As the technology becomes readily available, more and more packagers are installing networked systems to make data management easier.
by Annie Lubinsky, Managing EditorNetworking, the sharing of digital information among multiple packaging devices, creates communication between different control systems; handles the different functions of a line from beginning to end; and, most importantly, allows packaging engineers instant and complete access to data gathered from every machine on the line. Having this data means that packaging engineers can control inventory, troubleshoot before problems crop up, schedule maintenance when needed, and make compliance data available to those who request it. Beyond that, the data will show how the pharmaceutical company can run its business more efficiently, cut costs, and increase sales. Networking also allows for effective communication between the company and the outside world.
When installing and integrating a packaging line, networking becomes a feature that adds value. Collecting and using production data has been the responsibility of packaging engineers for many years. While a networked system is not simple to install, it greatly simplifies the work of data handling for the packaging engineer.
ADVANTAGES
"The advantages of networking are that it creates a more reliable and more automated method of making products of high quality," says Mark Lewis, corporate communications manager at Omron Electronics Inc., a subsidiary of Omron Corp., located in Schaumburg, IL.
Peter Kambol, marketing manager at Markem Corp. (Keene, NH), agrees. "As manufacturing has moved away from mechanical to digital controls, it has become an advantage to turn to networking," he says. "Networking has these advantages: first, it reduces costs by reducing human error; second, it makes for faster changeovers; third, security is increased because there is limited access to proprietary information." By using a network to extract needed information, the entire system is more secure, because there is only one source and there are no opportunities to make mistakes due to rekeying. All information is entered by one person in a responsible position. The data can be available to the production floor in read-only format without the opportunity to change it.
Networking is growing as the technologies emerge to meet certain needs. "What's driving networking is the need to get information—tracking the product, checking the quality—directly from the factory floor to other parts of the business," says Dave Hietanen, communications product manager at GE FANUC Automation (Charlottesville, VA). "The data gathered during networking include speed and quality information. Each individual machine will keep track of how each piece meets quality criteria. Then the information moves up, via the network, to a higher-level computer. At that point, statistical process controls are used. When multiple levels and stations are contributing information, a higher-level computer can look at the whole process, see how the company is doing overall, mark trends, and catch deviations before they become failures." A network can create a drive for improvement within a company, Hietanen says. It can also help a company with validation or FDA compliance.
"A customer or FDA may question a certain batch of product," says Michael Jordan, validation leader at O'Neal Inc. (Greenville, SC). "With a network, you can pull the information, such as the production parameters, the time, and the date."
Easy access to information drives companies to install networked systems. James Enman, vice president of ESS Packaging Machinery Inc. (Roseto, PA), says that ESS installs a datalink capacity on its machinery. "The big pharmaceutical companies are interested in setting up a data highway, and we provide the hardware for this," he says. "About 10% of our clients—usually large companies—request networking."
A pharmaceutical company can obtain network-ready equipment fairly easily. "From a packaging systems supplier standpoint, we are usually able to meet specifications for networking," says Dave Schuh, vice president of sales and marketing at MGS Machine Corp. (Maple Grove, MN). "This typically involves ensuring proper interpretation of requests for networking and providing the services necessary, such as hardware and the software linkages from each machine to the data highway. Most of the application requests involve using proven networking technology or easy-to-integrate machines."
CHALLENGES OF NETWORKING
Introducing networking to a facility has its challenges. "It is not a simple matter," says Tom Muth, sales and marketing manager at Automation and Enterprise Solutions, a division of Omron Electronics Inc. (Schaumburg, IL). "To take the information technology side and connect it to the manufacturing world is complex. Bringing the two together and determining how to go about getting the data is a challenge."
"The difficulty is different systems," Lewis says. "You can have different controls in one plant."
Converting to a networked system can be expensive; in addition, integrating the latest technology with older systems can be difficult. Ranganath Misra, engineering manager and staff engineer at FANUC Robotics North America Inc. (Rochester Hills, MI), adds, "The latest technology makes networking of controllers a relatively straightforward and inexpensive process compared with integrating older model controllers. New model controllers have networking hardware and software that make data communication much more reliable."
