Whitepaper

WHITEPAPER

Container Closure Requirements: Preparing for USP <382> <661.1> and <661.2>

March 26, 2024 | By: Logan Luke and Shiri Hechter

Container closure integrity, which is verified by container closure integrity testing (CCIT), is critical to ensure the sterility of drug products. Physical, chemical, and biological assessments must be carried out to make sure components are compatible and fit for use. USP <661.1> <661.2> & <382> will be official by the end 2025. This whitepaper provides an overview of the changes that these new general chapters will bring to CCIT.

For a full discussion of the content in this whitepaper, you can also watch the on-demand webinar.

Learn more about the authors/presenters below.

Shiri Hechter

ASQ CQA and CSSGB
Analytical Chemistry Testing Expert

Shiri Hechter is an organic chemist. She received her master’s degree in organic chemistry from Tel-Aviv University in 2005. Shiri began her career at Gibraltar Labs in 2006. She started as a Chemistry Group Leader in the analytical chemistry department. After two years she was promoted to the Quality Assurance (QA) department as a quality...

Logan Luke

Logan holds a degree in microbiology and has 5 years of experience working at Nelson Labs. He has worked in the sterilization, IDs, and packaging departments. He has extensive knowledge in the packaging section and has aided many customers with their package testing needs, from the benchtop to trouble shooting and validation design. He is well versed in a broad spectrum of packaging tests, from lot release package testing for pharmaceutical products to full package validations, including shipping and distribution. He is also a member of the Parenteral Drug Association (PDA).

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