{"id":1474,"date":"2026-02-05T03:17:39","date_gmt":"2026-02-05T03:17:39","guid":{"rendered":"https:\/\/www.pharglass.com\/?p=1474"},"modified":"2026-02-10T05:55:06","modified_gmt":"2026-02-10T05:55:06","slug":"sterile-prefillable-cartridges-1-5ml-1-8ml-3ml-4ml-type-i-glass-iso-13485-ep-3-2-1-compliant","status":"publish","type":"post","link":"https:\/\/www.pharglass.com\/ru\/sterile-prefillable-cartridges-1-5ml-1-8ml-3ml-4ml-type-i-glass-iso-13485-ep-3-2-1-compliant\/","title":{"rendered":"Sterile Prefillable Cartridges \u2013 1.5ml, 1.8ml, 3ml, 4ml Type I Glass, ISO 13485 &#038; EP 3.2.1 Compliant"},"content":{"rendered":"<figure class=\"wp-block-gallery has-nested-images columns-2 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=\"903\" height=\"904\" data-id=\"1673\" src=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/58-1.jpg\" alt=\"\" class=\"wp-image-1673\" srcset=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/58-1.jpg 903w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/58-1-300x300.jpg 300w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/58-1-150x150.jpg 150w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/58-1-768x769.jpg 768w\" sizes=\"auto, (max-width: 903px) 100vw, 903px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"903\" height=\"883\" data-id=\"1674\" src=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/61-1.jpg\" alt=\"\" class=\"wp-image-1674\" srcset=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/61-1.jpg 903w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/61-1-300x293.jpg 300w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/61-1-768x751.jpg 768w\" sizes=\"auto, (max-width: 903px) 100vw, 903px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"906\" height=\"910\" data-id=\"1675\" src=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/62-1.jpg\" alt=\"\" class=\"wp-image-1675\" srcset=\"https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/62-1.jpg 906w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/62-1-300x300.jpg 300w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/62-1-150x150.jpg 150w, https:\/\/www.pharglass.com\/wp-content\/uploads\/2026\/02\/62-1-768x771.jpg 768w\" sizes=\"auto, (max-width: 906px) 100vw, 906px\" \/><\/figure>\n<\/figure>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Sterile Prefillable Cartridges \u2013 1.5ml, 1.8ml, 3ml, 4ml Type I Glass | ISO 13485 &amp; EP 3.2.1 Compliant<\/strong><\/h2>\n\n\n\n<p><em>Ready-to-Fill Primary Packaging by Pharglass for Autoinjectors, Pens &amp; Wearable Injectors<\/em><\/p>\n\n\n\n<p>Pharglass <strong>sterile prefillable cartridges<\/strong> are precision-engineered for next-generation self-injection therapies, including <strong>GLP-1 agonists (e.g., semaglutide, tirzepatide), insulin, monoclonal antibodies, and high-viscosity biologics<\/strong>. \u0414\u043e\u0441\u0442\u0443\u043f\u043d\u043e \u0432 <strong>1.5ml, 1.8ml, 3ml, and 4ml<\/strong> capacities, these cartridges are made from <strong>\u041d\u0435\u0439\u0442\u0440\u0430\u043b\u044c\u043d\u043e\u0435 \u0431\u043e\u0440\u043e\u0441\u0438\u043b\u0438\u043a\u0430\u0442\u043d\u043e\u0435 \u0441\u0442\u0435\u043a\u043b\u043e \u0442\u0438\u043f\u0430 I<\/strong> and fully comply with <strong>EP 3.2.1<\/strong>, <strong>USP<\/strong>, \u0438 <strong>ISO 13485<\/strong> quality standards\u2014ensuring the highest level of chemical inertness, dimensional accuracy, and patient safety.<\/p>\n\n\n\n<p>Each cartridge is <strong>gamma or ETO sterilized to SAL 10\u207b\u2076<\/strong>, pre-assembled with a medical-grade bromobutyl plunger, and packaged in <strong>nest trays within double sterile pouches<\/strong>, making them true <strong>ready-to-fill (RTF)<\/strong> components. This eliminates in-house cleaning, depyrogenation, and sterilization\u2014reducing contamination risk, operational costs, and time-to-market for drug-device combination products.<\/p>\n\n\n\n<p>Designed for seamless integration with leading autoinjector and pen platforms (including Ypsomed, Owen Mumford, Haselmeier, and SHL Medical), Pharglass cartridges deliver consistent glide force, low protein binding, and reliable dosing performance.