U.S. Biologics, Advanced Therapies & Medical Devices Manufacturing and Testing

reprocessing
validations

Recent industry challenges and FDA Guidance mean more scrutiny is placed on your validations.

With more than 25 years of experience and extensive knowledge of the regulatory requirements, the team at WuXi AppTec has a proven track record of success with reprocessing validations for thousands of devices.

Let our team work with you to develop a customized approach that meets current global regulatory expectations for your product.

 

CLEANING VALIDATION
Regulatory agencies expect “worst case” scenarios for cleaning validations. A customized approach based on your product and indication will be developed by our technical experts. The test plan will ensure your IFU is properly challenged and the efficacy of your cleaning instructions are established.

DISINFECTION VALIDATION
The team at WuXi AppTec understands the unique challenges that can occur in disinfection efficacy studies, including process agents and materials with antimicrobial properties. Where appropriate, method development will be recommended prior to validation to ensure no interference.

STERILIZATION VALIDATION
Our sterilization validation programs are designed to meet the complexity of your unique device. WuXi AppTec’s approach considers a variety of sterilization processes and works with you in determining the best approach based on the design and compatibility of your device.

 

CLEANING VALIDATION PROCESS

IDENTIFY CRITERIA
Identify the targeted acceptance criteria and develop the best testing protocol to prove the efficacy of your process.

SOIL & CLEAN
Simulate clinical use by repeated soiling and cleaning using worst-case parameters.

EXTRACT & ANALYZE
Extract residual soil and quantitatively test for relevant markers, such as protein and hemoglobin, using validated methods.

PROVIDE RESULTS
Provide a final report, including summary of data and a clear interpretation of proof of process efficacy.

 

Additional related services include packaging validation.