{"id":1484,"date":"2026-02-05T03:20:02","date_gmt":"2026-02-05T03:20:02","guid":{"rendered":"https:\/\/www.pharglass.com\/?p=1484"},"modified":"2026-02-10T06:09:24","modified_gmt":"2026-02-10T06:09:24","slug":"lyophilization-vials-for-freeze-dried-powders-type-i-borosilicate-2ml-50ml-usp-ep-ybb-compliant","status":"publish","type":"post","link":"https:\/\/www.pharglass.com\/de\/lyophilization-vials-for-freeze-dried-powders-type-i-borosilicate-2ml-50ml-usp-ep-ybb-compliant\/","title":{"rendered":"Lyophilisationsfl\u00e4schchen f\u00fcr gefriergetrocknete Pulver - Typ I Borosilikat, 2ml-50ml, USP\/EP\/YBB-konform"},"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=\"821\" height=\"835\" data-id=\"1692\" src=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/73-1.jpg\" alt=\"\" class=\"wp-image-1692\" srcset=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/73-1.jpg 821w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/73-1-295x300.jpg 295w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/73-1-768x781.jpg 768w\" sizes=\"auto, (max-width: 821px) 100vw, 821px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"828\" height=\"831\" data-id=\"1693\" src=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/74.jpg\" alt=\"\" class=\"wp-image-1693\" srcset=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/74.jpg 828w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/74-300x300.jpg 300w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/74-150x150.jpg 150w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/74-768x771.jpg 768w\" sizes=\"auto, (max-width: 828px) 100vw, 828px\" \/><\/figure>\n<\/figure>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><em>High-Performance Primary Packaging by Pharglass | Optimized for Stability, Integrity &amp; Scalability<\/em><\/p>\n\n\n\n<p>Pharglass <strong>lyophilization vials<\/strong> are precision-engineered for the reliable freeze-drying of sensitive therapeutics\u2014from small-molecule antibiotics to complex <strong>mRNA vaccines, monoclonal antibodies, peptides, and viral vectors<\/strong>. Available in a full range of standard capacities (<strong>2ml, 5ml, 10ml, 20ml, 30ml, and 50ml<\/strong>), these vials are manufactured from <strong>Typ I neutrales Borosilikatglas<\/strong>, ensuring exceptional chemical resistance, low extractables, and long-term stability of freeze-dried cakes.<\/p>\n\n\n\n<p>Fully compliant with <strong>USP<\/strong>, <strong>European Pharmacopoeia (EP) 3.2.1<\/strong>, und <strong>Chinese YBB00292005-2-2015<\/strong> standards, Pharglass lyo vials meet the stringent quality requirements of global regulatory agencies (FDA, EMA, NMPA). Their consistent wall thickness, flat-bottom design, and precise dimensional tolerances ensure uniform heat transfer during primary and secondary drying\u2014minimizing collapse, melt-back, and batch failure.<\/p>\n\n\n\n<p>Ideal for both clinical and commercial-scale lyophilization, our vials integrate seamlessly with leading freeze-dryer systems from <strong>SP Industries, GEA, Telstar, and IMA<\/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>Hauptmerkmale und Vorteile<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u2705 <strong>Full Size Range: 2ml to 50ml<\/strong> \u2013 Supports everything from pediatric doses to bulk drug substance<\/li>\n\n\n\n<li>\u2705 <strong>Typ I Borosilikatglas<\/strong> \u2013 Highest pharmaceutical grade; ideal for parenterals and biologics<\/li>\n\n\n\n<li>\u2705 <strong>Triple Pharmacopeial Compliance<\/strong> \u2013 USP, EP, and YBB certified for global market access<\/li>\n\n\n\n<li>\u2705 <strong>Optimized Geometry<\/strong> \u2013 Flat bottom + uniform walls = consistent thermal conduction &amp; low breakage<\/li>\n\n\n\n<li>\u2705 <strong>Geringe Partikelzahl und kontrollierte Oberfl\u00e4chenqualit\u00e4t<\/strong> \u2013 Minimizes nucleation defects and cake heterogeneity<\/li>\n\n\n\n<li>\u2705 <strong>Standard-ISO-Halsausf\u00fchrungen<\/strong> - Kompatibel mit Serumstopfen, B\u00f6rdelverschl\u00fcssen und Flip-off-Kappen<\/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>Technische Daten<\/strong><\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>Spezifikation<\/th><\/tr><\/thead><tbody><tr><td><strong>Produktname<\/strong><\/td><td>Lyophilization Vials for Freeze-Dried Powders<\/td><\/tr><tr><td><strong>Marke<\/strong><\/td><td>Pharglass<\/td><\/tr><tr><td><strong>Fassungsverm\u00f6gen (ISO-Gr\u00f6\u00dfen)<\/strong><\/td><td>2R (2ml), 5R (5ml), 10R (10ml), 20R (20ml), 30R (30ml), 50R (50ml)<\/td><\/tr><tr><td><strong>Glas Typ<\/strong><\/td><td>Typ I Neutrales Borosilikatglas<\/td><\/tr><tr><td><strong>Einhaltung der Vorschriften<\/strong><\/td><td>USP &lt;660&gt;, EP 3.2.1, YBB00292005-2-2015, ISO 8362-1<\/td><\/tr><tr><td><strong>Farboptionen<\/strong><\/td><td>Clear (standard) or Amber (UV-protective, on request)<\/td><\/tr><tr><td><strong>Bottom