Cyclic-olefin copolymers (COC) have been included as a category for pharmaceutical packaging in the latest revision of the U.S. Pharmacopeia (USP) standard for pharmaceutical packaging.
Cyclic-olefins have been designated as a material category alongside other plastics such as polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), and PET-G, according to Topas Advanced Polymers, a supplier of COC.
Since their introduction more than 20 years ago, Topas says its COC has enjoyed strong growth in primary pharmaceutical packaging (syringes, vials, containers, etc.) as well as medical devices (insulin pumps and inhalers).
Topas Advanced Polymers also announced that its COC materials have earned compliance with US Pharmacopeia (USP) 661.1, a newly instituted standard for plastic packaging systems for the pharmaceutical industry.
The company claims to be the first thermoplastic resin manufacturer to achieve compliance with the new standard, which took effect May 1.
Six of Topas Advanced Polymers’ COC pharma grades have been tested and approved by Toxikon, a pre-clinical contract research and testing organisation.
USP’s recently revised Chapter 661 incorporates standards to better characterise plastic materials and resins, according to Gunther Appel, TOPAS global product and quality manager.
“If you have well-characterised materials, chances are you will have a well-characterised container that is suitable for packaging pharmaceuticals,” said Appel. “You have the flexibility to assess solutions based on risk.”
Compliance with USP 661.1 is a prerequisite for pharmaceutical and packaging companies and plastics processors who are involved in the development and manufacture of new pharmaceutical packaging.
USP 661.1 provides the testing rationale for plastic materials of construction and packaging systems used for pharmaceuticals.
The new USP chapter will help determine whether a material is deemed well-characterised by establishing its identity, biocompatibility (biological reactivity), general physicochemical properties, additive compositions, and level of extractable metals.