{"id":1482,"date":"2026-02-05T03:19:33","date_gmt":"2026-02-05T03:19:33","guid":{"rendered":"https:\/\/www.pharglass.com\/?p=1482"},"modified":"2026-02-10T06:06:48","modified_gmt":"2026-02-10T06:06:48","slug":"double-stoppered-lyophilization-vials-usp-type-i-glass-for-biologics-mrna-vaccines","status":"publish","type":"post","link":"https:\/\/www.pharglass.com\/fa\/double-stoppered-lyophilization-vials-usp-type-i-glass-for-biologics-mrna-vaccines\/","title":{"rendered":"\u0648\u06cc\u0627\u0644\u200c\u0647\u0627\u06cc \u0644\u06cc\u0648\u0641\u06cc\u0644\u06cc\u0632\u0627\u0633\u06cc\u0648\u0646 \u062f\u0648 \u062f\u0631\u067e\u0648\u0634 \u2013 \u0634\u06cc\u0634\u0647 \u0646\u0648\u0639 I USP \u0628\u0631\u0627\u06cc \u0645\u062d\u0635\u0648\u0644\u0627\u062a \u0628\u06cc\u0648\u0644\u0648\u0698\u06cc\u06a9 \u0648 \u0648\u0627\u06a9\u0633\u0646\u200c\u0647\u0627\u06cc mRNA"},"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=\"827\" height=\"829\" data-id=\"1688\" src=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/70-1.jpg\" alt=\"\" class=\"wp-image-1688\" srcset=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/70-1.jpg 827w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/70-1-300x300.jpg 300w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/70-1-150x150.jpg 150w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/70-1-768x770.jpg 768w\" sizes=\"auto, (max-width: 827px) 100vw, 827px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"825\" height=\"824\" data-id=\"1689\" src=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/71-1.jpg\" alt=\"\" class=\"wp-image-1689\" srcset=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/71-1.jpg 825w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/71-1-300x300.jpg 300w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/71-1-150x150.jpg 150w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/71-1-768x767.jpg 768w\" sizes=\"auto, (max-width: 825px) 100vw, 825px\" \/><\/figure>\n<\/figure>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><em>Enhanced Container Closure Integrity by Pharglass | Dual-Stopper Design for Reconstitution &amp; Long-Term Stability<\/em><\/p>\n\n\n\n<p>\u0641\u064e\u0631\u06af\u0644\u0627\u0633 <strong>double-stoppered lyophilization vials<\/strong> are engineered for the most demanding freeze-dried therapeutics\u2014where <strong>container closure integrity (CCI)<\/strong>, <strong>reconstitution reliability<\/strong>, \u060c \u0648 <strong>long-term stability<\/strong> are non-negotiable. Made from <strong>USP Type I neutral borosilicate glass<\/strong>, these vials feature a <strong>dual-stopper system<\/strong>: an inner stopper that seals the lyophilized cake during storage, and an outer stopper that maintains sterility and enables safe, controlled reconstitution with diluent.<\/p>\n\n\n\n<p>This innovative design is ideal for:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>mRNA-LNP vaccines<\/strong> requiring strict moisture control<\/li>\n\n\n\n<li><strong>High-potency biologics<\/strong> (e.g., monoclonal antibodies, enzymes)<\/li>\n\n\n\n<li><strong>Two-chamber reconstitution systems<\/strong> without complex devices<\/li>\n\n\n\n<li><strong>Clinical trial materials<\/strong> needing multi-step dosing or dilution<\/li>\n<\/ul>\n\n\n\n<p>\u0645\u0637\u0627\u0628\u0642 \u0628\u0627 <strong>USP<\/strong>, <strong>\u0641\u0635\u0644 \u06f3.\u06f2.