Sterile Prefillable Cartridges – 1.5ml, 1.8ml, 3ml, 4ml Type I Glass, ISO 13485 & EP 3.2.1 Compliant

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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 Vidrio de borosilicato neutro de tipo I and fully comply with PE 3.2.1, USP, y 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.

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Principales características y ventajas

• ✅ Sterile & Ready-to-Fill (RTF) – SAL 10⁻⁶ via gamma or ETO; load directly into fill-finish lines
• ✅ Vidrio de borosilicato tipo 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
• ✅ Embalaje Nest-Tray – Prevents contact, breakage, and ensures robotic handling compatibility

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Especificaciones técnicas

Parámetro	Especificación
Nombre del producto	Sterile Prefillable Cartridges
Marca	Pharglass
Capacidades	1.5ml, 1.8ml, 3.0ml, 4.0ml (standard); custom volumes available
Tipo de vidrio	Vidrio de borosilicato neutro de tipo I
Conformidad	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)
Silicone Oil	Medical-grade, controlled dosage for optimal glide force
Nivel de endotoxinas	<0.25 EU/ml (as per LAL test)
Formato del envase	Cartridges in rigid nest trays → sealed in double sterile pouches → export cartons
Estabilidad de almacenamiento	Stable from -20°C to +40°C; suitable for cold-chain biologics
MOQ	5,000 pieces
Aplicaciones	GLP-1 therapies, insulin pens, mAbs, biosimilars, wearable injector reservoirs, clinical trial materials

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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 Certificates of Analysis (CoA), sterilization validation reports, y Drug Master File (DMF) assistance for FDA/EMA submissions.

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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

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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.

📩 Póngase en contacto con nosotros for samples, compliance documentation, or a volume quote for your next autoinjector program!