Design<\/strong><\/td><td>Flat-bottom (optimized for lyophilizer trays)<\/td><\/tr><tr><td><strong>Hals-Finish<\/strong><\/td><td>ISO-Standardausf\u00fchrung (z. B. 13 mm, 20 mm) f\u00fcr Gummistopfen<\/td><\/tr><tr><td><strong>Thermal Resistance<\/strong><\/td><td>Validated from -40\u00b0C to +70\u00b0C (suitable for aggressive lyo cycles)<\/td><\/tr><tr><td><strong>Verpackung<\/strong><\/td><td>Bulk in cleanroom-washed cartons or nest trays for automated handling<\/td><\/tr><tr><td><strong>Sterilit\u00e4tsoptionen<\/strong><\/td><td>Non-sterile (standard); gamma or ETO sterilized (SAL 10\u207b\u2076) available<\/td><\/tr><tr><td><strong>MOQ<\/strong><\/td><td>5.000 St\u00fcck<\/td><\/tr><tr><td><strong>Anwendungen<\/strong><\/td><td>Lyophilized vaccines, mAbs, enzymes, antibiotics, mRNA-LNPs, diagnostic reagents, cell &amp; gene 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 Glass Quality Matters in Lyophilization<\/strong><\/h3>\n\n\n\n<p>The success of a freeze-drying cycle depends not just on formulation\u2014but on <strong>container performance<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Poor glass \u2192 alkali leaching \u2192 pH shift \u2192 protein aggregation<\/li>\n\n\n\n<li>Inconsistent walls \u2192 uneven drying \u2192 collapsed cake or residual moisture<\/li>\n\n\n\n<li>Surface defects \u2192 uncontrolled nucleation \u2192 variable reconstitution time<\/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 melting &amp; forming control<\/strong> to eliminate cords and stones<\/li>\n\n\n\n<li><strong>Strict hydrolytic resistance testing<\/strong> (powdered glass test per USP)<\/li>\n\n\n\n<li><strong>Automatisierte Sichtpr\u00fcfung<\/strong> for cracks, chips, and particulates<\/li>\n\n\n\n<li><strong>Batch-specific CoA<\/strong> with dimensions, weight, and compliance data<\/li>\n<\/ul>\n\n\n\n<p>Our vials are used in <strong>commercialized lyophilized drugs<\/strong> across North America, Europe, and Asia.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Kundenspezifische Anpassung &amp; regulatorische Unterst\u00fctzung<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Gepr\u00e4gte Volumenmarkierungen oder Kundenlogos<\/li>\n\n\n\n<li>Vorsterilisiert <strong>Fertig zum Ausf\u00fcllen (RTF)<\/strong> Konfiguration in doppelten sterilen Beuteln<\/li>\n\n\n\n<li>Compatibility testing with your specific lyo cycle<\/li>\n\n\n\n<li>Full regulatory documentation: CoA, CoC, DMF support, 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 lab to launch\u2014freeze-dry with confidence.<\/strong><br>Pharglass lyophilization vials combine pharmaceutical excellence, global compliance, and scalable supply to support your most critical freeze-dried products.<\/p>\n\n\n\n<p>\ud83d\udce9 <strong>Kontaktieren Sie uns heute<\/strong> for samples, validation reports, or a quote tailored to your lyo program!<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Hochleistungs-Prim\u00e4rverpackungen von Pharglass | Optimiert f\u00fcr Stabilit\u00e4t, Integrit\u00e4t und Skalierbarkeit Pharglass Gefriertrocknungsfl\u00e4schchen sind pr\u00e4zisionsgefertigt f\u00fcr die zuverl\u00e4ssige Gefriertrocknung empfindlicher Therapeutika - von kleinen ... <a title=\"Lyophilisationsfl\u00e4schchen f\u00fcr gefriergetrocknete Pulver - Typ I Borosilikat, 2ml-50ml, USP\/EP\/YBB-konform\" class=\"read-more\" href=\"https:\/\/www.pharglass.com\/de\/lyophilization-vials-for-freeze-dried-powders-type-i-borosilicate-2ml-50ml-usp-ep-ybb-compliant\/\" aria-label=\"Mehr Informationen \u00fcber Lyophilization Vials for Freeze-Dried Powders \u2013 Type I Borosilicate, 2ml\u201350ml, USP\/EP\/YBB Compliant\">Weiterlesen &#8230;<\/a><\/p>","protected":false},"author":1,"featured_media":1691,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-1484","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\/de\/wp-json\/wp\/v2\/posts\/1484","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharglass.com\/de\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharglass.com\/de\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharglass.com\/de\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharglass.com\/de\/wp-json\/wp\/v2\/comments?post=1484"}],"version-history":[{"count":4,"href":"https:\/\/www.pharglass.com\/de\/wp-json\/wp\/v2\/posts\/1484\/revisions"}],"predecessor-version":[{"id":1882,"href":"https:\/\/www.pharglass.com\/de\/wp-json\/wp\/v2\/posts\/1484\/revisions\/1882"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.pharglass.com\/de\/wp-json\/wp\/v2\/media\/1691"}],"wp:attachment":[{"href":"https:\/\/www.pharglass.com\/de\/wp-json\/wp\/v2\/media?parent=1484"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharglass.com\/de\/wp-json\/wp\/v2\/categories?post=1484"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharglass.com\/de\/wp-json\/wp\/v2\/tags?post=1484"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}