Skip to main content

Cured Silicone Elastomers for Pharmaceutical Manufacturing and Packaging Components

Type of Posting: General Chapter Prospectus
Posting Date: 27–Dec–2019
Expert Committee: General Chapters—Packaging and Distribution

Input Deadline: 26-Jan–2020 

Proposed New Title: <668> Cured Silicone Elastomers for Pharmaceutical Manufacturing and Packaging Components

Suggested audience: R&D scientists, contract research organizations, contract manufacturing organizations, Regulatory Affairs, QA/QC specialists
 
Estimated proposal PF:  Pharmacopeial Forum 46(5) [Sep.–Oct. 2020] 

Background and objective(s):  The General Chapters—Packaging and Distribution Expert Committee will propose a new chapter, <668> Cured Silicone Elastomers for Pharmaceutical Manufacturing and Packaging Components, based on comments received from the Pharmaceutical Forum 45(2) [Mar.—Apr. 2019] publication of <665> Plastic Materials, Components, and Systems Used in the Manufacturing of Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products. 

Description of scope and application:  This chapter would apply to cured silicone components such as tubing, gaskets, and O-rings that are used in manufacturing operations for drug substances and drug products, as well as silicone components for pharmaceutical packaging systems. 

Preliminary outline:  

  • Biological Reactivity
  • Identification
  • Physicochemical Tests:
  • Appearance
  • Acidity or alkalinity 
  • Reducing Substances
  • Substances soluble in hexane
  • Phenylated compounds
  • Mineral Oils
  • Volatile matter
  • Residual peroxides
  • Platinum

Anticipated implementation timing: To be determined based on stakeholder feedback.  


Contact: Leslie Furr, M.S., Associate Scientific Liaison, (240-221-2022, leslie.furr@usp.org)


CN-20-027-00