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By Ian McPherson, Apprion and Hesh Kagan, Invensys Process Systems

To help improve a multitude of results, the pharmaceutical industry the past few years has increasingly looked at and tapped into wireless technologies that automate production, process controls, security, safety, logistics, product authentication and other aspects of the overall business. Notably, the Food and Drug Administration (FDA) has advocated use of wireless technologies such as Radio Frequency Identification (RFID) to help verify the pedigree of pharmaceutical supplies as they are transported throughout the supply chain.

A recent Gartner Research report, entitled, “RFID is the Limit,” stated that “industries with the greatest opportunities to use RFID include retail, aerospace and defense, while the healthcare, logistics and pharmaceutical industries will adopt RFID the fastest.”

Wireless is here to stay and growing steadily. Zigbee . . . Wi-Fi . . . Wi-Max . . . 802.11 . . . Sensors . . . Passive and Active RFID . . . VoIP . . . Bluetooth . . . Mesh Networks, and so on – each technology can be leveraged and applied for specific beneficial purposes.

With this added emphasis on wireless systems has come a certain amount of immediate success, as well as great promise for even better results down the road. However, this success has also brought with it a new realization: Better ways are needed to help manage the overall growth of often disparate wireless systems that can interfere with each other or compete for bandwidth in limited spectrum allocations.

The need for an overall management platform for different wireless systems has become even more critical as use spreads to different departments and different locations. Users may begin experiencing increased interference on the links. Transmission may be interrupted. There may be availability problems, data loss and performance degradation. If ad hoc growth continues unmanaged, the technology that would potentially offer a way to improve productivity, efficiency and cut costs, could also add uncertainty, cost and regulatory vulnerability.

Clearly, the most significant challenge to pharmaceutical companies wishing to take advantage of the benefits, however, is managing the limited available bandwidth when integrating multiple communication protocols and standards, and maintaining and supporting the ongoing security requirements wireless networks must have. Unlike wired networks, each enterprise has only a finite amount of radio bandwidth that must be shared across multiple departments that typically haven’t needed to coordinate activities in the past. Also unlike wired networks, where access can be physically restricted, wireless frequencies can be accessible with even the most basic wireless communications devices. This means that today - and likely for many years to come - managing wireless communications will pose a greater challenge than technology performance.

The consequences of unmanaged wireless systems are already becoming evident. For years, the medical device industry has been using wireless technology in such applications as intravenous pumps, pacemakers, wheelchairs, and more recently for metering insulin injections via a patch that calculates sugar intake and sends a wireless signal to the patch for dosing, with very good results. In September 2000, the CDRH (Center for Devices and Radiological Health) issued a guidance for industry, entitled Wireless Medical Telemetry Risks and Recommendations.

As a result, the FDA has been examining the use of telemetry and electromagnetic interference (EMI) in medical devices – especially since the FCC opened up radio frequency usage in December 2005 for a previously restricted medical device radio spectrum and has advised switching frequencies on some devices to avoid interference. Applications are just beginning to emerge.

Solving these problems requires resource planning, performance management, and a common wireless systems management platform across the extended enterprise. The same general principles of wired network systems management also apply to wireless networks, but since the radio spectrum is finite and most wireless devices operate in unlicensed frequencies there are new and unique challenges. As with wired networks, it is essential now to apply enterprise-level management practices for the operation of wireless networks.

In order for these wireless systems to truly improve productivity, security and efficiency while reducing costs, managers must address at least the following elements to be successful: • Manage and Scale the System Architecture • Prioritize Business Value at the Enterprise Level • Integrate Security Measures and Policies System-Wide

Optimum execution of any enterprise-wide policy requires a communications architecture that can accommodate the technology of the best categorical network technologies and vendors, emerging standards and best wireless integration practices. The architecture must be based on a well developed security model that includes functions like authentication and role-based access control.

Eventually, your network management center should treat your wireless systems the same way it would any another network, by focusing on managing enterprise-wide communications -- not the individual technology. Because there will never be a single wireless protocol and frequency, and therefore the appropriate technology must be matched with the right application, the best approach for system-wide growth is to have an integrated yet flexible management strategy that can deliver immediate benefits, but also can be “future proofed” to adapt to business changes and technology developments.

Few companies have the resources to maintain staff necessary to manage a complete wireless infrastructure, especially because demand for specialists with relevant skills is very high and supply is limited. As a result, outsourcing to one of the emerging specialist firms is currently the most cost effective strategy to maximize benefits and minimize risks.

Like wired networks, wireless networks link and deliver data between different points. However, the potential for far more granular data and detailed measurements in areas such as “process variables” exist with wireless because they have the advantage of being implemented more cost-effectively, and there’s none of the cost of running wires between multiple points. As a result, it is possible to set up measures for virtually any point or process of the enterprise and receive this information in real time.

Each department undoubtedly can make a strong case for deploying wireless networks within its internal operations, but issues of scalability, security and investment protection make it imperative that these decisions be coordinated at the enterprise level, where priorities such as process controls, security or logistics needs can best be evaluated and executed.

For example, a company competing in a mature marketplace on a strategy of being the low-cost provider might deploy wireless vibration sensors that tell when any asset is not operating optimally, and see savings on maintenance show up immediately in the bottom-line. In contrast, a company competing on fast, reliable delivery might find the added cost of an RFID product tracking system would improve its competitive position.

