Pharmaceutical-Grade Lyophilization Containers by Pharglass | Triple-Certified | Eliminate In-House Sterilization
Pharglass Sterile Freeze-Dry Vials in 2ml, 5ml, and 10ml capacities are precision-engineered for aseptic fill-finish operations requiring immediate, contamination-free integration into lyophilization workflows. Fully compliant with Chinese YBB00292005-2-2015, ایزو ۸۳۶۲-۱ (international standard for injection vials), and aligned with USP <660> / EP 3.2.1, these vials deliver the chemical inertness, dimensional accuracy, and sterility assurance demanded by modern biologics, vaccines, and sensitive small-molecule APIs.
Supplied as true Ready-to-Use (RTU) components, each vial is pre-assembled with a medical-grade bromobutyl stopper, sterilized to SAL 10⁻⁶ via gamma irradiation or ethylene oxide (ETO), and double-bagged in sterile pouches within rigid nest trays. This eliminates the need for washing, depyrogenation, and terminal sterilization—reducing facility burden, validation complexity, and time-to-market for critical parenteral products.
Ideal for clinical trials, personalized medicine, and commercial-scale lyophilization, Pharglass RTU vials ensure consistent cake formation, reliable container closure integrity (CCI), and seamless compatibility with leading freeze-dryer systems.
Key Features & Benefits
- ✅ Ready-to-Use (RTU) Format – Load directly into aseptic filling lines; no cleaning or sterilization needed
- ✅ Sterile to SAL 10⁻⁶ – Validated gamma or ETO sterilization
- ✅ Compliance: YBB, ISO 8362-1, USP <660>, EP 3.2.1
- ✅ Capacities: 2ml, 5ml, 10ml – optimized for high-value biologics and pediatric doses
- ✅ Type I Borosilicate Glass – Low leachables, high hydrolytic resistance
- ✅ Nest-Tray Packaging – Enables robotic handling and prevents contact damage
Technical Specifications
| Parameter | Specification |
|---|---|
| Product Name | Sterile Freeze-Dry Vials (RTU) |
| Brand | Pharglass |
| Capacities (ISO Sizes) | 2R (2ml), 5R (5ml), 10R (10ml) |
| Glass Type | Type I Neutral Borosilicate Glass |
| Standards Met | ISO 8362-1, YBB00292005-2-2015, USP <660>, EP 3.2.1 |
| Sterilization Method | Gamma (25 kGy) or Ethylene Oxide (ETO), validated to SAL 10⁻⁶ |
| Stopper | Bromobutyl rubber (coated or uncoated options) |
| Endotoxin Level | <0.25 EU/ml (LAL test compliant) |
| Particulate Control | Meets light-obscuration limits per USP <788> |
| Packaging | Vials in precision nest trays → sealed in double sterile pouches → export cartons |
| Storage Conditions | Stable from -20°C to +40°C; low humidity environment |
| MOQ | 5,000 pieces |
| Applications | Lyophilized monoclonal antibodies, mRNA vaccines, peptides, antibiotics, diagnostic kits, cell therapy products |
Why Choose RTU Over Traditional Vials?
Traditional bulk vials require extensive in-house processing:
- Washing → risk of residual detergents
- Depyrogenation at >250°C → energy-intensive, potential glass stress
- Sterilization validation → added cost and complexity
Pharglass RTU vials solve these challenges:
- Reduced contamination risk – fully closed system from manufacturer to fill line
- Lower operational costs – eliminate washer/depyro equipment and validation
- Faster tech transfer – ideal for multi-site CDMO networks
- Regulatory-ready – full documentation package included
Quality & Regulatory Support
- Manufactured under ISO 15378 (GMP for primary packaging)
- Full batch traceability with Certificate of Analysis (CoA) و Certificate of Sterilization
- Extractables & Leachables (E&L) data available
- Drug Master File (DMF) support for FDA, NMPA, and EMA submissions
Customization Options
- Amber glass for light-sensitive formulations
- Fluoropolymer-coated stoppers for high-viscosity drugs
- Laser serialization or embossed volume markings
- Custom packaging configurations for automated lines
Accelerate your lyophilization process—without compromising quality.
Pharglass Sterile Freeze-Dry Vials combine global compliance, sterility assurance, and operational efficiency in one ready-to-deploy solution.
📩 Contact us today for samples, sterilization validation reports, or a quote tailored to your biologic or vaccine program!
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