APR September/October 2020 - 135

lower leachables, particles and resistance to hydrolytic attack compared
to glass. This is just an overall better product.

There are other primary container options on the
market such as Schott Type I Plus, which is a pure
glass coating on borosilicate glass that eliminates
ion migration. Why has this option not become
more mainstream in the marketplace?
Because it only addresses a niche need in the marketplace. For drugs that
have sensitivity to metal ions due to chelation, such as zoledronic acid...
this could be a good option. However, it does not solve all the other
problems that are omnipresent with glass. Borosilicate glass containers
are prone to chipping and breakage and are far more dimensionally
variable than plastic containers, which can compromise sealing integrity.
These shortcomings are not overcome by incorporating a coating layer
on glass containers. SiO2's hybrid containers combine the best features
of glass and the best features of plastic with none of the shortcomings.
In addition, the coating applied to the inside surface of the container is
engineered to be chemically consistent and uniform. The coating can be
optimized for the specific drugs to ensure drug stability over the shelf life.

glass to reduce the occurrence of breakage, as with chemically
strengthened aluminosilicate glass or Valor glass, ...it can still break.
Look no further than the protective gorilla glass on everyone's
mobile phone. This is in principle the same material...it breaks!

What makes SiO2 technology so attractive to the
US government that they have invested
$143 million in their primary containers for the
eventual launch of COVID-19 vaccine
Besides the performance advantages of SiO2 technology, there
are a few key things that differentiates SiO2. The most obvious is
securing a US source of primary containers since most of the supply
is overseas. SiO2 manufacturing is based in Auburn, Alabama.
Second, there has been ongoing concerns of a glass shortage
due to the vacuum of demand from COVID-19 vaccine developers
and the existing biologic drug market that continues to grow.
The glass-like material that's inside each SiO2 container is derived
from raw materials that have no ties to the glass supply chain. Its
more closely related to raw materials used in the manufacture of

There are new and improved glass options on
the market that claim to improve breakage and
chemical resistance that leads to delamination.
What is the future for this glass?

microelectronic devices and silicone polymers. Lastly, the ability to

Again, it addresses a segment of the market, but is still burdened
with inherent issues. Despite improvements in the strength of

4 months to add that capacity due to the inherent flexibility and

scale-up SiO2 technology is unmatched compared to traditional
glass manufacturing. In a very short time, 80 million units of vial
manufacturing capacity is already on-line in Auburn, Alabama and
another 50 million coming on-line in December. It only takes 3 to
design of their manufacturing unit operations.

www.americanpharmaceuticalreview.com

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APR September/October 2020

Table of Contents for the Digital Edition of APR September/October 2020
