{"id":1514,"date":"2026-02-05T05:18:31","date_gmt":"2026-02-05T05:18:31","guid":{"rendered":"https:\/\/www.pharglass.com\/?p=1514"},"modified":"2026-02-10T06:27:51","modified_gmt":"2026-02-10T06:27:51","slug":"ep-3-2-1-compliant-glass-vials-for-biopharma-2ml-to-50ml-oem-sterile-options","status":"publish","type":"post","link":"https:\/\/www.pharglass.com\/ar\/ep-3-2-1-compliant-glass-vials-for-biopharma-2ml-to-50ml-oem-sterile-options\/","title":{"rendered":"EP 3.2.1 \u0642\u0648\u0627\u0631\u064a\u0631 \u0632\u062c\u0627\u062c\u064a\u0629 \u0645\u062a\u0648\u0627\u0641\u0642\u0629 \u0645\u0639 \u0645\u0639\u0627\u064a\u064a\u0631 EP 3.2.1 \u0644\u0644\u0623\u062f\u0648\u064a\u0629 \u0627\u0644\u062d\u064a\u0648\u064a\u0629 - 2 \u0645\u0644 \u0625\u0644\u0649 50 \u0645\u0644\u060c \u062e\u064a\u0627\u0631\u0627\u062a \u062a\u0635\u0646\u064a\u0639 \u0627\u0644\u0645\u0639\u062f\u0627\u062a \u0627\u0644\u0623\u0635\u0644\u064a\u0629 \u0648\u0627\u0644\u0645\u0639\u0642\u0645\u0629"},"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=\"750\" height=\"750\" data-id=\"1769\" src=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/111.jpg\" alt=\"\" class=\"wp-image-1769\" srcset=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/111.jpg 750w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/111-300x300.jpg 300w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/111-150x150.jpg 150w\" sizes=\"auto, (max-width: 750px) 100vw, 750px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"750\" height=\"750\" data-id=\"1770\" src=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/112.jpg\" alt=\"\" class=\"wp-image-1770\" srcset=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/112.jpg 750w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/112-300x300.jpg 300w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/112-150x150.jpg 150w\" sizes=\"auto, (max-width: 750px) 100vw, 750px\" \/><\/figure>\n<\/figure>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><em>High-Integrity Primary Packaging by Pharglass | Type I Borosilicate | Ready for Biologics, Vaccines &amp; Advanced Therapies<\/em><\/p>\n\n\n\n<p>\u0641\u0627\u0631\u063a\u0644\u0627\u0633 <strong>EP 3.2.1 compliant glass vials<\/strong> are engineered to meet the exacting demands of modern biopharmaceutical manufacturing. Fully aligned with <strong>European Pharmacopoeia Chapter 3.2.1<\/strong>\u2014the benchmark for glass containers used in parenteral preparations\u2014these vials are manufactured from <strong>\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 I<\/strong> to ensure ultra-low leachables, exceptional hydrolytic resistance, and long-term stability for sensitive molecules, including <strong>monoclonal antibodies, mRNA vaccines, viral vectors, peptides, and cell &amp; gene therapies<\/strong>.<\/p>\n\n\n\n<p>Available in standard capacities from <strong>2ml to 50ml (2R\u201350R)<\/strong>, our vials feature consistent wall thickness, flat-bottom geometry, and precise dimensional tolerances for seamless integration into automated fill-finish and lyophilization lines. Whether you require <strong>non-sterile bulk vials for in-house processing<\/strong> \u0623\u0648 <strong>pre-sterilized Ready-to-Fill (RTF) units<\/strong>, Pharglass offers flexible configurations\u2014including <strong>OEM branding and custom packaging<\/strong>\u2014to support clinical trials, commercial launches, and global regulatory submissions (EMA, FDA, NMPA).