{"id":1490,"date":"2026-02-05T03:21:31","date_gmt":"2026-02-05T03:21:31","guid":{"rendered":"https:\/\/www.pharglass.com\/?p=1490"},"modified":"2026-02-10T06:14:17","modified_gmt":"2026-02-10T06:14:17","slug":"ybb-usp-type-i-compliant-lyophilization-vials-2ml-to-50ml-sterile-freeze-dry-glass-vials","status":"publish","type":"post","link":"https:\/\/www.pharglass.com\/fr\/ybb-usp-type-i-compliant-lyophilization-vials-2ml-to-50ml-sterile-freeze-dry-glass-vials\/","title":{"rendered":"Flacons de lyophilisation conformes aux normes YBB et USP Type I - Flacons st\u00e9riles en verre lyophilis\u00e9 de 2 ml \u00e0 50 ml"},"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=\"829\" height=\"826\" data-id=\"1704\" src=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/82-1.jpg\" alt=\"\" class=\"wp-image-1704\" srcset=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/82-1.jpg 829w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/82-1-300x300.jpg 300w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/82-1-150x150.jpg 150w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/82-1-768x765.jpg 768w\" sizes=\"auto, (max-width: 829px) 100vw, 829px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"834\" height=\"828\" data-id=\"1705\" src=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/83-1.jpg\" alt=\"\" class=\"wp-image-1705\" srcset=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/83-1.jpg 834w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/83-1-300x298.jpg 300w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/83-1-150x150.jpg 150w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/83-1-768x762.jpg 768w\" sizes=\"auto, (max-width: 834px) 100vw, 834px\" \/><\/figure>\n<\/figure>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><em>Ready-to-Fill Primary Packaging by Pharglass | Triple Pharmacopeial Compliance | Optimized for Biologics, Vaccines &amp; Antibiotics<\/em><\/p>\n\n\n\n<p>Pharglass <strong>sterile lyophilization vials<\/strong> are engineered for the most demanding freeze-drying applications\u2014from mRNA vaccines and monoclonal antibodies to high-potency antibiotics and peptide therapeutics. Available in standard capacities from <strong>2ml \u00e0 50ml (2R-50R)<\/strong>, these vials are manufactured from <strong>Verre borosilicat\u00e9 neutre de type I<\/strong> and fully compliant with <strong>USP<\/strong>, <strong>European Pharmacopoeia (EP) 3.2.1<\/strong>, et <strong>Chinese YBB00292005-2-2015<\/strong> standards\u2014ensuring global regulatory acceptance.<\/p>\n\n\n\n<p>Each vial is <strong>pre-sterilized to SAL 10\u207b\u2076 via gamma irradiation or ethylene oxide (ETO)<\/strong>, pre-assembled with a medical-grade bromobutyl stopper, and packaged in <strong>double sterile pouches within rigid nest trays<\/strong>, making them true <strong>Pr\u00eat \u00e0 remplir (RTF)<\/strong> components. This eliminates the need for in-house washing, depyrogenation, and sterilization\u2014reducing contamination risk, operational costs, and time-to-market for critical parenteral products.<\/p>\n\n\n\n<p>With uniform wall thickness, flat-bottom geometry, and tight dimensional tolerances, Pharglass lyo vials ensure consistent heat transfer, minimal breakage, and reliable container closure integrity (CCI) throughout aggressive freeze-dry cycles\u2014even at elevated secondary drying temperatures up to +70\u00b0C.<\/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>Sterile &amp; Ready-to-Fill (RTF)<\/strong> \u2013 SAL 10\u207b\u2076; load directly into aseptic fill-finish lines<\/li>\n\n\n\n<li>\u2705 <strong>Triple Pharmacopeial Compliance<\/strong> \u2013 USP, EP, and YBB certified for FDA, EMA &amp; NMPA submissions<\/li>\n\n\n\n<li>\u2705 <strong>Full Size Range: 2ml\u201350ml<\/strong> \u2013 Supports clinical trials to commercial-scale production<\/li>\n\n\n\n<li>\u2705 <strong>Verre borosilicat\u00e9 de type I<\/strong> \u2013 Ultra-low leachables, ideal for sensitive biologics<\/li>\n\n\n\n<li>\u2705 <strong>Low Particulates &amp; Controlled Surface Quality<\/strong> \u2013 Minimizes cake defects and aggregation<\/li>\n\n\n\n<li>\u2705 <strong>Nest-Tray Packaging<\/strong> \u2013 Enables robotic handling and prevents contact damage<\/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>Sterile Lyophilization Vials (RTF)<\/td><\/tr><tr><td><strong>Marque<\/strong><\/td><td>Pharglass<\/td><\/tr><tr><td><strong>Capacit\u00e9s (tailles ISO)<\/strong><\/td><td>2R (2ml), 5R (5ml), 10R (10ml), 20R (20ml), 30R (30ml), 50R (50ml)<\/td><\/tr><tr><td><strong>Type de verre<\/strong><\/td><td>Verre borosilicat\u00e9 neutre de type I<\/td><\/tr><tr><td><strong>Conformit\u00e9<\/strong><\/td><td>USP &lt;660&gt;, EP 3.2.1, YBB00292005-2-2015, ISO 8362-1<\/td><\/tr><tr><td><strong>Sterilization<\/strong><\/td><td>Gamma (25 kGy) or ETO, validated to SAL 10\u207b\u2076<\/td><\/tr><tr><td><strong>Bouchon<\/strong><\/td><td>Coated or uncoated bromobutyl rubber (low extractables)<\/td><\/tr><tr><td><strong>Niveau d'endotoxines<\/strong><\/td><td>&lt;0.25 EU\/ml (per LAL test)<\/td><\/tr><tr><td><strong>Moisture Content<\/strong><\/td><td>&lt;0.1% residual moisture in packaging environment<\/td><\/tr><tr><td><strong>Packaging Format<\/strong><\/td><td>Vials in precision nest trays \u2192 double sterile pouches \u2192 export cartons<\/td><\/tr><tr><td><strong>Storage Stability<\/strong><\/td><td>Stable from -20\u00b0C to +40\u00b0C; suitable for cold-chain products<\/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, mAbs, enzymes, antibiotics, cell &amp; gene therapies, diagnostic reagents<\/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 Global Pharma Chooses Pharglass RTF Lyo Vials<\/strong><\/h3>\n\n\n\n<p>In lyophilization, <strong>container quality directly impacts drug stability, yield, and patient safety<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Poor glass \u2192 alkali leaching \u2192 protein denaturation<\/li>\n\n\n\n<li>Inconsistent geometry \u2192 uneven drying \u2192 collapsed cake<\/li>\n\n\n\n<li>Non-sterile vials \u2192 microbial contamination \u2192 batch rejection<\/li>\n<\/ul>\n\n\n\n<p>Pharglass mitigates these risks through:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Advanced annealing<\/strong> to relieve internal stress<\/li>\n\n\n\n<li><strong>Inspection visuelle et dimensionnelle automatis\u00e9e<\/strong><\/li>\n\n\n\n<li><strong>Test d'\u00e9tanch\u00e9it\u00e9 \u00e0 l'h\u00e9lium<\/strong> for CCI validation (&lt;1 \u00d7 10\u207b\u2076 mbar\u00b7L\/s)<\/li>\n\n\n\n<li><strong>Full traceability<\/strong> and batch-specific documentation<\/li>\n<\/ul>\n\n\n\n<p>Our vials support <strong>commercialized lyophilized drugs<\/strong> across North America, Europe, China, and emerging markets.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Personnalisation et soutien r\u00e9glementaire<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Amber glass option for light-sensitive APIs<\/li>\n\n\n\n<li>Custom stopper formulations (e.g., fluoropolymer-coated for high-viscosity drugs)<\/li>\n\n\n\n<li>Laser serialization or embossed logos<\/li>\n\n\n\n<li>Full regulatory dossier support: CoA, CoC, DMF, E&amp;L data<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><strong>From molecule to patient\u2014delivered with sterility, stability, and speed.<\/strong><br>When your freeze-dried therapy can\u2019t afford compromise, choose Pharglass sterile lyophilization vials\u2014where global compliance meets manufacturing excellence.<\/p>\n\n\n\n<p>\ud83d\udce9 <strong>Contactez-nous d\u00e8s aujourd'hui<\/strong> for samples, sterilization validation reports, or a quote for your next lyo program!<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Emballage primaire pr\u00eat \u00e0 remplir par Pharglass | Triple conformit\u00e9 pharmacop\u00e9e | Optimis\u00e9 pour les produits biologiques, les vaccins et les antibiotiques Les flacons de lyophilisation st\u00e9rile de Pharglass sont con\u00e7us pour les ... <a title=\"YBB &#038; USP Type I Compliant Lyophilization Vials \u2013 2ml to 50ml Sterile Freeze-Dry Glass Vials\" class=\"read-more\" href=\"https:\/\/www.pharglass.com\/fr\/ybb-usp-type-i-compliant-lyophilization-vials-2ml-to-50ml-sterile-freeze-dry-glass-vials\/\" aria-label=\"En savoir plus sur YBB &#038; USP Type I Compliant Lyophilization Vials \u2013 2ml to 50ml Sterile Freeze-Dry Glass Vials\">Lire plus<\/a><\/p>","protected":false},"author":1,"featured_media":1703,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-1490","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\/1490","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=1490"}],"version-history":[{"count":4,"href":"https:\/\/www.pharglass.com\/fr\/wp-json\/wp\/v2\/posts\/1490\/revisions"}],"predecessor-version":[{"id":1886,"href":"https:\/\/www.pharglass.com\/fr\/wp-json\/wp\/v2\/posts\/1490\/revisions\/1886"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.pharglass.com\/fr\/wp-json\/wp\/v2\/media\/1703"}],"wp:attachment":[{"href":"https:\/\/www.pharglass.com\/fr\/wp-json\/wp\/v2\/media?parent=1490"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharglass.com\/fr\/wp-json\/wp\/v2\/categories?post=1490"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharglass.com\/fr\/wp-json\/wp\/v2\/tags?post=1490"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}