{"id":34398,"date":"2024-07-15T13:28:00","date_gmt":"2022-10-20T11:28:00","guid":{"rendered":"https:\/\/fhi.nl\/nieuws\/moet-uw-reactor-of-doseersysteem-voldoen-aan-gmp\/"},"modified":"2024-07-15T08:33:58","modified_gmt":"2024-07-15T06:33:58","slug":"moet-uw-reactor-of-doseersysteem-voldoen-aan-gmp","status":"publish","type":"news","link":"https:\/\/fhi.nl\/en\/news\/moet-uw-reactor-of-doseersysteem-voldoen-aan-gmp\/","title":{"rendered":"Does your reactor or dosing system have to comply with GMP?"},"content":{"rendered":"<header id=\"header\" class=\"header header--low\">\n\n\t\n\t\t\t<div class=\"header__background header__background--graphic\"><\/div>\n\t\n\t<div class=\"container\">\n\t\t<div class=\"header__content\">\n\t\t\t<div class=\"header__first header__first--alone\">\n\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t<h1 class=\"header__title\" >\n\t\t\t\t\tDoes your reactor or dosing system have to comply with GMP?\t\t\t\t<\/h1>\n\n\t\t\t\t<div class=\"header__dots-line\">\n\t\t\t\t\t<svg width=\"431\" height=\"9\" viewbox=\"0 0 431 9\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M430.799 4.192a1.136 1.136 0 1 1-2.272-.001 1.136 1.136 0 0 1 2.272 0Zm-27.272 0a1.135 1.135 0 1 1-2.27 0 1.135 1.135 0 0 1 2.27 0Zm-27.27 0a1.136 1.136 0 1 1-2.272-.001 1.136 1.136 0 0 1 2.272 0Zm-27.272 0a1.39 1.39 0 1 1-2.78 0 1.39 1.39 0 0 1 2.78 0Zm-27.78 0a1.645 1.645 0 1 1-3.29 0 1.645 1.645 0 0 1 3.29 0Zm-28.29 0a1.9 1.9 0 1 1-3.799 0 1.9 1.9 0 0 1 3.799 0Zm-28.799 0a2.154 2.154 0 1 1-4.308 0 2.154 2.154 0 0 1 4.308 0Zm-29.308 0a2.41 2.41 0 1 1-4.819 0 2.41 2.41 0 0 1 4.819 0Zm-29.819 0a2.663 2.663 0 1 1-5.326.001 2.663 2.663 0 0 1 5.326-.001Zm-30.327 0a2.919 2.919 0 1 1-5.837 0 2.919 2.919 0 0 1 5.837 0Zm-30.837 0a3.173 3.173 0 1 1-6.345.001 3.173 3.173 0 0 1 6.345 0Zm-31.346 0a3.428 3.428 0 1 1-6.856 0 3.428 3.428 0 0 1 6.856 0Zm-31.856 0a3.683 3.683 0 1 1-7.365 0 3.683 3.683 0 0 1 7.365 0Zm-32.365 0a3.937 3.937 0 1 1-7.875 0 3.937 3.937 0 0 1 7.875 0Zm-32.874 0a4.192 4.192 0 1 1-8.384 0 4.192 4.192 0 0 1 8.384 0Z\" fill=\"#FFF960\"\/><\/svg>\t\t\t\t<\/div>\n\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\n\t\t\t\n\t\t<\/div>\n\t<\/div>\n<\/header>\n\n\t<div class=\"header__meta\">\n\t<div class=\"container\">\n\t\t<div class=\"header__meta__category\">\n\n\t\t\t\n\t\t\t\t\t\t\t<div class=\"header__meta__detail\">\n\t\t\t\t\t<div>Subject<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/fhi.nl\/en\/kennishub\/?_onderwerp_kennishub=algemene-laboratorium-apparatuur\" class=\"header__meta__detail--categorie\">\n\t\t\t\t\t\t\t\tGeneral laboratory equipment\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/fhi.nl\/en\/kennishub\/?_onderwerp_kennishub=laboratorium-technologie\" class=\"header__meta__detail--categorie\">\n\t\t\t\t\t\t\t\tLaboratory Technology\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div class=\"text bg--white\">\n\t<div class=\"container\">\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"text__content text__content--1-col\">\n\t\t\t<h2><em>Suurmond is responding to the growing demand<\/em><br>&nbsp;<\/h2><p><strong>The demanding regulations regarding production in the pharmaceutical industry benefit the quality and safety of products. We increasingly see a demand in R&amp;D for equipment that complies with GMP. Suurmond BV and its suppliers have experience with these strict regulations when it comes to reactors and dosing systems. From lab to production scale.