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