Introduction
Advertisements for many on-line educational institutions feature workers in fear of being displaced from their positions by robots and the need for “Information Technology” education. While concern for having positions that will last for your intended working career has been around for a long time, in recent years it has increased significantly. A philosophy of manufacturing called Lights Out or Lights-out-Manufacturing refers to factories or companies that operate fully automated and do not require the presence of humans on site. The name lights out comes from the concept that you don’t need the lights on for a robotic operation. While called lights out, very few facilities, if any, operate exclusively with all lights out. Companies that can implement these manufacturing philosophies completely or in a large portion of their operation will have significant cost savings, e.g., lower level of electrical needs (no lights), may be able to reduce utility costs for heating/cooling as the automated facility may not need the same comfort levels as humans, reduced personnel costs, and so forth. Is this something the American Pharmaceutical Industry is ready for?
What are the Advantages of LightsOut Manufacturing?
One of the initial pushes for lights-out, was the reduction of labor costs. Many of these costs have significantly increased, e.g., due to minimum wage increases, cost of living increases, and the like. One way in which a company can implement lights-out manufacturing is to use it as a second or third shift option. This would allow for production of products that have high-level operator intervention during daytime hours and low-intervention processes can run overnight. This benefit can also be expanded by having operators’ set-up for overnight manufacturing during the day while they are overseeing other operations. (Eddy, 2013) Others report this benefit as a minimal impact to labor costs. (Anonymous, 2014)
Assuming that you have reliable, well-designed and operating equipment, the labor costs required to keep the equipment operating is reduced. (Anonymous, 2014)
Another advantage is that many utility companies have lower consumption charges for overnight or off-hours operations. This may result in lower utility costs. (Eddy, 2013) One might look at this as having an energy efficient facility during the lights-out operations. (Anonymous, 2014)
Some companies state that there is added productivity with these types of systems. (Anonymous, 2014) Companies can focus their hiring and compensation on highly skilled workers, utilizing their technical skills and knowledge. (Anonymous, 2014)
Lastly, any maybe most importantly, this allows for a significant competitive edge. (Anonymous, 2014)
As automation increases, many common issues in companies can be reduced or eliminated, e.g.:
- Automated systems always perform calculations the same way. As such they do not make errors (unless they are programmed incorrectly). This eliminates many requirements for double checking of calculations or results.
- The use of automation also reduces the actual amount of time it takes to complete many activities.
- It can eliminate many problems with illegible or poorly written data and results.
- Data is processed the exact same way each time. There are no opportunities to interpret data differently from one sample to another.
Fundamental Issues for Consideration
There are a variety of issues that need to be taken into consideration before pursuing or implementing lights-out. Some of these concerns include:
- Equipment Performance: The reliability of equipment can be a major issue as there are no personnel available or very few in the facility to perform interventions, tweak the machine, or adjust operational parameters. (Eddy, 2013)
- The capabilities of the equipment: Is the specific manufacturing equipment capable of continuous operation? Is the equipment stable and rigid? Does it have sufficient power? Is it possible to monitor activity? Is it capable of either correcting issues itself or provide for remote resolution of problems? Are there provisions for handling thermal issues? Is there disaster avoidance technology available? (Eddy, 2013)
- Can the equipment adequately handle the “product” or “component” being run on the machine? Will it operate throughout the production run? Are there issues with clogging, pressures, or the like that will hinder production? (Eddy, 2013)
- How is material loaded and unloaded? Do you have a continuous feed for adding material? What type of automated system is available for loading, e.g., bar feeders or robots? How much material can be held during a lightsout operation? Does the loader/unloader communicate with other pieces of equipment? (Eddy, 2013)
- Preventative Maintenance: A maintenance program is imperative and invaluable, regardless of the manufacturing approach used. When operators are not present, one either needs a system for obtaining repair help and/or notifying management that an issue has occurred. This may be achieved having reliable contract service providers available. (Eddy, 2013)
- Remote Monitoring Systems: No matter how well an operation occurs, there is always the potential for something to go wrong. As such, a remote monitoring and/or electronic notification system is invaluable. Many controllers can be adapted to send out communication messages to email or mobile phones so that corrective actions can occur. Even better is whether the remote notification includes an option for remote correction. (Eddy, 2013)
- Management Buy-in and Commitment: A program of this magnitude cannot possibly thrive without management support that has been transmitted to the affected employees. It is also critical for support staff to buy-in to these programs. Like most major changes, there is fear associated with the change. It is helpful for the employees to have buy-in and understand the importance of their roles in its success. (Eddy, 2013)
Robotics: A Key to Lights-out
Robotic arms have been used in many different manufacturing operations for years to move parts or select acceptable versus defective parts from conveyor belts. As the technology for the robotic arms and robots have advanced, they have numerous capabilities.