<\/strong><\/p><h3>GMP for high quality and safety<\/h3><p>There are quite a few requirements to comply with GMP. Both in terms of the materials used, the roughness of the surface and the cleanability of the dosing system. Because contamination is undesirable and not even allowed. The ultimate goal of GMP is to always guarantee the same high quality product, without the risk of cross-contamination by residual product in any of the components of the process equipment.<\/p><h3>Suurmond and GMP<\/h3><p>Because Suurmond offers modular solutions, a lot is possible. In terms of material use, selection of components. Suurmond can go very far with this and is willing to go the extra mile. This is possible thanks to our suppliers of high-end components. Our supplier <strong><a href=\"https:\/\/www.buchiglas.com\/en\/index.html\" target=\"_blank\" rel=\"noopener\" data-mce-href=\"https:\/\/www.buchiglas.com\/en\/index.html\">BUCHI<\/a><\/strong> is even leading the way with their cGMP reactors.<\/p><h3>cGMP glass reactors<\/h3><p>Cleaning is extremely important in the pharmaceutical industry. Relevant parts of the <strong><a href=\"https:\/\/en.suurmond.com\/wp-content\/uploads\/2022\/10\/20220829-BUCHI-Brochure-G_Glass-Clean_room_design_e.pdf?_gl=1*mkhdmh*_ga*Njk2NDE1ODAxLjE2MjU0Nzg4MTU.*_ga_ZDSL42QBPR*MTY2NjI2NTIzMC41NC4xLjE2NjYyNjUyNTMuMC4wLjA.\" target=\"_blank\" rel=\"noopener\" data-mce-href=\"https:\/\/en.suurmond.com\/wp-content\/uploads\/2022\/10\/20220829-BUCHI-Brochure-G_Glass-Clean_room_design_e.pdf?_gl=1*mkhdmh*_ga*Njk2NDE1ODAxLjE2MjU0Nzg4MTU.*_ga_ZDSL42QBPR*MTY2NjI2NTIzMC41NC4xLjE2NjYyNjUyNTMuMC4wLjA.\">B\u00dcCHI cGMP reactors<\/a><\/strong> are<\/p><p><img decoding=\"async\" src=\"https:\/\/fhi.nl\/app\/uploads\/filemanager\/107\/1666265471_cgmp midipilot_glas reactor.png\" alt=\"\" width=\"142\" height=\"300\" data-mce-src=\"https:\/\/fhi.nl\/app\/uploads\/filemanager\/107\/1666265471_cgmp midipilot_glas reactor.png\"> <em>B\u00dcCHI cGMP midiPilot glass reactor system <\/em><br><em>for the clean room<\/em><\/p><p>therefore made of stainless steel. The frame is made of welded, polished square stainless steel tubes. The valves also have polished valve bodies and stainless steel handles. The patented b\u00fcchiflex glass connections are also made of polished stainless steel and have a minimal thread section.<br>The cover plate is made of Hastelloy C22 with welded Tri-clamp adapter (also available in other materials).<\/p><p>For the clean room, the stirring motor is equipped without external ventilation to prevent turbulence in the clean room. This is also available as an ATEX version.<\/p><p>Switzerland is an important player in the pharmaceutical industry. The Swiss B\u00dcCHI can therefore be called a pioneer in this field. They always respond to new developments on time.