{"id":1270,"date":"2026-02-04T06:06:56","date_gmt":"2026-02-04T06:06:56","guid":{"rendered":"https:\/\/www.pharglass.com\/?p=1270"},"modified":"2026-02-06T05:55:15","modified_gmt":"2026-02-06T05:55:15","slug":"13mm-15mm-20mm-butyl-rubber-stopper-pharmaceutical-lyophilization-closures","status":"publish","type":"post","link":"https:\/\/www.pharglass.com\/de\/13mm-15mm-20mm-butyl-rubber-stopper-pharmaceutical-lyophilization-closures\/","title":{"rendered":"13mm 15mm 20mm Butylkautschukstopfen Pharmazeutische Lyophilisationsverschl\u00fcsse"},"content":{"rendered":"
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13mm, 15mm & 20mm Butyl Rubber Stopper for Lyophilization \u2013 Premium Freeze-Dried Product Closure with Low Extractables<\/strong><\/h1>\n\n\n\n

Medical-Grade Lyophilization Closures<\/strong> Designed for Biologics, Vaccines, and High-Purity Pharmaceuticals<\/strong> in Type I Borosilicate Glass Vials<\/strong><\/h2>\n\n\n\n

Die 13mm, 15mm, and 20mm Butyl Rubber Stopper for Lyophilization<\/strong> from PharGlass<\/strong> is engineered specifically for freeze-dried (lyophilized) pharmaceuticals<\/strong>, offering superior moisture barrier performance<\/strong>, low extractables<\/strong>, und excellent resealability<\/strong> after vial sealing. These pharmaceutical lyophilization closures<\/strong> are ideal for biologic drugs<\/strong>, mRNA vaccines<\/strong>, monoclonal antibodies (mAbs)<\/strong>, und sterile powder formulations<\/strong> that require long-term stability under controlled humidity conditions.<\/p>\n\n\n\n

Unlike standard rubber stoppers, our lyophilization-grade butyl rubber stoppers<\/strong> are manufactured using high-purity raw materials<\/strong> and undergo rigorous extractables testing<\/strong> to ensure they meet the stringent requirements of USP<\/strong>, EP 3.1.9<\/strong>, und FDA 21 CFR 177.1520<\/strong> Normen.<\/p>\n\n\n\n

Manufactured under ISO 9001:2015<\/strong> und GMP-konform<\/strong> conditions in Henan, China, every stopper is tested for moisture permeability<\/strong>, visual defects<\/strong>, und bioburden control<\/strong> \u2014 ensuring consistent quality and regulatory compliance for global markets.<\/p>\n\n\n\n

