The pharmaceutical formulations manufacturing is beginning to concentrate on continuous manufacturing and granulation is one of the key processes that requires to be continuous. Not only does continuous granulation allow for lower costs, but also very efficient and effective manufacturing operations, with a very low space and energy requirement.

With very few new and innovative drugs being approved or in the pipeline, generic manufacturers have a very high advantage when they can make their manufacturing process more cost effective.

A lot of the leading pharmaceutical formulations manufacturers have already started looking at larger / continuous productions processes, and are in active discussions with machine manufacturing companies to come up with such solutions. A large part of the challenge to make the granulation processes continuous is the ability to make it GMP and also the ability to prove a total clean state, once cleaning is completed. Due to above challenges, companies are looking at re-registering their processes by alternative methods like:

Direct Compression

While this method is good for companies that have limited manufacturing capabilities and almost no expertise in granulation, it has its own challenges too. It works with a very few products and materials handling is a key step as well. With direct compression, it is imperative to make sure that segregation is avoided and product consistency is maintained. When it comes to costs, this also becomes an expensive method, as inputs are more expensive and difficult to get to the required standards.

Dry Granulation

Dry Granulation inherently happens to be a continuous granulation method and is around for a number of years. The process requires well designed and engineered equipment that can consistently maintain process parameters and ensure good productivity. There is also a need to have closed and integrated solutions to ensure high yield.

Dry granulation using Roller compactors is the most preferred method today for granulation in a continuous way. Since this is a continuous process, it is easier to achieve Larger Batch sizes and can help lower the cost of manufacturing substantially. Most roller compactors are compact and have a very small foot print, thereby allowing for a smaller GMP area. Closed and integrated operations can be achieved easily compared to other methods of manufacturing without compromising on process.