High-Integrity Primary Packaging by Pharglass | USP/EP/YBB Certified | Secure Closure for Sensitive Parenterals
Pharglass serum vials are engineered to meet the exacting standards of modern injectable therapy packaging. Fully compliant with ISO 8362-4—the international standard for glass vials with screw caps—these containers combine Typ I neutrales Borosilikatglas with a robust screw-thread closure system to deliver superior chemical resistance, leak-proof sealing, and long-term stability for antibiotics, vaccines, biologics, and diagnostic reagents.
Available in capacities from 2ml to 30ml, our serum vials feature precision-molded threads that ensure consistent torque, easy opening/closing, and reliable resealability—ideal for multi-dose withdrawal in clinical or pharmacy settings. Unlike traditional crimp-sealed vials, the screw cap design eliminates needle puncture risks, reduces coring, and enhances user safety during repeated access.
Manufactured under strict quality controls and certified to USP, EP 3.2.1, und YBB00292005-2-2015, Pharglass serum vials provide the purity and performance demanded by global regulatory authorities.
Hauptmerkmale und Vorteile
- ✅ ISO 8362-4 Compliant – International standard for screw-cap serum vials
- ✅ Typ I Borosilikatglas – Ultra-low leachables; ideal for pH-sensitive drugs
- ✅ Screw Cap with Integrated Seal – Tamper-evident, resealable, and needle-free access
- ✅ Capacity Range: 2ml–30ml - Unterstützt alles, von pädiatrischen Dosen bis hin zu Massenformulierungen
- ✅ Reduced Contamination Risk – No rubber coring or particulate generation during use
- ✅ Farboptionen: Clear (standard) or Amber (UV protection for light-sensitive APIs)
Technische Daten
| Parameter | Spezifikation |
|---|---|
| Produktname | ISO 8362-4 Compliant Serum Vials |
| Marke | Pharglass |
| Kapazitäten | 2ml, 5ml, 10ml, 20ml, 30ml (standard ISO sizes) |
| Glas Typ | Typ I Neutrales Borosilikatglas |
| Einhaltung der Vorschriften | ISO 8362-4, USP <660>, EP 3.2.1, YBB00292005-2-2015 |
| Verschlusssystem | Polypropylene (PP) screw cap with integrated elastomeric seal (bromobutyl or halobutyl) |
| Thread Design | Standardized ISO 8362-4 thread profile for universal compatibility |
| Sterilitätsoptionen | Non-sterile (standard); gamma or ETO sterilized (SAL 10⁻⁶) on request |
| Endotoxinspiegel | <0,25 EU/ml (für sterile Versionen) |
| Verpackung | Bulk in clean cartons or nest trays for automated filling lines |
| MOQ | 5.000 Stück |
| Anwendungen | Antibiotics (e.g., ceftriaxone, vancomycin), liquid vaccines, hormones, diagnostic enzymes, veterinary injectables |
Why Choose Screw-Cap Serum Vials Over Crimp Vials?
Traditional crimp-sealed vials require repeated needle punctures—introducing critical risks:
- Rubber coring → particulates in solution
- Loss of sterility after first use
- Inconsistent resealing → moisture/oxygen ingress
Die ISO 8362-4 screw-cap system solves these issues:
- No needle entry needed – simply unscrew, withdraw dose, and reseal
- Maintains sterility for multi-dose use (up to 28 days post-first puncture, per USP <797>)
- Tamper-evident band ensures patient safety and regulatory compliance
This makes our vials ideal for hospital pharmacies, compounding centers, and emergency medicine.
Quality Assurance & Regulatory Support
- Gefertigt in ISO 9001 & ISO 15378 certified facilities
- Full batch traceability and Certificates of Analysis (CoA)
- Extractables & leachables (E&L) data available
- DMF support for FDA, EMA, and NMPA submissions
Customization Options
- Custom cap colors for dose differentiation (e.g., blue for 1g, red for 2g)
- Laser marking or embossing for serialization
- Vorsterilisiert Fertig zum Ausfüllen (RTF) Konfiguration
- Compatibility testing with your specific drug formulation
Safety. Simplicity. Global Compliance.
When your therapy demands more than a standard vial, choose Pharglass ISO 8362-4 serum vials—engineered for the future of multi-dose parenteral delivery.
📩 Kontaktieren Sie uns heute for samples, compliance documentation, or a volume quote for your antibiotic or vaccine program!
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