Vials

ZEONEX^® and ZEONOR^® Cyclo Olefin Polymers

Medical-grade Polymer Resin Delivers

Zeon's Cyclo Olefin Polymer (COP) enables vials with exceptional strength over a range of storage conditions, along with low moisture permeability and low risk of contamination from extractables and leachables. Medical-grade resins ZEONEX^® 690R, 790R, 5000 and ZEONOR^® 1020R have been assessed for compliance with USP Class VI and <661.1>, ISO 10993, in addition to JP and EU standards. Drug master file information available upon request.

COP Details

Durability

ZEONEX^® and ZEONOR^®Cyclo Olefin Polymer (COP) provides drop and impact-resistance for Pharmaceutical primary packaging. Vials made of ZEONEX^® and ZEONOR^® exhibit superior impact strength compared to glass and maintain impact strength even at cryogenic temperatures (-194 ^oC). There is little to no change in ZEONEX^® and ZEONOR^® mechanical properties post-sterilization.

Bar graph on the Impact strength from Liquid to room temperature X-axis: Temperature (Celsius) Y-axis: Charpy impact strength (KJ/m2)

Inert and Non-Reactive

ZEONEX^® and ZEONOR^® COP provides enhanced compatibility for minimal interaction with biopharmaceuticals. Unlike glass, ZEONEX^® and ZEONOR^® has a lower surface energy and hydrophobic properties that reduce protein binding. Compared to other commonly-used plastics for pharmaceutical packaging, ZEONEX^® and ZEONOR^® COP is extremely pure and has low residual metal content, which helps reduce contamination risk. Vials made of ZEONEX^® and ZEONOR^® COP are compatible with many organic solvents used to stabilize biopharmaceutical reagents.

Moisture Permeability

Compared to other plastics, ZEONEX^® and ZEONOR^® COP has a low water vapor transmission rate (WVTR). ZEONEX^® and ZEONOR^® COP vials provide an exceptional moisture barrier, maintaining the efficacy of sensitive pharmaceutical formulations by preventing evaporation and moisture-related degradation.

Sterilization

Vials and other parenteral packaging applications benefit from ZEONEX^® and ZEONOR^® COP’s compatibility across various sterilization methods. The material is suitable for autoclave/steam*, EtO, and Gamma irradiation, sterilization methods. and there is little to no impact on its mechanical properties.

*Grades ZEONEX^® 690R and 790R are compatible with steam/autoclave sterilization.

Industries

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