COC Designated by USP for Pharma Packaging

TOPAS Advanced Polymers announced on Aug. 17, 2016 that the US Pharmacopeial Convention (USP) has designated cyclic olefins as a material category along with polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), and PETG. The company also announced that its cyclic olefin copolymer (COC) has earned compliance with the revised United States Pharmacopeia (USP) <661.1> standard for pharma plastic packaging systems, which took effect on May 1.

According to TOPAS, USP <661.1> compliance is a prerequisite for pharmaceutical packaging companies and plastics processors involved with the development and manufacture of new pharmaceutical packaging. USP <661.1>, which provides testing rationale for plastic materials of construction and packaging systems used for pharmaceuticals, helps to establish a material’s identity, biocompatibility (biological reactivity), general physicochemical properties, additive compositions, and level of extractable metals.

Gunther Appel, TOPAS global product and quality manager, stated in a press release that the revised USP <661.1> “incorporates standards to better characterize plastic materials and resins.” Appel also stated that, “If you have well-characterized materials, chances are you will have a well-characterized container that is suitable for packaging pharmaceuticals … You have the flexibility to assess solutions based on risk.”

The company states that USP <661.1> compliance “validates that [the company’s] COC products are well-characterized, ensuring that the materials’ properties and attributes can be matched to the performance requirements of the pharma packaging system.” Pre-clinical contract research and testing organization, Toxikon Corp, has tested and approved six of TOPAS Advanced Polymers’ COC pharma grades, the company stated in a press release.

Source: TOPAS Advanced Polymers