Revised USP Chapter <383> Cured Silicone Elastomers

In Pharmacopeial Forum (PF) 50(6), the USP General Chapters—Packaging and Distribution Expert Committee (GCPD) published a revised version of USP's new chapter <383> Cured Silicone Elastomers for Pharmaceutical Packaging and Manufacturing Components. The draft chapter is open for comments until 31 January 2025. The new USP chapter <383> will become official on 1 December 2027. However, early adoption of the requirements in this chapter is permitted by USP.

Proposed Changes to USP Chapter <383>

The GCPD is proposing the following revisions to address comments received with the publication of the new USP chapter <383> in March 2024. The following changes are proposed:

• Revise the Scope to clarify the applicability of the chapter to cured silicone elastomers used for manufacturing components. The scope of the chapter includes elastomeric closures for pharmaceutical packaging and components used in the manufacturing of drug products and active pharmaceutical ingredients, such as diaphragms, gaskets, O-rings, and tubing.
• Move the Iodine solution preparation procedure from the Physicochemical Tests, Residual peroxides section to the Physicochemical Tests, Reducing substances section.
• Delete Procedure 1 and Acceptance criteria 1 (titration with sodium thiosulfate) from the Physicochemical Tests, Residual peroxides section.

More information is available after registration to the USP Pharmacopeial Forum.