{"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\/fa\/13mm-15mm-20mm-butyl-rubber-stopper-pharmaceutical-lyophilization-closures\/","title":{"rendered":"\u062f\u0631\u067e\u0648\u0634\u200c\u0647\u0627\u06cc \u062f\u0627\u0631\u0648\u06cc\u06cc \u0644\u06cc\u0648\u0641\u06cc\u0644\u06cc\u0632\u0627\u0633\u06cc\u0648\u0646 \u0627\u0632 \u0644\u0627\u0633\u062a\u06cc\u06a9 \u0628\u0648\u062a\u06cc\u0644 \u06f1\u06f3 \u0645\u06cc\u0644\u06cc\u200c\u0645\u062a\u0631\u060c \u06f1\u06f5 \u0645\u06cc\u0644\u06cc\u200c\u0645\u062a\u0631 \u0648 \u06f2\u06f0 \u0645\u06cc\u0644\u06cc\u200c\u0645\u062a\u0631"},"content":{"rendered":"
\n
\"\"<\/figure>\n\n\n\n
\"\"<\/figure>\n<\/figure>\n\n\n\n
\n
\"\"<\/figure>\n<\/figure>\n\n\n\n
\n
\"\"<\/figure>\n\n\n\n
\"\"<\/figure>\n\n\n\n
\"\"<\/figure>\n<\/figure>\n\n\n\n
\n\n\n\n

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

\u0622\u0646 13mm, 15mm, and 20mm Butyl Rubber Stopper for Lyophilization<\/strong> \u0627\u0632 \u0641\u0627\u0631\u06af\u0644\u0633<\/strong> is engineered specifically for freeze-dried (lyophilized) pharmaceuticals<\/strong>, offering superior moisture barrier performance<\/strong>, low extractables<\/strong>, \u060c \u0648 excellent resealability<\/strong> after vial sealing. These pharmaceutical lyophilization closures<\/strong> are ideal for biologic drugs<\/strong>, mRNA vaccines<\/strong>, monoclonal antibodies (mAbs)<\/strong>, \u060c \u0648 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>, \u060c \u0648 FDA 21 CFR 177.1520<\/strong> \u0627\u0633\u062a\u0627\u0646\u062f\u0627\u0631\u062f\u0647\u0627.<\/p>\n\n\n\n

\u062a\u0648\u0644\u06cc\u062f \u0634\u062f\u0647 \u062a\u062d\u062a ISO 9001:2015<\/strong> \u0648 GMP-compliant<\/strong> conditions in Henan, China, every stopper is tested for moisture permeability<\/strong>, visual defects<\/strong>, \u060c \u0648 bioburden control<\/strong> \u2014 ensuring consistent quality and regulatory compliance for global markets.<\/p>\n\n\n\n

\n\n\n\n

\u2705 \u0648\u06cc\u0698\u06af\u06cc\u200c\u0647\u0627\u06cc \u06a9\u0644\u06cc\u062f\u06cc:<\/h3>\n\n\n\n
\u0648\u06cc\u0698\u06af\u06cc<\/th>\u062a\u0648\u0636\u06cc\u062d\u0627\u062a<\/th><\/tr><\/thead>
\u0645\u0648\u0627\u062f<\/strong><\/td>\u0628\u0627 \u062f\u0631\u062c\u0647\u0654 \u067e\u0632\u0634\u06a9\u06cc 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>
Low Extractables<\/strong><\/td>Minimizes leachables that could compromise drug purity or safety<\/td><\/tr>
Customizable Sizes<\/strong><\/td>\u0645\u0648\u062c\u0648\u062f \u062f\u0631 13mm, 15mm, 20mm, 25mm, 28mm, 30mm, 32mm<\/strong><\/td><\/tr>
\u06af\u0632\u06cc\u0646\u0647\u200c\u0647\u0627\u06cc \u0631\u0646\u06af<\/strong><\/td>Gray, Red, White, Black, Blue, Yellow (customizable per request)<\/td><\/tr>
\u067e\u0634\u062a\u06cc\u0628\u0627\u0646\u06cc OEM\/ODM<\/strong><\/td>\u0628\u0644\u0647 \u2013 \u0627\u0646\u062f\u0627\u0632\u0647 \u0633\u0641\u0627\u0631\u0634\u06cc\u060c \u0631\u0646\u06af\u060c \u0686\u0627\u067e \u0644\u0648\u06af\u0648\u060c \u0639\u0645\u0644\u06cc\u0627\u062a \u0633\u0637\u062d\u06cc<\/td><\/tr>
\u0633\u06cc\u0627\u0633\u062a \u0646\u0645\u0648\u0646\u0647\u0654 \u0631\u0627\u06cc\u06af\u0627\u0646<\/strong><\/td>\u0646\u0645\u0648\u0646\u0647\u200c\u0647\u0627\u06cc \u0631\u0627\u06cc\u06af\u0627\u0646 \u0628\u0631\u0627\u06cc \u0622\u0632\u0645\u0648\u0646 \u0633\u0627\u0632\u06af\u0627\u0631\u06cc \u062f\u0631 \u062f\u0633\u062a\u0631\u0633 \u0647\u0633\u062a\u0646\u062f.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\n

