+1 (888) 794-0077

Testing Facilities

Facilities

WuXi AppTec Laboratory Testing Division 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 and in our new facility in Suzhou, China. We are committed to supporting customer needs in a global market place.

Atlanta, GA

WuXi AppTec Laboratory Testing Division’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

St. Paul, MN

WuXi AppTec Laboratory Testing Division’s St. Paul site is our Center of Excellence for Preclinical Safety. Our FDA-registered testing and manufacturing facilities in St. Paul 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 platform. Contact us for more information.