Understanding the Changes to USP 661

By Stephen Doherty and Amtul Qamar Confused about the revisions to USP <661>?  We can help.  In May 2016, the revision of USP General Chapter <661> with the new title “Plastic Packaging Systems and Their Material of Construction” took effect.  The revision represents a major change in the testing strategies related to plastic container systems.  The testing strategy has adapted to move from generic testing strategy to a more targeted testing strategy based on materials of construction and product use.  The chapter has also been separated into different components.  <661.1> Plastic Materials of Construction and <661.2> Plastic Packaging Systems for Pharmaceutical Use.  The release of the revised USP, along with the introduction of new chapters <1663> “Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems” and <1664> “Assessment of Drug Product Leachable Associated with Pharmaceutical Packaging/Delivery Systems”, works to bring the USP <661> into allowing for a well characterized container closure system and ensuring that the chosen packing system does not adversely impact the pharmaceutical stored within. In a departure from the general testing approach in the previous 661, the revision makes use of specific extraction solution and conditions, as well as varying extraction conditions (Table 1).  In addition, the testing strategy has become much more comprehensive.  Rather than relying...
Source: Mass Device - Category: Medical Equipment Authors: Tags: News Well Toxikon Source Type: news