{"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\/ru\/13mm-15mm-20mm-butyl-rubber-stopper-pharmaceutical-lyophilization-closures\/","title":{"rendered":"13mm 15mm 20mm Butyl Rubber Stopper Pharmaceutical Lyophilization Closures"},"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> \u0432 Type I Borosilicate Glass Vials<\/strong><\/h2>\n\n\n\n

\u0421\u0430\u0439\u0442 13mm, 15mm, and 20mm Butyl Rubber Stopper for Lyophilization<\/strong> \u0441 \u0441\u0430\u0439\u0442\u0430 PharGlass<\/strong> is engineered specifically for freeze-dried (lyophilized) pharmaceuticals<\/strong>, offering superior moisture barrier performance<\/strong>, low extractables<\/strong>, \u0438 excellent resealability<\/strong> after vial sealing. These pharmaceutical lyophilization closures<\/strong> are ideal for biologic drugs<\/strong>, mRNA vaccines<\/strong>, monoclonal antibodies (mAbs)<\/strong>, \u0438 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>, \u0438 FDA 21 CFR 177.1520<\/strong> \u0441\u0442\u0430\u043d\u0434\u0430\u0440\u0442\u044b.<\/p>\n\n\n\n

Manufactured under ISO 9001:2015<\/strong> \u0438 GMP-compliant<\/strong> conditions in Henan, China, every stopper is tested for moisture permeability<\/strong>, visual defects<\/strong>, \u0438 bioburden control<\/strong> \u2014 ensuring consistent quality and regulatory compliance for global markets.<\/p>\n\n\n\n

