Cyclic olefin copolymers from TOPAS Advanced Polymers meet the requirements of U.S. Pharmacopeia (USP) <661.1>, a new subchapter as part of Chapter <661> Plastic Packaging Systems and Their Materials of Construction, the resin maker reports.
TOPAS explains that six of its COC pharma grades have been tested and found to meet the requirements of USP <661.1> by Toxikon Corp., a leading preclinical contract research and testing organization.
USP <661> encourages users to develop packaging with well-characterized materials. “If you have well-characterized materials, chances are you will have a well-characterized container that is suitable for packaging pharmaceuticals,” states Gunther Appel, TOPAS global product and quality manager. “You have the flexibility to assess solutions based on risk.” USP <661.1> provides the testing rationale to 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.
Appel tells PMP News that pharma packaging professionals are tasked with ensuring compliance of their packaging system as described in USP <661>: “The packaging system should adequately protect the pharmaceutical product, should be compatible with the pharmaceutical product, and should be composed of materials that are safe for use.”
As a result, “proving compliance of materials used in pharmaceutical packaging applications is the first step for them," he says. “TOPAS took this first step to enable pharma packaging professionals to start immediately with the further steps in the approval process described in USP <661.2> or other subsequent chapters of USP <661>.”
TOPAS COC has been used in primary pharmaceutical packaging (syringes, vials, containers, etc.) as well as medical devices (insulin pumps and inhalers). For more details visit www.topas.com.
To read more on USP Chapter <661>, please see our article, USP: 'It’s your product and you know the risk—you determine the testing.
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