{"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\/ru\/ybb-usp-type-i-compliant-lyophilization-vials-2ml-to-50ml-sterile-freeze-dry-glass-vials\/","title":{"rendered":"\u0424\u043b\u0430\u043a\u043e\u043d\u044b \u0434\u043b\u044f \u043b\u0438\u043e\u0444\u0438\u043b\u0438\u0437\u0430\u0446\u0438\u0438, \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0443\u044e\u0449\u0438\u0435 \u0441\u0442\u0430\u043d\u0434\u0430\u0440\u0442\u0430\u043c YBB \u0438 USP Type I - \u043e\u0442 2 \u043c\u043b \u0434\u043e 50 \u043c\u043b \u0441\u0442\u0435\u0440\u0438\u043b\u044c\u043d\u044b\u0445 \u0441\u0442\u0435\u043a\u043b\u044f\u043d\u043d\u044b\u0445 \u0444\u043b\u0430\u043a\u043e\u043d\u043e\u0432 \u0434\u043b\u044f \u0437\u0430\u043c\u043e\u0440\u0430\u0436\u0438\u0432\u0430\u043d\u0438\u044f \u0438 \u0432\u044b\u0441\u0443\u0448\u0438\u0432\u0430\u043d\u0438\u044f"},"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 class=\"wp-block-paragraph\"><em>Ready-to-Fill Primary Packaging by Pharglass | Triple Pharmacopeial Compliance | Optimized for Biologics, Vaccines &amp; Antibiotics<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">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 to 50ml (2R\u201350R)<\/strong>, these vials are manufactured from <strong>\u041d\u0435\u0439\u0442\u0440\u0430\u043b\u044c\u043d\u043e\u0435 \u0431\u043e\u0440\u043e\u0441\u0438\u043b\u0438\u043a\u0430\u0442\u043d\u043e\u0435 \u0441\u0442\u0435\u043a\u043b\u043e \u0442\u0438\u043f\u0430 I<\/strong> and fully compliant with <strong>USP<\/strong>, <strong>European Pharmacopoeia (EP) 3.2.1<\/strong>, \u0438 <strong>Chinese YBB00292005-2-2015<\/strong> standards\u2014ensuring global regulatory acceptance.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">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>\u0413\u043e\u0442\u043e\u0432\u044b\u0435 \u043a \u0437\u0430\u043f\u043e\u043b\u043d\u0435\u043d\u0438\u044e (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 class=\"wp-block-paragraph\">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>\u041a\u043b\u044e\u0447\u0435\u0432\u044b\u0435 \u043e\u0441\u043e\u0431\u0435\u043d\u043d\u043e\u0441\u0442\u0438 \u0438 \u043f\u0440\u0435\u0438\u043c\u0443\u0449\u0435\u0441\u0442\u0432\u0430<\/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>\u0411\u043e\u0440\u043e\u0441\u0438\u043b\u0438\u043a\u0430\u0442\u043d\u043e\u0435 \u0441\u0442\u0435\u043a\u043b\u043e \u0442\u0438\u043f\u0430 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>\u0423\u043f\u0430\u043a\u043e\u0432\u043a\u0430 \u0434\u043b\u044f \u0433\u043d\u0435\u0437\u0434 \u0441 \u043b\u043e\u0442\u043a\u0430\u043c\u0438<\/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>\u0422\u0435\u0445\u043d\u0438\u0447\u0435\u0441\u043a\u0438\u0435 \u0445\u0430\u0440\u0430\u043a\u0442\u0435\u0440\u0438\u0441\u0442\u0438\u043a\u0438<\/strong><\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u041f\u0430\u0440\u0430\u043c\u0435\u0442\u0440<\/th><th>\u0422\u0435\u0445\u043d\u0438\u0447\u0435\u0441\u043a\u0438\u0435 \u0445\u0430\u0440\u0430\u043a\u0442\u0435\u0440\u0438\u0441\u0442\u0438\u043a\u0438<\/th><\/tr><\/thead><tbody><tr><td><strong>\u041d\u0430\u0437\u0432\u0430\u043d\u0438\u0435 \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u0430<\/strong><\/td><td>Sterile Lyophilization Vials (RTF)<\/td><\/tr><tr><td><strong>\u0411\u0440\u0435\u043d\u0434<\/strong><\/td><td>Pharglass<\/td><\/tr><tr><td><strong>Capacities (ISO Sizes)<\/strong><\/td><td>2R (2 \u043c\u043b), 5R (5 \u043c\u043b), 10R (10 \u043c\u043b), 20R (20 \u043c\u043b), 30R (30 \u043c\u043b), 50R (50 \u043c\u043b)<\/td><\/tr><tr><td><strong>\u0422\u0438\u043f \u0441\u0442\u0435\u043a\u043b\u0430<\/strong><\/td><td>\u041d\u0435\u0439\u0442\u0440\u0430\u043b\u044c\u043d\u043e\u0435 \u0431\u043e\u0440\u043e\u0441\u0438\u043b\u0438\u043a\u0430\u0442\u043d\u043e\u0435 \u0441\u0442\u0435\u043a\u043b\u043e \u0442\u0438\u043f\u0430 I<\/td><\/tr><tr><td><strong>\u0421\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0438\u0435 \u0442\u0440\u0435\u0431\u043e\u0432\u0430\u043d\u0438\u044f\u043c<\/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>\u041f\u0440\u043e\u0431\u043a\u0430<\/strong><\/td><td>Coated or uncoated bromobutyl rubber (low extractables)<\/td><\/tr><tr><td><strong>\u0423\u0440\u043e\u0432\u0435\u043d\u044c \u044d\u043d\u0434\u043e\u0442\u043e\u043a\u0441\u0438\u043d\u0430<\/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>\u0424\u043e\u0440\u043c\u0430\u0442 \u0443\u043f\u0430\u043a\u043e\u0432\u043a\u0438<\/strong><\/td><td>Vials in precision nest trays \u2192 double sterile pouches \u2192 export cartons<\/td><\/tr><tr><td><strong>\u0423\u0441\u0442\u043e\u0439\u0447\u0438\u0432\u043e\u0441\u0442\u044c \u043f\u0440\u0438 \u0445\u0440\u0430\u043d\u0435\u043d\u0438\u0438<\/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 \u0448\u0442.