors in fluid bed granulation. In preparation for the practical part of the seminar, Erik Johansson, senior application analyst at Umetrics, expounded the subject of “full factorial designs”. Then the seminar participants developed their own case studies with the help of the MODDE software and went directly into the laboratory with them for the practical implementation on the fluid bed granulator. Wehrl\u00e9 began the second day of the seminar with an introduction to the SPC (Statistical Process Control) methodology for optimized process stability. Erik Johansson continued with the subject of “fractional factorial designs”. Afterwards, Andrea Hartung, a staff member of the Pharma Service at OYSTAR H\u00fcttlin, presented real process data from a granulation of the angiotensin converting enzyme (ACE) inhibitor Enalapril obtained with the help of DoE. <\/p>\n
Following on from this first seminar, three further events will take place in 2010 to complete the series and will cover the areas of cleaning and validation as well as granulation and coating. Participants attending all four seminars will gain the “Expert of Solids” qualification. It is, however, also possible to attend just individual events only. With two additional seminars on the subjects of scale-up and Process Analytical Technology (PAT), attendees are also able to gain the “Master of Solids” qualification.<\/p>\n","protected":false},"excerpt":{"rendered":"
In order to make process technology know-how available, the Pharma Service at OYSTAR H\u00fcttlin is holding a series of seminars. The series began with the seminar entitled “Statistical Design Space Development – From DoE To Granules”. Twenty attendees acquired theoretical knowledge on Design of Experiment (DoE) and subsequently had the opportunity to put this know-how […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-544595","post","type-post","status-publish","format-standard","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/544595","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/comments?post=544595"}],"version-history":[{"count":0,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/544595\/revisions"}],"wp:attachment":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/media?parent=544595"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/categories?post=544595"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/tags?post=544595"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}