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 to device manufacturers. 

In last week’s blog post, we highlighted the importance of bioburden monitoring, both quantitatively and qualitatively, as supportive evidence for a valid radiation dose. We arrived at this conclusion through a historic data review of verification dose experiments.
Read More Topics: Medical Device, ISO 11737-1, Technical Expertise, Radiation Sterilization Validation

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 sterilization is a critical element of sterility assurance programs. ISO 11137-1, ISO 11137-2 and ISO TS 13004 specify the requirements for establishing a sterilization dose based on known product bioburden, including quantity and resistance.
Read More Topics: Medical Device, ISO 11737-1, Technical Expertise, Radiation Sterilization Validation

Product Adoption for Sterilization Validation

Posted by Jill Warren, Technical Specialist on October 16, 2018

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 option:  product adoption.

WuXi AppTec Technical Experts answer common questions about product adoption when completing a sterilization validation.  The question to be answered is - whether or not to validate independently or adopt into a family?
Read More Topics: Technical Expertise, Medical Device, Regulatory Expertise, Sterilization Validation, Bioburden

Poor Extraction Methods Can Impact Study Results

Posted by Dan Fowler, Principal Scientist on October 09, 2018

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 medical device or testing substrate and then quantify those residuals for specific test markers such as protein, hemoglobin or carbohydrates.
Read More Topics: Technical Expertise, Medical Device, Regulatory Expertise, Reprocessing

wuxi apptec to exhibit at devicetalks boston

Posted by Rachel Callender on October 04, 2018
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 will meet the endpoints you need to support your product’s safety.
Read More Topics: ISO 10993-1, regulatory consultants, histopathology, Regulatory Expertise, Technical Expertise, E & L, Regulatory, hemocompatibility

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

Posted by Britney Bartel, Marketing Manager on September 18, 2018

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 continuing education classes, breakout sessions and an expo. The meeting brings together suppliers, manufacturers and end users within the tissue-product ecosystem.
Read More Topics: Technical Expertise, Medical Device, Regulatory Expertise, ISO 10993-1, Contract Manufacturing, AATB Accreditation, Aseptic Technique

Register Now for the PDA Chapter Dinner and Biocompatibility Presentation

Posted by Rachel Callender on September 17, 2018
WuXi AppTec Associate Director of Regulatory Toxicology Vanessa Haase, PhD, will present on biocompatibility testing as part of biological evaluation and ISO 10993.
Read More Topics: ISO 10993-1, regulatory consultants, histopathology, Regulatory Expertise, Technical Expertise, E & L, Regulatory, hemocompatibility

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

Posted by Britney Bartel, Marketing Manager on September 11, 2018

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 version of ISO 10993 Part 1, published in August 2018, emphasizes the need for biological evaluations to begin with chemical characterization. In this case study, Dr. Haase outlines a risk-based approach to device preclinical safety in accordance with ISO 10993. The case study, which features a blood-contacting device, summarizes chemical characterization, toxicological risk assessment and a biocompatibility test strategy for evaluating the relevant biological end points. Dr. Haase will speak at 11:15 am on September 24.
Read More Topics: Technical Expertise, Medical Device, Regulatory Expertise, ISO 10993-1

Designing Disinfectant Efficacy Studies for All of Your Facility Locations

WuXi AppTec’s team of technical experts and trained laboratory analysts understand how to design and execute robust validations to control your facility’s environment along with monitoring your overall environmental program.

But what if your company has more than one location?
Read More Topics: Technical Expertise, Medical Device, Regulatory Expertise, Microbiology, Efficacy Study, USP<1072>

WuXi AppTec Now Offers Dual Route Subchronic Toxicity Test

Posted by Sarah Steinmetz, Director Study Operations on August 21, 2018

For your medical device study designs and protocols, our scientists build in the most effective in-vivo or in-vitro model to meet the study goals and stay compliant with governing laws, including the Animal Welfare Act (AWA) when applicable.

At an international level, ISO 10993 working groups, including participants from WuXi AppTec, are challenged to find alternatives to existing in-vivo models as well as ways to meet study endpoints in new and creative ways to reduce current requirements. At the same time, these working groups must ensure that any alternative model or reduction in requirements does not impact the scientific outcomes of the study or, at a minimum, demonstrates equivalency.
Read More Topics: Technical Expertise, Medical Device, Regulatory Expertise, Biological Safety Testing, biocompatibility