{"id":16214,"date":"2023-08-30T09:49:11","date_gmt":"2023-08-30T09:49:11","guid":{"rendered":"https:\/\/procleanroom.com\/the-importance-of-cleanroom-validation\/"},"modified":"2023-08-30T10:16:44","modified_gmt":"2023-08-30T10:16:44","slug":"het-belang-van-cleanroomvalidatie","status":"publish","type":"post","link":"https:\/\/procleanroom.com\/nl\/het-belang-van-cleanroomvalidatie\/","title":{"rendered":"Het belang van cleanroomvalidatie"},"content":{"rendered":"<section class=\"l-section wpb_row height_small\"><div class=\"l-section-h i-cf\"><div class=\"g-cols type_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column \"><div class=\"wpb_wrapper\">\n<h4><strong>Weet u of uw cleanroom nog voldoet aan de gewenste ISO-klasse?<\/strong><\/h4>\n<p>Managing Director Niels Ferguson legt uit: \u201cDoor gebruik, veroudering, vervuiling of schade aan componenten kan het voorkomen dat de cleanroom niet meer de gewenste ISO-klasse haalt. Een hoger dan gewenste ISO-klasse kan zeer nadelige gevolgen hebben voor het werkproces en eindproduct(en).\u201d<\/p>\n<p><strong>Als voorbeeld:<\/strong><\/p>\n<ul>\n<li>Er kan meer tijd en moeite nodig zijn om het eindproduct volgens de juiste specificaties te reinigen (specificaties van Grade 4 en Grade 2 bijvoorbeeld). Wat resulteert in een lagere productiesnelheid.<\/li>\n<li>Er zijn grotere hoeveelheden schoonmaakproducten nodig om de gewenste specificaties te bereiken. Wat resulteert in hogere productiekosten per product.<\/li>\n<li>Het product kan na reiniging en inspectie opnieuw vervuild raken, voordat het wordt verpakt.<\/li>\n<\/ul>\n<p><em><strong>\u201cCleanroom \u2013 ruimte waarin de concentratie van airborne deeltjes gereguleerd en geclassificeerd is en welke zodanig is geconstrueerd om de introductie, generatie en behoud van deeltjes in de ruimte te minimaliseren.\u201d<\/strong><\/em><\/div> <\/div> <div class=\"wpb_text_column \"><div class=\"wpb_wrapper\"><p>Ref. Internationale norm ISO14644-1 eerste editie\u00a02015<\/p>\n<table style=\"width: 100%;\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td style=\"width: 28%;\"><strong>Cleanroom Standaard<\/strong><\/td>\n<td style=\"width: 12%;\" colspan=\"6\"><strong>Cleanroom Classificatie<\/strong><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 28%;\">ISO 14644-1 : 2015<\/td>\n<td style=\"width: 12%;\">Klasse 3<\/td>\n<td style=\"width: 12%;\">Klasse 4<\/td>\n<td style=\"width: 12%;\">Klasse 5<\/td>\n<td style=\"width: 12%;\">Klasse 6<\/td>\n<td style=\"width: 12%;\">Klasse 7<\/td>\n<td style=\"width: 12%;\">Klasse 8<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 28%;\">Federal Standard 209E<\/td>\n<td style=\"width: 12%;\">1<\/td>\n<td style=\"width: 12%;\">10<\/td>\n<td style=\"width: 12%;\">100<\/td>\n<td style=\"width: 12%;\">1.000<\/td>\n<td style=\"width: 12%;\">10.000<\/td>\n<td style=\"width: 12%;\">100.000<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 28%;\">EU GGMP<\/td>\n<td style=\"width: 12%;\">&#8211;<\/td>\n<td style=\"width: 12%;\">&#8211;<\/td>\n<td style=\"width: 12%;\">A\/B<\/td>\n<td style=\"width: 12%;\">&#8211;<\/td>\n<td style=\"width: 12%;\">C<\/td>\n<td style=\"width: 12%;\">D<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 28%;\">Luchtwisselingen \/ uur<\/td>\n<td style=\"width: 12%;\">360-540<\/td>\n<td style=\"width: 