Enhanced Container Closure Integrity by Pharglass | Dual-Stopper Design for Reconstitution & Long-Term Stability
Pharglass double-stoppered lyophilization vials are engineered for the most demanding freeze-dried therapeutics—where container closure integrity (CCI), reconstitution reliability, e long-term stability are non-negotiable. Made from USP Type I neutral borosilicate glass, these vials feature a dual-stopper system: an inner stopper that seals the lyophilized cake during storage, and an outer stopper that maintains sterility and enables safe, controlled reconstitution with diluent.
This innovative design is ideal for:
- mRNA-LNP vaccines requiring strict moisture control
- High-potency biologics (e.g., monoclonal antibodies, enzymes)
- Two-chamber reconstitution systems without complex devices
- Clinical trial materials needing multi-step dosing or dilution
Compliant with USP <660>, EP 3.2.1, ISO 8362-1, e YBB standards, Pharglass double-stoppered vials deliver superior protection against moisture ingress, oxygen permeation, and microbial contamination—critical for maintaining potency in lyophilized products with low residual moisture specifications (<1%).
Key Features & Benefits
- ✅ Dual-Stopper System – Inner stopper protects lyo cake; outer stopper enables sterile reconstitution
- ✅ USP Type I Borosilicate Glass – Ultra-low leachables, high chemical resistance
- ✅ Optimized for mRNA & Biologics – Minimizes degradation during storage and handling
- ✅ Superior CCI Performance – Validated via helium leak testing (<1 × 1 × 10⁻⁶ mbar·L/s)
- ✅ Compatible with Standard Lyophilizers – Fits all common tray configurations (2R–50R)
- ✅ Clear or Amber Options – Amber version protects light-sensitive APIs
Technical Specifications
| Parâmetro | Especificação |
|---|---|
| Nome do produto | Double-Stoppered Lyophilization Vials |
| Brand | Pharglass |
| Capacities | 2ml (2R), 5ml (5R), 10ml (10R), 20ml (20R), 30ml (30R) (standard ISO sizes) |
| Glass Type | USP/EP Type I Neutral Borosilicate Glass |
| Compliance | USP <660>, EP 3.2.1, ISO 8362-1, YBB00292005-2-2015 |
| Stopper Configuration | Dual bromobutyl rubber stoppers (inner + outer), coated or uncoated |
| Neck Finish | Standard ISO finish (e.g., 13mm, 20mm) for crimp seals or flip-off caps |
| Endotoxin Level | <0.25 EU/ml (for sterile versions) |
| Sterility Options | Non-sterile (standard); gamma or ETO sterilized (SAL 10⁻⁶) on request |
| Embalagem | Bulk in clean cartons or nest trays for automated loading |
| MOQ | 5,000 pieces |
| Applications | Lyophilized mRNA vaccines, viral vectors, monoclonal antibodies, peptides, antibiotics, diagnostic kits, personalized cell therapies |
Why Choose Double-Stoppered Vials Over Single-Stopper?
Traditional single-stopper vials require needle puncture for reconstitution—introducing risks of:
- Particulate generation from rubber coring
- Moisture ingress after first use (in multi-dose scenarios)
- Loss of sterility during manual diluent transfer
The dual-stopper design eliminates these issues:
- Diluent is pre-loaded in the upper chamber (or added aseptically)
- Reconstitution occurs in a closed system—simply push the outer stopper to mix
- No needle entry needed—preserving sterility and reducing operator error
This makes double-stoppered vials a smart choice for point-of-care use, emergency medicine, e resource-limited settings.
Validation & Regulatory Support
Pharglass provides full documentation for global submissions:
- Helium leak test reports (CCI validation)
- Thermal cycling data (from -70°C to +70°C)
- Extractables & leachables (E&L) studies
- Drug Master File (DMF) support for FDA/EMA/NMPA
Manufactured under ISO 9001 e ISO 15378 quality systems, with full batch traceability.
Customization Options
- Pre-filled diluent chamber (with client’s buffer)
- Color-coded stoppers for dose differentiation
- Laser marking for serialization
- Ready-to-fill (RTF) sterile configuration in double pouches
Innovate with confidence. Protect with precision.
When your lyophilized therapy demands more than a standard vial, choose Pharglass double-stoppered lyophilization vials—where engineering meets patient safety.
📩 Contact us today for samples, CCI validation data, or a customized solution for your mRNA or biologic program!
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