TOPAS Advanced Polymers is First Resin Maker to Meet Newly Revised USP 661.1 Standard for Plastic Materials of Construction
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 PETG, it was announced today by TOPAS Advanced Polymers, one of the world’s leading COC suppliers. Since their introduction more than 20 years ago, TOPAS 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 U.S. Pharmacopeia (USP) 661.1, a newly instituted standard for plastic packaging systems for the pharmaceutical industry. The company is 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 Corp., a leading pre-clinical contract research and testing organization.
USP’s recently revised Chapter 661 incorporates standards to better characterize plastic materials and resins, according to Gunther Appel, TOPAS global product and quality manager. “If you have well-characterized materials, chances are you will have a well-characterized 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-characterized by establishing its identity, biocompatibility (biological reactivity), general physicochemical properties, additive compositions, and level of extractable metals.
With compliance to USP 661.1, TOPAS Advanced Polymers validates that its COC products are well-characterized, ensuring that the materials’ properties and attributes can be matched to the performance requirements of the pharma packaging system, according to Appel.