Pharmazeutische Glasfläschchen gemäß ISO-Norm und USP-Standards für den weltweiten Markt
PharGlass delivers ISO and USP-compliant pharmaceutical glass vials designed to meet the highest global standards in quality, safety, and regulatory compliance. These 10ml clear borosilicate glass vials sind Ready-to-Use (RTU), ETO sterilized, washed, and depyrogenated—ideal for injectable drugs, biologics, vaccines, and sterile liquid formulations intended for export to North America, Europe, Asia, and beyond.
Manufactured under GMP-konforme Anlagen in Henan, China, our vials are engineered to ensure chemical stability, sterility, and compatibility with sensitive pharmaceutical products—making them a trusted choice for manufacturers seeking reliable packaging solutions that pass stringent international inspections.
✅ Why Choose PharGlass ISO & USP Compliant Vials?
- Einhaltung von Vorschriften: Meets USP <660>, USP <85>, EP 3.2.1, und ISO 15884 standards for pharmaceutical glassware.
- High Purity & Inertness: Hergestellt aus Borosilikatglas Typ I, resistant to leaching and pH changes—critical for long-term stability.
- Steril und gebrauchsfertig: Pre-sterilized via Ethylenoxid (ETO), thoroughly washed, and validated for use without additional processing.
- Depyrogenated: Endotoxin levels below 0.25 EU/mL, ensuring safe use in injectable applications.
- Mit Gummistopfen verschlossen: Ensures leak-proof containment and prevents microbial ingress.
- Hot Stamping Compatible: Enables permanent marking of batch numbers, expiry dates, and barcodes.
- Individuell anpassbares Branding: Akzeptiert custom logos, cap colors, and labeling for OEM/ODM clients.
💡 According to the U.S. Pharmacopeia (USP), glass containers must be free from defects and contaminants that could affect drug safety or efficacy. Our vials undergo rigorous testing to ensure full compliance with USP Chapter <660> for glass containers.
🔬 Wichtige Produktdaten
| Attribut | Spezifikation |
|---|---|
| Art der Versiegelung | Stopper |
| Form | Runder Zylinder |
| Mit Duftstäbchen | Nein |
| Handhabung der Oberfläche | Heißprägen |
| Modellnummer | RTU |
| Markenname | PharGlass |
| Material des Gehäuses | Glas (Borosilikatglas) |
| Material des Kragens | Glas |
| Produktname | 2R 2ml 3ml Clear RTU Washed Sterile Glass Bottle Vial |
| Kapazität | 10ml |
| Material | Glas |
| Farbe der Kappe | Individuelle Farben erhältlich |
| Verwendung | Liquid Pharmaceuticals, Injectables, Biologics |
| Druckabwicklung | Etiketten, Heißprägung |
| Ort der Herkunft | Henan, China |
| Industrielle Nutzung | Arzneimittelverpackungen |
| MOQ | 5000 Stück |
| OEM/ODM | Akzeptabel |
| Logo | Individuelles Logo möglich |
| Verpackung | Karton |
🌐 Applications in Global Pharmaceutical Markets
These vials are widely used by manufacturers exporting to:
- North America: FDA-regulated markets requiring strict adherence to USP standards.
- Europe: CE-marked products compliant with EU pharmacopoeia (EP).
- Asia-Pacific: Countries like Japan, South Korea, and India with high-quality requirements.
- Middle East & Africa: Growing demand for sterile injectables and vaccines.
Ideal for:
- Injectable medications (antibiotics, analgesics)
- Impfstoffe (mRNA, subunit, live attenuated)
- Biologics (monoclonal antibodies, recombinant proteins)
- Generic drugs requiring cost-effective, compliant packaging
📊 The global pharmaceutical packaging market is projected to exceed $150 billion by 2030, driven by demand for compliant, sustainable, and smart packaging solutions (Source: Statista).
🌍 Exzellenz in der Fertigung & Qualitätssicherung
Gefertigt in Henan, China, unter GMP-konforme Anlagen, Jedes Fläschchen durchläuft folgende Schritte:
- Automatisierte Prüfung for defects (cracks, bubbles, surface flaws)
- Sterilisation mit ETO-Gas (residual levels <10 ppm)
- Entpyrogenisierungsverfahren to remove endotoxins
- Dichtheitsprüfung unter Vakuumdruck
- Optische und Maßprüfungen
- Compliance testing against USP, EP, and ISO standards
Alle Produkte sind Zertifiziert nach ISO 9001, ISO 13485 und von der FDA zugelassen, ensuring alignment with global regulatory expectations.
🎯 Anpassungsmöglichkeiten
PharGlass supports full branding and functional customization:
- Heißgeprägte Etiketten (Chargennummern, Verfallsdaten, Losnummern)
- Individuelle Farben für Kappen for product differentiation (e.g., blue for antibiotics, red for emergency use)
- Private Etikettierung und Aufdruck eines individuellen Logos
- Großverpackung in Kartons optimiert für die Lagerabwicklung und den Versand
📦 Verpackung und Logistik
- Verpackung: Standard-Exportkartons (auf Bestellung anpassbar)
- Versandbedingungen: FOB, CIF, DDP verfügbar
- Vorlaufzeit: 15–30 Tage nach Auftragsbestätigung
- Zertifizierungen: ISO 9001, ISO 13485, CE, bei der FDA registrierter Hersteller
✅ Trusted by Global Pharmaceutical Manufacturers
PharGlass hat geliefert high-compliance packaging solutions to leading pharmaceutical companies across North America, Europe, and Asia. Our vials are trusted for their consistency, clarity, and regulatory readiness in global supply chains.
📞 Kontaktieren Sie uns heute
Need samples? Want to discuss custom labeling or regulatory support? Our technical team is ready to assist with product specifications, MOQ negotiation, and bulk orders. Let’s build compliant, globally accepted packaging together.
PharGlass – Engineering Trust for Global Pharmaceutical Markets.
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