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\u2705 Hauptmerkmale:<\/h3>\n\n\n\n
Merkmal<\/th>Beschreibung<\/th><\/tr><\/thead>
Material<\/strong><\/td>Medical-grade Butylkautschuk<\/strong>, Bromobutyl<\/strong>, oder Chlorobutyl<\/strong> (recommended for freeze-dried applications)<\/td><\/tr>
Design Type<\/strong><\/td>Flat-faced or dual-lip<\/strong> \u2013 optimized for vacuum sealing during lyophilization cycle<\/td><\/tr>
Feuchtigkeitsbarriere<\/strong><\/td>Exceptional resistance to water vapor ingress \u2013 critical for dry powder stability<\/td><\/tr>
Geringe Extrahierbarkeit<\/strong><\/td>Minimizes leachables that could compromise drug purity or safety<\/td><\/tr>
Anpassbare Gr\u00f6\u00dfen<\/strong><\/td>Verf\u00fcgbar in 13mm, 15mm, 20mm, 25mm, 28mm, 30mm, 32mm<\/strong><\/td><\/tr>
Farboptionen<\/strong><\/td>Gray, Red, White, Black, Blue, Yellow (customizable per request)<\/td><\/tr>
OEM\/ODM-Unterst\u00fctzung<\/strong><\/td>Yes \u2013 custom size, color, logo printing, surface treatment<\/td><\/tr>
Politik der kostenlosen Muster<\/strong><\/td>Free samples available for compatibility testing<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
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Technical Specifications: 13mm, 15mm & 20mm Lyophilization Rubber Stopper<\/strong><\/h2>\n\n\n\n
Parameter<\/strong><\/th>Spezifikation<\/strong><\/th><\/tr><\/thead>
Produktname<\/strong><\/td>13mm 15mm 20mm Butyl Rubber Stopper for Pharmaceutical Lyophilization<\/td><\/tr>
Modellnummer<\/strong><\/td>03<\/td><\/tr>
Markenname<\/strong><\/td>PharGlass<\/strong><\/td><\/tr>
Material<\/strong><\/td>Butylkautschuk<\/strong>, Bromobutyl Rubber<\/strong>, Chlorobutyl Rubber<\/strong><\/td><\/tr>
Farbe<\/strong><\/td>Gray, Red, White, Black, Blue, Yellow, or Customer Request<\/td><\/tr>
Sizes Available<\/strong><\/td>13mm<\/strong>, 15mm<\/strong>, 20mm<\/strong>, 25mm, 28mm, 30mm, 32mm<\/td><\/tr>
Ort der Herkunft<\/strong><\/td>Henan, China<\/td><\/tr>
Verwendung<\/strong><\/td>Primary closure for freeze-dried glass vials<\/strong><\/td><\/tr>
Processing Service<\/strong><\/td>Precision compression molding<\/td><\/tr>
Verpackung<\/strong><\/td>Plastic Bag + Export Carton<\/td><\/tr>
MOQ<\/strong><\/td>10.000 St\u00fcck<\/td><\/tr>
Verf\u00fcgbarkeit von Proben<\/strong><\/td>Free Samples<\/td><\/tr>
OEM\/ODM-Unterst\u00fctzung<\/strong><\/td>Acceptable<\/td><\/tr>
Merkmal<\/strong><\/td>Medical Grade<\/strong>, Lyophilization Grade<\/strong>, Low Moisture Permeability<\/strong>, Geringe Extrahierbarkeit<\/strong><\/td><\/tr>
Single Package Size<\/strong><\/td>10\u00d720\u00d715 cm<\/td><\/tr>
Bruttogewicht<\/strong><\/td>1.000 kg per unit<\/td><\/tr>
Zertifizierungen<\/strong><\/td>ISO 9001:2015<\/strong>, ISO 14001<\/strong>, OHSAS 18001<\/strong><\/td><\/tr>
Einhaltung von Vorschriften<\/strong><\/td>USP<\/strong>, EP 3.1.9<\/strong>, JP XVII<\/strong>, FDA 21 CFR 177.1520<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
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Why Chlorobutyl Rubber Is the Gold Standard for Freeze-Dried Products<\/strong><\/h2>\n\n\n\n

For lyophilized (freeze-dried) pharmaceuticals<\/strong>, the choice of rubber material is critical. Here\u2019s why Chlorbutylkautschuk<\/strong> is preferred over standard butyl:<\/p>\n\n\n\n

\ud83d\udd39 Superior Moisture Barrier<\/strong>: Chlorobutyl reduces water vapor transmission by up to 30%<\/strong> compared to butyl rubber (Source: Zeitschrift f\u00fcr pharmazeutische Wissenschaften<\/em>, 2022).
\ud83d\udd39 Lower Extractables Profile<\/strong>: Essential for sensitive biologics where even trace impurities can affect efficacy.
\ud83d\udd39 Better Chemical Resistance<\/strong>: Resists degradation from residual solvents and excipients used in formulation.
\ud83d\udd39 Enhanced Seal Integrity<\/strong>: Maintains tight closure under vacuum conditions during the lyophilization cycle.<\/p>\n\n\n\n

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According to the European Pharmacopoeia (EP 3.1.9)<\/strong>, halogenated butyl rubbers<\/strong> (e.g., chlorobutyl) are recommended for high-purity biologics<\/strong> due to their low leachables<\/strong> und high chemical inertness<\/strong>.<\/p>\n<\/blockquote>\n\n\n\n

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Top Applications in Pharma & Biotech<\/strong><\/h2>\n\n\n\n