Trends in Fill Finish Facilities

DPS Engineering’s, Strategic Consultant, Sue Cooke, presented DPS’s perspective on Trends in Fill Finish Facilities at the very successful IDA, Enterprise Ireland Biopartnering event in NIBRT on 15th April.

Sue talked about a conservative mature sector operating at the point of highest product value.  The presentation highlighted that while the sector is not the most active for innovations, advances relating to risk reduction, improved product quality and efficiency are bringing improvements. We are seeing incremental innovations primarily by equipment suppliers.

From a facility design perspective, the trends are towards leaner facilities with a focus on reduced cost of goods and sustainability as well as a real move towards more flexible facilities for multiproduct manufacturing.

Single use systems are now readily available for fill finish unit operations and are being implemented with real advantages for reducing costs and increasing flexibility and minimising risk for multiple product facilities. Isolated filling lines are becoming the norm.

There is increased adoption of the ASTM-E2500-07, Verification strategy for Commissioning and Qualification supporting greater efficiencies and a faster time to market.

The sector is continuing to grow and with the new generation of biomolecules with smaller batch sizes and varied container formats we are also seeing exciting developments in flexible lines.