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Single-use Pharmaceutical Solutions Defy Economies of Scale

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For more than a decade there have been many changes in how drugs are manufactured. But we are currently witnessing a pharmaceutical industry that is undergoing a paradigm shift in its manufacturing practices with an increased interest and focus on mobile single use technology coupled with a drive towards flexible manufacturing.

In parallel, we are hearing how the Internet of Things (IoT) and Industry 4.0 are becoming increasingly important to the continued success and competitiveness of global manufacturing. But how will Industry 4.0 impact the pharmaceutical sector and specifically how drugs are manufactured?

The “Facility of the Future” concept first caught my attention about three years ago and since then we have been working internally and with customers developing automation solutions to help address the challenges found in such a facility.

Let us discuss how advances such as single-use technology are affecting the?primary biopharmaceutical manufacturing process and how automation is evolving to help support the facility of the future.

With the Industrial Internet of Things (IIoT) and Industry 4.0-capable systems providing the momentum, I am seeing companies demanding more agile and flexible manufacturing practices in order to meet an industry drive towards more personalized medicines.

At the same time, manufacturers are demanding more competitive solutions that meet regulatory and security challenges.

These considerations, coupled with a growing trend of locating smaller more agile facilities closer to customer markets, are pushing manufactures towards facilities that make extensive use of mobile, single-use equipment that can be easily reconfigured to support the manufacture of multiple products.

Additionally, manufacturers are looking for repeatable and scalable solutions that can be developed in one location and then deployed in other locations, minimising capex and reducing time to market.? This is what is known as a Facility of the Future.

...unlike in the hybrid facility, there is no fixed equipment in the facility of the future and, as such, the process train can be easily and fully reconfigured

While single-use equipment has been around for many years, the primary difference between the Facility of the Future and hybrid facilities is that, unlike in the hybrid facility, there is no fixed equipment in the Facility of the Future and as such, the process train can be easily and fully reconfigured.

The “batch of you” philosophy is also rewriting the economies-of-scale rule book that has underpinned pharma for so many years. But in order to make it feasible, pharmaceutical companies must deploy technology leveraging every single capability and nuance of a fully integrated and connected processing and automation system.

Single-use technology helps answer this challenge for many of our customers, but it does have additional demands and challenges over those of traditional manufacturing facilities.

For example, facilities should be multi-product capable, they must use disposable, single-use consumables and they have to deploy an agile, plug-and-play architecture to make changeovers as quick, seamless and economical as possible.

Single-use solutions must focus on the operational capabilities and agility of the hardware to meet the demands of a flexible mobile facility.

Savings in time and effort in batch changeovers are reflected in the ultimate financial performance of the system. Customers require complete mobility of equipment in the Facility of the Future, but this presents further challenges in terms of the physical movement of totes over 500 liters.

Mobility also requires that skids from any vendor can communicate with one another and be easily integrated into a centralized process control system. Indeed, any delay in these practices, through alarms or delayed and ineffective handshaking, will add to the batch run’s costs.

We are also advising our customers that they must consider the increased complexity that their operators face working within a fully mobile facility.

In any one batch, an operator may be required to make up to 900 individual connections. Even if they get this 99% correct, that still leaves nine errors – any one of which may cause a batch to fail. In order to guide the operator through the connections of these single-use tubes, various solutions have been developed that use graphical aids to help operators visualize the work instruction.

To achieve this, it is vital that mobile, single-use skids can be networked and communicate with each other and?centralised process control and?MES systems and not operate as standalone units.

When we speak with our customers, they are very direct about these and other challenges and are calling upon us to help them develop the most effective solutions possible.

The changing landscape is certainly redefining how the industry operates, but it can learn from other industries, such as automotive, that already have significant experience of precise and auditable operator-interaction control; and other industries that have embraced mobile, plug-and-play concepts.

In my mind, the automation concept must enhance and not hinder the overall objectives of the Facility of the Future.

By listening to our customers and delivering solutions that meet their most pressing needs, we are in a great position to help define the future roadmap – where data is king and patients get the increasingly complex treatments they need, without economics and technology getting in the way.

Billy Sisk
Billy Sisk
Life Sciences Industry Manager EMEA, Rockwell Automation
Billy has worked extensively both in automation and IT and is responsible for Rockwell Automation’s life science market strategy across EMEA. Through his high performing team, Billy helps pharmaceutical manufacturers bring innovative treatments to patients faster, while improving quality, yield and product security.

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