Tibor Hlobik

Sr. Director, PFS, Marketing

March 14, 2012

Quality Performance of Advanced Cyclic Olefin Plastic Prefillable Syringes

Tibor Hlobik, Director, Prefillable Solutions and Technologies
Mike Gills, Customer Technical Support Process Engineer

Growth in biopharmaceutical therapeutics is leading innovation with prefillable syringe systems. These complex sensitive drug products require highly inert primary packaging materials for improved stability and delivery in perfect quality for reduced safety risk. This poster will provide a quality comparison of primary prefillable syringe options including glass, coatings/laminates and cyclic olefin polymers, and highlight the findings of a case study comparing 1mL long syringe attributes.

In the case study, syringes were 100% inspected and classified for visual defects.  Filled syringes were measured for quantitative particulate levels (including visible and sub-visible), and subjected to simulated transportation conditions.

Syringes made of glass or plastic contain visual defects that are associated with forming and handling. However, Daikyo Crystal Zenith® syringes showed significantly fewer defects than glass, and there was no incidence of broken flanges, a major defect, as compared to glass. It can be expected that when used for pharmaceutical drug product packaging, Daikyo Crystal Zenith syringe technology can offer a reduced level of incoming rejects and end-of-line rejects associated with 100% inspection, and minimizes the risk associated with the cost of poor quality.

Particulate matter in injectable drug solutions consists of extraneous mobile undissolved particles, other than gas bubbles, unintentionally present in solutions. Both glass and plastic syringes can contribute particulate to filled solutions in subvisible and visible size ranges. On average, filled syringes increase in particle loads after transportation simulation. However, Daikyo Crystal Zenith syringe technology contributes significantly less particulate to filled solutions as compared to glass in both pre- and post-transportation conditions, and is expected to reduce particulate contribution to drug products.

For more information on this study, read the scientific poster.

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