Validation

ASI's staff has experience with equipment, facility, utility, computer hardware/software, process, cleaning, and test method validation/qualification in environments ranging from bulk chemical manufacturing to aseptic filling.

ASI is experienced with all aspects of qualification and validation from validation master planning through IQ/OQ/PQ generation/execution to authoring the final report.

Philosophy 

ASI is a strong proponent of the newly established E55.03 standard, “A Science and Risk-Based Approach to Qualification of Biopharmaceutical and Pharmaceutical Manufacturing Systems”.  E55.03 champions the streamlining the development of formalized technical documentation; and focuses on the use of engineering judgment to determine the appropriate level of documentation required for technical tasks, and to achieve the goal of assuring both technical correctness and readability by reviewers.

Validation Expertise

  • Control Systems
  • Aseptic Filling
  • Bulk Powder/Liquid Handling
  • Sterilization
  • Drying/Coating/Granulating
  • Tabletting
  • Product Contact Glasses
  • DW, DI, & RO Systems Purification
  • Packaging/Fill/Labeling
  • Form/Fill/Seal
  • Blow/Fill/Seal
  • Controls and Instrumentation
  • Steam/EtO/Radiation
  • Product Containment
  • Clean Rooms
  • Clean Steam Lyophilization
  • Fermentation
  • Distillation/Crystallization
  • Mixing/Milling
  • Stability Chambers
  • Coolers/Freezers
  • HVAC
  • Molding