Medical Grade Cyclo Olefin Polymer

Zeon COP Pellets falling on a grey background

Medical Grade ZEONEX^® and ZEONOR^® Advantages

Compliant with USP class VI and <661.1>, ISO 10993, and various Pharmacopeia regulations (EP, JP), ZEONEX^® and ZEONOR^® Medical and Pharmacopeia Grade resins, made of Cyclo Olefin Polymer (COP), are the ideal choice for pharmaceutical drug storage and drug delivery devices.

Superior drop resistance vs. glass
Mechanically tough and durable, even at cryogenic temperatures
Low protein adsorption
Low moisture permeability
High purity
Compatible with a range of sterilization methods
FDA Drug Master File (DMF) available upon request

Durable from cryogenic to steam sterilization

Medical Grade ZEONEX^® and ZEONOR^® have superior impact strength over a wide range of temperatures. Compared to polypropylene (PP) and COC, ZEONEX^® and ZEONOR^® Cyclo Olefin Polymer are durable even at cryogenic conditions (-194 ^oC), providing dependable protection for pharmaceuticals during cold-chain storage. ZEONEX^® and ZEONOR^® are also mechanically tough and can withstand increased stress from viscous drug formulations and auto-injector devices.

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

Purity

ZEONEX^® and ZEONOR^® contain less-than-detectable residual metals and no additives or process aides. Compared to conventional barrier polymers, materials packaged using ZEONEX^® and ZEONOR^® have very low risk of contamination from off-gassing or extractables.

Low Moisture Permeation

ZEONEX^® and ZEONOR^®'s high moisture barrier property contributes to stable drug concentrations and longer shelf life of moisture sensitive pharmaceuticals.

Low Protein Adsorption

ZEONEX^® and ZEONOR^®’s low surface energy of 26 mN/m minimizes protein adsorption, resulting in lower aggregation compared to glass surfaces. The inert surface helps maintain the stability and safety of peptide and protein-based pharmaceuticals.

Sterilization compatible

ZEONEX^® and ZEONOR^® are compatible with Gamma, EtO, vaporized hydrogen peroxide (VHP) and steam sterilization*, providing flexibility for selecting the best sterilization method for the specific application. *Grades ZEONEX® 690R and 790R are compatible with steam sterilization

Technical Highlights

	Unit	Test	ZEONEX^® 690R	ZEONEX^® 790R	ZEONOR^® 1020R	ZEONEX^® 5000
Pharmacopeia registerred			Yes	Yes	Yes	Yes
Properties
Melt flow rate (MFR) (280 ⁰C, 21.18 N)	g/10min	JIS K719, ISO 1133	16.9	6.7	19.6	8.4 (230 ⁰C)
Glass transition temperature (Tg) (20 ⁰C/min)	⁰C	JIS K7121	136	161.7	101.7	68.9
Deg. of light transmission (t = 3mm)	%	ASTM D1003	91.5	91.5	91.5	91.4
Sterilization Compatibility
Ethylene Oxide			Yes	Yes	Yes	Yes
Gamma irradiation			Yes	Yes	Yes	Yes
Steam / autoclave			Yes	Yes	No	No
Vaporized hydrogen peroxide			Yes	Yes	Yes	Yes
Pharmaceutical Storage Compatibility
Surface reactivity			Inert	Inert	Inert	Inert

Applications

Engineered to Perform

syringe-injection pen or insulin cartridge pen

Pre-Filled Syringes

Injectable delivery devices from ZEONEX^® and ZEONOR^® offer excellent durability – during molding, filling, storage, and use by medical professionals.

Vials

Vials made of ZEONEX^® and ZEONOR^® Medical Grade Cyclo Olefin Polymer offer low protein adsorption, shatter-resistance, and excellent moisture barrier protection.

A woman adjusting her wearable drug delivery system on her arm

Wearable Drug Delivery Devices

Shatter-resistant and lightweight, ZEONEX^® and ZEONOR^® offer superior drug stability with the ease to mold geometries and enable features not possible with other plastics.

Certifications

Our certifications affirm our commitment to Quality and Compliance. Our factories are certified for ISO 9001 and 14001, representing world-class standards for Quality and Environmental considerations. Our Medical Grade ZEONEX^® and ZEONOR^® Cyclo Olefin Polymer resins are compliant with USP Class VI and <661.1>, with FDA Drug Master Files available upon request, representing our commitment to providing materials that meet the strictest performance standards for pharmaceutical packaging.