In May 2016, the U.S. Pharmacopeia Convention (USP) revised Chapter 661, which describes requirements for plastic containers used for drug products. The impact of this revision goes well beyond the U.S. health care market, since USP standards are followed by more than 140 countries.
As part of Covestro’s ongoing commitment to its customers and the medical industry, the company had already been working to help our customers show that our medical-grade Makrolon® and Apec® resins meet the requirements included with the revisions.
What has Changed?
The revised chapter, USP <661> Plastic Packaging Systems and their Materials of Construction, establishes tests and specifications that are necessary to ensure that plastic packaging systems and the materials they are made of are suitable and safe for use with drug products. Two new subchapters were created: <661.1> Plastic Materials of Construction and <661.2> Plastic Packaging Systems for Pharmaceutical Use. Characterization of materials of construction is described in subchapter 661.1. A short summary of the revised USP 661.1 chemical test requirements is given in the table below:
|Test Parameter||Revised USP <661.1>|
|Polymer Additives||Direct chimical testing to identify and quantify additives|
USP 661.2 now requires packaging system manufacturers to conduct extractables and leachables testing for relevant plastic additives in the complete packaging system. Details on the prescribed detection limits and extraction conditions can be found in the USP 661 documentation.
Testing and Results
To assist its customers in demonstrating compliance with USP 661, Covestro’s laboratories reviewed the 661.1 protocols and conducted extraction experiments with medical-grade Makrolon® and Apec® resins that can be used for pharmaceutical packaging. These protocols included extraction by water, ethanol and dilute hydrochloric acid. In addition to prescribed elements, Covestro analyzed for additives used in the company’s products. All results were under, if not well-under, the limits stated within USP 661.1. Covestro’s test results therefore demonstrate that the tested Makrolon® and Apec® medical-grade resins meet the criteria stipulated in the revised USP 661.
To facilitate the regulatory review process for its customers, Covestro is able to provide documentation that attests to the compliance of medical-grade Makrolon® or Apec® resins to USP 661 requirements.
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