<\/td><\/tr><tr><td><strong>\u041f\u0440\u0438\u043b\u043e\u0436\u0435\u043d\u0438\u044f<\/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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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>Automated visual &amp; dimensional inspection<\/strong><\/li>\n\n\n\n<li><strong>Helium leak testing<\/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 class=\"wp-block-paragraph\">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>\u041d\u0430\u0441\u0442\u0440\u043e\u0439\u043a\u0430 \u0438 \u043d\u043e\u0440\u043c\u0430\u0442\u0438\u0432\u043d\u0430\u044f \u043f\u043e\u0434\u0434\u0435\u0440\u0436\u043a\u0430<\/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 class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\">\ud83d\udce9 <strong>\u0421\u0432\u044f\u0436\u0438\u0442\u0435\u0441\u044c \u0441 \u043d\u0430\u043c\u0438 \u0441\u0435\u0433\u043e\u0434\u043d\u044f<\/strong> for samples, sterilization validation reports, or a quote for your next lyo program!<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>\u0413\u043e\u0442\u043e\u0432\u0430\u044f \u043a \u0437\u0430\u043f\u043e\u043b\u043d\u0435\u043d\u0438\u044e \u043f\u0435\u0440\u0432\u0438\u0447\u043d\u0430\u044f \u0443\u043f\u0430\u043a\u043e\u0432\u043a\u0430 \u043e\u0442 Pharglass | \u0422\u0440\u043e\u0439\u043d\u043e\u0435 \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0438\u0435 \u0442\u0440\u0435\u0431\u043e\u0432\u0430\u043d\u0438\u044f\u043c \u0424\u0430\u0440\u043c\u0430\u043a\u043e\u043f\u0435\u0438 | \u041e\u043f\u0442\u0438\u043c\u0438\u0437\u0438\u0440\u043e\u0432\u0430\u043d\u0430 \u0434\u043b\u044f \u0431\u0438\u043e\u043b\u043e\u0433\u0438\u0447\u0435\u0441\u043a\u0438\u0445 \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442\u043e\u0432, \u0432\u0430\u043a\u0446\u0438\u043d \u0438 \u0430\u043d\u0442\u0438\u0431\u0438\u043e\u0442\u0438\u043a\u043e\u0432 \u0421\u0442\u0435\u0440\u0438\u043b\u044c\u043d\u044b\u0435 \u043b\u0438\u043e\u0444\u0438\u043b\u0438\u0437\u0430\u0446\u0438\u043e\u043d\u043d\u044b\u0435 \u0444\u043b\u0430\u043a\u043e\u043d\u044b Pharglass \u0440\u0430\u0437\u0440\u0430\u0431\u043e\u0442\u0430\u043d\u044b \u0434\u043b\u044f \u0441\u0430\u043c\u044b\u0445 ... <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\/ru\/ybb-usp-type-i-compliant-lyophilization-vials-2ml-to-50ml-sterile-freeze-dry-glass-vials\/\" aria-label=\"\u041f\u0440\u043e\u0447\u0438\u0442\u0430\u0442\u044c \u0431\u043e\u043b\u044c\u0448\u0435 \u043e YBB &#038; USP Type I Compliant Lyophilization Vials \u2013 2ml to 50ml Sterile Freeze-Dry Glass Vials\">\u0427\u0438\u0442\u0430\u0442\u044c \u0434\u0430\u043b\u0435\u0435<\/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\/ru\/wp-json\/wp\/v2\/posts\/1490","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharglass.com\/ru\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharglass.com\/ru\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharglass.com\/ru\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharglass.com\/ru\/wp-json\/wp\/v2\/comments?post=1490"}],"version-history":[{"count":4,"href":"https:\/\/www.pharglass.com\/ru\/wp-json\/wp\/v2\/posts\/1490\/revisions"}],"predecessor-version":[{"id":1886,"href":"https:\/\/www.pharglass.com\/ru\/wp-json\/wp\/v2\/posts\/1490\/revisions\/1886"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.pharglass.com\/ru\/wp-json\/wp\/v2\/media\/1703"}],"wp:attachment":[{"href":"https:\/\/www.pharglass.com\/ru\/wp-json\/wp\/v2\/media?parent=1490"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharglass.com\/ru\/wp-json\/wp\/v2\/categories?post=1490"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharglass.com\/ru\/wp-json\/wp\/v2\/tags?post=1490"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}