CONCERNS WITH PLASTIC
BioPharm: What are the primary concerns with using plastic?
Waller (SCHOTT): Concerns are scratch sensitivity, inferior barrier against oxygen and water vapor, and limited long-term experience. A polymer
could be scratch-sensitive if it is not handled more delicately than glass. It is important to keep in mind that scratches
are not only a cosmetic defect but can also impair camera inspection. Furthermore, polymers do have challenges in the area
of barrier protection against oxygen and water-vapor permeation, and this could pose a problem for certain drugs. Glass has
been around much longer, and leading companies have a wealth of knowledge on how it interacts with certain medications. So
it really boils down to understanding and selecting the material that suits a specific application most effectively.
Reynolds (West): Glass is a traditional packaging material in the pharmaceutical industry. It has been used for many years, and any novel
material presents a potentially risky change in a market that is extremely risk-adverse. However, there are more than 20 products
that have been approved and are currently on the market in systems using cyclic olefin polymer (Daikyo Crystal Zenith, developed
by Daikyo Seiko and sold by West and Daikyo Seiko). Many other products are available in a variety of plastic materials from
other manufacturers. Plastic is not a new material for drug packaging, but for many applications, such as biologics, there
is still a concern about the number of products that are approved in plastic.
In addition, there are features of plastic that are different than glass. As an example, oxygen permeability of polymers is
typically inferior to glass, and manufacturers must evaluate packaging options on a drug-by-drug basis to ensure that if a
product is oxygen-sensitive, proper care is used to select appropriate packaging systems.
In all cases, it is important to understand the needs of the integrated drug-delivery system and evaluate appropriate solutions.
When working with a company on high-value or sophisticated biologic products, we may recommend a polymer as an alternative
to be evaluated alongside glass. Given what we know about the limitations of glass, it is important to evaluate alternatives
based on the drug product, including in what format it will be used (e.g., vial or syringe and whether the primary container
will be used within a device). We would make a recommendation to our customers based on the most appropriate packaging solution
for their product.