Our All-Inclusive Approach to Microbial Identification

Posted by Elizabeth Fassinger, General Microbiology Manager on December 11, 2018

WuXi AppTec’s robust approach to microbial identification (ID) testing surpasses the industry standard offered by other laboratories.

Our clients come to us when a microbial excursion has occurred. Understanding what the microbial contaminants are, and where they have been introduced into the manufacturing process, is critical in determining the root cause of the microbial excursion, as well as effective corrective actions to prevent re-occurrence.  

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Topics: Medical Device, Technical Expertise, Microbiology, Microbial Identification

Environmental Monitoring Supports a Risk-Based Approach to Manufacturing Control

Posted by Richard Nardini, Environmental Services Manager on December 04, 2018

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

Environmental monitoring is one way a device manufacturer demonstrates control within a production area. Environmental samples from water, air and surfaces support verification of process controls and ultimately support product safety. Trending this valuable data offers manufacturers a qualitative indicator of the cleanliness and controls within their production areas.

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Topics: Medical Device, Technical Expertise, Microbiology

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?

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Topics: Medical Device, Technical Expertise, Microbiology, Regulatory Expertise, USP<1072>, Efficacy Study

Cleaning Validations and Process Robustness: How to Build a Study Design

Posted by Dan Fowler, Principal Scientist on August 14, 2018

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:

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Topics: Medical Device, Technical Expertise, Microbiology, Reprocessing, Regulatory Expertise

Facility Disinfectant Efficacy Studies – Complex, Resource Demanding and Extremely Necessary

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.

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Topics: Medical Device, Technical Expertise, Microbiology, Validation Study, Surface Disinfectant

Helping Manufacturers Understand Product Bioburden Before Dose Setting

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

To determine the best-suited dose-setting method, we first help manufacturers better understand product bioburden by employing the most effective testing methods and techniques.

We are equipped to support a broad range of products—from simple to complex, including complicated situations.

An advantage of partnering with WuXi AppTec is that we stay up-to-date on industry changes, and work with you to find the process that best fits your product needs.

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Topics: Medical Device, Regulatory, Technical Expertise, Microbiology, ISO 11737-1, Bioburden, Radiation Sterilization Validation