Balancing security risk with improved efficiency.
Remote monitoring and diagnostic capabilities are becoming increasingly critical tools in pharmaceutical processing and packaging operations, and for good reason. With the ability to monitor plant operations 24/7, manufacturers can detect and correct problems sooner, reduce downtime, and make smarter decisions. These tools can help improve overall equipment efficiency (OEE) not only within one line or one plant, but within an entire global network of operations.
But with these benefits come challenges. In an increasingly networked world, manufacturers are understandably concerned about cybersecurity and are reluctant to grant third-party access to their systems. Although remote monitoring and diagnostic capabilities promise—and can potentially deliver—a host of benefits, pharmaceutical manufacturers need to know their lines are secure, and they are seeking this reassurance from their suppliers.
Keeping Tabs on Assets
Remote monitoring and diagnostics offer real-time status checks of equipment and other critical manufacturing assets. The technology also offers insights about the health and efficiency of equipment. OEMs offering remote monitoring capabilities can deliver routine patches, enhancements, and fixes to equipment to ensure peak efficiency. This type of “predictive maintenance” reduces the length and duration of equipment downtime. It is far more efficient than “reactive” or “preventive” maintenance because it is based on actual monitoring of equipment and performance, and it gives users more control over downtime schedules for equipment servicing.1
Advances in Human Machine Interfaces (HMI) feature sophisticated mimic screens that provide operators a detailed perspective of important operational functions, from both a micro and macro level. This information helps to optimize decisions by giving users a full perspective—from any location—on a 24/7 basis. These real-time monitoring capabilities can be particularly valuable for in an industry with validated environments, subject to regulatory oversight such as the pharmaceutical industry.
The time savings from remote diagnosis can be significant. Take one example of a labeler that suddenly fails to print correctly on a blister pack line. The entire operation needs to be shut down until the problem is resolved. First, plant maintenance mechanics attempt to fix the labeler, and if they are unsuccessful they call the equipment supplier’s technical support. Despite walking operators through troubleshooting by phone, the problem remains unresolved. Without the ability to remotely access the system and diagnose the cause of the failure, a service representative would then need to travel to the plant and inspect the labeler on site. Meanwhile, during this time the line remains shuttered, and productivity screeches to a halt.
If, on the other hand, service representatives were able to access the equipment’s operating systems remotely, they could begin a thorough diagnosis immediately and more quickly resolve the problem. The time and expense of travel would be eliminated, and in this scenario the labeler could be up and running—along with the entire line—in a matter of hours or even minutes.
From both a business and national security standpoint, cybersecurity is one of the most significant threats facing the world today. Despite all the benefits offered by remote monitoring, some manufacturers are leery of exposing their networks and sharing data with outside vendors.
Even the most casual news observer is well-aware of notorious security breaches in which some of the world’s most powerful corporations have been subject to hacking and stolen data. Stealing consumer data from a department store is serious enough, but for producers of regulated drugs, the potentially life-threatening damage caused by a hacker is daunting.
For an industry that is particularly risk-averse, it may seem to make business sense to stay safe and limit remote access to outsiders, even at the risk of lost productivity and efficiency. A number of pharmaceutical manufacturers will continue to restrict access to their systems. For example, they may only let equipment suppliers monitor and diagnose their equipment through the manufacturer’s own HMI or only within the plant’s environment and equipment, rather than over the internet or through a cloud service, in order to prevent the transmission of viruses or malware.
While we can anticipate more remote monitoring equipment to enter the marketplace, we can also expect to find more technologies to prevent unauthorized access to secure manufacturing systems. These technologies seek to close those vulnerable “back doors” where data can be breached by hackers. Industry leaders including Cisco, Rockwell, Siemens, GE, and others have offered security solutions. Other manufacturers are stressing the importance of adopting data exchange standards with embedded security features, such as the OPC Foundation’s United Architecture OPC-UA protocols.2
A Delicate Balance
The last decade or so has witnessed numerous breakthroughs in data acquisition and sharing, and this data-driven environment has the potential to drive huge efficiencies. There is no question that the internet has radically transformed manufacturing and improved productivity. Looking to the future, however, manufacturers seem poised to focus their efforts more on security and asset protection than on open sharing.
Without a doubt, market adoption of remote monitoring capabilities will continue. But so too will the development of security enhancements to keep data safe. It looks certain that the pharmaceutical industry will continue to face the dilemma of balancing the need for improved productivity through remote monitoring and diagnostics, while being mindful of the need for security and data protection.
Remote monitoring benefits and risk mitigation will be top of mind for exhibitors and attendees at this year’s Pharma EXPO (McCormick Place, Chicago; Nov. 6 – 9, 2016), an event co-produced by PMMI, the Association for Processing and Packaging Technologies, and the International Society for Pharmaceutical Engineering (ISPE). Pharma EXPO will be co-located with PACK EXPO International 2016. Together, the shows will feature more than 2,500 exhibitors and draw 50,000 attendees.
To register for Pharma EXPO, visit www.pharmaexpo.com. Attendees will have access to both shows with one badge.
- Market Report, PMMI State of the Industry – US Packaging Machinery Report, 2015, p. 42.
PMMI, The Association for Packaging and Processing Technologies, represents the voice of more than 700 North American manufacturers of equipment, components, and materials for processing and packaging. We work to advance a variety of industries by connecting consumer goods companies with manufacturing solutions through the world class PACK EXPO portfolio of trade shows, leading trade media and a wide range of resources to empower our members. The PACK EXPO trade shows unite the world of processing and packaging to advance the industries they serve: PACK EXPO International, PACK EXPO Las Vegas, Pharma EXPO, PACK EXPO East, EXPO PACK México, EXPO PACK Guadalajara and ProFood Tech, launching in April 2017. PMMI Media Group connects manufacturers to the latest solutions, trends and innovations in processing and packaging year-round through brands including Packaging World, Automation World, Healthcare Packaging, Contract Packaging, and Packaging + Processing OEM. PMMI Business Drivers assist members in pursuing operational excellence through workforce development initiatives, deliver actionable business intelligence on economic, market, and industry trends to support members’ growth strategies, and actively connect the supply chain throughout the year. Learn more at PACKEXPO.com, PMMIMediaGroup.com, and PMMI.org.