{"id":1482,"date":"2026-02-05T03:19:33","date_gmt":"2026-02-05T03:19:33","guid":{"rendered":"https:\/\/www.pharglass.com\/?p=1482"},"modified":"2026-02-10T06:06:48","modified_gmt":"2026-02-10T06:06:48","slug":"double-stoppered-lyophilization-vials-usp-type-i-glass-for-biologics-mrna-vaccines","status":"publish","type":"post","link":"https:\/\/www.pharglass.com\/fr\/double-stoppered-lyophilization-vials-usp-type-i-glass-for-biologics-mrna-vaccines\/","title":{"rendered":"Flacons de lyophilisation \u00e0 double bouchage - USP Type I Glass pour les produits biologiques et les vaccins ARNm"},"content":{"rendered":"<figure class=\"wp-block-gallery has-nested-images columns-default is-cropped wp-block-gallery-1 is-layout-flex wp-block-gallery-is-layout-flex\">\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"827\" height=\"829\" data-id=\"1688\" src=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/70-1.jpg\" alt=\"\" class=\"wp-image-1688\" srcset=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/70-1.jpg 827w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/70-1-300x300.jpg 300w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/70-1-150x150.jpg 150w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/70-1-768x770.jpg 768w\" sizes=\"auto, (max-width: 827px) 100vw, 827px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"825\" height=\"824\" data-id=\"1689\" src=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/71-1.jpg\" alt=\"\" class=\"wp-image-1689\" srcset=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/71-1.jpg 825w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/71-1-300x300.jpg 300w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/71-1-150x150.jpg 150w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/71-1-768x767.jpg 768w\" sizes=\"auto, (max-width: 825px) 100vw, 825px\" \/><\/figure>\n<\/figure>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><em>Enhanced Container Closure Integrity by Pharglass | Dual-Stopper Design for Reconstitution &amp; Long-Term Stability<\/em><\/p>\n\n\n\n<p>Pharglass <strong>double-stoppered lyophilization vials<\/strong> are engineered for the most demanding freeze-dried therapeutics\u2014where <strong>container closure integrity (CCI)<\/strong>, <strong>reconstitution reliability<\/strong>, et <strong>long-term stability<\/strong> are non-negotiable. Made from <strong>USP Type I neutral borosilicate glass<\/strong>, these vials feature a <strong>dual-stopper system<\/strong>: an inner stopper that seals the lyophilized cake during storage, and an outer stopper that maintains sterility and enables safe, controlled reconstitution with diluent.<\/p>\n\n\n\n<p>This innovative design is ideal for:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>mRNA-LNP vaccines<\/strong> requiring strict moisture control<\/li>\n\n\n\n<li><strong>High-potency biologics<\/strong> (e.g., monoclonal antibodies, enzymes)<\/li>\n\n\n\n<li><strong>Two-chamber reconstitution systems<\/strong> without complex devices<\/li>\n\n\n\n<li><strong>Clinical trial materials<\/strong> needing multi-step dosing or dilution<\/li>\n<\/ul>\n\n\n\n<p>Conforme \u00e0 <strong>USP<\/strong>, <strong>EP 3.2.1<\/strong>, <strong>ISO 8362-1<\/strong>, et <strong>YBB standards<\/strong>, Pharglass double-stoppered vials deliver superior protection against moisture ingress, oxygen permeation, and microbial contamination\u2014critical for maintaining potency in lyophilized products with low residual moisture specifications (&lt;1%).<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Principales caract\u00e9ristiques et avantages<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u2705 <strong>Dual-Stopper System<\/strong> \u2013 Inner stopper protects lyo cake; outer stopper enables sterile reconstitution<\/li>\n\n\n\n<li>\u2705 <strong>USP Type I Borosilicate Glass<\/strong> \u2013 Ultra-low leachables, high chemical resistance<\/li>\n\n\n\n<li>\u2705 <strong>Optimized for mRNA &amp; Biologics<\/strong> \u2013 Minimizes degradation during storage and handling<\/li>\n\n\n\n<li>\u2705 <strong>Superior CCI Performance<\/strong> \u2013 Validated via helium leak testing (&lt;1 \u00d7 1\u202f\u00d7\u202f10\u207b\u2076 mbar\u00b7L\/s)<\/li>\n\n\n\n<li>\u2705 <strong>Compatible with Standard Lyophilizers<\/strong> \u2013 Fits all common tray configurations (2R\u201350R)<\/li>\n\n\n\n<li>\u2705 <strong>Clear or Amber Options<\/strong> \u2013 Amber version protects light-sensitive APIs<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Sp\u00e9cifications techniques<\/strong><\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Param\u00e8tres<\/th><th>Sp\u00e9cifications<\/th><\/tr><\/thead><tbody><tr><td><strong>Nom du produit<\/strong><\/td><td>Double-Stoppered Lyophilization Vials<\/td><\/tr><tr><td><strong>Marque<\/strong><\/td><td>Pharglass<\/td><\/tr><tr><td><strong>Capacit\u00e9s<\/strong><\/td><td>2ml (2R), 5ml (5R), 10ml (10R), 20ml (20R), 30ml (30R) <em>(tailles ISO standard)<\/em><\/td><\/tr><tr><td><strong>Type de verre<\/strong><\/td><td>USP\/EP Type I Neutral Borosilicate Glass<\/td><\/tr><tr><td><strong>Conformit\u00e9<\/strong><\/td><td>USP &lt;660&gt;, EP 3.2.1, ISO 8362-1, YBB00292005-2-2015<\/td><\/tr><tr><td><strong>Stopper Configuration<\/strong><\/td><td>Dual bromobutyl rubber stoppers (inner + outer), coated or uncoated<\/td><\/tr><tr><td><strong>Finition du manche<\/strong><\/td><td>Standard ISO