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

sterility assurance

WuXi AppTec offers a full range of sterility assurance and sterilization management services, with testing programs designed to mitigate critical concerns and meet regulations worldwide. A total package of program components is available to assist you in developing the necessary processes to support cleanroom and manufacturing facility design, validations, and routine environmental monitoring. Our proven methods and processes offer complete program assurance designed to reduce risks and help you better position your program to avoid contamination events, product recalls, and back orders triggered by sterility issues.

Product Types:

Proven Expertise

  • Over 20 years of experience
  • Expert members on international guidance committees
  • Leaders/participants on industry committees
  • Registrations/Certifications: ISO 17025 • FDA • ISTA

Comprehensive Service Offerings

Clean Room Design Requirements, Validation & Monitoring

Identify environmental needs in your design stage and validate the cleanliness of your environment.

  • Clean Room Design and Validation Support
  • Facility Evaluations: Process & Materials Flow
  • Microbial Control Points
  • Water and Gas Systems Testing & Validation

Cleaning Validations & Sterility Assurance

Prove the efficacy of your cleaning process.

  • Efficacy of Sanitizers / Surface Cleaning Validation (Microbial and Viral)
  • Cleaning Agents and Techniques Analysis
  • Cleaning of Surface Materials Evaluations
  • Microbial & Viral Clearance / Inactivation Studies

Microbiology Services

Manage your entire microbial environmental sampling program.

  • Bioburden Testing
  • Controlled Environment Testing
  • Microbial Identification
  • Sterility Testing and Dose Audits
  • Lot Release (Analytical and Microbial)

Package Testing & Validation

Prove the integrity and acceptability of your packaging.

  • Sterile Barrier System (SBS) Testing
  • SBS Seal and Whole Package Strength
  • SBS Integrity & Stability
  • Package System Design and Qualification Testing
  • Full Range of Chemical / Analytical Testing of Materials Used
  • Extractables & Leachables Analysis on Container Closures and Processing Materials
  • Stability Analysis of Product and Package

Program Features

  • Full range of services, with testing to meet regulations worldwide.
  • Expert guidance in designing product-specific testing plans for successful submissions.
  • State-of-the-art equipment.
  • Specialized studies in sterilization and reprocessing validations.
  • Total validation program management support.
  • Submission-ready validation report manuals.