\u06f1<\/strong>, <strong>\u0627\u06cc\u0632\u0648 \u06f8\u06f3\u06f6\u06f2-\u06f1<\/strong>, \u060c \u0648 <strong>YBB standards<\/strong>, Pharglass double-stoppered vials deliver superior protection against moisture ingress, oxygen permeation, and microbial contamination\u2014critical for maintaining potency in lyophilized products with low residual moisture specifications (&lt;1%).<\/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>Dual-Stopper System<\/strong> \u2013 Inner stopper protects lyo cake; outer stopper enables sterile reconstitution<\/li>\n\n\n\n<li>\u2705 <strong>USP Type I Borosilicate Glass<\/strong> \u2013 Ultra-low leachables, high chemical resistance<\/li>\n\n\n\n<li>\u2705 <strong>Optimized for mRNA &amp; Biologics<\/strong> \u2013 Minimizes degradation during storage and handling<\/li>\n\n\n\n<li>\u2705 <strong>Superior CCI Performance<\/strong> \u2013 Validated via helium leak testing (&lt;1 \u00d7 1\u202f\u00d7\u202f10\u207b\u2076 mbar\u00b7L\/s)<\/li>\n\n\n\n<li>\u2705 <strong>Compatible with Standard Lyophilizers<\/strong> \u2013 Fits all common tray configurations (2R\u201350R)<\/li>\n\n\n\n<li>\u2705 <strong>Clear or Amber Options<\/strong> \u2013 Amber version protects light-sensitive APIs<\/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>Double-Stoppered Lyophilization Vials<\/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<\/strong><\/td><td>2ml (2R), 5ml (5R), 10ml (10R), 20ml (20R), 30ml (30R) <em>(standard ISO sizes)<\/em><\/td><\/tr><tr><td><strong>\u0646\u0648\u0639 \u0634\u06cc\u0634\u0647<\/strong><\/td><td>USP\/EP Type I Neutral Borosilicate Glass<\/td><\/tr><tr><td><strong>\u0627\u0646\u0637\u0628\u0627\u0642<\/strong><\/td><td>USP , EP 3.2.1, ISO 8362-1, YBB00292005-2-2015<\/td><\/tr><tr><td><strong>Stopper Configuration<\/strong><\/td><td>Dual bromobutyl rubber stoppers (inner + outer), coated or uncoated<\/td><\/tr><tr><td><strong>Neck Finish<\/strong><\/td><td>Standard ISO finish (e.g., 13mm, 20mm) for crimp seals or flip-off caps<\/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 (for sterile versions)<\/td><\/tr><tr><td><strong>Sterility Options<\/strong><\/td><td>Non-sterile (standard); gamma or ETO sterilized (SAL 10\u207b\u2076) on request<\/td><\/tr><tr><td><strong>\u0628\u0633\u062a\u0647\u200c\u0628\u0646\u062f\u06cc<\/strong><\/td><td>Bulk in clean cartons or nest trays for automated loading<\/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 mRNA vaccines, viral vectors, monoclonal antibodies, peptides, antibiotics, diagnostic kits, personalized cell 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 Choose Double-Stoppered Vials Over Single-Stopper?<\/strong><\/h3>\n\n\n\n<p>Traditional single-stopper vials require needle puncture for reconstitution\u2014introducing risks of:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Particulate generation<\/strong> from rubber coring<\/li>\n\n\n\n<li><strong>Moisture ingress<\/strong> after first use (in multi-dose scenarios)<\/li>\n\n\n\n<li><strong>Loss of sterility<\/strong> during manual diluent transfer<\/li>\n<\/ul>\n\n\n\n<p>\u0622\u0646 <strong>dual-stopper design eliminates these issues<\/strong>:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Diluent is pre-loaded<\/strong> in the upper chamber (or added aseptically)<\/li>\n\n\n\n<li><strong>Reconstitution occurs in a closed system<\/strong>\u2014simply push the outer stopper to mix<\/li>\n\n\n\n<li><strong>No needle entry needed<\/strong>\u2014preserving sterility and reducing operator error<\/li>\n<\/ol>\n\n\n\n<p>This makes double-stoppered vials a smart choice for <strong>point-of-care use<\/strong>, <strong>emergency medicine<\/strong>, \u060c \u0648 <strong>resource-limited settings<\/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>Validation &amp; Regulatory Support<\/strong><\/h3>\n\n\n\n<p>Pharglass provides full documentation for global submissions:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Helium leak test reports (CCI validation)<\/li>\n\n\n\n<li>Thermal cycling data (from -70\u00b0C to +70\u00b0C)<\/li>\n\n\n\n<li>Extractables &amp; leachables (E&amp;L) studies<\/li>\n\n\n\n<li>Drug Master File (DMF) support for FDA\/EMA\/NMPA<\/li>\n<\/ul>\n\n\n\n<p>\u062a\u0648\u0644\u06cc\u062f \u0634\u062f\u0647 \u062a\u062d\u062a <strong>ISO 9001<\/strong> \u0648 <strong>\u0627\u06cc\u0632\u0648 \u06f1\u06f5\u06f3\u06f7\u06f8<\/strong> quality systems, with full batch traceability.<\/p>\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>Pre-filled diluent chamber (with client\u2019s buffer)<\/li>\n\n\n\n<li>Color-coded stoppers for dose differentiation<\/li>\n\n\n\n<li>Laser marking for serialization<\/li>\n\n\n\n<li>Ready-to-fill (RTF) sterile configuration in double pouches<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><strong>Innovate with confidence. Protect with precision.<\/strong><br>When your lyophilized therapy demands more than a standard vial, choose Pharglass double-stoppered lyophilization vials\u2014where engineering meets patient safety.<\/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, CCI validation data, or a customized solution for your mRNA or biologic program!<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>\u0627\u0631\u062a\u0642\u0627\u06cc \u06cc\u06a9\u067e\u0627\u0631\u0686\u06af\u06cc \u0628\u0633\u062a\u0647\u200c\u0628\u0646\u062f\u06cc \u0638\u0631\u0641 \u062a\u0648\u0633\u0637 Pharglass | \u0637\u0631\u0627\u062d\u06cc \u062f\u0648\u067e\u0644\u0645\u067e \u0628\u0631\u0627\u06cc \u0628\u0627\u0632\u0633\u0627\u0632\u06cc \u0648 \u067e\u0627\u06cc\u062f\u0627\u0631\u06cc \u0628\u0644\u0646\u062f\u0645\u062f\u062a \u0648\u06cc\u0627\u0644\u200c\u0647\u0627\u06cc \u0644\u06cc\u0648\u0641\u06cc\u0644\u06cc\u0632\u0627\u0633\u06cc\u0648\u0646 \u062f\u0648\u067e\u0644\u0645\u067e Pharglass \u0628\u0631\u0627\u06cc \u062e\u0634\u06a9\u200c\u06a9\u0631\u062f\u0646 \u0627\u0646\u062c\u0645\u0627\u062f\u06cc \u0633\u062e\u062a\u200c\u06af\u06cc\u0631\u0627\u0646\u0647\u200c\u062a\u0631\u06cc\u0646 \u2026 <a title=\"Double-Stoppered Lyophilization Vials \u2013 USP Type I Glass for Biologics &#038; mRNA Vaccines\" class=\"read-more\" href=\"https:\/\/www.pharglass.com\/fa\/double-stoppered-lyophilization-vials-usp-type-i-glass-for-biologics-mrna-vaccines\/\" aria-label=\"\u062f\u0631\u0628\u0627\u0631\u06c0 Double-Stoppered Lyophilization Vials \u2013 USP Type I Glass for Biologics &#038; mRNA Vaccines \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":1687,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-1482","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\/1482","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=1482"}],"version-history":[{"count":4,"href":"https:\/\/www.pharglass.com\/fa\/wp-json\/wp\/v2\/posts\/1482\/revisions"}],"predecessor-version":[{"id":1880,"href":"https:\/\/www.pharglass.com\/fa\/wp-json\/wp\/v2\/posts\/1482\/revisions\/1880"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.pharglass.com\/fa\/wp-json\/wp\/v2\/media\/1687"}],"wp:attachment":[{"href":"https:\/\/www.pharglass.com\/fa\/wp-json\/wp\/v2\/media?parent=1482"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharglass.com\/fa\/wp-json\/wp\/v2\/categories?post=1482"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharglass.com\/fa\/wp-json\/wp\/v2\/tags?post=1482"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}