قوارير التجفيف بالتجميد المقاومة ل 70 درجة مئوية - زجاج كهرماني أو شفاف من النوع الأول للاستقرار الحراري

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High-Performance Primary Packaging by Pharglass | USP/EP/YBB Compliant | Optimized for Aggressive Freeze-Dry Cycles

فارغلاس 70°C resistant lyophilization vials are engineered for demanding freeze-drying processes that require extended exposure to elevated temperatures during primary and secondary drying—common in modern formulations of peptides, monoclonal antibodies, mRNA-LNPs, vaccines, and high-concentration biologics. Made from زجاج البورسليكات المحايد من النوع I, these vials withstand thermal stress up to +70°C without deformation, cracking, or loss of container closure integrity (CCI).

Available in both clear (for visual inspection) and amber (for light-sensitive APIs), our lyo vials meet USP, EP 3.2.1, و YBB00292005-2-2015 standards, ensuring low extractables, minimal particulates, and exceptional chemical resistance—critical for maintaining drug stability throughout lyophilization and long-term storage.

Designed with consistent wall thickness, flat bottoms, and precise dimensional tolerances, Pharglass vials ensure uniform heat transfer, reliable stopper seating, and seamless compatibility with automated loading systems from leading lyophilizer OEMs (e.g., SP Industries, GEA, Telstar).

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الميزات والفوائد الرئيسية

• ✅ Validated for +70°C Thermal Exposure – Stable during aggressive secondary drying cycles
• ✅ زجاج البورسليكات البورسليكات من النوع I – Highest pharmaceutical grade for parenterals
• ✅ Amber or Clear Options – Protect light-sensitive drugs or enable visual inspection
• ✅ Low Breakage Rate – Optimized geometry for thermal shock resistance
• ✅ ISO 8362-1 & ISO 9001 Compliant – Global standard for injection vials
• ✅ Ideal for High-Value Biologics – Low protein binding, minimal surface interaction

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المواصفات الفنية

المعلمة	المواصفات
اسم المنتج	70°C Resistant Lyophilization Vials
العلامة التجارية	فارغلاس
Capacities	2ml, 5ml, 10ml, 20ml, 30ml, 50ml (standard); custom sizes available
نوع الزجاج	النوع I زجاج البورسليكات المحايد من النوع الأول
خيارات الألوان	Clear (transparent) or Amber (brown, UV-protective)
الامتثال	برنامج حماية البيئة ، بروتوكول حماية البيئة 3.2.1، Ybb00292005-2-2015، ISO 8362-1
المقاومة الحرارية	Stable at continuous exposure up to +70°C; validated through 50+ lyo cycles
سُمك الجدار	Uniform design for consistent heat transfer and reduced stress points
التصميم السفلي	Flat-bottom (standard for lyophilization trays)
تشطيب الرقبة	Standard ISO 8362 finishes (e.g., 13mm, 20mm) for serum stoppers
التعبئة والتغليف	كميات كبيرة في علب كرتونية مغسولة في غرف الأبحاث أو صواني متداخلة للمناولة الآلية
موك	5,000 قطعة
التطبيقات	Lyophilized vaccines, mAbs, peptides, antibiotics, mRNA therapeutics, diagnostic reagents, clinical trial materials

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Why Thermal Stability Matters in Lyophilization

Traditional vials may crack or deform during high-temperature secondary drying—especially when removing bound water from viscous or high-sugar formulations. This leads to:

• Batch loss due to breakage or stopper pop-up
• Contamination risk from compromised seals
• Regulatory delays from inconsistent CCI data

Pharglass addresses these challenges through:

• Advanced annealing processes to relieve internal glass stress
• Rigorous thermal cycling validation (from -40°C to +70°C)
• Strict control of hydrolytic resistance (اختبار الزجاج المسحوق حسب USP)
• Particulate-free surfaces to prevent nucleation defects

Our vials are trusted by global CDMOs supporting FDA- and EMA-approved lyophilized products.

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Customization & Support

• Custom embossing (logo, batch code, volume marking)
• Pre-sterilized (gamma/ETO) ready-to-fill (RTF) options
• اختبار التوافق مع دورة الليو الخاصة بك
• Regulatory documentation (CoA, CoC, DMF support)

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When your lyophilization cycle pushes limits, your vial shouldn’t be the weak link.
Pharglass 70°C resistant lyophilization vials deliver the thermal resilience, purity, and reliability required for today’s most advanced freeze-dried therapeutics.

📩 اتصل بنا اليوم for thermal validation reports, samples, or a quote for your next lyo program!