{"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\/fa\/sterile-freeze-dry-vials-ybb-iso-8362-1-compliant-2ml-10ml-ready-to-use-rtu\/","title":{"rendered":"\u0648\u06cc\u0627\u0644\u200c\u0647\u0627\u06cc \u0627\u0633\u062a\u0631\u06cc\u0644 \u062e\u0634\u06a9\u200c\u0627\u0646\u062c\u0645\u0648\u062f\u06cc \u2013 \u0645\u0637\u0627\u0628\u0642 YBB \u0648 ISO 8362-1\u060c \u06f2 \u0645\u06cc\u0644\u06cc\u200c\u0644\u06cc\u062a\u0631\u2013\u06f1\u06f0 \u0645\u06cc\u0644\u06cc\u200c\u0644\u06cc\u062a\u0631\u060c \u0622\u0645\u0627\u062f\u0647 \u0645\u0635\u0631\u0641 (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>\u0641\u064e\u0631\u06af\u0644\u0627\u0633 <strong>Sterile Freeze-Dry Vials<\/strong> in <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>\u0686\u06cc\u0646\u06cc YBB00292005-2-2015<\/strong>, <strong>\u0627\u06cc\u0632\u0648 \u06f8\u06f3\u06f6\u06f2-\u06f1<\/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>\u0622\u0645\u0627\u062f\u0647 \u0645\u0635\u0631\u0641 (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>Ideal for <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>\u0648\u06cc\u0698\u06af\u06cc\u200c\u0647\u0627 \u0648 \u0645\u0632\u0627\u06cc\u0627\u06cc \u06a9\u0644\u06cc\u062f\u06cc<\/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>\u0627\u0646\u0637\u0628\u0627\u0642<\/strong>: YBB, ISO 8362-1, USP &lt;660>, EP 3.2.1<\/li>\n\n\n\n<li>\u2705 <strong>\u0638\u0631\u0641\u06cc\u062a\u200c\u0647\u0627<\/strong>: 2ml, 5ml, 10ml \u2013 optimized for high-value biologics and pediatric doses<\/li>\n\n\n\n<li>\u2705 <strong>\u0634\u06cc\u0634\u0647\u0654 \u0628\u0648\u0631\u0648\u0633\u06cc\u0644\u06cc\u06a9\u0627\u062a \u0646\u0648\u0639 I<\/strong> \u2013 Low leachables, high hydrolytic resistance<\/li>\n\n\n\n<li>\u2705 <strong>\u0628\u0633\u062a\u0647\u200c\u0628\u0646\u062f\u06cc \u0633\u06cc\u0646\u06cc\u200c\u0644\u0627\u0646\u0647<\/strong> \u2013 \u0627\u0645\u06a9\u0627\u0646 \u062c\u0627\u0628\u062c\u0627\u06cc\u06cc \u0628\u0627 \u0631\u0628\u0627\u062a \u0631\u0627 \u0641\u0631\u0627\u0647\u0645 \u0645\u06cc\u200c\u06a9\u0646\u062f \u0648 \u0627\u0632 \u0622\u0633\u06cc\u0628 \u0646\u0627\u0634\u06cc \u0627\u0632 \u062a\u0645\u0627\u0633 \u062c\u0644\u0648\u06af\u06cc\u0631\u06cc \u0645\u06cc\u200c\u06a9\u0646\u062f.<\/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>\u0645\u0634\u062e\u0635\u0627\u062a \u0641\u0646\u06cc<\/strong><\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u067e\u0627\u0631\u0627\u0645\u062a\u0631<\/th><th>\u0645\u0634\u062e\u0635\u0627\u062a<\/th><\/tr><\/thead><tbody><tr><td><strong>\u0646\u0627\u0645 \u0645\u062d\u0635\u0648\u0644<\/strong><\/td><td>Sterile Freeze-Dry Vials (RTU)<\/td><\/tr><tr><td><strong>\u0628\u0631\u0646\u062f<\/strong><\/td><td>\u0641\u064e\u0631\u06af\u0644\u0627\u0633<\/td><\/tr><tr><td><strong>\u0638\u0631\u0641\u06cc\u062a\u200c\u0647\u0627 (\u0627\u0628\u0639\u0627\u062f ISO)<\/strong><\/td><td>2R (2ml), 5R (5ml), 10R (10ml)<\/td><\/tr><tr><td><strong>\u0646\u0648\u0639 \u0634\u06cc\u0634\u0647<\/strong><\/td><td>\u0634\u06cc\u0634\u0647\u0654 \u0628\u0648\u0631\u0648\u0633\u06cc\u0644\u06cc\u06a9\u0627\u062a \u062e\u0646\u062b\u06cc \u0646\u0648\u0639 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>\u0631\u0648\u0634 \u0627\u0633\u062a\u0631\u06cc\u0644\u200c\u0633\u0627\u0632\u06cc<\/strong><\/td><td>\u06af\u0627\u0645\u0627 (\u06f2\u06f5 \u06a9\u06cc\u0644\u0648\u06af\u0631\u06cc) \u06cc\u0627 \u0627\u06a9\u0633\u06cc\u062f \u0627\u062a\u06cc\u0644\u0646 (ETO)\u060c \u0627\u0639\u062a\u0628\u0627\u0631\u0633\u0646\u062c\u06cc\u200c\u0634\u062f\u0647 \u062a\u0627 \u0633\u0637\u062d \u0627\u0637\u0645\u06cc\u0646\u0627\u0646 \u0627\u06cc\u0645\u0646\u06cc (SAL) \u06f1\u06f0\u207b\u2076<\/td><\/tr><tr><td><strong>\u062f\u0631\u0648\u0627\u0632\u0647\u200c\u0628\u0627\u0646<\/strong><\/td><td>Bromobutyl rubber (coated or uncoated options)<\/td><\/tr><tr><td><strong>\u0633\u0637\u062d \u0627\u0646\u062f\u0648\u062a\u0648\u06a9\u0633\u06cc\u0646<\/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>\u0628\u0633\u062a\u0647\u200c\u0628\u0646\u062f\u06cc<\/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>\u062d\u062f\u0627\u0642\u0644 \u0633\u0641\u0627\u0631\u0634<\/strong><\/td><td>\u06f5\u06f0\u06f0\u06f0 \u062a\u06a9\u0647<\/td><\/tr><tr><td><strong>\u06a9\u0627\u0631\u0628\u0631\u062f\u0647\u0627<\/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>\u062a\u0648\u0644\u06cc\u062f \u0634\u062f\u0647 \u062a\u062d\u062a <strong>\u0627\u06cc\u0632\u0648 \u06f1\u06f5\u06f3\u06f7\u06f8<\/strong> (GMP for primary packaging)<\/li>\n\n\n\n<li>Full batch traceability with <strong>Certificate of Analysis (CoA)<\/strong> \u0648 <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>\u0627\u0645\u0631\u0648\u0632 \u0628\u0627 \u0645\u0627 \u062a\u0645\u0627\u0633 \u0628\u06af\u06cc\u0631\u06cc\u062f<\/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>\u0638\u0631\u0648\u0641 \u0644\u06cc\u0648\u0641\u06cc\u0644\u06cc\u0632\u0627\u0633\u06cc\u0648\u0646 \u0628\u0627 \u062f\u0631\u062c\u0647 \u062f\u0627\u0631\u0648\u06cc\u06cc \u0633\u0627\u062e\u062a \u0641\u0627\u0631\u06af\u0644\u0633 | \u062f\u0627\u0631\u0627\u06cc \u0633\u0647 \u06af\u0648\u0627\u0647\u06cc | \u062d\u0630\u0641 \u0627\u0633\u062a\u0631\u06cc\u0644\u200c\u0633\u0627\u0632\u06cc \u062f\u0631\u0648\u0646\u200c\u0633\u0627\u0632\u0645\u0627\u0646\u06cc   \u0648\u06cc\u0627\u0644\u200c\u0647\u0627\u06cc \u0627\u0633\u062a\u0631\u06cc\u0644 \u0645\u0646\u062c\u0645\u062f \u062e\u0634\u06a9 \u0641\u0627\u0631\u06af\u0644\u0633 \u062f\u0631 \u0638\u0631\u0641\u06cc\u062a\u200c\u0647\u0627\u06cc \u06f2 \u0645\u06cc\u0644\u06cc\u200c\u0644\u06cc\u062a\u0631\u060c \u06f5 \u0645\u06cc\u0644\u06cc\u200c\u0644\u06cc\u062a\u0631 \u0648 \u06f1\u06f0 \u0645\u06cc\u0644\u06cc\u200c\u0644\u06cc\u062a\u0631 \u0628\u0627 \u0645\u0647\u0646\u062f\u0633\u06cc \u062f\u0642\u06cc\u0642 \u0628\u0631\u0627\u06cc \u0634\u0631\u0627\u06cc\u0637 \u0622\u0633\u067e\u062a\u06cc\u06a9 \u2026 <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\/fa\/sterile-freeze-dry-vials-ybb-iso-8362-1-compliant-2ml-10ml-ready-to-use-rtu\/\" aria-label=\"\u062f\u0631\u0628\u0627\u0631\u06c0 Sterile Freeze-Dry Vials \u2013 YBB &#038; ISO 8362-1 Compliant, 2ml\u201310ml, Ready-to-Use (RTU) \u0628\u06cc\u0634\u062a\u0631 \u0628\u062e\u0648\u0627\u0646\u06cc\u062f\">\u0628\u06cc\u0634\u062a\u0631 \u0628\u062e\u0648\u0627\u0646\u06cc\u062f<\/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\/fa\/wp-json\/wp\/v2\/posts\/1496","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharglass.com\/fa\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharglass.com\/fa\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharglass.com\/fa\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharglass.com\/fa\/wp-json\/wp\/v2\/comments?post=1496"}],"version-history":[{"count":4,"href":"https:\/\/www.pharglass.com\/fa\/wp-json\/wp\/v2\/posts\/1496\/revisions"}],"predecessor-version":[{"id":1888,"href":"https:\/\/www.pharglass.com\/fa\/wp-json\/wp\/v2\/posts\/1496\/revisions\/1888"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.pharglass.com\/fa\/wp-json\/wp\/v2\/media\/1715"}],"wp:attachment":[{"href":"https:\/\/www.pharglass.com\/fa\/wp-json\/wp\/v2\/media?parent=1496"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharglass.com\/fa\/wp-json\/wp\/v2\/categories?post=1496"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharglass.com\/fa\/wp-json\/wp\/v2\/tags?post=1496"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}