Paul Mills, senior product manager at Markem (Nottingham, Nottinghamshire, UK), says, "One significant disadvantage is that you need an infrastructure to make networking happen—either cables or radio—so the system can be complicated to install. However, productivity and security are much higher, so the advantages of networking far outweigh the disadvantages." Markem's printers can communicate with a database via a network to ensure that the correct information is printed on the correct package.
Packaging engineers need to decide which system to use. "It is a toss-up whether to network or not and which networked system to use," says Lewis. "Different people select different networks depending on what they need. An open network is good when you need to integrate a lot of different devices on one network, such as I/O switches and terminals, PLCs, etc. The downside is you can have a speed problem. Sometimes a proprietary network will offer a benefit, such as speed."
Schuh also feels that deciding which system to use can involve some risk. "The difficulty is making the initial selection and knowing that the cost to change it, if necessary, is high," he explains. "The rapid rate of change and growth of technology makes it hard to know which system to use. Will your selected networking supplier remain as strong as the competitive alternatives over the years to come? Or will the technology become obsolete and need to be replaced?"
Validating a network can be a time-consuming task. "A big part of validating the packaging line is validating the networked system," says Jordan. "Not only do you have to validate the control for each piece of equipment, you also have to validate the communication from each PLC to the SCADA (supervisory control and data acquisition) system and from there to each computer on the network. Each input must be validated to show that it goes to the right computer from the right database."
OPEN VS. CLOSED SYSTEMS
One area of sweeping change is the movement from closed systems to open ones. A system with a closed architecture has no standard way of being connected to another system, and linking this closed system with other equipment is difficult.
"An open system should ideally be based on an industry standard, and therefore easy to connect to other machines," Mills says. "There are varying degrees of openness. A system can operate on either an open standard or with a manufacturer's published standards."
A monitoring system needs to handle all the machines on the line, even if they're from different suppliers. "Control standardization, especially with specialized equipment such as that used for packaging, is unlikely, so any solution has to deal with a networked device. An open-device network puts these pieces of equipment on a common network," says Muth. "Ultimately, you want to bring the production-level data and the business aspects of the operation into a system using Ethernet."
Right now, there is no single industry standard for networking, but Mills believes that two current standards will form the backbone of any system in the years to come. "The first is Ethernet or TCP/IP, which is universally accepted as a standard," he says. "Next is OPC, which stands for OLE (object linking and embedding) for Process Control. This allows PLCs to be linked to control and process and automation systems, but OPC has not yet extended into coding equipment. I believe that OPC will become the industry standard, and that it will eventually extend to coding equipment."
Different levels of networking allow information to travel from machine to machine, from machine to database, from database to ERP (enterprise resource planning) programs, and from one business enterprise to another. "On one level, the PLCs and PCs within a company need to talk to each other," Mills explains. "On another level, these systems need to talk to the bigger world. ODBC (open database connectivity) is one of the standards used for that."
Muth says that e-commerce also drives the networking need. "The customer's order goes straight from the computer to the factory floor," he explains, "and the manufacturer can tell where the order resides on the floor and when it will ship."
ENTERPRISE RESOURCE PLANNING
ERP contains the entire network of business control—manufacturing, production information, vendors, etc. "Data move up into the ERP, where, combined with inventory and financial information, the system can look for problems like bottlenecks or inaccurate schedules of inventory orders or incorrect scheduling of machine utilization," says Muth.
The networked system allows data to be collected for quality control and overall plant management. "The quality control aspect allows a company to satisfy its own internal quality standards," says Schuh. "This information can also be published in response to FDA or customer requests for quality and compliance information." MGS Machine supports networking plans with hardware and software for stand-alone units and entire packaging lines.
One contract packager, Sharp Corp. (Conshohocken, PA), decided in 1998 to implement MFG/PRO, a QAD product to handle ERP within its operation. "Sharp had evaluated several ERP software packages and selected MFG/PRO because it fit our requirements, which included the need for a good validation module and the ability to do actual costing," says Ray Renza, senior vice president of corporate development. "Sharp organized the project with a core team to learn and drive the implementation down to a selected group of functional business representatives covering accounting, quality, engineering, purchasing, material planning, operations, sales, and information technology. After several months of conference room pilots and employee training, Sharp went live in late 1999 at all locations in Pennsylvania and New Jersey."
