Plastic is a relatively new material for parenteral containers. BioPharm International spoke with Graham Reynolds, vice-president of marketing and innovation of Pharmaceutical Delivery Systems at West Pharmaceutical
Services and Gary Waller, North American vice-president of sales and marketing for SCHOTT Pharmaceutical Systems, to gain
insight on the drivers for and concerns with use of plastic in vials and syringes.
Photo Credit: Maria Toutoudaki/Getty Images
TRENDS IN PARENTERAL CONTAINERS
BioPharm: Do you see a trend toward using plastic instead of glass in parenteral containers, such as syringes and vials?
Reynolds (West): There has been a trend toward the use of plastic for primary containment for pharmaceuticals and biopharmaceuticals for many
years. The primary market change has been in Japan, where estimates suggest that 60–70% of all prefilled syringes in the Japanese
market are plastic, rather than glass. The trend has been driven by increasing demand for higher quality products that will
reduce breakage and increase functionality.
Issues with glass breakage and delamination are also causing concern in the marketplace. Glass can break at any time: in production,
when used within a device such as an auto-injector, or even when in use by the patient or caregiver. Breakage in production
or in the final product may cause loss of sterility of the drug product and hazards to patients and caregivers. With the increasing
use of devices as part of a combination product, a glass container may not be visible, resulting in concerns about breakage
when a device is dropped and a tendency to err on the side of caution. For example, patient instructions may suggest an auto-injector
should be discarded if dropped, due to the risk of glass breakage.
Although Japan has led the way in adopting plastic as a primary container, there has been increased interest from Europe and
the United States in use of plastic instead of glass. Recent surveys have placed interest in plastic at different levels,
but it is West's understanding that the majority of pharmaceutical and biopharmaceutical companies are at least considering
plastic as an alternative to glass.
Waller (SCHOTT): In fact, both materials have advantages as well as disadvantages. Polymer or plastic resists breakage extremely well and
is also inert and resistant to broad range of polar solvents, acids, and bases. Polymer can also be used to produce flexible
designs and dimensions that are often more difficult to manufacture with glass. Japan has historically been using polymer
syringes, due to safety and breakage issues. But it's not really a global phenomenon.