Page McAndrew, PhD.

Director, Scientific Communications

May 08, 2020

Daikyo Crystal Zenith® Cyclic Olefin Polymer – the Right Polymer for Drug Product Packaging

Considering the world of commercial transparent polymers, Daikyo Crystal Zenith® cyclic olefin polymer (COP) clearly stands out – having very good resistance to oxygen/water and compatibility with drug product (it comprises only carbon and hydrogen). Other transparent polymers may suffer limitations, in one or more ways. For example, poly(vinylidene chloride) has outstanding resistance to oxygen/water, but lacks compatibility; sterilization can result in release of HCl. For parenteral drug products, polymer-based containment/delivery systems have many advantages compared to glass.

Daikyo Crystal Zenith Vials

The advantages include:

  • lower risk of interaction with drug (because of lower surface energy)
  • lower risk of pitting/delamination
  • potentially fewer leachables
  • better fracture resistance

And because coefficients of thermal expansion match more closely between rubber/polymer than between rubber/glass, there is lower risk of loss of container closure integrity (CCI) at cryogenic temperatures. In view of the advantages of polymers, the obvious question concerns the best polymer. The requirements are:

  • transparency
  • resistance to oxygen/water
  • compatibility with drug product

These points were considered in detail in the presentation: "Challenges in Low-Temperature Storage of Cell Therapy Drug Products at PepTalk 2020."  Considered also were the O2 and CO2 permeability rates of COP-based containment systems, from room temperature down to -80oC and -180oC. Rates were for the first time quantified; and they were demonstrated in fact to be low. Moreover, these systems demonstrated excellent CCI down to -180oC. These data indicate that COP-based systems should be suitable for a wide range of drug products stored at cryogenic temperatures. For more, contact an Account Manager or Technical Customer Service (TCS) representative.

 

 

 

 

Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd. Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.