<\/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>Full Compliance with EP 3.2.1<\/strong> \u2013 Essential for EMA dossiers and EU market authorization<\/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 Minimizes interaction with pH-sensitive biologics<\/li>\n\n\n\n<li>\u2705 <strong>Capacity Range: 2ml\u201350ml<\/strong> \u2013 Scalable from early-phase trials to commercial supply<\/li>\n\n\n\n<li>\u2705 <strong>Sterile (SAL 10\u207b\u2076) or Non-Sterile Options<\/strong> \u2013 Gamma or ETO sterilization available<\/li>\n\n\n\n<li>\u2705 <strong>OEM Customization<\/strong> \u2013 Branding, serialization, color-coded stoppers, and more<\/li>\n\n\n\n<li>\u2705 <strong>Global Harmonization<\/strong> \u2013 Also meets USP &lt;660> and YBB standards for multi-market filings<\/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>EP 3.2.1 Compliant Biopharma Glass Vials<\/td><\/tr><tr><td><strong>\u0627\u0644\u0639\u0644\u0627\u0645\u0629 \u0627\u0644\u062a\u062c\u0627\u0631\u064a\u0629<\/strong><\/td><td>Pharglass (OEM\/private label available)<\/td><\/tr><tr><td><strong>\u0627\u0644\u0633\u0639\u0627\u062a (\u0645\u0642\u0627\u0633\u0627\u062a ISO)<\/strong><\/td><td>2 \u0631 (2 \u0645\u0644)\u060c 5 \u0631 (5 \u0645\u0644)\u060c 10 \u0631 (10 \u0645\u0644)\u060c 20 \u0631 (20 \u0645\u0644)\u060c 30 \u0631 (30 \u0645\u0644)\u060c 50 \u0631 (50 \u0645\u0644)<\/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>Primary Standard<\/strong><\/td><td>European Pharmacopoeia 3.2.1<\/td><\/tr><tr><td><strong>Aligned With<\/strong><\/td><td>USP &lt;660&gt;, YBB00292005-2-2015, ISO 8362-1<\/td><\/tr><tr><td><strong>Hydrolytic Resistance<\/strong><\/td><td>\u2264 0.10 ml 0.01N HCl\/g glass (powdered glass test)<\/td><\/tr><tr><td><strong>\u062e\u064a\u0627\u0631\u0627\u062a \u0627\u0644\u0623\u0644\u0648\u0627\u0646<\/strong><\/td><td>Clear (standard); Amber (UV protection, on request)<\/td><\/tr><tr><td><strong>\u062a\u0634\u0637\u064a\u0628 \u0627\u0644\u0631\u0642\u0628\u0629<\/strong><\/td><td>Standard ISO finish (e.g., 13mm, 20mm) for bromobutyl stoppers<\/td><\/tr><tr><td><strong>\u062e\u064a\u0627\u0631\u0627\u062a \u0627\u0644\u0639\u0642\u0645<\/strong><\/td><td><\/td><\/tr><tr><td>\u2022 <strong>Non-sterile<\/strong>: Bulk in clean cartons or nest trays<\/td><td><\/td><\/tr><tr><td>\u2022 <strong>Sterile<\/strong>: Gamma\/ETO sterilized to SAL 10\u207b\u2076, double-pouched in RTF trays<\/td><td><\/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 (for sterile versions)<\/td><\/tr><tr><td><strong>\u0645\u0648\u0643<\/strong><\/td><td>5,000 pieces (flexible for OEM programs)<\/td><\/tr><tr><td><strong>\u0627\u0644\u062a\u0637\u0628\u064a\u0642\u0627\u062a<\/strong><\/td><td>Lyophilized &amp; liquid biologics, mRNA-LNP vaccines, ADCs, enzymes, antibiotics, diagnostic kits<\/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 EP 3.2.1 Compliance Matters in Biopharma<\/strong><\/h3>\n\n\n\n<p>\u0625\u0646 <strong>European Pharmacopoeia 3.2.1<\/strong> sets strict requirements for:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Chemical durability<\/strong> (hydrolytic resistance)<\/li>\n\n\n\n<li><strong>Thermal stability<\/strong><\/li>\n\n\n\n<li><strong>Freedom from defects<\/strong> (bubbles, cords, stones)<\/li>\n\n\n\n<li><strong>Dimensional accuracy<\/strong><\/li>\n<\/ul>\n\n\n\n<p>Non-compliant containers risk <strong>protein aggregation, pH drift, or particulate contamination<\/strong>\u2014critical failure modes for high-value biologics. Pharglass ensures every batch undergoes:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Batch-specific EP testing<\/strong><\/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 container closure integrity (CCI)<\/li>\n<\/ul>\n\n\n\n<p>Our vials are already used in <strong>EMA-approved biologic products<\/strong> across Europe and beyond.