As you may be aware, the USP <661> guidelines for testing of containers updated on May 1st 2016. Methodize would like to take some time to clarify what these changes mean for you and how testing houses are handling these changes. The updated USP General Chapter <661>, now entitled, Plastic Packaging Systems and Their Materials of Construction, has changed significantly and consists of three general chapters:
- USP <661> is an introductory section and establishes the Scope of the <661> Chapter. There are no longer test methodologies outlined in USP <661>.
- USP <661.1> provides test methods and specifications for Plastic Materials of Construction. The testing is based on, although not completely harmonized with, the testing outlined in European Pharmacopeia (EP) 3.1.3. A summary of the new required testing (along with a comparison to the former USP <661> testing) is provided in Table 1 below.
- USP <661.2> provides test methods and specifications of Plastics Packaging Systems for Pharmaceutical Use. Additionally, there is guidance regarding characterization of the packaging systems, package integrity testing and biological safety testing.
Testing houses are now offering the new testing methodologies outlined in USP <661.1>. and USP <661.2>. Please contact Methodize for updated cost information specific to your raw material and/or container system.
Testing houses will continue to offer the former (“old”) <661> testing to serve their clients who perform the testing for reasons other than a label claim of compliance to USP. As many of our clients are transitioning routine analysis to the updated USP <661.1>, the former test methods are being performed to be able to compare the test results of the current USP <661.1> to former <661>. All reports with former USP <661> testing will indicate that the test methods are not compliant with current USP, will reference the former USP (USP 38) and will no longer list reportable acceptance criteria.
Jack Slovick President Methodize Inc P.O. Box 463 Nevis, MN 56467 763.639.0238 (cell) www.methodizeinc.com