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u041a\u043b\u044e\u0447\u0435\u0432\u044b\u0435 \u043e\u0441\u043e\u0431\u0435\u043d\u043d\u043e\u0441\u0442\u0438 \u0438 \u043f\u0440\u0435\u0438\u043c\u0443\u0449\u0435\u0441\u0442\u0432\u0430<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u2705 <strong>Sterile &amp; Ready-to-Fill (RTF)<\/strong> \u2013 SAL 10\u207b\u2076 via gamma or ETO; load directly into fill-finish lines<\/li>\n\n\n\n<li>\u2705 <strong>\u0411\u043e\u0440\u043e\u0441\u0438\u043b\u0438\u043a\u0430\u0442\u043d\u043e\u0435 \u0441\u0442\u0435\u043a\u043b\u043e \u0442\u0438\u043f\u0430 I<\/strong> \u2013 EP 3.2.1 \/ USP &lt;660> compliant; ideal for sensitive biologics<\/li>\n\n\n\n<li>\u2705 <strong>Multiple Volumes<\/strong> \u2013 1.5ml, 1.8ml, 3ml, 4ml to support diverse therapeutic needs<\/li>\n\n\n\n<li>\u2705 <strong>ISO 13485 Certified Manufacturing<\/strong> \u2013 Full quality management for medical device components<\/li>\n\n\n\n<li>\u2705 <strong>Low Particulates &amp; Controlled Silicone<\/strong> \u2013 Minimizes aggregation in high-concentration formulations<\/li>\n\n\n\n<li>\u2705 <strong>\u0423\u043f\u0430\u043a\u043e\u0432\u043a\u0430 \u0434\u043b\u044f \u0433\u043d\u0435\u0437\u0434 \u0441 \u043b\u043e\u0442\u043a\u0430\u043c\u0438<\/strong> \u2013 Prevents contact, breakage, and ensures robotic handling compatibility<\/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>\u0422\u0435\u0445\u043d\u0438\u0447\u0435\u0441\u043a\u0438\u0435 \u0445\u0430\u0440\u0430\u043a\u0442\u0435\u0440\u0438\u0441\u0442\u0438\u043a\u0438<\/strong><\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u041f\u0430\u0440\u0430\u043c\u0435\u0442\u0440<\/th><th>\u0422\u0435\u0445\u043d\u0438\u0447\u0435\u0441\u043a\u0438\u0435 \u0445\u0430\u0440\u0430\u043a\u0442\u0435\u0440\u0438\u0441\u0442\u0438\u043a\u0438<\/th><\/tr><\/thead><tbody><tr><td><strong>\u041d\u0430\u0437\u0432\u0430\u043d\u0438\u0435 \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u0430<\/strong><\/td><td>Sterile Prefillable Cartridges<\/td><\/tr><tr><td><strong>\u0411\u0440\u0435\u043d\u0434<\/strong><\/td><td>Pharglass<\/td><\/tr><tr><td><strong>\u0415\u043c\u043a\u043e\u0441\u0442\u0438<\/strong><\/td><td>1.5ml, 1.8ml, 3.0ml, 4.0ml <em>(standard); custom volumes available<\/em><\/td><\/tr><tr><td><strong>\u0422\u0438\u043f \u0441\u0442\u0435\u043a\u043b\u0430<\/strong><\/td><td>\u041d\u0435\u0439\u0442\u0440\u0430\u043b\u044c\u043d\u043e\u0435 \u0431\u043e\u0440\u043e\u0441\u0438\u043b\u0438\u043a\u0430\u0442\u043d\u043e\u0435 \u0441\u0442\u0435\u043a\u043b\u043e \u0442\u0438\u043f\u0430 I<\/td><\/tr><tr><td><strong>\u0421\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0438\u0435 \u0442\u0440\u0435\u0431\u043e\u0432\u0430\u043d\u0438\u044f\u043c<\/strong><\/td><td>EP 3.2.1, USP &lt;660&gt;, ISO 13485, ISO 11040-4 (dimensional), YBB00292005-2-2015<\/td><\/tr><tr><td><strong>Sterilization<\/strong><\/td><td>Gamma (25 kGy) or Ethylene Oxide (ETO), validated to SAL 10\u207b\u2076<\/td><\/tr><tr><td><strong>Plunger<\/strong><\/td><td>Coated or uncoated bromobutyl rubber (low extractables)<\/td><\/tr><tr><td><strong>Silicone Oil<\/strong><\/td><td>Medical-grade, controlled dosage for optimal glide force<\/td><\/tr><tr><td><strong>\u0423\u0440\u043e\u0432\u0435\u043d\u044c \u044d\u043d\u0434\u043e\u0442\u043e\u043a\u0441\u0438\u043d\u0430<\/strong><\/td><td>&lt;0.25 EU\/ml (as per LAL test)<\/td><\/tr><tr><td><strong>\u0424\u043e\u0440\u043c\u0430\u0442 \u0443\u043f\u0430\u043a\u043e\u0432\u043a\u0438<\/strong><\/td><td>Cartridges in rigid nest trays \u2192 sealed in double sterile pouches \u2192 export cartons<\/td><\/tr><tr><td><strong>\u0423\u0441\u0442\u043e\u0439\u0447\u0438\u0432\u043e\u0441\u0442\u044c \u043f\u0440\u0438 \u0445\u0440\u0430\u043d\u0435\u043d\u0438\u0438<\/strong><\/td><td>Stable from -20\u00b0C to +40\u00b0C; suitable for cold-chain biologics<\/td><\/tr><tr><td><strong>MOQ<\/strong><\/td><td>5,000 \u0448\u0442.