Product

Product Introduction

 COP Vials (Cyclo Olefin Polymer Vials for Injection)

**FDA Product Name**: Cyclo Olefin Polymer Vials for Injections

**DMF Number**: 038475

 Product Description

This product is manufactured from medical-grade Cyclo Olefin Polymer (COP) using an injection-blow molding process, specially designed for packaging injectables, biological preparations, and high-value pharmaceuticals. The vials feature excellent optical clarity and low protein adsorption, suitable for lyophilization, refrigerated storage, and ambient temperature storage.

Core Advantages

- **High Transparency & Low Birefringence**: Facilitates visual inspection of particles or precipitates in drug solutions with no polarized light interference.

- **Extremely Low Extractables & Leachables**: Free of metal ions and halogens, preventing interactions with sensitive drugs such as proteins and nucleic acids.

- **Chemical & Cryogenic Resistance**: Resistant to chemicals within pH 1–14 and various organic solvents, and can withstand cryogenic freezing at -196°C in liquid nitrogen.

- **High Shatter Resistance**: More impact-resistant than glass vials, reducing breakage risks during transportation.

- **Suitable for Aseptic Filling**: Compatible with gamma irradiation, electron beam, and ethylene oxide (EO) sterilization without discoloration or degradation.

 Applications

High-value injectables including monoclonal antibodies, vaccines, blood products, liposomes, and CGT (Cell and Gene Therapy) pharmaceuticals.

For further technical parameters or sample support, please contact us to access the specification sheet corresponding to our FDA registration number (038475).