12%;\">300-540<\/td>\n<td style=\"width: 12%;\">240-480<\/td>\n<td style=\"width: 12%;\">150-240<\/td>\n<td style=\"width: 12%;\">60-90<\/td>\n<td style=\"width: 12%;\">5-48<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/p><\/div> <\/div> <div class=\"w-separator type_invisible size_large thick_1 style_solid color_border cont_none\"><span class=\"w-separator-h\"><\/span><\/div><div class=\"g-cols wpb_row type_default vc_inner \"><div class=\"vc_col-sm-6 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column \"><div class=\"wpb_wrapper\"><strong>Validatie-interval<\/strong><\/p>\n<p>Volgens ISO 14644-1:2015 moeten cleanrooms en flowkasten worden gevalideerd volgens een onderhouds- en validatieprogramma dat is afgestemd op het individuele proces.<\/p>\n<p>In de praktijk leidt dit bij cleanrooms met ISO-klasse 6 of hoger doorgaans tot een validatie-interval van 12 maanden. Voor cleanrooms of flowkasten met ISO-klasse 5 of lager bedraagt de validatie-interval doorgaans 6 maanden.<\/div> <\/div> <\/div><\/div><\/div><div class=\"vc_col-sm-6 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-image\"><div class=\"us-frame\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"768\" src=\"https:\/\/procleanroom.com\/wp-content\/uploads\/2023\/08\/11071-1024x768.jpg\" class=\"attachment-large size-large\" alt=\"\" srcset=\"https:\/\/procleanroom.com\/wp-content\/uploads\/2023\/08\/11071-1024x768.jpg 1024w, https:\/\/procleanroom.com\/wp-content\/uploads\/2023\/08\/11071-300x225.jpg 300w, https:\/\/procleanroom.com\/wp-content\/uploads\/2023\/08\/11071-768x576.jpg 768w, https:\/\/procleanroom.com\/wp-content\/uploads\/2023\/08\/11071-1536x1152.jpg 1536w, https:\/\/procleanroom.com\/wp-content\/uploads\/2023\/08\/11071-2048x1536.jpg 2048w, https:\/\/procleanroom.com\/wp-content\/uploads\/2023\/08\/11071-600x450.jpg 600w, https:\/\/procleanroom.com\/wp-content\/uploads\/2023\/08\/11071-467x350.jpg 467w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"w-separator type_invisible size_large thick_1 style_solid color_border cont_none\"><span class=\"w-separator-h\"><\/span><\/div><div class=\"g-cols wpb_row type_default vc_inner \"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column \"><div class=\"wpb_wrapper\"><strong>ProCleanroom validatie<br \/>\n<\/strong>In overleg kunnen onze gekwalificeerde CTCB-I engineers onderstaande test uitvoeren:<\/p>\n<ul>\n<li>Deeltjestellingen (particle counts, concentratie airborne deeltjes) \u2013 standaard<\/li>\n<li>Metingen van luchtsnelheid<\/li>\n<li>Meting van lichtintensiteit (Lux)<\/li>\n<li>Luchtwisselingen (circulatievoud)<\/li>\n<li>Drukverschil testen<\/li>\n<li>Hersteltijd test en bepaling<\/li>\n<li>Aerosol rookvisualisatietest<\/li>\n<li>Geluidsmeting \u2013 geluidsdruk (dB(A))<\/li>\n<li>Temperatuur en luchtvochtigheidsmetingen<\/li>\n<li>HEPA of ULPA filter integriteitstest \/ effici\u00ebntietest (Aerosol challenge \/ DOP test)<\/li>\n<\/ul>\n<\/div> <\/div> <div class=\"w-separator type_invisible size_medium thick_1 style_solid color_border cont_none\"><span class=\"w-separator-h\"><\/span><\/div><div class=\"wpb_text_column \"><div class=\"wpb_wrapper\">\n<h3>Reinheidsklasse voor geselecteerde luchtledige deeltjes<\/h3>\n<p><span style=\"font-weight: 400;\">Voor\u00a0cleanrooms en cleanzones\u00a0volgens ISO 