Microbiological Updates to 11137-1:2025 – Demonstrating Stability in Bioburden Numbers and Types
The previous version of ISO 11137-1 contained a requirement that manufacturers of products with low bioburden counts...
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Updates to ISO 10993-1: Focus on Foreseeable Misuse
There are many updates to ISO 10993-1 a few of which can significantly impact how devices are...
Rapid Sterility Testing: Enhancing Compliance, Efficiency, and Accuracy
This webinar examines how rapid sterility testing technologies enhance efficiency, reduce time-to-results, and improve overall product safety...
New FDA Draft Guidance for Chemical Analysis
In this podcast our host Brandon Miller from Regulatory Compliance Associates is joined by Raymond Colton, Director of E&L...
ISO 10993-1: Key update on the new revision of this critical standard
This webinar delves into the latest updates to ISO 10993-1, the cornerstone standard guiding biocompatibility assessment for...
Reprocessing Rethought: An Open Forum Discussion On Approaches for Cleaning Validations of Single-Use 3D Printed Devices Processed at Healthcare Facilities
The presence of 3D printed single-use devices that require processing (cleaning and disinfection or sterilization) at the...
Documenting Device Changes in Biological Risk Assessments: Part Three
This is the third whitepaper in a four-part series covering different examples of how to document device...
Documenting Device Changes in Biological Risk Assessments: Part Two
This whitepaper, the second in a four-part series covering different examples of device changes to be documented...
Transitioning From Cell-Based Assays to qPCR-Driven Analyses To Ensure Viral Safety in Biologics Manufacturing
The production of biological products in biopharmaceutical manufacturing involves significant risks of viral contamination from human and...
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....