{"id":1496,"date":"2026-02-05T03:23:03","date_gmt":"2026-02-05T03:23:03","guid":{"rendered":"https:\/\/www.pharglass.com\/?p=1496"},"modified":"2026-02-10T06:16:54","modified_gmt":"2026-02-10T06:16:54","slug":"sterile-freeze-dry-vials-ybb-iso-8362-1-compliant-2ml-10ml-ready-to-use-rtu","status":"publish","type":"post","link":"https:\/\/www.pharglass.com\/ru\/sterile-freeze-dry-vials-ybb-iso-8362-1-compliant-2ml-10ml-ready-to-use-rtu\/","title":{"rendered":"\u0421\u0442\u0435\u0440\u0438\u043b\u044c\u043d\u044b\u0435 \u0444\u043b\u0430\u043a\u043e\u043d\u044b \u0434\u043b\u044f \u0441\u0443\u0448\u043a\u0438 \u0432 \u0437\u0430\u043c\u043e\u0440\u043e\u0436\u0435\u043d\u043d\u043e\u043c \u0441\u043e\u0441\u0442\u043e\u044f\u043d\u0438\u0438 - \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0438\u0435 \u0441\u0442\u0430\u043d\u0434\u0430\u0440\u0442\u0430\u043c YBB \u0438 ISO 8362-1, 2 \u043c\u043b-10 \u043c\u043b, \u0433\u043e\u0442\u043e\u0432\u044b\u0435 \u043a \u0438\u0441\u043f\u043e\u043b\u044c\u0437\u043e\u0432\u0430\u043d\u0438\u044e (RTU)"},"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=\"914\" height=\"913\" data-id=\"1716\" src=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/91-1.jpg\" alt=\"\" class=\"wp-image-1716\" srcset=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/91-1.jpg 914w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/91-1-300x300.jpg 300w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/91-1-150x150.jpg 150w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/91-1-768x767.jpg 768w\" sizes=\"auto, (max-width: 914px) 100vw, 914px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"919\" height=\"914\" data-id=\"1717\" src=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/92-1.jpg\" alt=\"\" class=\"wp-image-1717\" srcset=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/92-1.jpg 919w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/92-1-300x298.jpg 300w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/92-1-150x150.jpg 150w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/92-1-768x764.jpg 768w\" sizes=\"auto, (max-width: 919px) 100vw, 919px\" \/><\/figure>\n<\/figure>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><em>Pharmaceutical-Grade Lyophilization Containers by Pharglass | Triple-Certified | Eliminate In-House Sterilization<\/em><\/p>\n\n\n\n<p>Pharglass <strong>Sterile Freeze-Dry Vials<\/strong> \u0432 <strong>2ml, 5ml, and 10ml<\/strong> capacities are precision-engineered for aseptic fill-finish operations requiring immediate, contamination-free integration into lyophilization workflows. Fully compliant with <strong>Chinese YBB00292005-2-2015<\/strong>, <strong>ISO 8362-1<\/strong> (international standard for injection vials), and aligned with <strong>USP &lt;660&gt; \/ EP 3.2.1<\/strong>, these vials deliver the chemical inertness, dimensional accuracy, and sterility assurance demanded by modern biologics, vaccines, and sensitive small-molecule APIs.<\/p>\n\n\n\n<p>Supplied as true <strong>Ready-to-Use (RTU)<\/strong> components, each vial is pre-assembled with a medical-grade bromobutyl stopper, sterilized to <strong>SAL 10\u207b\u2076 via gamma irradiation or ethylene oxide (ETO)<\/strong>, and double-bagged in sterile pouches within rigid nest trays. This eliminates the need for washing, depyrogenation, and terminal sterilization\u2014reducing facility burden, validation complexity, and time-to-market for critical parenteral products.<\/p>\n\n\n\n<p>\u0418\u0434\u0435\u0430\u043b\u044c\u043d\u043e \u043f\u043e\u0434\u0445\u043e\u0434\u0438\u0442 \u0434\u043b\u044f <strong>clinical trials, personalized medicine, and commercial-scale lyophilization<\/strong>, Pharglass RTU vials ensure consistent cake formation, reliable container closure integrity (CCI), and seamless compatibility with leading freeze-dryer systems.<\/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>Ready-to-Use (RTU) Format<\/strong> \u2013 Load directly into aseptic filling lines; no cleaning or sterilization needed<\/li>\n\n\n\n<li>\u2705 <strong>Sterile to SAL 10\u207b\u2076<\/strong> \u2013 Validated gamma or ETO sterilization<\/li>\n\n\n\n<li>\u2705 <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>: YBB, ISO 8362-1, USP &lt;660>, EP 3.2.1<\/li>\n\n\n\n<li>\u2705 <strong>\u0415\u043c\u043a\u043e\u0441\u0442\u0438<\/strong>: 2ml, 5ml, 10ml \u2013 optimized for high-value biologics and pediatric doses<\/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 Low leachables, high hydrolytic resistance<\/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 Freeze-Dry Vials (RTU)<\/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 (2ml), 5R (5ml), 10R (10ml)<\/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>Standards Met<\/strong><\/td><td>ISO 8362-1, YBB00292005-2-2015, USP &lt;660&gt;, EP 3.2.1<\/td><\/tr><tr><td><strong>\u041c\u0435\u0442\u043e\u0434 \u0441\u0442\u0435\u0440\u0438\u043b\u0438\u0437\u0430\u0446\u0438\u0438<\/strong><\/td><td>Gamma (25 kGy) or Ethylene Oxide (ETO), validated to SAL 