Daikyo Crystal Zenith® - A unique plastic material for the total life-cycle containment of high value biopharmaceuticals
Daikyo Crystal Zenith is an ideal material for drug containment systems. Crystal Zenith’s unique physical and chemical properties can help solve the challenges of storing and administering biopharmaceutical drug products. Daikyo Crystal Zenith bulk storage containers, vials, prefillable syringes and cartridges represent the ideal solution of the total life-cycle containment of high-value biopharmaceutical drugs. All primary packaging components, including the nest, tub and tray, and secondary packaging components are manufactured in an ISO 7 (class 10.000) clean room environment with virtually no human contact during manufacturing, leading to ultra-low levels of particulate matter. In addition, all Daikyo Crystal Zenith products and corresponding elastomeric components are 100 percent vision inspected prior to release.
Daikyo Crystal Zenith provides an impressive array of physical and chemical properties that are attractive to drug manufacturers:
- High heat resistance: Daikyo Crystal Zenith products are autoclavable
- Excellent low temperature characteristics, including tolerance of freeze drying and liquid nitrogen exposures
- Excellent drainability: Daikyo Crystal Zenith offers a non-wettable surface with low surface energy and contact angle of 80°, compared to 7° for glass
- High break resistance
- High transparency
- Low extractables: Daikyo Crystal Zenith has virtually no metal extractables
- Solvent resistance
- Wide pH range, from 2 to 12
- Easy, safe, environmentally friendly disposal: all products can be incinerated, leaving virtually no ash
Daikyo Crystal Zenith Bulk Containment Systems
Daikyo Crystal Zenith bulk containers represent a safe and secure storage system for high-value drug substances and active pharmaceutical ingredients (APIs). Optimized elastomeric formulations used as integrated liner within the lid allow for low temperature storage of valuable solutions. Daikyo Crystal Zenith 8mL and 1-liter bulk containers are available as sterilized ready-to-use products.
Daikyo Crystal Zenith Standard and Conical Vials
Daikyo Crystal Zenith vials provide an excellent storage system for sensitive drug compounds. Ultra-low extractable profiles assure long-term stability of drugs. Conical shaped vials are the ideal storage system for small volume, high-value biopharmaceutical compounds, as the hydrophobic nature of the Crystal Zenith material provides ideal drainability. Daikyo Crystal Zenith standard 2mL and 5mL vials are available as sterilized ready-to-use products.
Daikyo Crystal Zenith Syringe Systems
Daikyo Crystal Zenith syringe systems represent the current best-in-class solution for storage of high-value biopharmaceutical compounds, specifically for sensitive proteinaceous solutions. The unique combination of the cyclic olefinic polymer-based Daikyo Crystal Zenith material with Daikyo Flurotec® laminated elastomeric components provides a silicone oil free syringe system that can significantly reduce the occurrence of protein aggregation. As a result, Daikyo Crystal Zenith syringe systems can help reduce product reject rates.
Daikyo Crystal Zenith syringe systems are available or in development in the following formats: 0.5mL Luer Lock, 1mL Luer Lock, 1mL standard inserted needle, 1mL long inserted needle and 5mL Luer Lock. Most systems can be provided in convenient sterilized ready-to-use presentations. Samples of all sizes are available.
Daikyo Crystal Zenith® and Daikyo Flurotec® are registered trademarks of Daikyo Seiko, Ltd.