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Whitepapers



Our whitepapers allow you to dig deeper into topics and understand the science behind our services, as well as ways we can help solve your business challenges.



May 1, 2019

Use of Exaggerated Surface Area to Solution Volume Ratios in Extractables Studies; Equilibrium Case

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The goal of this whitepaper is to provide guidance and justify appropriate practices about the proper use of exaggerated test...

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March 25, 2019

Establishing the Proper Alcohol/Water Proportion for Simulating Solvents Used in Controlled Extraction Studies

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The purpose of this paper is to provide guidance on determining the proper alcohol/water proportion for simulating solvents used in...

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February 18, 2019

Use of Accelerated Conditions in Extractables and/or Leachables Studies

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The purpose of this paper is to consider the scientific basis for accelerated contact conditions (via the proper combination of...

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December 18, 2018

Regulatory Landscape for EO Residue Levels in Medical Devices

By: , Gregory Grams, Mike Padilla and Peter Strain

Ethylene oxide gas sterilization, in particular, is one of the most efficient and effective ways of deactivating bacteria and other...

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November 30, 2018

EO Residue Levels in Medical Devices: Best Practices for Demonstrating Compliance with ISO 10993-7

By: , Gregory Grams, Mike Padilla, Peter Strain and Erik Haghedooren

Sterilizing medical devices via ethylene oxide gas is an effective and common practice within the industry. EO gas is active...

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