10\u207b\u2076<\/td><\/tr><tr><td><strong>\u041f\u0440\u043e\u0431\u043a\u0430<\/strong><\/td><td>Bromobutyl rubber (coated or uncoated options)<\/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 (LAL test compliant)<\/td><\/tr><tr><td><strong>Particulate Control<\/strong><\/td><td>Meets light-obscuration limits per USP &lt;788&gt;<\/td><\/tr><tr><td><strong>\u0423\u043f\u0430\u043a\u043e\u0432\u043a\u0430<\/strong><\/td><td>Vials in precision nest trays \u2192 sealed in double sterile pouches \u2192 export cartons<\/td><\/tr><tr><td><strong>Storage Conditions<\/strong><\/td><td>Stable from -20\u00b0C to +40\u00b0C; low humidity environment<\/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 monoclonal antibodies, mRNA vaccines, peptides, antibiotics, diagnostic kits, cell therapy products<\/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 RTU Over Traditional Vials?<\/strong><\/h3>\n\n\n\n<p>Traditional bulk vials require extensive in-house processing:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Washing \u2192 risk of residual detergents<\/li>\n\n\n\n<li>Depyrogenation at >250\u00b0C \u2192 energy-intensive, potential glass stress<\/li>\n\n\n\n<li>Sterilization validation \u2192 added cost and complexity<\/li>\n<\/ul>\n\n\n\n<p><strong>Pharglass RTU vials solve these challenges<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Reduced contamination risk<\/strong> \u2013 fully closed system from manufacturer to fill line<\/li>\n\n\n\n<li><strong>Lower operational costs<\/strong> \u2013 eliminate washer\/depyro equipment and validation<\/li>\n\n\n\n<li><strong>Faster tech transfer<\/strong> \u2013 ideal for multi-site CDMO networks<\/li>\n\n\n\n<li><strong>Regulatory-ready<\/strong> \u2013 full documentation package included<\/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>Quality &amp; Regulatory Support<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Manufactured under <strong>ISO 15378<\/strong> (GMP for primary packaging)<\/li>\n\n\n\n<li>Full batch traceability with <strong>Certificate of Analysis (CoA)<\/strong> \u0438 <strong>Certificate of Sterilization<\/strong><\/li>\n\n\n\n<li>Extractables &amp; Leachables (E&amp;L) data available<\/li>\n\n\n\n<li>Drug Master File (DMF) support for FDA, NMPA, and EMA submissions<\/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>Customization Options<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Amber glass for light-sensitive formulations<\/li>\n\n\n\n<li>Fluoropolymer-coated stoppers for high-viscosity drugs<\/li>\n\n\n\n<li>Laser serialization or embossed volume markings<\/li>\n\n\n\n<li>Custom packaging configurations for automated lines<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><strong>Accelerate your lyophilization process\u2014without compromising quality.<\/strong><br>Pharglass Sterile Freeze-Dry Vials combine global compliance, sterility assurance, and operational efficiency in one ready-to-deploy solution.<\/p>\n\n\n\n<p>\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 tailored to your biologic or vaccine program!<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>\u041a\u043e\u043d\u0442\u0435\u0439\u043d\u0435\u0440\u044b \u0434\u043b\u044f \u043b\u0438\u043e\u0444\u0438\u043b\u0438\u0437\u0430\u0446\u0438\u0438 \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u0435\u0441\u043a\u043e\u0433\u043e \u043a\u043b\u0430\u0441\u0441\u0430 \u043e\u0442 Pharglass | Triple-Certified | Eliminate In-House Sterilization Pharglass Sterile Freeze-Dry Vials in 2ml, 5ml, and 10ml capacity are precision-engineered for aseptic ... <a title=\"Sterile Freeze-Dry Vials \u2013 YBB &#038; ISO 8362-1 Compliant, 2ml\u201310ml, Ready-to-Use (RTU)\" class=\"read-more\" href=\"https:\/\/www.pharglass.com\/ru\/sterile-freeze-dry-vials-ybb-iso-8362-1-compliant-2ml-10ml-ready-to-use-rtu\/\" aria-label=\"\u041f\u0440\u043e\u0447\u0438\u0442\u0430\u0442\u044c \u0431\u043e\u043b\u044c\u0448\u0435 \u043e Sterile Freeze-Dry Vials \u2013 YBB &#038; ISO 8362-1 Compliant, 2ml\u201310ml, Ready-to-Use (RTU)\">\u0427\u0438\u0442\u0430\u0442\u044c \u0434\u0430\u043b\u0435\u0435<\/a><\/p>","protected":false},"author":1,"featured_media":1715,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-1496","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\/1496","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=1496"}],"version-history":[{"count":4,"href":"https:\/\/www.pharglass.com\/ru\/wp-json\/wp\/v2\/posts\/1496\/revisions"}],"predecessor-version":[{"id":1888,"href":"https:\/\/www.pharglass.com\/ru\/wp-json\/wp\/v2\/posts\/1496\/revisions\/1888"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.pharglass.com\/ru\/wp-json\/wp\/v2\/media\/1715"}],"wp:attachment":[{"href":"https:\/\/www.pharglass.com\/ru\/wp-json\/wp\/v2\/media?parent=1496"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharglass.com\/ru\/wp-json\/wp\/v2\/categories?post=1496"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharglass.com\/ru\/wp-json\/wp\/v2\/tags?post=1496"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}