<\/td><\/tr><tr><td><strong>\u041f\u0440\u0438\u043b\u043e\u0436\u0435\u043d\u0438\u044f<\/strong><\/td><td>GLP-1 therapies, insulin pens, mAbs, biosimilars, wearable injector reservoirs, clinical trial materials<\/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 Global Pharma Trusts Pharglass RTF Cartridges<\/strong><\/h3>\n\n\n\n<p>In the era of high-value injectables, <strong>container quality directly impacts drug stability, patient comfort, and regulatory approval<\/strong>. Pharglass addresses critical challenges:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Protein aggregation?<\/strong> \u2192 Ultra-smooth glass surface + low silicone migration<\/li>\n\n\n\n<li><strong>Dosing inconsistency?<\/strong> \u2192 Tight tolerance on OD, length, and tip concentricity<\/li>\n\n\n\n<li><strong>Supply chain delays?<\/strong> \u2192 Dedicated RTF production lines with scalable capacity<\/li>\n<\/ul>\n\n\n\n<p>Our facility operates under <strong>ISO 13485<\/strong> with full documentation support\u2014including <strong>Certificates of Analysis (CoA)<\/strong>, <strong>sterilization validation reports<\/strong>, \u0438 <strong>Drug Master File (DMF)<\/strong> assistance for FDA\/EMA submissions.<\/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 &amp; Partnership<\/strong><\/h3>\n\n\n\n<p>We support your unique drug-device needs with:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Custom tip geometries (Luer lock, staked needle interface, etc.)<\/li>\n\n\n\n<li>Plunger coating optimization for viscous drugs<\/li>\n\n\n\n<li>Laser etching or barcoding for serialization<\/li>\n\n\n\n<li>Regulatory dossier collaboration<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><strong>From molecule to patient\u2014delivered with precision.<\/strong><br>Pharglass sterile prefillable cartridges empower innovators to bring life-changing injectable therapies to market faster, safer, and more reliably.<\/p>\n\n\n\n<p>\ud83d\udce9 <strong>\u0421\u0432\u044f\u0436\u0438\u0442\u0435\u0441\u044c \u0441 \u043d\u0430\u043c\u0438 \u0441\u0435\u0433\u043e\u0434\u043d\u044f<\/strong> for samples, compliance documentation, or a volume quote for your next autoinjector program!<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Sterile Prefillable Cartridges \u2013 1.5ml, 1.8ml, 3ml, 4ml Type I Glass | ISO 13485 &amp; EP 3.2.1 Compliant Ready-to-Fill Primary Packaging by Pharglass for Autoinjectors, &#8230; <a title=\"Sterile Prefillable Cartridges \u2013 1.5ml, 1.8ml, 3ml, 4ml Type I Glass, ISO 13485 &#038; EP 3.2.1 Compliant\" class=\"read-more\" href=\"https:\/\/www.pharglass.com\/ru\/sterile-prefillable-cartridges-1-5ml-1-8ml-3ml-4ml-type-i-glass-iso-13485-ep-3-2-1-compliant\/\" aria-label=\"\u041f\u0440\u043e\u0447\u0438\u0442\u0430\u0442\u044c \u0431\u043e\u043b\u044c\u0448\u0435 \u043e Sterile Prefillable Cartridges \u2013 1.5ml, 1.8ml, 3ml, 4ml Type I Glass, ISO 13485 &#038; EP 3.2.1 Compliant\">\u0427\u0438\u0442\u0430\u0442\u044c \u0434\u0430\u043b\u0435\u0435<\/a><\/p>","protected":false},"author":1,"featured_media":1671,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-1474","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\/ru\/wp-json\/wp\/v2\/posts\/1474","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharglass.com\/ru\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharglass.com\/ru\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharglass.com\/ru\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharglass.com\/ru\/wp-json\/wp\/v2\/comments?post=1474"}],"version-history":[{"count":4,"href":"https:\/\/www.pharglass.com\/ru\/wp-json\/wp\/v2\/posts\/1474\/revisions"}],"predecessor-version":[{"id":1873,"href":"https:\/\/www.pharglass.com\/ru\/wp-json\/wp\/v2\/posts\/1474\/revisions\/1873"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.pharglass.com\/ru\/wp-json\/wp\/v2\/media\/1671"}],"wp:attachment":[{"href":"https:\/\/www.pharglass.com\/ru\/wp-json\/wp\/v2\/media?parent=1474"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharglass.com\/ru\/wp-json\/wp\/v2\/categories?post=1474"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharglass.com\/ru\/wp-json\/wp\/v2\/tags?post=1474"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}