Type of Posting: Notice of Intent to Revise
Posting Date: 16-Dec–2022
Targeted Official Date: 01-Sep–2023, Interim Revision Announcement
Expert Committee: Packaging and Distribution Expert Committee
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the General Chapters–Packaging and Distribution Expert Committee intends to revise <661.2> Plastic Packaging Systems for Pharmaceutical Use.
Comments were received indicating that a revision to several sections is needed. The Expert Committee proposes to revise the <661.2> Plastic Packaging Systems for Pharmaceutical Use to address the following:
- Solution C1, extraction time and temperature, would be revised to address the concern that some plastic packaging materials start to melt and deform at the low temperature currently outlined in the chapter (70°). The revision would include an addition extraction time and temperature of 50 ± 2° for 72h. The change in the chapter would be as follows:
- Heat in an autoclave until 121 ± 2° is reached (typically in 20–30 min), and maintain at this temperature for 30 min. If heating at 121° leads to the deterioration of the container, heat at 100 ± 2° in an autoclave or oven. If heating at 100° leads to the deterioration of the container, heat at 70 ± 2° for 24h in an autoclave or oven. If heating at 70° leads to the deterioration of the container, heat at 50 ± 2° for 72h
- Total Organic Carbon (TOC) acceptance criteria in <661.2> would be revised to realign with the acceptance criteria in <643> Total Organic Carbon which was revised in 2021. The change in the chapter would be as follows:
- The difference in TOC concentrations between Solution C1 and a suitable blank is NMT 32 mg/L for containers ≤ 5 mL; NMT 24 mg/L for containers > 5 and ≤ 100 mL; and NMT 8 mg/L for containers > 100 mL.
It is anticipated that the proposed revision will be published as an Interim Revision Announcement in Pharmacopeial Forum 49(2) [Mar. 2023 – Apr 2023] pursuant to the Rules and Procedures. The comment period for this revision would end on May 31, 2023. In the absence of any adverse comments, the proposed IRA would become official on September 1, 2023
Should you have any questions, please contact Desmond G. Hunt, Scientific Liaison to the General Chapters–Packaging and Distribution Expert Committee (301–816–8341 or firstname.lastname@example.org).