Sloppy networking practices, rather than intentional malicious interference, are the greatest threats to wireless security. These can include seemingly innocuous practices such as not changing passwords according to policy, using obvious passwords such as initials, adding or deleting devices improperly, and any number of other lapses. Interferences also can come from environmental or accidental RF noise, broken RF equipment, dynamic changes in the characterization of the RF site, and the range on non-compatible RF devices generally available. Prevention of these kinds of problems must be engineered into the network from its inception, and must be covered by an enterprise-aware security and performance management model.

For example, one network user might be taking wireless process measurements from a temperature transmitter while another person in the same plant might be running a wireless video camera for perimeter security. A third might be running an RFID inventory tracking application. Because they are in different departments and locations and doing different things on different protocols, they might think they are isolated, but in reality, those radio waves are co-mingling, creating tremendous potential for performance problems and mismanagement. This also highlights some of the issues that arise when trying to consolidate all applications around a single wireless technology rather than taking the systematic approach of creating a wireless infrastructure.

System-wide management policies must define all methods for using, sharing and securing the available bandwidth. This has implications for planning, implementation, operations, maintenance and expansion. For these reasons, building an effective wireless infrastructure requires an open framework and engineered solution, but just the opposite is happening today.

Policy management also ties into the end user’s existing IT requirements – one company might have IT policies in place that are very different from another in exactly the same industry. The system must be designed to comply with particular corporate requirements for activities like reporting errors, observing network behaviors, and optimization based on that information. It must cover every aspect of operation, from initial configuration to ongoing optimization.

Policies must also be in place for handling reporting criteria, handling of alarms and functional problems. Once the system detects interference, for example, what does it do, will it reroute traffic, change frequencies, or reconfigure antennas to be active or inactive? Some of the options depend on the capabilities of the technology, but within that framework, policy is necessary to guide choices.

Based on our combined experience and expertise, we have found that manufacturers today need a wireless infrastructure management platform as well as a technology lifecycle program. This is necessary to develop a clear roadmap and put best practices in place for an iterative management and expansion of wireless technology throughout a plant, facility or department. This platform must first focus on business outcomes and objectives, while providing an immediate and cost effective method for integrating the vast array of wireless-enabled products and devices that are increasingly coming to market.

Since there is great heterogeneity to wireless applications and there is no “one size fits all” technology solution, it is important to ensure that the necessary monitoring, management and security capabilities span the entire wireless enterprise to ensure the most efficient use of the limited resource. At the same, the platform should be flexible enough to allow for disparate applications to share the spectrum within the context of their importance, time sensitivity and mission criticality.

Our solution provides an integrated offering that includes software and services that unify the security, policy, and network performance management of a heterogeneous wireless infrastructure through a single interface. The solution includes a unique application infrastructure called the ION – the Intelligent Operations Network. ION is designed for process manufacturing environments that need a secure, scaleable and affordable method to deploy a common wireless infrastructure across the facility – and across multiple operational areas.

There are certainly a multitude of wireless applications to manage in the pharmaceutical industry. Security and validation are at the forefront of most people’s mind. Security is mandated by the FDA’s 21 CFR Part 11 regulation on electronic signatures/electronic records. Because the wireless technology typically does not interface with product directly, validation issues would be comparable to wired network technology. Financial reporting and disclosure regulations required by the Federal Sarbanes-Oxley act, and the use of web-based interfaces have also increased the need for secure access control to address compliance and liabililty concerns.

Anxious to capitalize on the growing interest in wireless networks and expand the range of applications, process technology vendors are quickly adding wireless products to their portfolio by replacing wires with transceivers, and manufacturers want to take advantage of these new technologies that reduce costs.

GlaxoSmithKline recently announced that it has begun putting radio frequency identification tags on individual bottles of HIV drug Trizivir, which is packaged at its Zebulon, N.C. plant. According to the company, the main goal of the project is to better authenticate the product, which is one of the 32 drugs most susceptible to counterfeiting or diversion. Another obvious benefit will be for the company to gain a better understanding of how to implement RFID and capture its myriad business benefits.” Other companies such as Pfizer have also started programs to implement RFID identification programs.

The FDA has stepped up its efforts to improve the safety and security of the nation's drug supply through the use of RFID technology. The FDA launched this effort by publishing a Compliance Policy Guide (CPG) for implementing RFID programs that are designed to enhance the safety and security of the drug supply. This action continues the FDA's commitment to promote the use of RFID by the U.S. drug supply chain by 2007.

Implementation of wireless technologies also aligns with the FDA’s efforts to increase efficiencies within the development and manufacturing sectors under their 21st Century Initiative as well as PAT. Not to be mislead by the name, PAT allows pharmaceutical manufacturers to optimize the way they use their plant assets to produce specific drugs, ultimately permitting them to reduce the price that the consumer pays for their products. PAT also allows pharmaceutical manufacturers to apply new technologies such as advanced process control and wireless networks.

With so much wireless activity emerging in the pharmaceutical industry, it is imperative to establish an enterprise-wide strategy and plan before going forward with wireless for the sake of going wireless. The plan should identify benefits that will be gained from using these new technologies, and flexible guidelines for implementing them that incorporate changes in future solutions and regulations. With such an approach, we believe the full promises of a wireless world can be maximized.