Ready-to-Fill Primary Packaging by Pharglass | Triple Pharmacopeial Compliance | Optimized for Biologics, Vaccines & Antibiotics
Pharglass sterile lyophilization vials are engineered for the most demanding freeze-drying applications—from mRNA vaccines and monoclonal antibodies to high-potency antibiotics and peptide therapeutics. Available in standard capacities from 2ml to 50ml (2R–50R), these vials are manufactured from Type I neutral borosilicate glass and fully compliant with USP, European Pharmacopoeia (EP) 3.2.1, and Chinese YBB00292005-2-2015 standards—ensuring global regulatory acceptance.
Each vial is pre-sterilized to SAL 10⁻⁶ via gamma irradiation or ethylene oxide (ETO), pre-assembled with a medical-grade bromobutyl stopper, and packaged in double sterile pouches within rigid nest trays, making them true Готовые к заполнению (RTF) components. This eliminates the need for in-house washing, depyrogenation, and sterilization—reducing contamination risk, operational costs, and time-to-market for critical parenteral products.
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—even at elevated secondary drying temperatures up to +70°C.
Ключевые особенности и преимущества
- ✅ Sterile & Ready-to-Fill (RTF) – SAL 10⁻⁶; load directly into aseptic fill-finish lines
- ✅ Triple Pharmacopeial Compliance – USP, EP, and YBB certified for FDA, EMA & NMPA submissions
- ✅ Full Size Range: 2ml–50ml – Supports clinical trials to commercial-scale production
- ✅ Боросиликатное стекло типа I – Ultra-low leachables, ideal for sensitive biologics
- ✅ Low Particulates & Controlled Surface Quality – Minimizes cake defects and aggregation
- ✅ Nest-Tray Packaging – Enables robotic handling and prevents contact damage
Технические характеристики
| Параметр | Технические характеристики |
|---|---|
| Название продукта | Sterile Lyophilization Vials (RTF) |
| Бренд | Pharglass |
| Capacities (ISO Sizes) | 2R (2 мл), 5R (5 мл), 10R (10 мл), 20R (20 мл), 30R (30 мл), 50R (50 мл) |
| Тип стекла | Нейтральное боросиликатное стекло типа I |
| Соответствие требованиям | USP <660>, EP 3.2.1, YBB00292005-2-2015, ISO 8362-1 |
| Sterilization | Gamma (25 kGy) or ETO, validated to SAL 10⁻⁶ |
| Stopper | Coated or uncoated bromobutyl rubber (low extractables) |
| Endotoxin Level | <0.25 EU/ml (per LAL test) |
| Moisture Content | <0.1% residual moisture in packaging environment |
| Packaging Format | Vials in precision nest trays → double sterile pouches → export cartons |
| Storage Stability | Stable from -20°C to +40°C; suitable for cold-chain products |
| MOQ | 5,000 шт. |
| Приложения | Lyophilized mRNA vaccines, mAbs, enzymes, antibiotics, cell & gene therapies, diagnostic reagents |
Why Global Pharma Chooses Pharglass RTF Lyo Vials
In lyophilization, container quality directly impacts drug stability, yield, and patient safety:
- Poor glass → alkali leaching → protein denaturation
- Inconsistent geometry → uneven drying → collapsed cake
- Non-sterile vials → microbial contamination → batch rejection
Pharglass mitigates these risks through:
- Advanced annealing to relieve internal stress
- Automated visual & dimensional inspection
- Helium leak testing for CCI validation (<1 × 10⁻⁶ mbar·L/s)
- Full traceability and batch-specific documentation
Our vials support commercialized lyophilized drugs across North America, Europe, China, and emerging markets.
Настройка и нормативная поддержка
- Amber glass option for light-sensitive APIs
- Custom stopper formulations (e.g., fluoropolymer-coated for high-viscosity drugs)
- Laser serialization or embossed logos
- Full regulatory dossier support: CoA, CoC, DMF, E&L data
From molecule to patient—delivered with sterility, stability, and speed.
When your freeze-dried therapy can’t afford compromise, choose Pharglass sterile lyophilization vials—where global compliance meets manufacturing excellence.
📩 Свяжитесь с нами сегодня for samples, sterilization validation reports, or a quote for your next lyo program!
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