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Pharmaceuticals

ZEONEX® Cyclo Olefin Polymer (COP) allows for advanced break-resistant pre-filled syringes, vials, and devices.  Common applications include parenteral and lyophilized biopharmaceuticals, high-viscosity drugs, hyaluronic acid, as well as contrast media.

Key attributes:

A broad range of ZEONEX grades are available.
TechConnect

TechConnect puts you in direct contact with a ZEON engineer who has the expertise in pharmaceutical applications to answer your technical questions and suggest which Cyclo Olefin Polymers (COP) grade will work best to meet your product needs.

The Gold Standard of High-Purity Plastic

High Purity/Low Offgassing

ZEONEX Cyclo Olefin Polymer (COP) medical grades are an extremely pure resin containing less-than-detectable residual metals or process aides. Compared with conventional barrier polymers, pharmaceuticals packaged using ZEONEX Cyclo Olefin Polymer (COP) have significantly reduced risk of contamination from off-gassing or extractables.

Low Protein Adsorption

ZEONEX Cyclo Olefin Polymer (COP) is optimal for long-term storage of protein- and peptide-based drugs where there is concern of protein adsorption, as found with glass and polypropylene (PP). ZEONEX Cyclo Olefin Polymer (COP) does not contribute to the pH shift of the diluent, often observed with glass, thus reducing the chance of protein agglomeration.

BSA, Lysozyme Comparison (Zeonex, polypropylene): cyclo olefin polymer is low protein binding; good long term drug storage.

Glass-Like Transparency

The ability to visually check the level and quality of drugs during quality inspection and injection/dispensing is critical. ZEONEX Cyclo Olefin Polymer (COP) provides high clarity and low haze for crystal-clear viewing of package contents, or, when used in multilayer packaging, can help improve the optical characteristics of the package.

Low Moisture Permeation

ZEONEX Cyclo Olefin Polymer (COP) has high moisture barrier property compared with that of conventional polymers, which promotes stability of reagent concentrations and provides longer device shelf life of moisture-sensitive compounds.

High-Precision Molding

ZEONEX Cyclo Olefin Polymer: high-precision molding, great clear medical plastic as a drug delivery device.ZEONEX Cyclo Olefin Polymer (COP) is suitable for use in precision injection-molded applications such as syringes and other drug delivery devices for prefilled drug storage. And, for vials and bottles, ZEONEX Cyclo Olefin Polymer (COP) is suitable for blow-molded packaging using conventional molding equipment.

Sterilization-Compatible

ZEONEX is compatible with all conventional means of sterilization, with little impact to mechanical properties.
ZEONEX Cyclo Olefin Polymer Unit Initial Steam EOG Gamma EB
Light transmission %, 3mm 91.7 92.1 91.9 87.1 88.1
Yellow index   0.37 0.47 0.49 2.45 1.64
Haze % 0.4 0.4 0.5 0.4 0.4
DuPont® impact test J 21.7 20 23.7 22.7 22.7
Tensile strength MPa 63 70 63 63 63
Tensile elongation % 100 50 100 100 100
Steam sterilization resistance of ZEONEX Cyclo Olefin Polymer
ZEONEX 690R Initial 1 cycle 3 cycles 5 cycles
% Transmission 91.7 92.1 92 91.6
Yellow Index 0.4 0.4 0.5 0.7
% Haze 0.37 0.47 0.69 1.04

Break-Resistant

ZEONEX Cyclo Olefin Polymer (COP) is ideal for drug storage devices for which there is risk of breakage during filling, transit or use. Break-resistance of Cyclo Olefin Polymer (COP) is maintained at cold storage temperatures.

Global Regulatory Status

Medical Grades Regulatory Status Test Results
ZEONOR 1020R
ZEONEX 5000
ZEONEX 690R
ZEONEX 790R
Japan Pharmacopoeia Plastic Containers for Pharmaceutical Products Pass
US Pharmacopoeia USP <88> Class VI Biological Reactivity Tests In-Vitro for Plastics, Systemic Injection, Intracutaneous Injection, Muscle Implantation Test Pass
USP <87> Biological Reactivity Test In-Vitro (MEM Elution) Pass
USP <151> Pyrogen Test with Rabbits Pass *
European Phamocopoeia 3.1.5. Polyethylene with additives for container for preparations for parenteral use and for opthalmic preparations Pass
ISO 10993 10993-4 Haemolysis Test Pass
10993-5 Cytotoxicity Test-Elution Method Pass
10993-6 Intramuscular Implant in the Rabbit Pass +
10993-10(a) Skin Irritation to the Rabbit Pass +
10993-10(b) Skin Sensitization to the Guinea-Pig Pass +
10993-11 Acute Systemic Toxicity to the Mouse Pass +

Chemical Resistance Chart for ZEONEX / ZEONOR medical grade polymers

Acid, Acetic 99% Good
Acid, Hydrochloric 35% Good
Acid, Sulfuric 95% Good
Alcohol, Ethyl Good
Alcohol, Iso-propyl Good
Alcohol, Methyl Good
Ammonia, 28% Good
Camphor Good
d-Limonene Poor
DMF(N,N-dimethylformamide) Good
DMSO Good
Formamide, 50% Good
Glycerine Good
Glycol, Polyethylene (PEG4000S, 50%) Good
Hyaluronic Acid Good
Hydrogen Peroxide, 30% Good
Iodine Solution Good
Ketone, Acetone Good
Ketone, Methyl Ethyl (MEK) Use with caution
Lipids / Fatty Acids Poor
m-Cresol Good
Menthol Good
Methysalicylic Acid Good
Oil, Fluorinated Good
Oil, Hydrocarbon Poor
Oil, Vegetable Poor
Silicon oil, Dimethylpolysiloxane Good
Silicone oil, Di-methyl Phenyl Use with caution
Silicone oil, Methyl Phenyl  Good
Soap, liquid type Good
Sodium Chloride solution (Saline) Good
Sodium Hydroxide solution Good
Tween 20 10% solution Good
Tween 80 10% solution Good
Urea, 50% Good

ZEONEX/ZEONOR Grade Review for Medical Applications

ZEONEX Grade Tg (°C) MFI (g/10min) Transmission (%) Moisture Absorption Sterilization Processing MSDS
ZEONEX 5000 69 9* 92 <0.01 EOG, Gamma, peroxide Injection blow molding and film extrusion MSDS for Zeonex 5000
ZEONOR 1020R 102 20       Injection and blow molding MSDS for Zeonor 1020R
ZEONEX 690R 136 17     Steam, EOG, Gamma, peroxide Injection blow molding and film extrusion MSDS for Zeonex 690R
ZEONEX 790R 163 6       Injection and blow molding MSDS for Zeonex 790R

TechConnect puts you in direct contact with a ZEON engineer who has the expertise in pharmaceutical applications to answer your technical questions and suggest which Cyclo Olefin Polymers (COP) grade will work best to meet your product needs.

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