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\u2705 \u041e\u0441\u043d\u043e\u0432\u043d\u044b\u0435 \u0445\u0430\u0440\u0430\u043a\u0442\u0435\u0440\u0438\u0441\u0442\u0438\u043a\u0438:<\/h3>\n\n\n\n
\u0425\u0430\u0440\u0430\u043a\u0442\u0435\u0440\u0438\u0441\u0442\u0438\u043a\u0430<\/th>\u041e\u043f\u0438\u0441\u0430\u043d\u0438\u0435<\/th><\/tr><\/thead>
\u041c\u0430\u0442\u0435\u0440\u0438\u0430\u043b<\/strong><\/td>\u041c\u0435\u0434\u0438\u0446\u0438\u043d\u0441\u043a\u0438\u0439 Butyl Rubber<\/strong>, Bromobutyl<\/strong>, or 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>
Moisture Barrier<\/strong><\/td>Exceptional resistance to water vapor ingress \u2013 critical for dry powder stability<\/td><\/tr>
\u041d\u0438\u0437\u043a\u043e\u0435 \u0441\u043e\u0434\u0435\u0440\u0436\u0430\u043d\u0438\u0435 \u044d\u043a\u0441\u0442\u0440\u0430\u043a\u0442\u0438\u0432\u043d\u044b\u0445 \u0432\u0435\u0449\u0435\u0441\u0442\u0432<\/strong><\/td>Minimizes leachables that could compromise drug purity or safety<\/td><\/tr>
\u041d\u0430\u0441\u0442\u0440\u0430\u0438\u0432\u0430\u0435\u043c\u044b\u0435 \u0440\u0430\u0437\u043c\u0435\u0440\u044b<\/strong><\/td>Available in 13mm, 15mm, 20mm, 25mm, 28mm, 30mm, 32mm<\/strong><\/td><\/tr>
\u0412\u0430\u0440\u0438\u0430\u043d\u0442\u044b \u0446\u0432\u0435\u0442\u0430<\/strong><\/td>Gray, Red, White, Black, Blue, Yellow (customizable per request)<\/td><\/tr>
\u041f\u043e\u0434\u0434\u0435\u0440\u0436\u043a\u0430 OEM\/ODM<\/strong><\/td>Yes \u2013 custom size, color, logo printing, surface treatment<\/td><\/tr>
\u041f\u043e\u043b\u0438\u0442\u0438\u043a\u0430 \u0431\u0435\u0441\u043f\u043b\u0430\u0442\u043d\u044b\u0445 \u043e\u0431\u0440\u0430\u0437\u0446\u043e\u0432<\/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
\u041f\u0430\u0440\u0430\u043c\u0435\u0442\u0440<\/strong><\/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<\/strong><\/th><\/tr><\/thead>
\u041d\u0430\u0437\u0432\u0430\u043d\u0438\u0435 \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u0430<\/strong><\/td>13mm 15mm 20mm Butyl Rubber Stopper for Pharmaceutical Lyophilization<\/td><\/tr>
\u041d\u043e\u043c\u0435\u0440 \u043c\u043e\u0434\u0435\u043b\u0438<\/strong><\/td>03<\/td><\/tr>
\u041d\u0430\u0437\u0432\u0430\u043d\u0438\u0435 \u0431\u0440\u0435\u043d\u0434\u0430<\/strong><\/td>PharGlass<\/strong><\/td><\/tr>
\u041c\u0430\u0442\u0435\u0440\u0438\u0430\u043b<\/strong><\/td>Butyl Rubber<\/strong>, Bromobutyl Rubber<\/strong>, Chlorobutyl Rubber<\/strong><\/td><\/tr>
\u0426\u0432\u0435\u0442<\/strong><\/td>Gray, Red, White, Black, Blue, Yellow, or Customer Request<\/td><\/tr>
Sizes Available<\/strong><\/td>13 \u043c\u043c<\/strong>, 15 \u043c\u043c<\/strong>, 20 \u043c\u043c<\/strong>, 25mm, 28mm, 30mm, 32mm<\/td><\/tr>
\u041c\u0435\u0441\u0442\u043e \u043f\u0440\u043e\u0438\u0441\u0445\u043e\u0436\u0434\u0435\u043d\u0438\u044f<\/strong><\/td>\u0425\u044d\u043d\u0430\u043d\u044c, \u041a\u0438\u0442\u0430\u0439<\/td><\/tr>
\u0418\u0441\u043f\u043e\u043b\u044c\u0437\u043e\u0432\u0430\u043d\u0438\u0435<\/strong><\/td>Primary closure for freeze-dried glass vials<\/strong><\/td><\/tr>
\u0421\u043b\u0443\u0436\u0431\u0430 \u043e\u0431\u0440\u0430\u0431\u043e\u0442\u043a\u0438<\/strong><\/td>Precision compression molding<\/td><\/tr>
\u0423\u043f\u0430\u043a\u043e\u0432\u043a\u0430<\/strong><\/td>Plastic Bag + Export Carton<\/td><\/tr>
MOQ<\/strong><\/td>10 000 \u0448\u0442.<\/td><\/tr>
\u041d\u0430\u043b\u0438\u0447\u0438\u0435 \u043e\u0431\u0440\u0430\u0437\u0446\u043e\u0432<\/strong><\/td>\u0411\u0435\u0441\u043f\u043b\u0430\u0442\u043d\u044b\u0435 \u043e\u0431\u0440\u0430\u0437\u0446\u044b<\/td><\/tr>
\u041f\u043e\u0434\u0434\u0435\u0440\u0436\u043a\u0430 OEM\/ODM<\/strong><\/td>\u041f\u0440\u0438\u0435\u043c\u043b\u0435\u043c\u044b\u0439<\/td><\/tr>
\u0425\u0430\u0440\u0430\u043a\u0442\u0435\u0440\u0438\u0441\u0442\u0438\u043a\u0430<\/strong><\/td>Medical Grade<\/strong>, Lyophilization Grade<\/strong>, Low Moisture Permeability<\/strong>, \u041d\u0438\u0437\u043a\u043e\u0435 \u0441\u043e\u0434\u0435\u0440\u0436\u0430\u043d\u0438\u0435 \u044d\u043a\u0441\u0442\u0440\u0430\u043a\u0442\u0438\u0432\u043d\u044b\u0445 \u0432\u0435\u0449\u0435\u0441\u0442\u0432<\/strong><\/td><\/tr>
\u0420\u0430\u0437\u043c\u0435\u0440 \u043e\u0434\u043d\u043e\u0433\u043e \u043f\u0430\u043a\u0435\u0442\u0430<\/strong><\/td>10\u00d720\u00d715 \u0441\u043c<\/td><\/tr>
\u0412\u0435\u0441 \u0431\u0440\u0443\u0442\u0442\u043e<\/strong><\/td>1.000 \u043a\u0433 \u0437\u0430 \u0435\u0434\u0438\u043d\u0438\u0446\u0443<\/td><\/tr>
\u0421\u0435\u0440\u0442\u0438\u0444\u0438\u043a\u0430\u0442\u044b<\/strong><\/td>ISO 9001:2015<\/strong>, ISO 14001<\/strong>, OHSAS 18001<\/strong><\/td><\/tr>
\u0421\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0438\u0435 \u043d\u043e\u0440\u043c\u0430\u0442\u0438\u0432\u043d\u044b\u043c \u0442\u0440\u0435\u0431\u043e\u0432\u0430\u043d\u0438\u044f\u043c<\/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 \u0445\u043b\u043e\u0440\u0431\u0443\u0442\u0438\u043b\u043a\u0430\u0443\u0447\u0443\u043a<\/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: \u0416\u0443\u0440\u043d\u0430\u043b \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u0435\u0441\u043a\u0438\u0445 \u043d\u0430\u0443\u043a<\/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> \u0438 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