The basis for Continuous Manufacturing (CM) are modern monitoring and controls. But, if we want to make full use of them, we need advanced analytics applications. And this is where Process Analytical Technology (PAT) come into play! Do you want to know more about the topic? Then this post is for you!

Continuous Manufacturing: a big step for Pharma Industry.

Continuous manufacturing (CM) is a modern technology that enable pharmaceutical innovation and modernization. And because of that, it has a positive impact in the industry and patients.

Continuous manufacturing is an integrated process consisting of a series of unit operations. In these operations, the input materials are continuously fed into and transformed within the process. And then, the processed output materials are continuously removed from the system.

For this reason, we need specific technology. If we want to channel the full potential of continuous manufacturing implementation, we need state-of-the-art tools. And not just that, they need to be systematic, as well as science- and risk-based methodologies. Which is how we get to PAT and Quality by Design (QbD).

How does Process Analytical Technology help Continuous Manufacturing?

CM delivers several benefits to the pharmaceutical industry. Among those benefits we can find:

  • Operational flexibility;
  • Manufacturing and cost efficiencies;
  • Improved processes with more consistent quality.

However, if we want to achieve these goals, we need extensive product and process understanding. And then, we need the ability to control process conditions in real-time.

How do we do that? We build an effective PAT for real-time online monitoring during development, and commercial manufacturing!

So, you may ask, why would we go for PAT? For start, if we apply process monitoring and the use of PAT tools, we can generate real-time information. Information on:

  • Process parameters;
  • Attributes of input materials;
  • In-process materials;
  • Final products and;
  • Manufacturing process.

This is great because this knowledge will lead the way to the development of a robust control strategy. And that will give us a higher degree of automation and a better control over the process.

Essentially, PAT provides real-time detection of process deviations and disturbances and effective material diversion. And this means that we can assure product quality.

But there are other applications! We generate large amount of real-time process and quality data during production. And so, we can use this data to support real-time release testing (RTRT).

So why are you not using PAT yet?

But if PAT is this amazing, why isn’t everyone using it yet? Well, in our experience, this happens because of a few reasons:

  • Regulatory and Financial concerns;
  • Lack of Technological maturity;
  • Reliability Risks;
  • Need of specialized technical skills.

However, from our experience, most of these barriers are easy to overcome. Whether because the technology is supported by regulatory agencies or because there are already quite a few specialized companies on the topic (like 4TE!), you can be sure that those concerns can be minimized, if not eliminated.

So, if by now we haven’t sold out yet on how great PAT can be for your process control strategy, we don’t think there’s anything more we can do.

But, if we managed to persuade you, then how can you implement it?

We took a deeper look at this topic in our Article from December 2020: A Roadmap to PAT implementation. You can download it from here:

Roadmap to PAT implementation

Would you like having PAT implemented in your process?

If you’d like to have PAT implemented in your process but you’re concerned about the barriers we mentioned before, don’t worry; we can help!

Our team is highly specialized in supporting the implementation of PAT for pharmaceutical processes.

We take a step-by-step approach where we start implementing PAT in simple cases to generate visible quick wins.

Once the benefits and knowledge foundation that PAT creates are clear, you will be ready to start the organization of bigger PAT projects.

If you think we could help making more out of your processes, get in touch with us! Take a look at our PAT Implementation Services and feel free to contact us.

Related Topics

If Process Analytical Tecnhology and its implementation is a topic of interest to you, please have a look in this article of ours: Data Integrity in Healthcare.