We will address conceptual topics and detailed challenges during design and implementation of high-speed syringe filling line for High Potent drugs. Challenges of mock-up, risk assessment, process design will be presented and discussed. Project management pros and cons will be presented.
Initial structure of the presentation: • Project set up and Project Management (funding, time line, site decision, why syringes) • Choice of filling line and isolator • Learnings from the mock-up study • Integration into the building (Layout, air management) • Strategy for filling toxic drugs (cleaning, operator protection) • Special challenges when filling toxic drugs into syringes (e.g., no outside washing possible!) • Use of NTT (No-Touch-Transfer) with fully automatic bag opening for inner and outer bag • Impact assessment of new Annex 1 for EU GMP