The sudden closure of a medical device sterilization plant in February and a second plant closure planned for later this year have raised questions about the effects on medtech manufacturers.
Microbiology
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...
Our All-Inclusive Approach to Microbial Identification
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...
White Paper: Unknowns are Unacceptable™
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.