14644-1:2015<\/span><\/p>\n<table style=\"width: 100%;\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td style=\"width: 28%;\"><em>ISO Classificatie Nummer<\/em><\/td>\n<td style=\"width: 12%;\" colspan=\"6\"><em>Maximale concentratie limieten\u00a0(deeltjes\/m\u00b3 lucht) voor deeltjes\u00a0gelijk aan en groter dan\u00a0de afmetingen zoals hieronder gespecificeerd<\/em><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 28%;\"><\/td>\n<td style=\"width: 12%;\"><b>\u22650.1\u00b5m<\/b><\/td>\n<td style=\"width: 12%;\"><b>\u22650.2\u00b5m<\/b><\/td>\n<td style=\"width: 12%;\"><b>\u22650.3\u00b5m<\/b><\/td>\n<td style=\"width: 12%;\"><b>\u22650.5\u00b5m<\/b><\/td>\n<td style=\"width: 12%;\"><b>\u22651.0\u00b5m<\/b><\/td>\n<td style=\"width: 12%;\"><b>\u22655.0\u00b5m<\/b><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 28%;\">ISO Klasse 1<\/td>\n<td style=\"width: 12%;\">10<\/td>\n<td style=\"width: 12%;\">&#8211;<\/td>\n<td style=\"width: 12%;\">&#8211;<\/td>\n<td style=\"width: 12%;\">&#8211;<\/td>\n<td style=\"width: 12%;\">&#8211;<\/td>\n<td style=\"width: 12%;\">&#8211;<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 22%;\">ISO Klasse 2<\/td>\n<td style=\"width: 12%;\">100<\/td>\n<td style=\"width: 12%;\">24<\/td>\n<td style=\"width: 12%;\">10<\/td>\n<td style=\"width: 12%;\">&#8211;<\/td>\n<td style=\"width: 12%;\">&#8211;<\/td>\n<td style=\"width: 12%;\">&#8211;<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 28%;\">ISO Klasse 3<\/td>\n<td style=\"width: 12%;\">1.000<\/td>\n<td style=\"width: 12%;\">237<\/td>\n<td style=\"width: 12%;\">102<\/td>\n<td style=\"width: 12%;\">35<\/td>\n<td style=\"width: 12%;\">&#8211;<\/td>\n<td style=\"width: 12%;\">&#8211;<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 28%;\">ISO Klasse 4<\/td>\n<td style=\"width: 12%;\">10.000<\/td>\n<td style=\"width: 12%;\">2.370<\/td>\n<td style=\"width: 12%;\">1.020<\/td>\n<td style=\"width: 12%;\">352<\/td>\n<td style=\"width: 12%;\">83<\/td>\n<td style=\"width: 12%;\">&#8211;<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 28%;\">ISO Klasse 5<\/td>\n<td style=\"width: 12%;\">100.000<\/td>\n<td style=\"width: 12%;\">23.700<\/td>\n<td style=\"width: 12%;\">10.200<\/td>\n<td style=\"width: 12%;\">3.520<\/td>\n<td style=\"width: 12%;\">832<\/td>\n<td style=\"width: 12%;\">&#8211;<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 28%;\">ISO Klasse 6<\/td>\n<td style=\"width: 12%;\">1.000.000<\/td>\n<td style=\"width: 12%;\">237.000<\/td>\n<td style=\"width: 12%;\">102.000<\/td>\n<td style=\"width: 12%;\">35.200<\/td>\n<td style=\"width: 12%;\">8.320<\/td>\n<td style=\"width: 12%;\">293<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 28%;\">ISO Klasse 7<\/td>\n<td style=\"width: 12%;\">&#8211;<\/td>\n<td style=\"width: 12%;\">&#8211;<\/td>\n<td style=\"width: 12%;\">&#8211;<\/td>\n<td style=\"width: 12%;\">352.000<\/td>\n<td style=\"width: 12%;\">83.200<\/td>\n<td style=\"width: 12%;\">2.930<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 28%;\">ISO Klasse 8<\/td>\n<td style=\"width: 12%;\">&#8211;<\/td>\n<td style=\"width: 12%;\">&#8211;<\/td>\n<td style=\"width: 12%;\">&#8211;<\/td>\n<td style=\"width: 12%;\">3.520.000<\/td>\n<td style=\"width: 12%;\">832.000<\/td>\n<td style=\"width: 12%;\">29.300<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 