Description
Advanced COP Prefilled Syringe (PFS) Series
- The BH0400-P01 is a high-performance prefilled syringe (PFS) crafted from premium Cyclic Olefin Polymer (COP). Available in 1mL Long and 2.25mL capacity options, this series is designed to overcome the limitations of traditional glass. It offers exceptional shatter resistance and maintains superior drug stability through high resistance to pH variations, ensuring no delamination during storage.
- Engineered for sensitive biologics, these COP syringes feature excellent barrier properties against water vapor and oxygen permeation. The material’s low protein adsorption characteristics and purity—being free from heavy metal ions and tungsten residue—make it ideal for high-value medications. Every unit is produced in a GMP-managed Class 100 cleanroom, adhering to ISO 9001 and ISO 13485 regulatory standards.
- For manufacturing flexibility, the series supports both Ethylene Oxide (EO) and Steam sterilization. Delivered in a standard Nest & Tub packaging configuration, the BH0400-P01 integrates seamlessly into automated filling lines. This platform provides pharmaceutical manufacturers with a reliable, high-clarity, and chemically inert primary packaging solution for modern clinical applications.
| Category | Technical Specifications | Details |
|---|---|---|
| Material & Design | Primary Material | Cyclic Olefin Polymer (COP) |
| Connection Type | Standard Luer Lock | |
| Visual Clarity | High Transparency | |
| Performance | Drug Stability | Exceptional pH resistance; No delamination |
| Barrier Properties | High barrier against water vapor and oxygen permeation | |
| Adsorption | Low protein adsorption | |
| Chemical Safety | Purity | Metal-free and Tungsten-free; No flake generation |
| Lubrication | Low siliconization or non-siliconized options | |
| Manufacturing | Quality Standards | ISO 9001, ISO 15378, YBB, USP Class VI |
| Sterilization Compatibility | Ethylene Oxide (EO) and Steam sterilization | |
| Customization | Flexible design and precise dimension control |

| Category | Technical Specifications | Details |
|---|---|---|
| Design Versatility | Customization | Customizable external shapes and standard/bespoke colors |
| Compatibility | Optimized for high-speed automated filling lines | |
| Ergonomics | Specialized plunger cavity design for smooth delivery | |
| Security | Supports syringe round or cut-flange anti-rotation valves | |
| Primary Applications | Biopharmaceuticals | GLP-1 agonists, Hormones, Monoclonal Antibodies |
| Specialized Medicine | Ophthalmic applications, Emergency medicine, Vaccines | |
| Aesthetics & Device | Medical Aesthetics and Auto-injector integration |
Related Tags: COP prefilled syringe, Cyclic Olefin Polymer PFS, break-resistant medical syringe, Class 100 cleanroom manufacturing.
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