In the past decade, Cyclo Olefin Polymer (COP) and Cyclo Olefin Copolymer (COC) based syringes, cartridges, and vials have attracted ever increasing attention from the pharma industry as a valid transparent plastic alternative to glass made primary drug containers. The main application focus is with injectable parenteral drugs, especially modern biopharmaceuticals. With ZEONEX® and ZEONOR®, ZEON offers fully amorphous and highly transparent thermoplastic resins. The balance of outstanding water barrier properties in combination with high purity, excellent chemical resistance, high transparency and no interaction with drugs, put ZEONEX® and ZEONOR® as a perfect alternative to glass or other plastics solutions for vials, syringes and other customer designed drug containers.
Regulatory Status
ZEON have four certified COP grades with medical/pharmaceutical approvals. Each grade has its own Type III Drug Master File registration, passes actual EU-, US- and JP-Pharmacopoeia requirements and selected chapters of ISO 10993 Biocompatibility. ZEONEX® and ZEONOR® provide the extremely low extractables and leachables levels needed for containers like prefilled syringes or cartridges (carpoules).
Resistance to Drugs
Due to the non-polar, hydrophobic and non-reactive surface nature of ZEONEX® and ZEONOR®, there will be no interaction with the pharmaceutical drugs inside the prefilled container. Typically, the adsorption of proteins or other biomolecules to ZEONEX® and ZEONOR® surface is very small compared to glass. Such adsorption can change the API concentration in the drug formulation. The trend towards new protein based pharmaceuticals, produced by modern biopharmaceutical methods, pushes the use of alternative packaging materials like ZEONEX® and ZEONOR® as first choice. ZEONEX® and ZEONOR® can be sterilised utilising steam autoclave, electron beam, gamma radiation and ethylene-oxide gas. Other handling benefits of ZEONEX® and ZEONOR® versus glass include their low specific weight and excellent shatter resistance.
A number of leading syringe and vial suppliers offer fully commercial RTU or RTF standard container designs made from ZEONEX® and ZEONOR®. A recent development is the introduction of multilayer vials to market. These constructions combine the excellent water barrier of ZEONEX® and ZEONOR® with high oxygen barrier and additional mechanical strength from other polymers like polyamides. Another big benefit of plastics containers versus glass containers is the freedom of design. Therefore ZEONEX® and ZEONOR® is very well suited for the development of fully customized drug cartridges in auto-injectors , pens and other injection devices.
Commercial refillable ZEONEX® syringes of various sizes
Analytical/Diagnostical Application
High transparency in UV-wavelength range and very low autofluorescence of ZEONEX® and ZEONOR®, makes them highly desirable for cuvettes, High Throughput Screening (HTS) microplates or biochips in analytical/diagnostics applications. Microfluidic arrays benefit from the excellent mouldability and precise transcription of microscopic structures, achieved with ZEONEX® and ZEONOR®.
Specialty Materials by ZEON
ZEON Corporation, headquartered in Tokyo/Japan, is a leading and globally operating, Specialty Polymer company. As part of its Specialty Materials operations, Zeon manufactures and sells Cyclo Olefin Polymers under the brand names ZEONEX® and ZEONOR®. Since the establishment of ZEON Corporation in 1950, the company has consistently taken advantage of its original technologies and created numerous unique products. Based on own C4 and C5 extraction technologies ZEON developed an integrated production system and is striving to create new products and new business areas by utilizing these core technologies. ZEONEX® and ZEONOR® polymers are prominent examples of how Zeon core competencies has established leadership in both major and niche markets around the world. ZEON Europe GmbH in Düsseldorf/Germany is the European marketing/sales organisation.
More detailed information about ZEONEX® and ZEONOR® properties and applications is available at www.zeonex.com
