BRIEFING
〈661.2〉 Plastic Packaging Systems for Pharmaceutical Use, USP 42 page 6838. The General Chapters—Packaging and Distribution Expert Committee is proposing the following revisions to clarify the intent of the chapter and to increase the ease in utilization. These proposed revisions do not change any of the testing requirements in the chapter. Listed below are the key changes being proposed:
The chapter has been reformatted so that all test methods and acceptance criteria for a specific requirement are contained within a section.
The implementation date is being changed from May 1, 2020 to December 1, 2025.
The Introduction and Scope have been revised to simplify and clarify the text.
Text has been added to the chapter to remind that end-users can meet the requirement of Plastic Materials of Construction 〈661.1〉 by meeting the requirements of this chapter.
Table 1 is added to list the application of tests.
Guidance has been given on how to address the testing of small fill volume containers (e.g., vials, blisters, etc.) to produce sufficient extract volume to accomplish the required testing.
The Chemical Safety Assessment section has been omitted and the entire Specifications section has been deleted as the acceptance criteria has been inserted under Physicochemical and Biological Reactivity Test Methods.
Source from USP and Please refer to USP for details:
plastic pharmaceutical packaging
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