50ml Multi-Dose Ready-to-Use (RTU) Vials – Type I Borosilicate Glass for Biologics & Vaccines
Manufactured by Pharglass | Sterile | ETO-Sterilized | USP/EP/YBB Compliant
Pharglass 50ml multi-dose Ready-to-Use (RTU) vials are engineered for the safe, reliable, and efficient packaging of high-value biologics, monoclonal antibodies, recombinant proteins, and large-volume vaccines. Made from premium Нейтральное боросиликатное стекло типа I, these vials offer exceptional chemical resistance, low extractables, and outstanding thermal stability—critical for sensitive parenteral formulations.
Designed for seamless integration into aseptic fill-finish lines, each vial is pre-washed, depyrogenated, and sterilized via Ethylene Oxide (ETO) to a sterility assurance level (SAL) of 10-⁶, eliminating the need for in-house cleaning and sterilization. This significantly reduces contamination risk, operational complexity, and time-to-market for drug developers and CDMOs.
Идеально подходит для multi-dose applications, these vials support repeated withdrawal while maintaining container closure integrity—ensuring patient safety and regulatory compliance throughout the product lifecycle.
Ключевые особенности и преимущества
- ✅ Боросиликатное стекло типа I – Compliant with USP <660>, EP 3.2.1, and YBB00292005-2-2015
- ✅ Ready-to-Use (RTU) – Pre-sterilized and pre-assembled with stopper and cap
- ✅ Multi-Dose Compatible – Supports multiple entries with standard needles
- ✅ Low Particulate & Low Leachables – Minimizes interaction with sensitive biologics
- ✅ Thermal Shock Resistant – Stable from -70°C to +100°C, suitable for cold-chain logistics
- ✅ Global Regulatory Alignment – Meets FDA, EMA, and NMPA packaging requirements
Технические характеристики
| Параметр | Технические характеристики |
|---|---|
| Название продукта | 50ml Multi-Dose RTU Vial |
| Бренд | Pharglass |
| Вместимость | 50ml (Nominal) |
| Тип стекла | Нейтральное боросиликатное стекло типа I |
| Соответствие требованиям | USP <660>, EP 3.2.1, YBB00292005-2-2015, ISO 8362-1 |
| Метод стерилизации | Оксид этилена (ETO) |
| Уровень обеспечения стерильности (SAL) | 10-⁶ |
| Уровень эндотоксина | <0.25 EU/ml (as per compendial methods) |
| Система закрытия | Bromobutyl rubber stopper + aluminum crimp seal (or flip-off cap, optional) |
| Формат упаковки | Nest-in-tray within double-layer sterile pouches, packed in export cartons |
| MOQ | 5 000 шт. |
| Приложения | Monoclonal antibodies, mRNA vaccines (large-volume), insulin, IVIG, biosimilars |
Note: Stopper and cap materials can be customized per client requirements (e.g., coated vs. uncoated, colored flip-off).
Why Choose Pharglass RTU Vials?
As a trusted global supplier of pharmaceutical primary packaging, Pharglass combines advanced manufacturing with rigorous quality control (ISO 15378 & ISO 13485 certified facilities) to deliver vials that meet the highest standards of safety and performance.
Our 50ml multi-dose RTU vials are produced in a Class 10,000 (ISO 7) cleanroom environment, with full traceability from raw material to finished goods. Every batch undergoes comprehensive testing for:
- Гидролитическая стойкость
- Particulate matter
- Точность размеров
- Container closure integrity (CCI)
We support Услуги OEM/ODM, including custom labeling, unique serialization, and tailored packaging configurations for clinical trials or commercial launch.
Typical Use Cases
- Large-volume vaccine formulations (e.g., pandemic response stockpiles)
- Hospital pharmacy multi-dose reconstitution
- Biopharma bulk fill of therapeutic proteins
- Global health programs requiring cost-effective, high-integrity packaging
Trusted by innovators. Engineered for life-saving medicines.
Contact Pharglass today for samples, regulatory documentation (DMF support available), and volume pricing for your next biologic or vaccine project.
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