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.
- Biological Reactivity
- Physicochemical Tests:
- Acidity or alkalinity
- Reducing Substances
- Substances soluble in hexane
- Phenylated compounds
- Mineral Oils
- Volatile matter
- Residual peroxides
Anticipated implementation timing: To be determined based on stakeholder feedback.
Contact: Leslie Furr, M.S., Associate Scientific Liaison, (240-221-2022, firstname.lastname@example.org)