Thanks to flexible automation platforms, biopharmaceutical OEMs can now use one-time use technology (SUT) to achieve intelligent and miniaturized production, and then rapidly expand production scale.

In the past decade, modular factories and single use technology (SUT) have rapidly developed and been widely applied in the biopharmaceutical industry. Data shows that over 85% of biopharmaceutical manufacturers rely on SUT for trial commercial scale production, followed by rapid commercial production.

Leading biopharmaceutical OEM manufacturers are fully aware of the challenges and opportunities in today's market. Undoubtedly, the market's demand for equipment agility is increasing. These devices not only need to meet the needs of new modular factories and support small batch production, but also need to be easily expandable to meet the requirements of commercial production.

And there is no doubt that equipment suppliers are the original creators of this flexible disposable production environment. You can recommend automation strategies to customers to help them better implement their plans and bring more value to them, which is particularly suitable when working with new innovative companies.

However, it is undoubtedly challenging to find which automation solution can effectively improve the intelligence and "plug and play" agility of disposable devices.

The dilemma of automation

In industries that pursue speed and flexibility, the last thing we want to see is complex automation platforms, as this will slow down equipment development or customer integration processes.

To avoid complexity, biopharmaceutical companies often abandon further intelligence after achieving automation of disposable devices. However, due to the lack of a control system, the delivered complete set of equipment is very "clumsy", which will ultimately bring great difficulties to debugging and verification during factory acceptance testing.

This will also create another issue: the integration strategies applied by each biopharmaceutical company's SUT are different. Some will be adjusted based on traditional distributed control systems (DCS) to achieve unified planning across the entire site, while others will choose to use systems that can give each machine control platform more autonomy. But this approach is prone to forming "automated islands", thereby weakening the ability of biopharmaceutical companies to implement comprehensive process control strategies, or to gain insights through analysis to improve quality and increase production.

At present, the industry is working hard to develop relevant standards in order to make the implementation of SUT and plug and play more unified and standardized. But at the same time, you must develop cost-effective and flexible automation strategies for your disposable devices to adapt to constantly changing paradigms.

How to choose a powerful platform to enhance flexibility to a higher level

The rapidly developing automation platform has become increasingly mature, which can simultaneously improve the flexibility and native intelligence of complete sets of equipment.

How do you evaluate the latest products? Here are some key questions:

Is the system easy to use and master?

The lower the complexity of the system, the shorter the development time of the device and the less time-consuming it is to implement modifications. The usability of the system is also very important. If the customer's automation platform knowledge is insufficient or lacks support, an easy-to-use system can reduce the technical barriers that customers need to overcome.

For example, this powerful control platform embeds process specific objects in the firmware, which helps enhance design consistency, reduce verification workload, and simplify your work. The integrated automatic hardware diagnostic function can effectively shorten the implementation time. The intuitive HMI can also simplify equipment monitoring and fault handling, which undoubtedly ensures customer satisfaction.

Can the control platform run on existing commercial off the shelf (COTS) software?

The COTS based system has been tested and can be configured according to your needs - without the need for reprogramming. For regulated industries like biopharmaceuticals, this means that industry-specific process objects can be embedded in firmware, making it a "validation ready" GAMP Class 4 solution ("configurable software" and "custom software").

Using COTS based systems can save a significant amount of time during initial system development and validation, and also improve system lifecycle management.

What communication protocols are supported?

If the control platform is built on an unmodified open Ethernet network, it can directly communicate with various controllers and I/O, thereby improving access to information and simplifying the integration of complete equipment.

In addition, this method is crucial for simplifying plug and play connections for mobile devices and reducing conversion time. Both of these advantages can encourage customers to adopt your technology.

Is the entire automation platform scalable?

An automated platform that can manage complex multivariate production in clinical stages and seamlessly scale up to commercial scale is crucial for the successful operation of biopharmaceutical companies. When evaluating an automation system for a complete set of equipment, it should be ensured that the system supports comprehensive expansion - from controllers, I/O to HMI, batch control, and analysis.

A truly scalable platform can enhance product flexibility and help you and your customers achieve a win-win situation. You can start small and gradually adjust your equipment using information technology. With the increasing richness of products, you can easily apply the applications and analysis data developed in one system to other systems.

The scalable automation platform adopts an open communication protocol, eliminating the need for significant upfront investment in automation infrastructure. It can expand as both parties develop, ultimately benefiting you and your customers from smarter devices.

Learn more about scalable automation architectures that will make your SUT equipment more flexible.

Understand how Rockwell Automation Technology is committed to creating smarter and more flexible biotechnology manufacturing solutions.