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Author: Martell Winters





November 7, 2023

Sterility Assurance for Single-Use Systems

This whitepaper provides an overview of assuring the sterility of single-use systems, which are common in pharmaceutical manufacturing. Learn more about the authors below.

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September 15, 2023

Developing a Contamination Control Strategy

This whitepaper provides an overview of developing a comprehensive contamination control strategy (CCS), taking into consideration the various aspects of pharmaceutical manufacturing. Learn more about the authors below.

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June 9, 2023

Are sterile devices microbiologically safe? Unraveling the relationship between pyrogens, bioburden, and sterility

Sterility assurance is of utmost importance for medical devices that come into contact with body cavities. However, bioburden and sterility are linked to a third concern—pyrogens—which may not be adequately addressed solely by ensuring device sterility. Pyrogens and Endotoxins: Understanding...

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January 15, 2021

Biological safety in the context of backward planetary protection and Mars Sample Return: conclusions from the Sterilization Working Group

The National Aeronautics and Space Administration (NASA) and the European Space Agency (ESA) are studying how samples might be brought back to Earth from Mars safely. Backward planetary protection is key in this complex endeavour, as it is required to...

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December 8, 2020

Decontamination and Sterile Processing of Personal Protective Equipment

When the COVID-19 pandemic hit, personal protective equipment (PPE), especially facemasks and respirators, were in short supply due to unforeseen, increased demand and shortages in raw materials and finished products. As can be imagined, the month of March 2020 brought...

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