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.

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

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.

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?

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.

The process of cleaning medical devices, either in healthcare settings or at a third-party manufacturer, includes many operational steps and variables. To prove the robustness of process design and to validate that normal process variables do not impact a product’s acceptance criteria, a cleaning validation is executed.

To comply with the 2015 FDA Guidance on reprocessing of medical devices, the validation design for your product should prove the following:

WuXi AppTec Laboratory Testing Division Medical Device complies with Good Laboratory Practices (GLP) that meet the latest FDA GLP regulations and OECD test guidelines and expectations. Studies that run compliant with GLP principles require a Study Director—a key role in ensuring a study’s success.

The Organisation for Economic Co-operation and Development (OECD) defines the role of the Study Director, as “…the single point of study control with ultimate responsibility for the overall scientific conduct of the study.”

Join WuXi AppTec’s technical and regulatory experts as we share our experience with ISO 10993 and what that guidance means for today’s medical device manufacturers.

On the first day, our team will share case studies regarding how Global Regulatory bodies currently interpret the guidance. As part of the working groups, our team will also share the upcoming changes to ISO 10993 parts 1, 17 and 18 and what those changes may mean moving forward for medical device manufacturers.

The second day is a deep this deep-dive into ISO 10993 Part 18. Sandi Schaible will look at the upcoming changes to ISO 10993 part 18 and what they may mean to chemical characterization test plans in the future. 

Maintaining a controlled environment within your facility includes performing a robust validation on the cleaning, disinfecting and sanitizing agents used on surface materials. This validation is beneficial to controlling the manufacturing environment and critical to reducing environmental excursions and contamination risks.

Disinfectant efficacy studies, which are regulatory requirements, are complex, time consuming and can be costly. This is because there are many factors to consider when designing a disinfectant efficacy validation for your facility’s disinfectants and sanitizers. As you work to meet the regulatory requirement, you’ll probably face constraints related to labor hours, financial cost, and time to design and execute a study.

Our Medical Device Contract Manufacturing with AATB Accreditation and ISO 13485 Certification offers manufacturing and assembly expertise for multiple tissues and tissue-based products, whether in pursuit of the 361 or 351 regulatory pathway.

In addition to our testing expertise, the team at WuXi AppTec recognizes many of your pain points when it comes to tissue manufacturing, too, and we have solutions. Our manufacturing and testing teams collaborate to offer you a turn-key solution.