High-Integrity Primary Packaging by Pharglass | USP/EP/YBB Certified | Secure Closure for Sensitive Parenterals
Pharglass serum vials are engineered to meet the exacting standards of modern injectable therapy packaging. Fully compliant with ISO 8362-4—the international standard for glass vials with screw caps—these containers combine Нейтральное боросиликатное стекло типа I with a robust screw-thread closure system to deliver superior chemical resistance, leak-proof sealing, and long-term stability for antibiotics, vaccines, biologics, and diagnostic reagents.
Available in capacities from 2ml to 30ml, our serum vials feature precision-molded threads that ensure consistent torque, easy opening/closing, and reliable resealability—ideal for multi-dose withdrawal in clinical or pharmacy settings. Unlike traditional crimp-sealed vials, the screw cap design eliminates needle puncture risks, reduces coring, and enhances user safety during repeated access.
Manufactured under strict quality controls and certified to USP, EP 3.2.1, и YBB00292005-2-2015, Pharglass serum vials provide the purity and performance demanded by global regulatory authorities.
Ключевые особенности и преимущества
- ✅ ISO 8362-4 Compliant – International standard for screw-cap serum vials
- ✅ Боросиликатное стекло типа I – Ultra-low leachables; ideal for pH-sensitive drugs
- ✅ Screw Cap with Integrated Seal – Tamper-evident, resealable, and needle-free access
- ✅ Capacity Range: 2ml–30ml – Supports everything from pediatric doses to bulk formulations
- ✅ Reduced Contamination Risk – No rubber coring or particulate generation during use
- ✅ Варианты цвета: Clear (standard) or Amber (UV protection for light-sensitive APIs)
Технические характеристики
| Параметр | Технические характеристики |
|---|---|
| Название продукта | ISO 8362-4 Compliant Serum Vials |
| Бренд | Pharglass |
| Емкости | 2ml, 5ml, 10ml, 20ml, 30ml (standard ISO sizes) |
| Тип стекла | Нейтральное боросиликатное стекло типа I |
| Соответствие требованиям | ISO 8362-4, USP <660>, EP 3.2.1, YBB00292005-2-2015 |
| Система закрытия | Polypropylene (PP) screw cap with integrated elastomeric seal (bromobutyl or halobutyl) |
| Thread Design | Standardized ISO 8362-4 thread profile for universal compatibility |
| Варианты стерильности | Non-sterile (standard); gamma or ETO sterilized (SAL 10⁻⁶) on request |
| Уровень эндотоксина | <0.25 EU/ml (for sterile versions) |
| Упаковка | Bulk in clean cartons or nest trays for automated filling lines |
| MOQ | 5,000 шт. |
| Приложения | Antibiotics (e.g., ceftriaxone, vancomycin), liquid vaccines, hormones, diagnostic enzymes, veterinary injectables |
Why Choose Screw-Cap Serum Vials Over Crimp Vials?
Traditional crimp-sealed vials require repeated needle punctures—introducing critical risks:
- Rubber coring → particulates in solution
- Loss of sterility after first use
- Inconsistent resealing → moisture/oxygen ingress
Сайт ISO 8362-4 screw-cap system solves these issues:
- No needle entry needed – simply unscrew, withdraw dose, and reseal
- Maintains sterility for multi-dose use (up to 28 days post-first puncture, per USP <797>)
- Tamper-evident band ensures patient safety and regulatory compliance
This makes our vials ideal for hospital pharmacies, compounding centers, and emergency medicine.
Quality Assurance & Regulatory Support
- Изготовлено в ISO 9001 & ISO 15378 certified facilities
- Full batch traceability and Certificates of Analysis (CoA)
- Extractables & leachables (E&L) data available
- DMF support for FDA, EMA, and NMPA submissions
Customization Options
- Custom cap colors for dose differentiation (e.g., blue for 1g, red for 2g)
- Laser marking or embossing for serialization
- Предварительно простерилизованный Готовые к заполнению (RTF) configuration
- Compatibility testing with your specific drug formulation
Safety. Simplicity. Global Compliance.
When your therapy demands more than a standard vial, choose Pharglass ISO 8362-4 serum vials—engineered for the future of multi-dose parenteral delivery.
📩 Свяжитесь с нами сегодня for samples, compliance documentation, or a volume quote for your antibiotic or vaccine program!
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