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>OEM &amp; Customization Services<\/strong><\/h3>\n\n\n\n<p>As a trusted partner to global pharma, Pharglass offers:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u0648\u0636\u0639 \u0627\u0644\u0639\u0644\u0627\u0645\u0627\u062a \u0627\u0644\u062e\u0627\u0635\u0629<\/strong> with your logo and product code<\/li>\n\n\n\n<li><strong>Custom stopper formulations<\/strong> (e.g., fluoropolymer-coated for high-viscosity mAbs)<\/li>\n\n\n\n<li><strong>Laser serialization<\/strong> or embossed volume markings<\/li>\n\n\n\n<li><strong>Tailored packaging<\/strong> (nest trays, bulk boxes, RTF configurations)<\/li>\n\n\n\n<li><strong>Regulatory support<\/strong>: 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<h3 class=\"wp-block-heading\"><strong>Sterile vs. Non-Sterile: Choose Your Workflow<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Non-sterile vials<\/strong>: Ideal for facilities with validated washing\/depyrogenation lines<\/li>\n\n\n\n<li><strong>Sterile RTF vials<\/strong>: Eliminate in-house processing\u2014load directly into aseptic fillers, reduce contamination risk, accelerate time-to-market<\/li>\n<\/ul>\n\n\n\n<p>Both options maintain full EP 3.2.1 compliance and traceability.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><strong>Engineered for Europe. Validated for the world.<\/strong><br>When your biologic therapy demands container excellence and regulatory confidence, choose Pharglass EP 3.2.1 compliant glass vials\u2014where science, compliance, and partnership converge.<\/p>\n\n\n\n<p>\ud83d\udce9 <strong>\u0627\u062a\u0635\u0644 \u0628\u0646\u0627 \u0627\u0644\u064a\u0648\u0645<\/strong> for samples, EP test reports, or a customized quote for your biopharma program!<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>\u0639\u0628\u0648\u0627\u062a \u0632\u062c\u0627\u062c\u064a\u0629 \u0623\u0648\u0644\u064a\u0629 \u0639\u0627\u0644\u064a\u0629 \u0627\u0644\u0646\u0642\u0627\u0621 \u0645\u0646 \u0641\u0627\u0631\u063a\u0644\u0627\u0633 | \u0627\u0644\u0646\u0648\u0639 \u0627\u0644\u0623\u0648\u0644 \u0645\u0646 \u0627\u0644\u0628\u0648\u0631\u0633\u0644\u064a\u0643\u0627\u062a | \u062c\u0627\u0647\u0632\u0629 \u0644\u0644\u0623\u062f\u0648\u064a\u0629 \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0629 \u0648\u0627\u0644\u0644\u0642\u0627\u062d\u0627\u062a \u0648\u0627\u0644\u0639\u0644\u0627\u062c\u0627\u062a \u0627\u0644\u0645\u062a\u0642\u062f\u0645\u0629 \u062a\u0645 \u062a\u0635\u0645\u064a\u0645 \u0627\u0644\u0642\u0648\u0627\u0631\u064a\u0631 \u0627\u0644\u0632\u062c\u0627\u062c\u064a\u0629 \u0627\u0644\u0645\u062a\u0648\u0627\u0641\u0642\u0629 \u0645\u0639 EP 3.2.1 \u0645\u0646 \u0641\u0627\u0631\u063a\u0644\u0627\u0633 EP 3.2.1 ... <a title=\"EP 3.2.1 Compliant Glass Vials for Biopharma \u2013 2ml to 50ml, OEM &#038; Sterile Options\" class=\"read-more\" href=\"https:\/\/www.pharglass.com\/ar\/ep-3-2-1-compliant-glass-vials-for-biopharma-2ml-to-50ml-oem-sterile-options\/\" aria-label=\"Read more about EP 3.2.1 Compliant Glass Vials for Biopharma \u2013 2ml to 50ml, OEM &#038; Sterile Options\">\u0625\u0642\u0631\u0623 \u0627\u0644\u0645\u0632\u064a\u062f<\/a><\/p>","protected":false},"author":1,"featured_media":1768,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-1514","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\/1514","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=1514"}],"version-history":[{"count":4,"href":"https:\/\/www.pharglass.com\/ar\/wp-json\/wp\/v2\/posts\/1514\/revisions"}],"predecessor-version":[{"id":1896,"href":"https:\/\/www.pharglass.com\/ar\/wp-json\/wp\/v2\/posts\/1514\/revisions\/1896"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.pharglass.com\/ar\/wp-json\/wp\/v2\/media\/1768"}],"wp:attachment":[{"href":"https:\/\/www.pharglass.com\/ar\/wp-json\/wp\/v2\/media?parent=1514"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharglass.com\/ar\/wp-json\/wp\/v2\/categories?post=1514"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharglass.com\/ar\/wp-json\/wp\/v2\/tags?post=1514"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}