The Market’s First Silicone-Oil-Free Syringe System
Pharmaceutical and biopharmaceutical companies face major challenges getting their drug products through the development and regulatory approval process with a minimum of risk to the drug and its benefit for patients. Recent market recalls have been caused by glass breakage, delamination and particulate. These issues could adversely affect the health of patients and create a serious financial burden on the drug manufacturer. A clear solution for mitigating risk is the Daikyo Crystal Zenith RU (ready to use), silicone-oil-free prefillable syringe system.
The Daikyo Crystal Zenith RU prefillable syringe system is ideally suited for packaging and administering large-molecule biopharmaceuticals and vaccines, among other candidates.
The Daikyo Crystal Zenith prefillable syringe system can:
- Help keep packaged drugs pure by reducing exposure to extractables and silicone oil, which minimizes potential leachables in the drug product
- Reduce the risk of protein aggregation caused by silicone oil in the drug product
- Provide consistent piston release and travel forces
- Reduce adsorption and improve drainability
- Help reduce returns and in-process clean-ups caused by broken glass
- Eliminates issues related to delamination and contamination from glass particulate
The Crystal Zenith prefillable syringe system includes a piston and nozzle cap with Daikyo Flurotec® barrier film on the drug contact surfaces. Flurotec film provides an effective barrier against organic and inorganic extractables and it imparts lubricity, so there is no need to apply free silicone oil to the syringe barrel or piston to enhance the syringe system’s functionality.
The silicone oil used in syringes currently on the market can transfer to the drug product, a cause of protein aggregation and a possible source of immunogenicity risk, which can lead to product returns and potential patient safety issues.
The syringe barrel is manufactured from Daikyo’s proprietary Crystal Zenith, a cyclic olefin polymer that is market-proven in Japan, Europe and the United States. The material can be autoclaved at 121 ºC and has excellent low-temperature characteristics.
Daikyo Seiko, Ltd. manufactures the Crystal Zenith prefillable syringe system at its facility in Japan using automated, world-class processes in a clean room environment. The components are vision inspected for a virtually defect-free product. Daikyo and West worked together to develop a packaging system that is appropriate for introducing the sterile pistons and syringe barrels directly into aseptic and barrier isolator filling lines as ready-to-use system components.
Read West’s scientific poster, “Detecting Siliceous Flakes in Glass Containers using Microscopic Techniques” or visit Tech News & Views for more detailed information about siliceous flakes. In addition, the West Podcast Series discusses the topic. Click here to listen. Visit www.WestPFSsolutions.com for additional information and solutions.