{"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\/ar\/sterile-freeze-dry-vials-ybb-iso-8362-1-compliant-2ml-10ml-ready-to-use-rtu\/","title":{"rendered":"\u0642\u0648\u0627\u0631\u064a\u0631 \u0645\u0639\u0642\u0645\u0629 \u0645\u062c\u0641\u0641\u0629 \u0628\u0627\u0644\u062a\u062c\u0645\u064a\u062f - \u0645\u062a\u0648\u0627\u0641\u0642\u0629 \u0645\u0639 \u0627\u0644\u0645\u0648\u0627\u0635\u0641\u0629 \u0627\u0644\u0642\u064a\u0627\u0633\u064a\u0629 YBB \u0648ISO 8362-1\u060c 2 \u0645\u0644 - 10 \u0645\u0644\u060c \u062c\u0627\u0647\u0632\u0629 \u0644\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 (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 class=\"wp-block-paragraph\"><em>Pharmaceutical-Grade Lyophilization Containers by Pharglass | Triple-Certified | Eliminate In-House Sterilization<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0641\u0627\u0631\u063a\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>\u0627\u0644\u0635\u064a\u0646\u064a\u0629 YBB0029292005-2-2015<\/strong>, <strong>\u0627\u0644\u0623\u064a\u0632\u0648 8362-1 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 class=\"wp-block-paragraph\">Supplied as true <strong>\u062c\u0627\u0647\u0632 \u0644\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 (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 class=\"wp-block-paragraph\">\u0645\u062b\u0627\u0644\u064a\u0629 \u0644\u0640 <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>\u0627\u0644\u0645\u064a\u0632\u0627\u062a \u0648\u0627\u0644\u0641\u0648\u0627\u0626\u062f \u0627\u0644\u0631\u0626\u064a\u0633\u064a\u0629<\/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\u0644\u0627\u0645\u062a\u062b\u0627\u0644<\/strong>: YBB, ISO 8362-1, USP &lt;660>, EP 3.2.1<\/li>\n\n\n\n<li>\u2705 <strong>\u0627\u0644\u0642\u062f\u0631\u0627\u062a<\/strong>: 2ml, 5ml, 10ml \u2013 optimized for high-value biologics and pediatric doses<\/li>\n\n\n\n<li>\u2705 <strong>\u0632\u062c\u0627\u062c \u0627\u0644\u0628\u0648\u0631\u0633\u0644\u064a\u0643\u0627\u062a \u0627\u0644\u0628\u0648\u0631\u0633\u0644\u064a\u0643\u0627\u062a \u0645\u0646 \u0627\u0644\u0646\u0648\u0639 I<\/strong> \u2013 Low leachables, high hydrolytic resistance<\/li>\n\n\n\n<li>\u2705 <strong>\u0639\u0628\u0648\u0627\u062a \u0639\u0634-\u0635\u064a\u0646\u064a\u0629 \u0627\u0644\u062a\u0639\u0628\u0626\u0629 \u0648\u0627\u0644\u062a\u063a\u0644\u064a\u0641<\/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>\u0627\u0644\u0645\u0648\u0627\u0635\u0641\u0627\u062a \u0627\u0644\u0641\u0646\u064a\u0629<\/strong><\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u0627\u0644\u0645\u0639\u0644\u0645\u0629<\/th><th>\u0627\u0644\u0645\u0648\u0627\u0635\u0641\u0627\u062a<\/th><\/tr><\/thead><tbody><tr><td><strong>\u0627\u0633\u0645 \u0627\u0644\u0645\u0646\u062a\u062c<\/strong><\/td><td>Sterile Freeze-Dry Vials (RTU)<\/td><\/tr><tr><td><strong>\u0627\u0644\u0639\u0644\u0627\u0645\u0629 \u0627\u0644\u062a\u062c\u0627\u0631\u064a\u0629<\/strong><\/td><td>\u0641\u0627\u0631\u063a\u0644\u0627\u0633<\/td><\/tr><tr><td><strong>\u0627\u0644\u0633\u0639\u0627\u062a (\u0645\u0642\u0627\u0633\u0627\u062a ISO)<\/strong><\/td><td>2R (2ml), 5R (5ml), 10R (10ml)<\/td><\/tr><tr><td><strong>\u0646\u0648\u0639 \u0627\u0644\u0632\u062c\u0627\u062c<\/strong><\/td><td>\u0627\u0644\u0646\u0648\u0639 I \u0632\u062c\u0627\u062c \u0627\u0644\u0628\u0648\u0631\u0633\u0644\u064a\u0643\u0627\u062a \u0627\u0644\u0645\u062d\u0627\u064a\u062f \u0645\u0646 \u0627\u0644\u0646\u0648\u0639 \u0627\u0644\u0623\u0648\u0644<\/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>\u0637\u0631\u064a\u0642\u0629 \u0627\u0644\u062a\u0639\u0642\u064a\u0645<\/strong><\/td><td>\u0623\u0634\u0639\u0629 \u062c\u0627\u0645\u0627 (25 \u0643\u064a\u0644\u0648 \u062c\u0631\u0627\u064a) \u0623\u0648 \u0623\u0643\u0633\u064a\u062f \u0627\u0644\u0625\u064a\u062b\u064a\u0644\u064a\u0646 (ETO)\u060c \u0645\u0639\u062a\u0645\u062f \u0648\u0641\u0642\u064b\u0627 \u0644\u0645\u0633\u062a\u0648\u0649 \u0627\u0644\u0623\u0645\u0627\u0646 (SAL) 