Product and Educational Services LLC ("PES")

Located in the PA Biotechnology Center, Doylestown, PA 18902

Home
Quality System Consulting
Manufacturing
Sterility Assurance
FDA Regulatory Affairs
Clinical Trial Support
About Us
Contact Us
Site Map

PES assures product sterility by:

  • contacting the appropriate sterilization facility (EtO, Gamma, or steam) on behalf of the client
  • writing and executing the sterilization validation plan
  • writing the appropriate sterilization validation protocols
  • managing the sterilization and sterilization validation process
  • contacting several testing laboratories to determine which facility will provide the testing service at a competitive cost
  • managing the laboratory testing program
  • placing the sterilized product into quarantine until the testing results are received
  • providing long term storage for accelerated aging tests