Quality Solutions Mitigate Total Cost of Ownership
In an earlier post, I discussed how the changing market, regulatory expectations and quality issues have an impact on a pharmaceutical manufacturer’s total cost of ownership.
There are a variety of solutions that are currently available to aid with these issues, and thus lower the total cost of ownership. For example, modern polymeric materials can be considered for primary packaging. In addition, the manufacture and processing of such polymers allows for flexibility in molding and forming throughout a drug product’s lifecycle. This means the drug can be contained in the same material from development through commercialization, which may lower evaluation costs.
High-quality components can also make a difference. Primary container closure systems typically consist of a vial, stopper and seal. Selecting a vial made from a cyclic olefin polymer, such as the Daikyo Crystal Zenith® polymer, and a high-quality, ready-to-use component that has been through optimized washing, sterilization and automated vision verification processes can combat issues from particulate and extractables. Administration systems can be developed using the same combination of materials. The key is to develop a delivery system based on the needs of the patient.
West is always working to find new and innovative solutions to our customers’ needs, and in April, we will introduce a new, high-quality line of elastomeric components that have been developed using Quality by Design principles. Check back with us often for more information.