Technical Specifications: 13mm, 15mm & 20mm Lyophilization Rubber Stopper<\/strong><\/h2>\n\n\n\n
\u067e\u0627\u0631\u0627\u0645\u062a\u0631<\/strong><\/th>\u0645\u0634\u062e\u0635\u0627\u062a<\/strong><\/th><\/tr><\/thead>
\u0646\u0627\u0645 \u0645\u062d\u0635\u0648\u0644<\/strong><\/td>13mm 15mm 20mm Butyl Rubber Stopper for Pharmaceutical Lyophilization<\/td><\/tr>
\u0634\u0645\u0627\u0631\u0647 \u0645\u062f\u0644<\/strong><\/td>03<\/td><\/tr>
\u0646\u0627\u0645 \u062a\u062c\u0627\u0631\u06cc<\/strong><\/td>\u0641\u0627\u0631\u06af\u0644\u0633<\/strong><\/td><\/tr>
\u0645\u0648\u0627\u062f<\/strong><\/td>Butyl Rubber<\/strong>, Bromobutyl Rubber<\/strong>, Chlorobutyl Rubber<\/strong><\/td><\/tr>
\u0631\u0646\u06af<\/strong><\/td>Gray, Red, White, Black, Blue, Yellow, or Customer Request<\/td><\/tr>
Sizes Available<\/strong><\/td>\u06f1\u06f3 \u0645\u06cc\u0644\u06cc\u200c\u0645\u062a\u0631<\/strong>, \u06f1\u06f5 \u0645\u06cc\u0644\u06cc\u200c\u0645\u062a\u0631<\/strong>, \u06f2\u06f0 \u0645\u06cc\u0644\u06cc\u200c\u0645\u062a\u0631<\/strong>, 25mm, 28mm, 30mm, 32mm<\/td><\/tr>
\u0645\u062d\u0644 \u0645\u0646\u0634\u0627\u0621<\/strong><\/td>\u0647\u0646\u0627\u0646\u060c \u0686\u06cc\u0646<\/td><\/tr>
\u0645\u0635\u0631\u0641<\/strong><\/td>Primary closure for freeze-dried glass vials<\/strong><\/td><\/tr>
Processing Service<\/strong><\/td>Precision compression molding<\/td><\/tr>
\u0628\u0633\u062a\u0647\u200c\u0628\u0646\u062f\u06cc<\/strong><\/td>Plastic Bag + Export Carton<\/td><\/tr>
\u062d\u062f\u0627\u0642\u0644 \u0633\u0641\u0627\u0631\u0634<\/strong><\/td>10,000 pcs<\/td><\/tr>
Sample Availability<\/strong><\/td>Free Samples<\/td><\/tr>
\u067e\u0634\u062a\u06cc\u0628\u0627\u0646\u06cc OEM\/ODM<\/strong><\/td>\u0642\u0627\u0628\u0644 \u0642\u0628\u0648\u0644<\/td><\/tr>
\u0648\u06cc\u0698\u06af\u06cc<\/strong><\/td>Medical Grade<\/strong>, Lyophilization Grade<\/strong>, Low Moisture Permeability<\/strong>, Low Extractables<\/strong><\/td><\/tr>
Single Package Size<\/strong><\/td>10\u00d720\u00d715 cm<\/td><\/tr>
Gross Weight<\/strong><\/td>1.000 kg per unit<\/td><\/tr>
\u06af\u0648\u0627\u0647\u06cc\u0646\u0627\u0645\u0647\u200c\u0647\u0627<\/strong><\/td>ISO 9001:2015<\/strong>, ISO 14001<\/strong>, OHSAS 18001<\/strong><\/td><\/tr>
\u062a\u0637\u0628\u06cc\u0642 \u0628\u0627 \u0645\u0642\u0631\u0631\u0627\u062a<\/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
\n\n\n\n

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 chlorobutyl rubber<\/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: Journal of Pharmaceutical Sciences<\/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

\n

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> \u0648 high chemical inertness<\/strong>.<\/p>\n<\/blockquote>\n\n\n\n

\n\n\n\n

\u0628\u0631\u062a\u0631\u06cc\u0646 \u06a9\u0627\u0631\u0628\u0631\u062f\u0647\u0627 \u062f\u0631 \u062f\u0627\u0631\u0648\u0633\u0627\u0632\u06cc \u0648 \u0632\u06cc\u0633\u062a\u200c\u0641\u0646\u0627\u0648\u0631\u06cc<\/strong><\/h2>\n\n\n\n