Environmental Monitoring Supports a Risk-Based Approach to Manufacturing Control

Robust Environmental Monitoring Program includes information to support process controls through sample collection, microbial testing and trending data. 

Environmental monitoring is one way a...

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WuXi AppTec to Exhibit at DeviceTalks West, Costa Mesa, California

Visit the WuXi AppTec exhibitor booth #206 at DeviceTalks West, December 11-12, 2018, to learn how we work as a seamless extension of your team and develop a comprehensive program that will meet the...

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Radiation Sterilization: Verifying Dose Survivors

A wealth of knowledge was gained from a historic data review of radiation dose verification failures. Our experts highlight the importance and application of this data set as well as its benefit...

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Radiation Sterilization: Product Bioburden and Verification Dose

WuXi AppTec supports the best practice of monitoring bioburden quantitatively and qualitatively to ensure the established radiation dose is valid.

For many medical device manufacturers, radiation...

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Product Adoption for Sterilization Validation

When your product has had a material change, a component added, or a new size developed, does this necessarily mean you must complete the sterilization validation of each?

There is another...

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Poor Extraction Methods Can Impact Study Results

When planning a cleaning validation study for your medical device, a validated extraction method is one requirement.

The purpose of an extraction process is to recover any residual soils from the...

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wuxi apptec to exhibit at devicetalks boston

Visit the WuXi AppTec exhibitor booth #513 at DeviceTalks Boston, which takes place Oct. 8-10, 2018. WuXi AppTec works as a seamless extension of your team to develop a comprehensive program that...

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WuXi AppTec Technical Experts at the American Association of Tissue Banks Expo, Booth #49

WuXi AppTec, a longtime member of the AATB, returns for the 42nd Annual Meeting, October 9-12, 2018.

The AATB annual meeting, held in Dallas, Texas, this year, encompasses a vast array of...

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Register Now for the PDA Chapter Dinner and Biocompatibility Presentation

WuXi AppTec Associate Director of Regulatory Toxicology Vanessa Haase, PhD, will present on biocompatibility testing as part of biological evaluation and ISO 10993.

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WuXi AppTec to Present Case Study: Enhancing Biocompatibility Testing via Device-Specific Chemical Analysis

Associate Director of Regulatory Toxicology, Dr. Vanessa Haase, will present the case study at the Q1 Productions Medical Device Sterilization conference on September 24, 2018.

The most recent...

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