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Testing Facilities

Testing Facility Locations

WuXi AppTec Medical Device Testing supports global manufactures with a full range of services for medical device, combination and tissue products. With facilities in Saint Paul, MN and Atlanta, GA as well as Suzhou, China, we are committed to supporting customer needs in a global market place.

Atlanta, Georgia

WuXi AppTec’s Atlanta site is our Center of Excellence for Microbiology, providing the full spectrum of microbiology consulting, testing and validation services required to meet sterility assurance goals throughout a product’s development and commercialization.

  • Sterility Assurance Packages
  • Microbiology Testing
  • Sterility, Bioburden and Endotoxin Testing
  • Process Validations
  • Microbial Challenge
  • Cleaning, Disinfection & Sanitization Efficacy Studies
  • Container Closure / Packaging Validations
  • Accelerated Aging / Shelf Life Studies

Our facilities are FDA registered, ISO certified and accredited by relevant regulatory bodies and industry associations.

  • FDA Registered
  • FDA HCT/P Registered

Saint Paul, Minnesota

WuXi AppTec’s Saint Paul site is our Center of Excellence for Preclinical Safety. Our FDA-registered testing and manufacturing facilities provide in vitro and in vivo biocompatibility, toxicology and analytical services, as well as contract cGMP manufacturing and processing for tissue-based products.

  • Combination Products Testing
  • Biocompatibility Testing
  • GLP Toxicology & PK
  • Mycoplasma Testing
  • In vivo Viral / Biodistribution
  • Histopathology / Clinical Pathology
  • Tissue Manufacturing
  • Extractables/Leachables Testing
  • Particulates Analysis
  • Nanotechnology Testing

Our facilities are FDA registered, ISO certified and accredited by relevant regulatory bodies and industry associations.

 

  • FDA Registered
  • FDA HCT/P Registered
  • Cleanroom ISO 14644-1 Class 7 (10,000)
  • ISO 13485 Compliance
  • American Association of Tissue Banks (AATB) Accredited
  • cGMP Compliant
  • GLP & GMP-Compliant Testing
  • AAALAC Accredited

Suzhou, China

We are pleased to announce a full offering of device testing services is now available to support our global medical device testing platform. Contact us for more information.