GMP Manufacturing Capabilities
The Pilot Plant is a cGMP, multi-product, multi-module pilot scale production facility. The Pilot Plant has a very flexible design with 100s of possible vessel train configurations, it can execute batches from ~2kg up to 150Kg and supports campaigns in the order of 1 batch up to ~1MT (including intermediate steps) final step output
FACILITY & EQUIPMENT
cGMP compliant Pilot Plant consisting of a dedicated manufacturing/office building with separate dedicated material receipt/storage areas and utilities
All operations controlled via a state of the art, validated, distributed control system (DCS) running Emerson DeltaV software, ensuring complete control of all process variables and providing full data collection and retention within the system historian
Default OEB 4 (1-10µg/m3 OEL) operation with ability to achieve OEB 5 (0.1-1]µg/m3 OEL) though implementation of flexible isolators & other control measures as needed
Main production facility is split into 4 discrete modules with a common layout and has 22 reactors ranging in operating volume from 250L to 2500L
250L Vessels – 5 Glass Lined Carbon Steel (GLCS) reactors
630L Vessels – 2 Hastelloy and 6 Glass Lined Carbon Steel (GLCS) reactors
1600L Vessels – 1 Hastelloy and 6 Glass Lined Carbon Steel (GLCS) reactors
2500L Vessels – 2 Glass Lined Carbon Steel (GLCS) reactors
2 additional Hastelloy hydrogenation reactors (1 Stirred Tank and 1 Buss Loop Hydrogenator)
High pressure capabilities in standard rector up to 6 barg design pressure
1 vessel (630L Hastelloy) with Cryogenic Capabilities down to -80deg
5 Hastelloy Agitated Filter Dryers – Filtration areas 0.25-0.75㎡
2 Vacuum Tray Dryers – 2-40Kg batch size
Wet and Dry milling capabilities, 2 Mobile High Sheer Wet Mills (Hastelloy) RPMs 2,400-6,000, Fitzpatrick Mill and Cone Mill Screen sizes 0.2-4mm
PAT equipment, MIR, pH & FBRM probes
