The unit operations that comprise our Integrated Continuous Manufacturing lines are novel, and provide advantages over existing conventional batch technologies. They permit reactions and formulation steps that are not possible in batch. The following unit operations are examples of process technologies we can implement for our pharmaceutical clients:
Continuous Reactor to Handle Solids in flow
A reactor with a particular geometry which favors handling solids in continuous flow
- Description: Developed for fast, exothermic reactions, the geometry of this reactor enables solid particulates to be processed in flow
Membrane Separator By-Pass
A system that allows automated cleaning in place of liquid-liquid membrane separators
- Description: Separates aqueous and organic streams without headspace, including difficult emulsions. The system automatically detects when membrane fouling occurs, responding by bypassing the compromised membrane to a fresh separation unit in addition to cleaning the fouled membrane. Upon completion of cleaning, the system reverts back to the first membrane separation unit.
Process to crystallize an API directly on the excipient surface
- Description: API in different solutions can be crystallized on crystalline or polymeric excipients to eliminate downstream processes such as granulation.
Integrated Nucleator and Tubular Crystallizer
Device to produce particles with mono-disperse, very narrow size distribution
- Description: A supersaturated solution is run into a nucleator device containing a specific seed initiating the nucleation process. Particles are then transferred into a tubular (plug flow) crystallizer where growth occurs.
Continuous, small scale rotary filtration and washing system for the purification of concentrated suspensions containing active pharmaceutical ingredients (APIs) or API intermediates
- Description: The process consists of spreading a concentrated suspension of one or more intermediates and/or APIs on a rotating porous surface; the product is then filtered using a high vacuum system. The product, which has the consistency of a wetcake, is completely purified through a washing process, and then removed from the filter surface.
Rapid, continuous, small-scale device that forms dry powder from a concentrated or diluted suspension that contains active pharmaceutical ingredients (APIs)
- Description: The process consists of converting a slurry or suspension into a dry flowable powder. The unit operation combines two main steps: (i) a rotary drum dryer, and (ii) a tubular, screw vacuum dryer. These two steps are continuous and run in an integrated manner.
Integration of extrusion and moulding processes for the continuous manufacturing of pharmaceutical tablets
- Description: A process for manufacturing solid oral dosage forms by direct integration of an extruder with a forming step. The extruder transforms the raw materials into a product of uniform composition and density (i.e. the extrudate), prior to shaping it into the final dosage form by the action of a moulding machine. The objective is to implement this process for both melt and wet extrusions.
Continuous process (powder handling free) for transforming a solution or suspension into pharmaceutical tablets
- Description: A process for manufacturing solid oral dosage forms directly from solutions of purified API. A solution is processed either through thin-film casting or electroprocessing to produce a thin layer of an API/excipient matrix. The film is subsequently engineered to form tablets of consistent physical dimensions (e.g. thickness, diameter and mass). All steps are continuous and run in an integrated manner.