{"id":1490,"date":"2026-02-05T03:21:31","date_gmt":"2026-02-05T03:21:31","guid":{"rendered":"https:\/\/www.pharglass.com\/?p=1490"},"modified":"2026-02-10T06:14:17","modified_gmt":"2026-02-10T06:14:17","slug":"ybb-usp-type-i-compliant-lyophilization-vials-2ml-to-50ml-sterile-freeze-dry-glass-vials","status":"publish","type":"post","link":"https:\/\/www.pharglass.com\/ar\/ybb-usp-type-i-compliant-lyophilization-vials-2ml-to-50ml-sterile-freeze-dry-glass-vials\/","title":{"rendered":"\u0642\u0648\u0627\u0631\u064a\u0631 \u0627\u0644\u062a\u062c\u0641\u064a\u0641 \u0628\u0627\u0644\u062a\u062c\u0645\u064a\u062f \u0628\u0627\u0644\u062a\u0628\u0631\u064a\u062f \u0627\u0644\u0645\u062a\u0648\u0627\u0641\u0642\u0629 \u0645\u0639 YBB \u0648 USP \u0645\u0646 \u0627\u0644\u0646\u0648\u0639 \u0627\u0644\u0623\u0648\u0644 - \u0642\u0648\u0627\u0631\u064a\u0631 \u0632\u062c\u0627\u062c\u064a\u0629 \u0645\u0639\u0642\u0645\u0629 \u0645\u062c\u0641\u0641\u0629 \u0628\u0627\u0644\u062a\u062c\u0645\u064a\u062f \u0633\u0639\u0629 2 \u0645\u0644 \u0625\u0644\u0649 50 \u0645\u0644"},"content":{"rendered":"
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Ready-to-Fill Primary Packaging by Pharglass | Triple Pharmacopeial Compliance | Optimized for Biologics, Vaccines & Antibiotics<\/em><\/p>\n\n\n\n

\u0641\u0627\u0631\u063a\u0644\u0627\u0633 sterile lyophilization vials<\/strong> are engineered for the most demanding freeze-drying applications\u2014from mRNA vaccines and monoclonal antibodies to high-potency antibiotics and peptide therapeutics. Available in standard capacities from 2ml to 50ml (2R\u201350R)<\/strong>, these vials are manufactured from \u0632\u062c\u0627\u062c \u0627\u0644\u0628\u0648\u0631\u0633\u0644\u064a\u0643\u0627\u062a \u0627\u0644\u0645\u062d\u0627\u064a\u062f \u0645\u0646 \u0627\u0644\u0646\u0648\u0639 I<\/strong> and fully compliant with USP<\/strong>, \u062f\u0633\u062a\u0648\u0631 \u0627\u0644\u0623\u062f\u0648\u064a\u0629 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a (EP) 3.2.1<\/strong>, \u0648 \u0627\u0644\u0635\u064a\u0646\u064a\u0629 YBB0029292005-2-2015<\/strong> standards\u2014ensuring global regulatory acceptance.<\/p>\n\n\n\n

Each vial is pre-sterilized to SAL 10\u207b\u2076 via gamma irradiation or ethylene oxide (ETO)<\/strong>, pre-assembled with a medical-grade bromobutyl stopper, and packaged in double sterile pouches within rigid nest trays<\/strong>, making them true \u062c\u0627\u0647\u0632 \u0644\u0644\u062a\u0639\u0628\u0626\u0629 (RTF)<\/strong> components. This eliminates the need for in-house washing, depyrogenation, and sterilization\u2014reducing contamination risk, operational costs, and time-to-market for critical parenteral products.<\/p>\n\n\n\n

With uniform wall thickness, flat-bottom geometry, and tight dimensional tolerances, Pharglass lyo vials ensure consistent heat transfer, minimal breakage, and reliable container closure integrity (CCI) throughout aggressive freeze-dry cycles\u2014even at elevated secondary drying temperatures up to +70\u00b0C.<\/p>\n\n\n\n

