Product

Product Brief: Prefilled Dual Chamber Devices Made of Cyclic Olefin Polymer

 I. Product Introduction

The COP Dual-Chamber Syringe System is manufactured from Cyclo Olefin Polymer (COP) and consists of a dual-chamber barrel, dual pistons, a plunger rod, and a needle shield. Its core design feature is the separate storage of lyophilized powder/drug powder and dedicated diluent within two independent chambers of the same syringe.

During clinical use, pressing the plunger moves the middle piston to the bypass position, allowing the diluent to flow into the front chamber and mix with the drug powder. After dissolution, the mixed solution can be injected directly. This "ready-to-reconstitute" design achieves physical separation of powder and diluent until just before administration.

Specification Range: 0.5ml – 20ml (dual-chamber规格)

Main Components: Dual-chamber barrel, front piston, middle piston, rear piston, plunger rod, needle shield

 1. Material Advantages: COP Polymer

Compared to glass, COP offers significant advantages:

| Feature | COP Material Advantage |

|---------|------------------------|

| Impact Resistance |不易破损， no risk of glass breakage; high transportation safety |

| Protein Adsorption | Extremely low protein adsorption, suitable for protein-based and peptide-based biologics |

| Chemical Resistance | Tolerates extreme pH range (1-14) and various organic solvents |

| Sterilization Flexibility | Compatible with steam, EO, gamma radiation, and electron beam sterilization |

| No Heavy Metal Residues | Contains no metal ions, avoiding interaction with sensitive drugs |

| Transparency | High optical clarity for easy visual inspection |

Compared to glass, polymer materials also eliminate the risk of glass delamination and past drug recalls caused by glass breakage.

 2. Dual-Chamber Structural Advantages

- Extended Drug Stability: Storing unstable biologics as lyophilized powder and reconstituting with diluent immediately before use significantly enhances long-term storage stability.

- Ready-to-Reconstitute, Convenient Operation: Eliminates the complex reconstitution steps required with traditional "vial + syringe" systems, reducing preparation time and contamination risk.

- Reduced Contamination Risk: The closed system minimizes drug exposure to the environment, preventing microbial and particulate contamination.

- Accurate Dosing: Direct injection after reconstitution eliminates transfer losses, ensuring dosing precision.

 3. Regulatory and Market Advantages

- CDE Filing Support: COP prefilled syringes have been approved for market entry in China with CDE registrations.

- Alignment with Industry Trends: Complies with the development direction of high-end, intelligent, and green pharmaceutical packaging as outlined in the "14th Five-Year Plan for Pharmaceutical Industry Development."

- Ready-to-Use Sterility Assurance: Pre-sterilized (SAL 10⁻⁶),可以直接 filling lines, simplifying manufacturing processes.

 III. Typical Applications

| Application Area | Specific Product Examples |

|------------------|---------------------------|

| Biologics | Monoclonal antibodies, vaccines, interferons, peptide drugs |

| Emergency Drugs | Thrombin, glucagon, and other emergency medications requiring reconstitution immediately before use |

| Aesthetic Medicine | Lyophilized powder products for medical aesthetics |

| High-Value Drugs | High-value injectables requiring long-term storage stability |

 IV. Comparison with Glass Dual-Chamber Syringes

| Comparison Item | COP Dual-Chamber Syringe | Glass Dual-Chamber Syringe |

|-----------------|--------------------------|----------------------------|

| Impact Resistance | Excellent,不易破损 | Poor, risk of breakage |

| Protein Adsorption | Extremely low | Relatively high |

| Heavy Metals/Extractables | No heavy metals, very low E&L | Potential metal ion leaching |

| Dimensional Precision | Injection molded, tight tolerances | Tubing process, relatively larger tolerances |

| Sterilization Flexibility | Multiple options available | Limited by glass properties |

| Transparency | High | High |

 V. Important Considerations

- Filling Process Requirements: Filling and assembly of dual-chamber systems are technically complex, requiring dedicated filling lines and stoppering equipment.

- Cost Considerations: The dual-chamber design and COP material entail higher costs than traditional single-chamber glass syringes. However, for high-value biologics, the clinical and commercial benefits are significant.

- Moisture Migration Control: Ensure that moisture from the diluent chamber does not migrate to the powder chamber, which could affect lyophilized powder stability.

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