3 modules10 lessons~6 h

Media Fill (Aseptic Process Simulation) Masterclass

Design, run and defend aseptic process simulations: worst case, interventions, lyophilisation and powders, incubation, acceptance, failure and requalification.

What you'll be able to do

✓ Explain what an APS proves and which requirements apply
✓ Design a worst-case simulation with the right medium, units and duration
✓ Plan inherent and corrective interventions and operator participation
✓ Simulate lyophilisation, powder filling and isolator processes correctly
✓ Incubate, inspect, reconcile and judge results with Annex 1 acceptance
✓ Handle failures, batch impact and requalification

Syllabus

MODULE 1Principles and designWhat an APS proves and how to design it.
- What an aseptic process simulation provesFree preview
- Designing the simulationFree preview
MODULE 2Interventions and special processesPeople, interventions, lyophilisation and powders.
- Interventions and people
- Lyophilised, powder and other special processes
- Running the simulation
MODULE 3Results and requalificationIncubation, acceptance, frequency and cases.
- Incubation and inspection
- Acceptance, failure and its consequences
- Frequency, requalification and change
- Case studies
- Final exam (25 questions)

Questions

Who is this course for?

People who plan, perform or approve media fills in sterile manufacturing.

Is there a certificate?

Yes, after the lessons and a 25-question final test (pass mark 70 %), with a QR verification page.

Which guidance does it follow?

EU GMP Annex 1 (2022), FDA aseptic processing guidance (2004), PIC/S PI 007, PDA TR 22 and Schedule M.