<\/p><p><span data-mce-object=\"iframe\" class=\"mce-preview-object mce-object-iframe\" data-mce-p-allowfullscreen=\"allowfullscreen\" data-mce-p-src=\"\/\/www.youtube.com\/embed\/DU3O-rsSI4A\"><span class=\"mce-shim\"><\/span><\/span><\/p><h3>Dosing systems<\/h3><p>Many dosing systems are used in the pharmaceutical industry. With the <strong><a href=\"https:\/\/nl.suurmond.com\/brand_products\/suurmond-suurdos-dosing-systems\/\" data-mce-href=\"https:\/\/nl.suurmond.com\/brand_products\/suurmond-suurdos-dosing-systems\/\">suurDOS\u00ae dosing systems<\/a><\/strong> Suurmond goes to great lengths to meet the requirements. Thanks to our suppliers with the same flexible attitude, Suurmond can offer tailor-made solutions. In the case of GMP, for example, consider pump and filter with surface roughness of Ra 0.8 \u00b5m, both CIP and SIP cleanable! PEEK tubing and special NPT fittings without corners and dead volume.<\/p><p><img decoding=\"async\" src=\"https:\/\/fhi.nl\/app\/uploads\/filemanager\/107\/1666266813_suurdosmicro.png\" alt=\"\" width=\"242\" height=\"200\" data-mce-src=\"https:\/\/fhi.nl\/app\/uploads\/filemanager\/107\/1666266813_suurdosmicro.png\"> <em>suurDOS\u00ae dosing system<\/em><\/p><p><br><\/p><p>An additional advantage of the suurDOS\u00ae is that an accurate and pulsation-free flow from 1\u00b5l per hour is possible, regardless of the differential pressure and volume flow! This saves you valuable APIs! An economical and safe solution, also for your process!<\/p><p><br><\/p><h3>Validation<\/h3><p>GMP provides a number of procedures and guidelines to make every part traceable. All batches must be validated. This means that these are recorded with certificates. Only a carefully recorded and controlled production process ensures the quality of a medicine. For laboratories this means that DIN is used as a guideline. This is a European directive. This also immediately complies with CE.<\/p><h3>Documentation<\/h3><p>Validation is facilitated by all documentation and certification that we provide. Suurmond makes Inspection documentation available for the wetted parts. 3.1 certificates and the Declaration of compliance 2.1 (DIN EN 10204:2005) are supplied for the metal products.<\/p><p><br><\/p><p><strong>DEMANDING PROCESSES, SUSTAINABLE SOLUTIONS!<\/strong><\/p>\t\t<\/div>\n\t<\/div>\n<\/div>\r\n\t<div class=\"articles bg--offwhite automatic\">\r\n\t\t<div class=\"container\">\r\n\t\t\t<div class=\"articles__header\">\r\n\t\t\t\t\t\t\t\t\t<div class='heading-wrapper'><svg width=\"13\" height=\"13\" viewbox=\"0 0 13 13\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><circle cx=\"6.394\" cy=\"6.5\" r=\"6.394\" fill=\"#000\"\/><\/svg><h2>Related articles<\/h2><\/div>\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"\/en\/profiel\/suurmond-reactor-systems\/\" class=\"button button--outline\">view profile<\/a>\r\n\t\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t<div class=\"post-grid post-grid--no-padding\">\r\n\t\t\t\t\n<a class=\"single-item single-item__articles\" href=\"https:\/\/fhi.nl\/en\/news\/marktontwikkelingen-en-uitdagingen-lange-levertijden-overleven\/\" data-id=\"39202\">\n\t<div class=\"single-item__articles-icon\">\n\t\t<svg width=\"103\" height=\"103\" viewbox=\"0 0 103 103\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n<path fill-rule=\"evenodd\" clip-rule=\"evenodd\" d=\"M49.5 98.9587V82.3076C33.3844 81.2758 20.6328 67.878 20.6328 51.5019C20.6328 35.1258 33.3844 21.728 49.5 20.6962V4.04134C24.1941 5.08952 4 25.9365 4 51.5C4 77.0635 24.1941 97.9105 49.5 98.9587ZM53.5 78.2983V61.8096H76.3238C72.5238 70.9498 63.8222 77.5397 53.5 78.2983ZM49.5 