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WHITEPAPER

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

March 26, 2024 | By: and

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.

 

Logan Luke

Logan Luke

Packaging Expert

Logan has worked at Nelson Labs since 2018. He has worked in the sterilization, microbial 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 troubleshooting and validation design. He is well versed in a broad spectrum of packaging tests,...

Shiri Hecter

Shiri Hecter

M.Sc., ASQ CQA and CSSGB

Shiri Hechter received her master’s degree in organic chemistry from Tel-Aviv University in 2005. During her time at Nelson Labs, Shiri supported the analytical testing of pharmaceutical products.

Complete the information in the form below to access the whitepaper.

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