Glossary Definition: Lights-Out Manufacturing

Sometimes called “dark factories,” lights-out manufacturing is a fully automated process that produces products with little to no human intervention entirely, or for a certain period of time. In this production model, robots take care of day-to-day operations with appropriate monitoring in place to alert humans as needed. For example, in the event of an alarm or adverse manufacturing event humans can be alerted, but won’t need to continually monitor manufacturing operations.

 As a result, products can be made from start to finish without the accommodation of human needs: worker salaries, lunch breaks, sleep, lights, and other utilities. The machines are powered by Artificial Intelligence (AI), and are ideally capable of working around the clock in the dark.

This manufacturing method is nothing new, with Japan’s FANUC factory operating as a dark factory since 2001. However, in recent times it has gained more global awareness and adoption.

In the coming years, experts predict that a number of manufacturing industries will adopt the lights-out model to reduce costs and increase efficiencies, including electronics, automotive, and consumer goods.

Lights-out manufacturing can also be referred to as:

• Lights-out operation
• Lights-out processing 
• Lights-out digital manufacturing 
• Dark factory / dark factories

Unlike continuous manufacturing, which is an end-to-end manufacturing process, human oversight is not required for full lights-out manufacturing. Machines and/or software handle production from beginning to end. Some factories may operate 24/7, without the need for conventional electricity or heating and cooling to accommodate human comfort levels.

In pharma, lights-out manufacturing is a fully automated process that develops therapies from start to finish without human intervention. Powered by artificial intelligence and tech stacks such as machine vision, cloud computing, and robotics, smart machines manufacture drugs without interruption.

Currently, achieving full lights-out manufacturing is more of a future-state aspiration in the pharmaceutical industry than a reality. More research is needed to figure out how to eliminate human intervention without compromising safety or quality standards.

In addition, there are a number of potential complications to consider for pharmaceutical applications of this method. These complications include:

• Equipment maintenance and performance
• Hindrances such as clogging and pressure
• Material loading and unloading
• Remote monitoring requirements

Lights-out manufacturing will become increasingly important as Pharma 4.0 continues to transform how life science teams work together, interact with their environments, share data, and expedite time to market. Not only does this manufacturing model have the potential to increase speed and efficiency, it also allows companies to scale the production of personalized medicines without deviations or compliance concerns.

As technological advancements continue to accelerate exponentially, pharma companies will consider ways to incorporate lights-out manufacturing as part of their roadmap or business strategy.

Once realized, this manufacturing model could help to reduce costs by eliminating resource waste, worker salaries, and the need for certain utilities. Furthermore, it can minimize the need for pauses introduced by a human to process and transfer information, allowing companies to bring products to market faster and more affordably.