High-Performance Primary Packaging by Pharglass | USP/EP/YBB Compliant | Optimized for Aggressive Freeze-Dry Cycles
فَرگلاس 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. ساخته شده از شیشهٔ بوروسیلیکات خنثی نوع I, these vials withstand thermal stress up to +70°C without deformation, cracking, or loss of container closure integrity (CCI).
Available in both شفاف (for visual inspection) and کهربایی (for light-sensitive APIs), our lyo vials meet USP, فصل ۳.۲.۱, ، 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).
ویژگیها و مزایای کلیدی
- ✅ Validated for +70°C Thermal Exposure – Stable during aggressive secondary drying cycles
- ✅ شیشهٔ بوروسیلیکات نوع 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
مشخصات فنی
| پارامتر | مشخصات |
|---|---|
| نام محصول | 70°C Resistant Lyophilization Vials |
| برند | فَرگلاس |
| ظرفیتها | 2ml, 5ml, 10ml, 20ml, 30ml, 50ml (standard); custom sizes available |
| نوع شیشه | شیشهٔ بوروسیلیکات خنثی نوع I |
| گزینههای رنگ | Clear (transparent) or Amber (brown, UV-protective) |
| انطباق | USP , EP 3.2.1, YBB00292005-2-2015, ISO 8362-1 |
| مقاومت حرارتی | Stable at continuous exposure up to +70°C; validated through 50+ lyo cycles |
| ضخامت دیوار | Uniform design for consistent heat transfer and reduced stress points |
| طراحی کف | Flat-bottom (standard for lyophilization trays) |
| پایان گردن | Standard ISO 8362 finishes (e.g., 13mm, 20mm) for serum stoppers |
| بستهبندی | بستهبندی عمده در کارتنهای شستهشده در اتاق تمیز یا سینیهای آشیانهای برای جابجایی خودکار |
| حداقل سفارش | ۵۰۰۰ تکه |
| کاربردها | Lyophilized vaccines, mAbs, peptides, antibiotics, mRNA therapeutics, diagnostic reagents, clinical trial materials |
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 (آزمون پودر شیشه مطابق USP)
- Particulate-free surfaces to prevent nucleation defects
Our vials are trusted by global CDMOs supporting FDA- and EMA-approved lyophilized products.
سفارشیسازی و پشتیبانی
- Custom embossing (logo, batch code, volume marking)
- Pre-sterilized (gamma/ETO) ready-to-fill (RTF) options
- آزمایش سازگاری با چرخه لیوفیلیزاسیون خاص شما
- مستندات نظارتی (CoA، CoC، پشتیبانی DMF)
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.
📩 امروز با ما تماس بگیرید for thermal validation reports, samples, or a quote for your next lyo program!
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