Weighing highly active substances in pharmaceutical production:
• Personal introduction by Bernhard Steidle and Dirk Collins
• What does ‘highly active’ mean?
• What do OEL/OEB/BIEL mean?
• How is the OEL measured? Brief description of an SMEPAC test
• Case study: Boehringer Ingelheim Biopharma Biberach
• Process description
• Special features of highly active substances. What to consider during transfer, cleaning and preparation
• Technical implementation: examples of technical special features.
• Comparison of different transfer systems: docking, double flap, rapid transfer port (RTP), endless liner
• Which is more important: aseptic or containment?
• Summary