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\u0627\u0644\u0645\u064a\u0632\u0627\u062a \u0648\u0627\u0644\u0641\u0648\u0627\u0626\u062f \u0627\u0644\u0631\u0626\u064a\u0633\u064a\u0629<\/strong><\/h3>\n\n\n\n
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  • \u2705 Sterile & Ready-to-Fill (RTF)<\/strong> \u2013 SAL 10\u207b\u2076; load directly into aseptic fill-finish lines<\/li>\n\n\n\n
  • \u2705 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0627\u0644\u062b\u0644\u0627\u062b\u064a \u0644\u0644\u0645\u0639\u0627\u064a\u064a\u0631 \u0627\u0644\u062f\u0648\u0627\u0626\u064a\u0629<\/strong> \u2013 USP, EP, and YBB certified for FDA, EMA & NMPA submissions<\/li>\n\n\n\n
  • \u2705 Full Size Range: 2ml\u201350ml<\/strong> \u2013 Supports clinical trials to commercial-scale production<\/li>\n\n\n\n
  • \u2705 \u0632\u062c\u0627\u062c \u0627\u0644\u0628\u0648\u0631\u0633\u0644\u064a\u0643\u0627\u062a \u0627\u0644\u0628\u0648\u0631\u0633\u0644\u064a\u0643\u0627\u062a \u0645\u0646 \u0627\u0644\u0646\u0648\u0639 I<\/strong> \u2013 Ultra-low leachables, ideal for sensitive biologics<\/li>\n\n\n\n
  • \u2705 \u062c\u0633\u064a\u0645\u0627\u062a \u0645\u0646\u062e\u0641\u0636\u0629 \u0648\u062c\u0648\u062f\u0629 \u0633\u0637\u062d \u0645\u0636\u0628\u0648\u0637\u0629<\/strong> \u2013 Minimizes cake defects and aggregation<\/li>\n\n\n\n
  • \u2705 \u0639\u0628\u0648\u0627\u062a \u0639\u0634-\u0635\u064a\u0646\u064a\u0629 \u0627\u0644\u062a\u0639\u0628\u0626\u0629 \u0648\u0627\u0644\u062a\u063a\u0644\u064a\u0641<\/strong> \u2013 Enables robotic handling and prevents contact damage<\/li>\n<\/ul>\n\n\n\n
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    \u0627\u0644\u0645\u0648\u0627\u0635\u0641\u0627\u062a \u0627\u0644\u0641\u0646\u064a\u0629<\/strong><\/h3>\n\n\n\n
    \u0627\u0644\u0645\u0639\u0644\u0645\u0629<\/th>\u0627\u0644\u0645\u0648\u0627\u0635\u0641\u0627\u062a<\/th><\/tr><\/thead>
    \u0627\u0633\u0645 \u0627\u0644\u0645\u0646\u062a\u062c<\/strong><\/td>Sterile Lyophilization Vials (RTF)<\/td><\/tr>
    \u0627\u0644\u0639\u0644\u0627\u0645\u0629 \u0627\u0644\u062a\u062c\u0627\u0631\u064a\u0629<\/strong><\/td>\u0641\u0627\u0631\u063a\u0644\u0627\u0633<\/td><\/tr>
    \u0627\u0644\u0633\u0639\u0627\u062a (\u0645\u0642\u0627\u0633\u0627\u062a ISO)<\/strong><\/td>2 \u0631 (2 \u0645\u0644)\u060c 5 \u0631 (5 \u0645\u0644)\u060c 10 \u0631 (10 \u0645\u0644)\u060c 20 \u0631 (20 \u0645\u0644)\u060c 30 \u0631 (30 \u0645\u0644)\u060c 50 \u0631 (50 \u0645\u0644)<\/td><\/tr>
    \u0646\u0648\u0639 \u0627\u0644\u0632\u062c\u0627\u062c<\/strong><\/td>\u0627\u0644\u0646\u0648\u0639 I \u0632\u062c\u0627\u062c \u0627\u0644\u0628\u0648\u0631\u0633\u0644\u064a\u0643\u0627\u062a \u0627\u0644\u0645\u062d\u0627\u064a\u062f \u0645\u0646 \u0627\u0644\u0646\u0648\u0639 \u0627\u0644\u0623\u0648\u0644<\/td><\/tr>
    \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644<\/strong><\/td>\u0628\u0631\u0646\u0627\u0645\u062c \u062d\u0645\u0627\u064a\u0629 \u0627\u0644\u0628\u064a\u0626\u0629 \u060c \u0628\u0631\u0648\u062a\u0648\u0643\u0648\u0644 \u062d\u0645\u0627\u064a\u0629 \u0627\u0644\u0628\u064a\u0626\u0629 3.2.1\u060c Ybb00292005-2-2015\u060c ISO 8362-1<\/td><\/tr>
    Sterilization<\/strong><\/td>Gamma (25 kGy) or ETO, validated to SAL 10\u207b\u2076<\/td><\/tr>
    \u0633\u062f\u0627\u062f\u0629<\/strong><\/td>Coated or uncoated bromobutyl rubber (low extractables)<\/td><\/tr>
    \u0645\u0633\u062a\u0648\u0649 \u0627\u0644\u0633\u0645\u0648\u0645 \u0627\u0644\u062f\u0627\u062e\u0644\u064a\u0629<\/strong><\/td><0.25 EU\/ml (per LAL test)<\/td><\/tr>
    Moisture Content<\/strong><\/td><0.1% residual moisture in packaging environment<\/td><\/tr>
    \u062a\u0646\u0633\u064a\u0642 \u0627\u0644\u062a\u063a\u0644\u064a\u0641<\/strong><\/td>Vials in precision nest trays \u2192 double sterile pouches \u2192 export cartons<\/td><\/tr>
    \u0627\u0633\u062a\u0642\u0631\u0627\u0631 \u0627\u0644\u062a\u062e\u0632\u064a\u0646<\/strong><\/td>Stable from -20\u00b0C to +40\u00b0C; suitable for cold-chain products<\/td><\/tr>
    \u0645\u0648\u0643<\/strong><\/td>5,000 \u0642\u0637\u0639\u0629<\/td><\/tr>
    \u0627\u0644\u062a\u0637\u0628\u064a\u0642\u0627\u062a<\/strong><\/td>Lyophilized mRNA vaccines, mAbs, enzymes, antibiotics, cell & gene therapies, diagnostic reagents<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
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    Why Global Pharma Chooses Pharglass RTF Lyo Vials<\/strong><\/h3>\n\n\n\n

    In lyophilization, container quality directly impacts drug stability, yield, and patient safety<\/strong>:<\/p>\n\n\n\n