High-Performance Primary Packaging by Pharglass | USP/EP/YBB Compliant | Optimized for Aggressive Freeze-Dry Cycles
Pharglass 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 Type I neutral borosilicate glass, 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, PE 3.2.1, and 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).
Key Features & Benefits
- ✅ Validated for +70°C Thermal Exposure – Stable during aggressive secondary drying cycles
- ✅ Type I Borosilicate Glass – 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
Technical Specifications
| Parameter | Specification |
|---|---|
| Product Name | 70°C Resistant Lyophilization Vials |
| Brand | Pharglass |
| Capacities | 2ml, 5ml, 10ml, 20ml, 30ml, 50ml (standard); custom sizes available |
| Glass Type | Type I Neutral Borosilicate Glass |
| Color Options | Clear (transparent) or Amber (brown, UV-protective) |
| Compliance | USP <660>, EP 3.2.1, YBB00292005-2-2015, ISO 8362-1 |
| Thermal Resistance | Stable at continuous exposure up to +70°C; validated through 50+ lyo cycles |
| Wall Thickness | Uniform design for consistent heat transfer and reduced stress points |
| Bottom Design | Flat-bottom (standard for lyophilization trays) |
| Neck Finish | Standard ISO 8362 finishes (e.g., 13mm, 20mm) for serum stoppers |
| Packaging | Bulk in cleanroom-washed cartons or nest trays for automated handling |
| MOQ | 5,000 pieces |
| Applications | 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 (powdered glass test per USP)
- Particulate-free surfaces to prevent nucleation defects
Our vials are trusted by global CDMOs supporting FDA- and EMA-approved lyophilized products.
Customization & Support
- Custom embossing (logo, batch code, volume marking)
- Pre-sterilized (gamma/ETO) ready-to-fill (RTF) options
- Compatibility testing with your specific lyo cycle
- Regulatory documentation (CoA, CoC, DMF support)
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.
📩 Póngase en contacto con nosotros for thermal validation reports, samples, or a quote for your next lyo program!
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