One-pot processing is a term that includes any technology that combines different unit operations of a pharmaceutical production process into one machine. In most cases, however, a onepot processor refers to a high shear mixer–granulator that is also equipped with drying technologies. Thus, onepot processing is the production of pharmaceutical granules using a wet granulation process in which dry mixing, liquid addition, wet granulation, drying and sizing of the granules is all performed in one machine.
Griet Van Vaerenbergh
The benefits of this type of processing are:
- By integrating granulating and drying capabilities into a single unit, capital investment in equipment and GMP floor space is lower compared with other alternatives.
- The number of material handling steps is decreased. Consequently, the total processing time is shorter while maintaining a high yield and keeping production support to a minimum. At the same time, the number of required operators is also reduced.
- Environmental variables, such as humidity, are eliminated from the manufacturing process, which may offer advantages for processing moisture-sensitive formulations.
- Requirements for solvent recovery systems are lower compared with fluid bed dryers.
- Reaching a high level of containment is easy by application of the correct measures at in and outlet valves.
- A single pot can be changed over in less than 2 hours, which makes it a very attractive technology if a large number of different products demanding a high number of product changeovers has to be produced.
Single pot processing has always been a niche technology in the pharma industry, but interest has increased in recent years because of the advantages it offers for producing highly potent compounds, such as oncology medicines and hormones. The concept of a onepot processor in itself already ensures contained processing. Because all unit operations are combined into one machine, the product is completely contained from charging the raw materials up to discharging the dry granulate ready for compression. No product transfers during the process are required, thus drastically reducing the exposure risk. By applying the correct containment measures to loading and discharge valves, a high level of containment is easily achieved.