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2023 Aseptic Conference

SES101b - Case Study: New Syringe Line for High Potent Drugs

‐ Mar 6, 2023 12:00pm

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


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