{"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\/pt\/ep-3-2-1-compliant-glass-vials-for-biopharma-2ml-to-50ml-oem-sterile-options\/","title":{"rendered":"Frascos de vidro em conformidade com a norma EP 3.2.1 para a ind\u00fastria biofarmac\u00eautica - 2 ml a 50 ml, op\u00e7\u00f5es OEM e est\u00e9reis"},"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>Pharglass <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>Vidro borossilicato neutro tipo 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> ou <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>Principais recursos e benef\u00edcios<\/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>Vidro de borosilicato tipo 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>Especifica\u00e7\u00f5es t\u00e9cnicas<\/strong><\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Par\u00e2metro<\/th><th>Especifica\u00e7\u00e3o<\/th><\/tr><\/thead><tbody><tr><td><strong>Nome do produto<\/strong><\/td><td>EP 3.2.1 Compliant Biopharma Glass Vials<\/td><\/tr><tr><td><strong>Marca<\/strong><\/td><td>Pharglass (OEM\/private label available)<\/td><\/tr><tr><td><strong>Capacities (ISO Sizes)<\/strong><\/td><td>2R (2ml), 5R (5ml), 10R (10ml), 20R (20ml), 30R (30ml), 50R (50ml)<\/td><\/tr><tr><td><strong>Tipo de vidro<\/strong><\/td><td>Vidro de borosilicato neutro tipo I<\/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>Op\u00e7\u00f5es de cores<\/strong><\/td><td>Clear (standard); Amber (UV protection, on request)<\/td><\/tr><tr><td><strong>Acabamento do bra\u00e7o<\/strong><\/td><td>Standard ISO finish (e.g., 13mm, 20mm) for bromobutyl stoppers<\/td><\/tr><tr><td><strong>Op\u00e7\u00f5es de esterilidade<\/strong><\/td><td><\/td><\/tr><tr><td>\u2022 <strong>N\u00e3o est\u00e9ril<\/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>N\u00edvel de endotoxina<\/strong><\/td><td>&lt;0.25 EU\/ml (for sterile versions)<\/td><\/tr><tr><td><strong>MOQ<\/strong><\/td><td>5,000 pieces (flexible for OEM programs)<\/td><\/tr><tr><td><strong>Aplicativos<\/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>O <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>Private labeling<\/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>Entre em contato conosco hoje mesmo<\/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>Embalagem Prim\u00e1ria de Alta Integridade da Pharglass | Borossilicato Tipo I | Pronta para Produtos Biol\u00f3gicos, Vacinas e Terapias Avan\u00e7adas Os frascos de vidro compat\u00edveis com a EP 3.2.1 da Pharglass s\u00e3o projetados ... <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\/pt\/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\">Leia mais<\/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\/pt\/wp-json\/wp\/v2\/posts\/1514","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharglass.com\/pt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharglass.com\/pt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharglass.com\/pt\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharglass.com\/pt\/wp-json\/wp\/v2\/comments?post=1514"}],"version-history":[{"count":4,"href":"https:\/\/www.pharglass.com\/pt\/wp-json\/wp\/v2\/posts\/1514\/revisions"}],"predecessor-version":[{"id":1896,"href":"https:\/\/www.pharglass.com\/pt\/wp-json\/wp\/v2\/posts\/1514\/revisions\/1896"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.pharglass.com\/pt\/wp-json\/wp\/v2\/media\/1768"}],"wp:attachment":[{"href":"https:\/\/www.pharglass.com\/pt\/wp-json\/wp\/v2\/media?parent=1514"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharglass.com\/pt\/wp-json\/wp\/v2\/categories?post=1514"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharglass.com\/pt\/wp-json\/wp\/v2\/tags?post=1514"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}