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Author: Shiri Hechter





August 19, 2025

Qualification of Primary Container Closure Systems for Parenteral and Ophthalmic Drug Products

Ensuring the integrity of container closure systems (CCS) is critical for the safety and efficacy of high-risk drug products. This whitepaper explores the regulatory landscape, key testing methods, and risk-based approaches required to qualify CCS for parenteral and ophthalmic applications....

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July 18, 2024

Whitepaper: Testing of High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol

Contamination from ethylene glycol and diethylene glycol in liquid formulation poses a high risk to patient safety. Throughout recent years there have been multiple fatalities reported due to the presence of these contaminants in drug products. This whitepaper covers the...

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March 26, 2024

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

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....

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February 2, 2023

Considerations for Method Validation

In this article published in Pharmaceutical Technology, Susan Schniepp and Shiri Hechter explain how an analytical method to be used for routine testing but not published in a pharmacopeia can be validated.   Read the Full Story in PharmTech

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