78.298V61.8096H26.681C30.4804 70.9484 39.1799 77.5377 49.5 78.298ZM47.0728 57.8096H25.3773C24.8906 55.7865 24.6328 53.6743 24.6328 51.5019C24.6328 37.3358 35.5955 25.7301 49.5 24.7058V37.013H34.0466C33.2709 37.013 32.5653 37.4615 32.2359 38.1637C31.9065 38.8659 32.0128 39.6952 32.5086 40.2916L47.0728 57.8096ZM55.9249 57.8096H77.6274C78.1141 55.7865 78.3719 53.6743 78.3719 51.5019C78.3719 37.3342 67.4068 25.7275 53.5 24.7055V37.013H68.9511C69.7268 37.013 70.4324 37.4615 70.7618 38.1637C71.0912 38.8659 70.9849 39.6952 70.4891 40.2916L55.9249 57.8096ZM53.5 82.3079V98.9587C78.8059 97.9105 99 77.0635 99 51.5C99 25.9365 78.8059 5.08952 53.5 4.04134V20.6959C69.6178 21.7254 82.3719 35.1242 82.3719 51.5019C82.3719 67.8796 69.6178 81.2784 53.5 82.3079ZM0 51.5C0 23.7271 21.9843 1.08883 49.5 0.0381213V0H51.5H53.5V0.0381213C81.0157 1.08883 103 23.7271 103 51.5C103 79.9427 79.9427 103 51.5 103C23.0573 103 0 79.9427 0 51.5ZM38.3102 41.013H64.6875L51.4989 56.8765L38.3102 41.013Z\" fill=\"#2DD881\"\/>\n<\/svg>\n\t<\/div>\n\t<div class=\"single-item__articles-title\"><div class='heading-wrapper'><h3>Market developments and challenges: Surviving long delivery times<\/h3><\/div><\/div>\n\t<div class=\"single-item__articles-terms\">\n\t\t\n\t\t\n\t\t\t\t\t\t<span class=\"button button--outline single-item__articles-term--branche single-item__articles-term\">Industrial 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fill=\"#2DD881\"\/>\n<\/svg>\n\t<\/div>\n\t<div class=\"single-item__articles-title\"><div class='heading-wrapper'><h3>Introducing Panasonic SPG2 Screen Printer<\/h3><\/div><\/div>\n\t<div class=\"single-item__articles-terms\">\n\t\t\n\t\t\n\t\t\t\t\t\t<span class=\"button button--outline single-item__articles-term--branche single-item__articles-term\">Industrial Electronics<\/span>\n\t\t\t\t\t\t\t\t<span class=\"button button--outline single-item__articles-term--branche single-item__articles-term\">Electronics &amp; Applications<\/span>\n\t\t\t\t\t\t\t\t<span class=\"button button--outline single-item__articles-term--branche single-item__articles-term\">Cleanroom equipment<\/span>\n\t\t\t\t\t\t\t\t<span class=\"button button--outline single-item__articles-term--branche single-item__articles-term\">Electronics manufacturing<\/span>\n\t\t\t\t\t<\/div>\n\t<div class=\"single-item__articles-author-date-wrapper\">\n\t\t\t\t\t<div class=\"single-item__articles-author\">\n\t\t\t\tSMD-TEC\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"single-item__articles-date\">\n\t\t\t\tJuly 19, 2021\t\t\t<\/div>\n\t\t\t<\/div>\n<\/a>\n\t\t\t<\/div>\r\n\t\t<\/div>\r\n\t<\/div>","protected":false},"excerpt":{"rendered":"<p>We are increasingly seeing a demand in R&amp;D for equipment that complies with GMP. Suurmond BV and its suppliers have experience with these strict regulations regarding reactors and dosing systems.<\/p>","protected":false},"featured_media":34399,"template":"","branches":[],"events":[8],"secretariat":[],"categories":[26,59],"themes_tax":[],"content_types":[514],"class_list":["post-34398","news","type-news","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Moet uw reactor aan GMP voldoen?<\/title>\n<meta name=\"description\" content=\"Steeds vaker zien we in de R&amp;D de vraag naar apparatuur die voldoet aan GMP. 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