Continuous manufacturing in the pharmaceutical industry
The ideal holiday arrangement for the world’s wealthy elite and a distant fantasy for the rest of us, private islands deliver ultimate isolation in our modern world.
While this may seem like paradise for those stuck in rush hour traffic, in the real world, communication is key. Here, Robert Holloway, Head of Order Fulfilment at industrial automation supplier EU Automation discusses the potential of continuous manufacturing compared with its isolated, batch manufacturing alternative.
Using traditional batch manufacturing methods, pharmaceutical companies often operate through so-called islands of automation — a series of disconnected, single unit processes. With production taking place in separate environments or on separate manufacturing lines, this traditional operating model is notorious for slowing assembly and high levels of downtime.
Last year however, the US Food and Drug Administration (FDA) called for manufacturers to abandon this outdated model and, instead, make the switch to continuous manufacturing (CM).
Renowned as a way to shorten the supply chain, increase agility and improve the flexibility of development and manufacturing, this continuous method has clear advantages compared with its stop-start, batch counterpart.
The FDA endorsement may have recently shone a light on the benefits, but continuous manufacturing is by no means a new process. In fact, for majority of other manufacturing industries, including automotive, oil and gas and electrical components, this method of production is a well-established standard. So, why has the pharmaceutical industry been slow to adopt the practice?
Despite its benefits, migrating to continuous manufacturing is not necessarily the remedy to cure all difficulties faced by the pharmaceutical industry. Changing processes often requires a changing of systems, more often considered a threat than an opportunity. This dramatic shift from batch to continuous manufacturing can cause reluctance from stakeholders and staff and the journey to introducing this method depends highly on conviction.
In additional to the cultural challenges, integration is a notable problem for the industry. Many original equipment manufacturers are only capable of supplying one piece of the puzzle. For continuous manufacturing to truly succeed, all of the pieces must fit together seamlessly.
For example, an equipment manufacturer may provide a solution for continuous coating or tablet packaging, but the same machinery may not be designed to integrate with the equipment that precedes or follows it. Without the expenditure of a costly equipment overhaul, the machinery will continue to be reliant on a human machine interface (HMI) to operate and control each separate single-unit cell.
To truly bridge these processes into one seamless operation, there are several requirements for the manufacturing facility. Unlike other industries, continuous manufacturing equipment for the pharmaceutical industry is relatively small. Therefore, floor space should be small and the equipment easy to reach, allowing for quick changeovers for multiproduct manufacturing. For manufacturers of more than one product, or highly complex prescription products, this small, modular and transferrable equipment is essential to enable formulation flexibility.
Batch manufacturing has existed for centuries; but, today, technological advancements have meant continuous manufacturing has become a natural progression for the industry.
The move towards continuous manufacturing is, without doubt, a huge step for manufacturers. Companies planning to make the migration should arm themselves with a long-term strategy and work with an expert partner for the implementation.
Despite the challenges of the transition, as industrial automation technology develops, the take up of continuous manufacturing holds a lot of potential for the pharmaceutical industry.