Robots tied to electronic vision systems can sort parts by a variety of parameters, including reading of bar codes. Fortunately, it has become much easier to program these units. Newer systems can be programmed using voice commands. (Eddy, 2013)
While it may seem easy to assume that no personnel are used at all in lights-out manufacturing processes, for this type of manufacturing operation to be successful, it takes careful planning, experienced workers, programming, on-going maintenance, and upkeep. Most of the robots used in lights-out are designed to work with people not replace them. For lights-out companies, instead of labor intensive operations, the workplace is now a high-tech operation. (Anonymous, 2014)
Lights Out Manufacturing is Not Good for All Processes
Some manufacturing processes are just too complex to go lights-out totally. The operation may need operator intervention to proceed. The manufacturing process needs to be well understood to assess the level of lights-out manufacturing that may be possible. To be competitive, industry in the United States must evaluate where these types of processes can be implemented.
Is the American Pharmaceutical Industry Ready for Lights-out?
One of the things frequently discussed about the pharmaceutical industry is the reluctance to make changes and look at newer technologies. For those of us with a great interest in the development of rapid microbiological methods twenty years ago, or so this was shown to be true. Most of these methods were more accurate than traditional methods, provided value in earlier batch release, and many other benefits but only a limited number are implemented even now. What is even worse is that many companies who were early adopters of rapid sterility test methods have subsequently discontinued use of rapid methods and returned to conventional microbiological methods. Another example, was the introduction of isolator technology. Many companies implemented isolators in Europe and Asia long before American companies implemented these technologies in the United States.
Despite the reluctance to change, over the years many examples of automated processes have been evidenced in facilities around the world that would suggest that lights-out manufacturing could be implemented in some areas of the pharmaceutical production facility. To maintain confidentiality, the companies where these processes were seen are not identified.
One of the early areas of automation in pharmaceutical companies was the development of automated lines for filling IV bags. Prior to this development, many of the bags were assembled and filled in handoperated lines. Depending upon the configuration selected, some of the machines fed in prefabricated bags, and other later designs made the bag as part of the process. (This is like the blow-fill-seal concept, but these bags were for intravenous use.) Depending upon the configuration of the equipment, many of these machines could operate with a single operator.
In the early 1980’s there were companies who utilized automated systems for summarization and evaluation of sterilization qualification studies. While humans were used for final approval, the data was automatically prepared and reported, including evaluation of acceptance criteria. This same company had implemented an automated batch release system, that checked all the release records and verified limits prior to identifying the acceptability of the batch for release. This went above and beyond just verifying that specific pieces of paperwork had been submitted. Robotic systems are available for the loading of sterilizer carts/pallets following bag filling. Other robots can unload the carts after transport to other areas. There are systems available for automated transfer of the sterilizer carts from one area of the facility to another. (Like those systems that move shopping carts in the big box store parking lots.) These types of transport systems could be used in any automated area of the facility.
In the compounding and formulation areas, there are robotic systems available that can “pull” the desired chemicals, weigh them out, and add them to a compounding tank. While that is said, properly validating these procedures can be comprehensive.
Automation of sterilization processes is also available. It is possible to use robotic systems for loading and unloading of sterilizers. Depending upon the capabilities of the filling line, the robots can collect the samples in the correct loading pattern, transport the units to the sterilizer and load the carts/pallets into the sterilizer. The same or other robots can remove the carts/pallets after the cycle and transport the units for additional packaging.
It is also possible to standardize the control systems for the sterilizers so that they operate using the same control system, even though individual cycles or parameters may be different. These types of controls can also handle different processes, e.g., saturated steam, steam with overpressure, steam with water spray, and so forth. Taking this a step further, a single control room can be set-up to oversee sterilization in many sterilizers, e.g., 16 sterilizers using SCADA (Supervisory Control and Data Acquisition) systems. All the data is processed through a station operated by a single or a couple of individuals. This type of operation significantly reduces the cost of operating the various sterilizers.
