Aseptic Processing

Module Lenght

from 1 to 2 days

Agenda

  • Material and Primary Containers
  • Autoclaves
  • Dry-heat Oven and Depyrogenation Tunnels
  • VHP Pass Box
  • Sterile Manufacturing Operations
  • Cleaning Validation in Aseptic Processing
  • Sterile Filtration Validation
  • Media Fill Test
  • In Process Material and Sterile Finished Form Qualification
  • Container Closure Integrity Test Validation
  • Material Qualification and Toxicological Assessment

Target audience

  • Quality Assurance
  • Quality Control
  • Regulatory Affairs
  • Technology Transfer
  • Validation

Learning tools

  • Presentations
  • Lectures
  • Case Studies
  • Discussion
  • Question & Answers session
  • Final Evaluation Test

Regulatory & technical references

  • Eu cGMP Annex 1
  • FDA Guidance for Aseptic Processing
  • USP 37 NF 29 <1229>, <1207>, <660>, <661>,<381> ,<1660>, <1663>, <1664>
  • ASTM F838
  • ICH Q7, ICH Q8
  • PDA TR 26 “Sterilizing Filtration of Liquids”
  • PDA TR27 “Pharmaceutical Packing Integrity”
  • PDA TR 29 “Points to consider for Cleaning Validation”

Number of trainers

One/Two

Tailoring option available

Yes

Final evaluation quiz

Yes

Contact

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