High-Integrity Primary Packaging by Pharglass | Type I Borosilicate | Ready for Biologics, Vaccines & Advanced Therapies
Pharglass EP 3.2.1 compliant glass vials are engineered to meet the exacting demands of modern biopharmaceutical manufacturing. Fully aligned with European Pharmacopoeia Chapter 3.2.1—the benchmark for glass containers used in parenteral preparations—these vials are manufactured from Type I neutral borosilicate glass to ensure ultra-low leachables, exceptional hydrolytic resistance, and long-term stability for sensitive molecules, including monoclonal antibodies, mRNA vaccines, viral vectors, peptides, and cell & gene therapies.
Available in standard capacities from 2ml to 50ml (2R–50R), our vials feature consistent wall thickness, flat-bottom geometry, and precise dimensional tolerances for seamless integration into automated fill-finish and lyophilization lines. Whether you require non-sterile bulk vials for in-house processing или pre-sterilized Ready-to-Fill (RTF) units, Pharglass offers flexible configurations—including OEM branding and custom packaging—to support clinical trials, commercial launches, and global regulatory submissions (EMA, FDA, NMPA).
Ключевые особенности и преимущества
- ✅ Full Compliance with EP 3.2.1 – Essential for EMA dossiers and EU market authorization
- ✅ Боросиликатное стекло типа I – Minimizes interaction with pH-sensitive biologics
- ✅ Capacity Range: 2ml–50ml – Scalable from early-phase trials to commercial supply
- ✅ Sterile (SAL 10⁻⁶) or Non-Sterile Options – Gamma or ETO sterilization available
- ✅ OEM Customization – Branding, serialization, color-coded stoppers, and more
- ✅ Глобальная гармонизация – Also meets USP <660> and YBB standards for multi-market filings
Технические характеристики
| Параметр | Технические характеристики |
|---|---|
| Название продукта | EP 3.2.1 Compliant Biopharma Glass Vials |
| Бренд | Pharglass (OEM/private label available) |
| 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 |
| Основной стандарт | European Pharmacopoeia 3.2.1 |
| В соответствии с | USP <660>, YBB00292005-2-2015, ISO 8362-1 |
| Устойчивость к гидролизу | ≤ 0.10 ml 0.01N HCl/g glass (powdered glass test) |
| Варианты цвета | Clear (standard); Amber (UV protection, on request) |
| Отделка шеи | Standard ISO finish (e.g., 13mm, 20mm) for bromobutyl stoppers |
| Варианты стерильности | |
| • Нестерильные: Bulk in clean cartons or nest trays | |
| • Sterile: Gamma/ETO sterilized to SAL 10⁻⁶, double-pouched in RTF trays | |
| Endotoxin Level | <0.25 EU/ml (for sterile versions) |
| MOQ | 5,000 pieces (flexible for OEM programs) |
| Приложения | Lyophilized & liquid biologics, mRNA-LNP vaccines, ADCs, enzymes, antibiotics, diagnostic kits |
Why EP 3.2.1 Compliance Matters in Biopharma
Сайт European Pharmacopoeia 3.2.1 sets strict requirements for:
- Chemical durability (hydrolytic resistance)
- Thermal stability
- Freedom from defects (bubbles, cords, stones)
- Точность размеров
Non-compliant containers risk protein aggregation, pH drift, or particulate contamination—critical failure modes for high-value biologics. Pharglass ensures every batch undergoes:
- Batch-specific EP testing
- Automated visual & dimensional inspection
- Helium leak testing for container closure integrity (CCI)
Our vials are already used in EMA-approved biologic products across Europe and beyond.
OEM & Customization Services
As a trusted partner to global pharma, Pharglass offers:
- Private labeling with your logo and product code
- Custom stopper formulations (e.g., fluoropolymer-coated for high-viscosity mAbs)
- Laser serialization or embossed volume markings
- Tailored packaging (nest trays, bulk boxes, RTF configurations)
- Regulatory support: CoA, CoC, DMF, E&L data
Sterile vs. Non-Sterile: Choose Your Workflow
- Non-sterile vials: Ideal for facilities with validated washing/depyrogenation lines
- Sterile RTF vials: Eliminate in-house processing—load directly into aseptic fillers, reduce contamination risk, accelerate time-to-market
Both options maintain full EP 3.2.1 compliance and traceability.
Engineered for Europe. Validated for the world.
When your biologic therapy demands container excellence and regulatory confidence, choose Pharglass EP 3.2.1 compliant glass vials—where science, compliance, and partnership converge.
📩 Свяжитесь с нами сегодня for samples, EP test reports, or a customized quote for your biopharma program!
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