There are robotic systems and/or robotic arms that can be used, typically in an isolator of some type to perform individual manufacturing steps. The benefit being that the step is performed the same way every time. Some have even been programmed to perform steps that in normal operation would have needed operator interventions, e.g., righting a tipped or fallen vial.
Many companies, particularly in places like Vietnam and Japan have implemented robotics into their aseptic processes. These robots operate to perform aseptic assembly and processing with almost no human intervention.
Warehousing operations are available today for completely automated procedures. Some of these options are available and in use for nonpharmaceutical companies around the world. Aspects of these systems have also been implemented in pharmaceutical companies.
For water systems, there are options to perform the chemistry testing in-line, testing for viable microorganisms in-line, and testing for endotoxin content, in very minimal time (near real time). This provides for “automated release” of these types of systems.
In recent years there has been a significant increase in the development of single-use technologies. Many of these technologies can be coupled with robotics to reduce the human intervention required. They also eliminate or significantly reduce the cleaning and decontamination needed post processing.
Few companies have gone further with these chemistry and microbiology advances to implement them for other equipment with similar needs, e.g., within product filling lines or compounding tanks.
For microbiology testing, there have been many advances introduced in the past two decades. There are systems for real-time testing of viable microorganisms present in the airborne environment. This supplements the continuous monitoring system for particulates. There have also been numerous systems introduced that have potential to reduce the testing time for many tests, however in most cases they are not intended to work without human intervention.
For chemistry testing, there has also been a significant increase in the development of new testing methods that may be portable, in-line or faster than traditional methods. Few of these methods eliminate the need for human intervention.
Electronic vision systems are readily available for inspection of products. Some companies have also qualified these systems for visual inspection of media fill containers (aseptic process simulation steps).
There are some systems that have been developed for laser-based headspace analysis and measurement that may be used for 100% in-line sterility testing. This has not yet been implemented in the pharmaceutical industry for this application but has great potential.
With the recent addition of new sterilants, it is also possible for machines to be modified to allow for sterilization in-place, e.g., filling lines. Technologies like ozonated water are attractive as they can be validated to show an overkill sterilization cycle and show a three-log reduction of endotoxin at ambient conditions. Newer sterilization gases have been successfully used for decontamination and/or sterilization of isolator technologies.
While these advances are components of lights-out manufacturing, most, if not all pharmaceutical facilities today are not part of a plan to achieve lights-out. There are many obstacles to overcome.
Obstacles to Lights-Out for Pharmaceuticals
Some of the obstacles that exist for pharmaceutical companies include:
- Handling deviations and investigations: Many times these processes are labor intensive and not automated. Programs are available for storing the records, but not to automate the evaluation processes.
- Supporting laboratory testing in most cases has not been considered for automation, beyond some automated sample handling procedures.
- Many companies are good at some aspects of lights-out, but do not have a comprehensive plan to achieve it throughout the facility.
- Fear of regulatory scrutiny and non-acceptance.
- Lack of standardization, reliability and performance of equipment within a facility. (DiStefano, 2010)
- Recognizing that some earlier attempts to lights-out manufacturing failed. (DiStefano, 2010)
- Failure to have sufficient personnel to support in this type of manufacturing process.
- And so forth.
Training and Workforce Development
One of the major concerns for many is what do we do with the various employees that will be eliminated or replaced with lightsout manufacturing? In many countries there is a significant increase in vocational education, especially in the use of SCADA systems, robotics, and information technology. High level programs are available for these types of systems and they can be used for workforce development. The ideal situation is not to eliminate all of these people but to retrain them to work in the newer manufacturing processes.
Conclusion
While the pharmaceutical industry is likely to be drawn into lights-out manufacturing kicking and screaming, and very slowly, the changes are coming. We need to start now to look at coordinated programs for implementation. We also need to be looking at how to develop our existing workforce and prepare them for careers in the newer methods and techniques.
Literature Cited
- Anonymous (2014) A Glimpse into Lights Out Manufacturing. MWES. Downloaded from: http://mwes.com/lights-out-manufacturing/ on February 8, 2018
- DiStefano, T. (2010) Lights Out! Centipede Systems. Downloaded from: http://www. centipedesystems.com/2010/07/lights-out/ on February 8, 2018.
- Eddy, M. (2013) Checklist for Lights-Out Manufacturing. Production Machining. Downloaded from: https://www.productionmachining.com/articles/checklist-for-lightsout-manufacturing on February 8, 2018