Currently, Renza says, "the system provides total integration and visibility among all sites, more accurate reporting, and a formalized documentation, along with change control procedures."
EFFICIENCY DATA
In a networked system, data from one computer can travel to all machines, ensuring that the machines receive accurate information; in addition, the machines can send data to a central location that will evaluate productivity and efficiency. "The machines can tell you how quickly they've performed, how many rejects there were, how many good packages were produced," says Mills. "For example, with a blister package, the blister machine knows how many blister packages were made but not how many were pulled off the line during inspection. The coder knows how many good packages were printed. So if the printer says you're working only at 50% efficiency, you know there is a problem. Networking has a two-way aspect."
Greater efficiency at the manufacturing level can be achieved with a networked system. The overall goals of a pharmaceutical company, which are included in its ERP system, are carried out at the manufacturing execution system (MES) level. The MES can determine how to deliver a certain number of tablets or bottles to a vendor by a certain date, for example. The MES creates a finite schedule to carry out capacity planning—the system knows which machines are available and when, how many qualified employees are available, how many hours each employees may work, and the amount of material ready for use. Schedules are planned nearly to the minute.
Konradin Plate, a consultant at Propack Data Operation Center (Wayne, NJ), says that quantifiable benefits as well as compliance may be derived from the networked MES. "Quantifiable benefits include better performance and higher productivity using the same resources and the same amount of time," he explains. "We create an optimized sequence by planning to process similar products first before changing the line over to a different type of products. We schedule on a finite level, and in some cases, we can reduce the production time by 20% using the same team and same equipment." Propack Data Corp., headquartered in Cary, NC, produces software for the pharmaceutical industry and maintains several operation centers.
Compliance with GMPs and FDA regulations becomes much easier with a networked system. "In a regulated industry such as the pharmaceutical industry, companies must comply to required guidelines," says Plate. "A networked system ensures 100% material tracking and a 100% audit trail. The information in the MES is integrated into the machines and into the ERP system, so the information in the database is available to everyone in the plant. The engineers will look at it to find ways to improve efficiency, and the quality team will make sure the batch is up to standard."
The network stores a great deal of information: warehousing; batch quality; weights; codes; inspection results; and environmental conditions, such as temperature and humidity. Plate, as well as other experts, points out that networking is a very accurate collector of data because information comes directly from the machine into the network. Eliminating data entry by an operator creates fewer mistakes, which in turn increases efficiency.
From an internal standpoint, efficiency drives the need for networking, according to Muth. From an external standpoint, the need to report quality information to customers drives the need for a network. "Each manufacturer keeps its quality standards up, based upon the information presented by its supplier from the factory floor," Muth explains.
A GROWING TREND
The practice of networking is growing. "If you look at a standard pharmaceutical company that has a few plants, including one in Puerto Rico, for example, it makes sense to have a network to support that business at the ERP level," says Plate. "A network makes supply chain management simpler."
Pharmaceutical companies that choose to incorporate networking often do so when they install a new packaging line. "Every customer and every project has different requirements and goals," says Chris Manley, director of engineering at Barry-Wehmiller Design Group Inc., the packaging integration division of Barry-Wehmiller Co. (St. Louis), which specializes in the turnkey integration of pharmaceutical packaging lines. In the planning stage of line integration, Manley says, "A preliminary description of operation for the control system and any human-machine interfaces (HMIs) or SCADA systems is developed, presenting a clear picture of operational requirements." With that description in hand, the company can proceed to engineer a network into the packaging line. Manley has noticed a definite trend toward networking: "In addition to a main line control PLC, it is common to see HMIs or SCADA systems present on today's high-tech packaging lines. These systems provide operators, maintenance, production, and quality control personnel with valuable information about the equipment and product being produced on a pharmaceutical packaging line."
Networking will become the norm as time goes on. "As with many new technologies, those who were among the first to install it were the larger pharmaceutical companies," says MGS Machine's Schuh. "But as the cost of hardware and software declines, the technology is more readily available to smaller companies. As companies interpret their requirements, they find themselves compelled to begin using a networked system in order to better manage their business."
FIRST PHOTO COURTESY OF GLENROY INC. (MENOMONEE FALLS, WI)
SECOND PHOTO COURTESY OF BARRY-WEHMILLER CO.
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