10\u207b\u2076<\/td><\/tr><tr><td><strong>\u0633\u062f\u0627\u062f\u0629<\/strong><\/td><td>Bromobutyl rubber (coated or uncoated options)<\/td><\/tr><tr><td><strong>\u0645\u0633\u062a\u0648\u0649 \u0627\u0644\u0633\u0645\u0648\u0645 \u0627\u0644\u062f\u0627\u062e\u0644\u064a\u0629<\/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>\u0627\u0644\u062a\u0639\u0628\u0626\u0629 \u0648\u0627\u0644\u062a\u063a\u0644\u064a\u0641<\/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>\u0645\u0648\u0643<\/strong><\/td><td>5,000 \u0642\u0637\u0639\u0629<\/td><\/tr><tr><td><strong>\u0627\u0644\u062a\u0637\u0628\u064a\u0642\u0627\u062a<\/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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\"><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>\u0627\u0646\u062e\u0641\u0627\u0636 \u0627\u0644\u062a\u0643\u0627\u0644\u064a\u0641 \u0627\u0644\u062a\u0634\u063a\u064a\u0644\u064a\u0629<\/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>\u0635\u064f\u0646\u0639\u062a \u062a\u062d\u062a <strong>ISO 15378<\/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>\u062e\u064a\u0627\u0631\u0627\u062a \u0627\u0644\u062a\u062e\u0635\u064a\u0635<\/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 class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\">\ud83d\udce9 <strong>\u0627\u062a\u0635\u0644 \u0628\u0646\u0627 \u0627\u0644\u064a\u0648\u0645<\/strong> for samples, sterilization validation reports, or a quote tailored to your biologic or vaccine program!<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>\u062d\u0627\u0648\u064a\u0627\u062a \u0627\u0644\u062a\u062c\u0641\u064a\u0641 \u0628\u0627\u0644\u062a\u062c\u0645\u064a\u062f \u0628\u0627\u0644\u062a\u062c\u0645\u064a\u062f \u0645\u0646 \u0627\u0644\u062f\u0631\u062c\u0629 \u0627\u0644\u0635\u064a\u062f\u0644\u0627\u0646\u064a\u0629 \u0645\u0646 \u0641\u0627\u0631\u063a\u0644\u0627\u0633 | \u0645\u0639\u062a\u0645\u062f\u0629 \u062b\u0644\u0627\u062b\u064a\u064b\u0627 | \u0627\u0644\u062a\u062e\u0644\u0635 \u0645\u0646 \u0627\u0644\u062a\u0639\u0642\u064a\u0645 \u0627\u0644\u062f\u0627\u062e\u0644\u064a \u0642\u0627\u0631\u0648\u0631\u0629 \u0641\u0627\u0631\u063a\u0644\u0627\u0633 \u0627\u0644\u0645\u0639\u0642\u0645\u0629 \u0627\u0644\u0645\u0639\u0642\u0645\u0629 \u0627\u0644\u0645\u062c\u0641\u0641\u0629 \u0628\u0627\u0644\u062a\u062c\u0645\u064a\u062f \u0628\u0633\u0639\u0627\u062a 2 \u0645\u0644\u060c 5 \u0645\u0644\u060c \u064810 \u0645\u0644 \u0645\u0635\u0645\u0645\u0629 \u0628\u062f\u0642\u0629 \u0645\u0646 \u0623\u062c\u0644 \u0627\u0644\u062a\u0639\u0642\u064a\u0645 ... <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\/ar\/sterile-freeze-dry-vials-ybb-iso-8362-1-compliant-2ml-10ml-ready-to-use-rtu\/\" aria-label=\"Read more about Sterile Freeze-Dry Vials \u2013 YBB &#038; ISO 8362-1 Compliant, 2ml\u201310ml, Ready-to-Use (RTU)\">\u0625\u0642\u0631\u0623 \u0627\u0644\u0645\u0632\u064a\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\/ar\/wp-json\/wp\/v2\/posts\/1496","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharglass.com\/ar\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharglass.com\/ar\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharglass.com\/ar\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharglass.com\/ar\/wp-json\/wp\/v2\/comments?post=1496"}],"version-history":[{"count":4,"href":"https:\/\/www.pharglass.com\/ar\/wp-json\/wp\/v2\/posts\/1496\/revisions"}],"predecessor-version":[{"id":1888,"href":"https:\/\/www.pharglass.com\/ar\/wp-json\/wp\/v2\/posts\/1496\/revisions\/1888"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.pharglass.com\/ar\/wp-json\/wp\/v2\/media\/1715"}],"wp:attachment":[{"href":"https:\/\/www.pharglass.com\/ar\/wp-json\/wp\/v2\/media?parent=1496"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharglass.com\/ar\/wp-json\/wp\/v2\/categories?post=1496"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharglass.com\/ar\/wp-json\/wp\/v2\/tags?post=1496"}],"curies":[{"name":"\u062f\u0628\u0644\u064a\u0648 \u0628\u064a","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}