High-Performance Primary Packaging by Pharglass | Optimized for Stability, Integrity & Scalability
Pharglass lyophilization vials are precision-engineered for the reliable freeze-drying of sensitive therapeutics—from small-molecule antibiotics to complex mRNA vaccines, monoclonal antibodies, peptides, and viral vectors. Available in a full range of standard capacities (2ml, 5ml, 10ml, 20ml, 30ml, and 50ml), these vials are manufactured from Type I neutral borosilicate glass, ensuring exceptional chemical resistance, low extractables, and long-term stability of freeze-dried cakes.
Fully compliant with USP, European Pharmacopoeia (EP) 3.2.1, and Chinese YBB00292005-2-2015 standards, Pharglass lyo vials meet the stringent quality requirements of global regulatory agencies (FDA, EMA, NMPA). Their consistent wall thickness, flat-bottom design, and precise dimensional tolerances ensure uniform heat transfer during primary and secondary drying—minimizing collapse, melt-back, and batch failure.
Ideal for both clinical and commercial-scale lyophilization, our vials integrate seamlessly with leading freeze-dryer systems from SP Industries, GEA, Telstar, and IMA.
Ключевые особенности и преимущества
- ✅ Full Size Range: 2ml to 50ml – Supports everything from pediatric doses to bulk drug substance
- ✅ Боросиликатное стекло типа I – Highest pharmaceutical grade; ideal for parenterals and biologics
- ✅ Triple Pharmacopeial Compliance – USP, EP, and YBB certified for global market access
- ✅ Optimized Geometry – Flat bottom + uniform walls = consistent thermal conduction & low breakage
- ✅ Low Particulates & Controlled Surface Quality – Minimizes nucleation defects and cake heterogeneity
- ✅ Стандартная отделка горловины ISO – Compatible with serum stoppers, crimp seals, and flip-off caps
Технические характеристики
| Параметр | Технические характеристики |
|---|---|
| Название продукта | Lyophilization Vials for Freeze-Dried Powders |
| 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 |
| Варианты цвета | Clear (standard) or Amber (UV-protective, on request) |
| Bottom Design | Flat-bottom (optimized for lyophilizer trays) |
| Отделка шеи | Standard ISO finish (e.g., 13mm, 20mm) for rubber stoppers |
| Thermal Resistance | Validated from -40°C to +70°C (suitable for aggressive lyo cycles) |
| Упаковка | Bulk in cleanroom-washed cartons or nest trays for automated handling |
| Варианты стерильности | Non-sterile (standard); gamma or ETO sterilized (SAL 10⁻⁶) available |
| MOQ | 5,000 шт. |
| Приложения | Lyophilized vaccines, mAbs, enzymes, antibiotics, mRNA-LNPs, diagnostic reagents, cell & gene therapies |
Why Glass Quality Matters in Lyophilization
The success of a freeze-drying cycle depends not just on formulation—but on container performance:
- Poor glass → alkali leaching → pH shift → protein aggregation
- Inconsistent walls → uneven drying → collapsed cake or residual moisture
- Surface defects → uncontrolled nucleation → variable reconstitution time
Pharglass mitigates these risks through:
- Advanced melting & forming control to eliminate cords and stones
- Strict hydrolytic resistance testing (powdered glass test per USP)
- Automated visual inspection for cracks, chips, and particulates
- Batch-specific CoA with dimensions, weight, and compliance data
Our vials are used in commercialized lyophilized drugs across North America, Europe, and Asia.
Настройка и нормативная поддержка
- Тисненая маркировка объема или логотипы клиентов
- Предварительно простерилизованный Готовые к заполнению (RTF) конфигурация в двойных стерильных пакетах
- Compatibility testing with your specific lyo cycle
- Full regulatory documentation: CoA, CoC, DMF support, E&L data
From lab to launch—freeze-dry with confidence.
Pharglass lyophilization vials combine pharmaceutical excellence, global compliance, and scalable supply to support your most critical freeze-dried products.
📩 Свяжитесь с нами сегодня for samples, validation reports, or a quote tailored to your lyo program!
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