Aseptic Fill Finish
MassBiologics has significant experience filling clinical and commercial products. Our Bosch filler is highly automated and can be configured to accommodate lot sizes as small as a few hundred vials with low line loss, to commercial scale filling of 250,000 units. Our facility is FDA licensed and the fill line employs RABS isolation technology for sterility assurance. Our manufacturing support services include labeling, unit dose packaging and custom kit assembly.
Clinical or Small Lot Size Fill Configuration:
- Bosch FLM-4080 Configured with 2 dosing needles
- Dosing with peristaltic pump, utilizing disposable product contact fluid path
- Non-destructive, automatic weight checks – maximizing sample recovery for small clinical fills.
- Bosch VRK-4010 automated capper
Commercial or High Volume Fill Configuration:
- Bosch FLM-4080 Configured with 8 dosing needles
- Time-Pressure Feed Dosing at up to 300 vpm utilizing product dedicated fluid path
- Non-destructive, automatic weight checks with automated adjustment of dosing to maximize throughput and process yield.
- Bosch VRK-4010 automated capper
- Bosch KIV-1020 encoder (prints UV matrix on overseal for lot identification)
Manufacturing Support Equipment
- High Volume Vapor Compression WFI Still, 5,000 gallon WFI Storage Tank
- Penn-Tech High Throughput Vial Washer
- Bosch Depyrogenation Tunnel
- Manual Visual Inspection Stations (4)
- Eisai, Semi-Automated Visual Inspection Stations (2)
Eisai, Fully Automated Inspection Station
Click here for more information or to schedule a call to discuss your manufacturing requirements.