Sterile Prefillable Cartridges – 1.5ml, 1.8ml, 3ml, 4ml Type I Glass | ISO 13485 & EP 3.2.1 Compliant
Ready-to-Fill Primary Packaging by Pharglass for Autoinjectors, Pens & Wearable Injectors
Pharglass sterile prefillable cartridges are precision-engineered for next-generation self-injection therapies, including GLP-1 agonists (e.g., semaglutide, tirzepatide), insulin, monoclonal antibodies, and high-viscosity biologics. Disponible en 1.5ml, 1.8ml, 3ml, and 4ml capacities, these cartridges are made from Verre borosilicaté neutre de type I and fully comply with EP 3.2.1, USP, et ISO 13485 quality standards—ensuring the highest level of chemical inertness, dimensional accuracy, and patient safety.
Each cartridge is gamma or ETO sterilized to SAL 10⁻⁶, pre-assembled with a medical-grade bromobutyl plunger, and packaged in nest trays within double sterile pouches, making them true ready-to-fill (RTF) components. This eliminates in-house cleaning, depyrogenation, and sterilization—reducing contamination risk, operational costs, and time-to-market for drug-device combination products.
Designed for seamless integration with leading autoinjector and pen platforms (including Ypsomed, Owen Mumford, Haselmeier, and SHL Medical), Pharglass cartridges deliver consistent glide force, low protein binding, and reliable dosing performance.
Principales caractéristiques et avantages
- ✅ Sterile & Ready-to-Fill (RTF) – SAL 10⁻⁶ via gamma or ETO; load directly into fill-finish lines
- ✅ Verre borosilicaté de type I – EP 3.2.1 / USP <660> compliant; ideal for sensitive biologics
- ✅ Multiple Volumes – 1.5ml, 1.8ml, 3ml, 4ml to support diverse therapeutic needs
- ✅ ISO 13485 Certified Manufacturing – Full quality management for medical device components
- ✅ Low Particulates & Controlled Silicone – Minimizes aggregation in high-concentration formulations
- ✅ Nest-Tray Packaging – Prevents contact, breakage, and ensures robotic handling compatibility
Spécifications techniques
| Paramètres | Spécifications |
|---|---|
| Nom du produit | Sterile Prefillable Cartridges |
| Marque | Pharglass |
| Capacités | 1.5ml, 1.8ml, 3.0ml, 4.0ml (standard) ; volumes personnalisés disponibles |
| Type de verre | Verre borosilicaté neutre de type I |
| Conformité | EP 3.2.1, USP <660>, ISO 13485, ISO 11040-4 (dimensional), YBB00292005-2-2015 |
| Sterilization | Gamma (25 kGy) or Ethylene Oxide (ETO), validated to SAL 10⁻⁶ |
| Plunger | Coated or uncoated bromobutyl rubber (low extractables) |
| Huile de silicone | Medical-grade, controlled dosage for optimal glide force |
| Niveau d'endotoxines | <0.25 EU/ml (as per LAL test) |
| Packaging Format | Cartridges in rigid nest trays → sealed in double sterile pouches → export cartons |
| Storage Stability | Stable from -20°C to +40°C; suitable for cold-chain biologics |
| MOQ | 5 000 pièces |
| Applications | GLP-1 therapies, insulin pens, mAbs, biosimilars, wearable injector reservoirs, clinical trial materials |
Why Global Pharma Trusts Pharglass RTF Cartridges
In the era of high-value injectables, container quality directly impacts drug stability, patient comfort, and regulatory approval. Pharglass addresses critical challenges:
- Protein aggregation? → Ultra-smooth glass surface + low silicone migration
- Dosing inconsistency? → Tight tolerance on OD, length, and tip concentricity
- Supply chain delays? → Dedicated RTF production lines with scalable capacity
Our facility operates under ISO 13485 with full documentation support—including Certificats d'analyse (CoA), sterilization validation reports, et Drug Master File (DMF) assistance for FDA/EMA submissions.
Customization & Partnership
We support your unique drug-device needs with:
- Custom tip geometries (Luer lock, staked needle interface, etc.)
- Plunger coating optimization for viscous drugs
- Laser etching or barcoding for serialization
- Regulatory dossier collaboration
From molecule to patient—delivered with precision.
Pharglass sterile prefillable cartridges empower innovators to bring life-changing injectable therapies to market faster, safer, and more reliably.
📩 Contactez-nous dès aujourd'hui for samples, compliance documentation, or a volume quote for your next autoinjector program!
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