finish (e.g., 13mm, 20mm) for crimp seals or flip-off caps<\/td><\/tr><tr><td><strong>Niveau d'endotoxines<\/strong><\/td><td>&lt;0,25 EU\/ml (pour les versions st\u00e9riles)<\/td><\/tr><tr><td><strong>Options de st\u00e9rilit\u00e9<\/strong><\/td><td>Non st\u00e9rile (standard) ; st\u00e9rilisation gamma ou ETO (SAL 10-\u2076) sur demande<\/td><\/tr><tr><td><strong>Emballage<\/strong><\/td><td>Bulk in clean cartons or nest trays for automated loading<\/td><\/tr><tr><td><strong>MOQ<\/strong><\/td><td>5 000 pi\u00e8ces<\/td><\/tr><tr><td><strong>Applications<\/strong><\/td><td>Lyophilized mRNA vaccines, viral vectors, monoclonal antibodies, peptides, antibiotics, diagnostic kits, personalized cell therapies<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Why Choose Double-Stoppered Vials Over Single-Stopper?<\/strong><\/h3>\n\n\n\n<p>Traditional single-stopper vials require needle puncture for reconstitution\u2014introducing risks of:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Particulate generation<\/strong> from rubber coring<\/li>\n\n\n\n<li><strong>Moisture ingress<\/strong> after first use (in multi-dose scenarios)<\/li>\n\n\n\n<li><strong>Perte de st\u00e9rilit\u00e9<\/strong> during manual diluent transfer<\/li>\n<\/ul>\n\n\n\n<p>Le <strong>dual-stopper design eliminates these issues<\/strong>:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Diluent is pre-loaded<\/strong> in the upper chamber (or added aseptically)<\/li>\n\n\n\n<li><strong>Reconstitution occurs in a closed system<\/strong>\u2014simply push the outer stopper to mix<\/li>\n\n\n\n<li><strong>Aucune entr\u00e9e d'aiguille n'est n\u00e9cessaire<\/strong>\u2014preserving sterility and reducing operator error<\/li>\n<\/ol>\n\n\n\n<p>This makes double-stoppered vials a smart choice for <strong>point-of-care use<\/strong>, <strong>emergency medicine<\/strong>, et <strong>resource-limited settings<\/strong>.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Validation &amp; Regulatory Support<\/strong><\/h3>\n\n\n\n<p>Pharglass provides full documentation for global submissions:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Helium leak test reports (CCI validation)<\/li>\n\n\n\n<li>Thermal cycling data (from -70\u00b0C to +70\u00b0C)<\/li>\n\n\n\n<li>Extractables &amp; leachables (E&amp;L) studies<\/li>\n\n\n\n<li>Drug Master File (DMF) support for FDA\/EMA\/NMPA<\/li>\n<\/ul>\n\n\n\n<p>Manufactured under <strong>ISO 9001<\/strong> et <strong>ISO 15378<\/strong> quality systems, with full batch traceability.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Options de personnalisation<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Pre-filled diluent chamber (with client\u2019s buffer)<\/li>\n\n\n\n<li>Color-coded stoppers for dose differentiation<\/li>\n\n\n\n<li>Laser marking for serialization<\/li>\n\n\n\n<li>Ready-to-fill (RTF) sterile configuration in double pouches<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><strong>Innovate with confidence. Protect with precision.<\/strong><br>When your lyophilized therapy demands more than a standard vial, choose Pharglass double-stoppered lyophilization vials\u2014where engineering meets patient safety.<\/p>\n\n\n\n<p>\ud83d\udce9 <strong>Contactez-nous d\u00e8s aujourd'hui<\/strong> for samples, CCI validation data, or a customized solution for your mRNA or biologic program!<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>La conception \u00e0 double bouchon pour la reconstitution et la stabilit\u00e9 \u00e0 long terme Les flacons de lyophilisation \u00e0 double bouchon Pharglass sont con\u00e7us pour les applications lyophilis\u00e9es les plus exigeantes ... <a title=\"Double-Stoppered Lyophilization Vials \u2013 USP Type I Glass for Biologics &#038; mRNA Vaccines\" class=\"read-more\" href=\"https:\/\/www.pharglass.com\/fr\/double-stoppered-lyophilization-vials-usp-type-i-glass-for-biologics-mrna-vaccines\/\" aria-label=\"En savoir plus sur Double-Stoppered Lyophilization Vials \u2013 USP Type I Glass for Biologics &#038; mRNA Vaccines\">Lire plus<\/a><\/p>","protected":false},"author":1,"featured_media":1687,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-1482","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-primary-packaging-forms","generate-columns","tablet-grid-50","mobile-grid-100","grid-parent","grid-50"],"_links":{"self":[{"href":"https:\/\/www.pharglass.com\/fr\/wp-json\/wp\/v2\/posts\/1482","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharglass.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharglass.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharglass.com\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharglass.com\/fr\/wp-json\/wp\/v2\/comments?post=1482"}],"version-history":[{"count":4,"href":"https:\/\/www.pharglass.com\/fr\/wp-json\/wp\/v2\/posts\/1482\/revisions"}],"predecessor-version":[{"id":1880,"href":"https:\/\/www.pharglass.com\/fr\/wp-json\/wp\/v2\/posts\/1482\/revisions\/1880"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.pharglass.com\/fr\/wp-json\/wp\/v2\/media\/1687"}],"wp:attachment":[{"href":"https:\/\/www.pharglass.com\/fr\/wp-json\/wp\/v2\/media?parent=1482"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharglass.com\/fr\/wp-json\/wp\/v2\/categories?post=1482"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharglass.com\/fr\/wp-json\/wp\/v2\/tags?post=1482"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}