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.