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 Type I neutral borosilicate glass, 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.
Ideal for multi-dose applications, these vials support repeated withdrawal while maintaining container closure integrity—ensuring patient safety and regulatory compliance throughout the product lifecycle.
Key Features & Benefits
- ✅ Type I Borosilicate Glass – 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
Technical Specifications
| Parâmetro | Especificação |
|---|---|
| Nome do produto | 50ml Multi-Dose RTU Vial |
| Brand | Pharglass |
| Capacity | 50ml (Nominal) |
| Glass Type | Type I Neutral Borosilicate Glass |
| Compliance | USP <660>, EP 3.2.1, YBB00292005-2-2015, ISO 8362-1 |
| Sterilization Method | Ethylene Oxide (ETO) |
| Sterility Assurance Level (SAL) | 10⁻⁶ |
| Endotoxin Level | <0.25 EU/ml (as per compendial methods) |
| Closure System | Bromobutyl rubber stopper + aluminum crimp seal (or flip-off cap, optional) |
| Packaging Format | Nest-in-tray within double-layer sterile pouches, packed in export cartons |
| MOQ | 5,000 units |
| Applications | 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:
- Hydrolytic resistance
- Particulate matter
- Dimensional accuracy
- Container closure integrity (CCI)
We support OEM/ODM services, 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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