Historically, the material of choice for packaging pharmaceutical parenterals, ophthalmic, biologics, vaccines and respiratory products has been glass. More sophisticated drug products and delivery technologies, and concerns regarding breakage and delamination are driving companies to transition their containment systems to plastic, especially for vials and syringes.
Glass to plastic driving factors include:
- FDA product recalls due to the risk of glass fragments in vials entering a patient through drug products
- Glass vial and syringe breakage during production, transport and use
- Residuals on glass components with some biologics
Plastic offers improved design flexibility and dimensional precision
- Increased consumer convenience and safety when using self-injection and needle-safety systems
- Prefillable plastic syringes can be designed with an integrated luer lock, customized with different colors and directly printed on
- Polymers have been tested to ensure biocompatibility and acceptability for multiple drugs and have been approved and marketed for packaging
- The increased focus on biologics, proteins and other complex solutions has brought the use of polymers to the forefront.
- Plastic unit-dose ampoules and bottles have gained increasing favor as non-breakable formats that provide sterility assurance to the point of use.