28%;\">ISO Klasse 9<\/td>\n<td style=\"width: 12%;\">&#8211;<\/td>\n<td style=\"width: 12%;\">&#8211;<\/td>\n<td style=\"width: 12%;\">&#8211;<\/td>\n<td style=\"width: 12%;\">35.200.000<\/td>\n<td style=\"width: 12%;\">8.320.000<\/td>\n<td style=\"width: 12%;\">293.000<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div> <\/div> <div class=\"w-separator type_invisible size_medium thick_1 style_solid color_border cont_none\"><span class=\"w-separator-h\"><\/span><\/div><div class=\"wpb_text_column \"><div class=\"wpb_wrapper\"><strong>Wilt u een cleanroom of flowkast die blijft presteren volgens de specificaties? Maak dan een afspraak!<\/strong><\/p>\n<p>ProCleanroom valideert ook vaste cleanrooms van andere leveranciers.<br \/>\n\ud835\udde3\ud835\uddff\ud835\uddfc\ud835\uddd6\ud835\uddf9\ud835\uddf2\ud835\uddee\ud835\uddfb\ud835\uddff\ud835\uddfc\ud835\uddfc\ud835\uddfa: \ud835\uddd5\ud835\ude02\ud835\uddf6\ud835\uddf9\ud835\uddf1 \ud835\ude06\ud835\uddfc\ud835\ude02\ud835\uddff \ud835\uddf2\ud835\ude05\ud835\uddfd\ud835\uddf2\ud835\uddff\ud835\ude01\ud835\uddf6\ud835\ude00\ud835\uddf2.<\/div> <\/div> <div class=\"w-actionbox color_primary controls_right\"><div class=\"w-actionbox-text\"><h2>Kom in contact met onze specialisten<\/h2><\/div><div class=\"w-actionbox-controls\"><a class=\"w-btn color_white style_outlined icon_none\" href=\"https:\/\/procleanroom.com\/nl\/contact\/\"><span class=\"w-btn-label\">Contact<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n","protected":false},"excerpt":{"rendered":"Weet u of uw cleanroom nog voldoet aan de gewenste ISO-klasse? Managing Director Niels Ferguson legt uit: \u201cDoor gebruik, veroudering, vervuiling of schade aan componenten kan het voorkomen dat de cleanroom niet meer de gewenste ISO-klasse haalt. Een hoger dan...","protected":false},"author":5,"featured_media":16186,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[245],"tags":[232,233,259,251,261,260],"class_list":["post-16214","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-media-nl","tag-cleanroom-nl","tag-cleanroom-technology-nl","tag-iso-class-nl","tag-precision-technology-nl","tag-procleanroom-nl","tag-validation-nl"],"_links":{"self":[{"href":"https:\/\/procleanroom.com\/nl\/wp-json\/wp\/v2\/posts\/16214","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/procleanroom.com\/nl\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/procleanroom.com\/nl\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/procleanroom.com\/nl\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/procleanroom.com\/nl\/wp-json\/wp\/v2\/comments?post=16214"}],"version-history":[{"count":6,"href":"https:\/\/procleanroom.com\/nl\/wp-json\/wp\/v2\/posts\/16214\/revisions"}],"predecessor-version":[{"id":16220,"href":"https:\/\/procleanroom.com\/nl\/wp-json\/wp\/v2\/posts\/16214\/revisions\/16220"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/procleanroom.com\/nl\/wp-json\/wp\/v2\/media\/16186"}],"wp:attachment":[{"href":"https:\/\/procleanroom.com\/nl\/wp-json\/wp\/v2\/media?parent=16214"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/procleanroom.com\/nl\/wp-json\/wp\/v2\/categories?post=16214"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/procleanroom.com\/nl\/wp-json\/wp\/v2\/tags?post=16214"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}