Although continuous manufacturing has been used in other industries for centuries to produce products ranging from glass bottles to breakfast cereals, it is still in relatively new in the pharmaceutical industry. This situation has often prompted the question among pharmaceutical companies, vendors and regulatory agencies: “If continuous manufacturing is routine for other consumer products, why can’t we do it too?” Potential obstacles such as transforming traditional batch processes to continuous processes, maintaining process control and potential regulatory challenges all seemed daunting.
Based on our experience, major advances have been made to implement continuous manufacturing in the pharmaceutical industry for both prescription and over-the-counter products. This achievement is largely due to a collaborative effort by pharmaceutical companies, equipment vendors and regulatory agencies to facilitate developments that seemed impossible as little as a decade ago. The evolution of process analytical technology (PAT), advanced process control (APC), process modeling methods and continuous manufacturing equipment have aligned in highly synergistic ways.
In continuous manufacturing, it is critical to measure materials’ properties and use them as inputs in process models to develop a robust process. This message certainly resonates with us at Jenike & Johanson, since our very inception as a company was based on the fundamental questions of: What material properties define how a powder “flows” and how can these properties be used in predictive models?
The possibilities of continuous manufacturing in the pharmaceutical industry are exciting, but many common powder handling challenges persist, including:
- How can I ensure my cohesive, milled API flows reliably?
- Will I be able to feed my blend components to my blender/granulator at a stable target feed rate?
- Can my raw material or product be reliably pneumatically conveyed between process steps?
- Are there segregation risks downstream of the final blending process that can affect content uniformity?
- Can I meet my target compression rates?
These are problems and questions we address everyday. Jenike & Johanson is ready to assist you as your company embarks on transforming your traditional batch processes to continuous manufacturing, so please contact us if you would like to discuss your goals and challenges further.