Reprinted from

PHARMACEUTICAL ENGINEERING®
The Official Magazine of ISPE Wireless Technology
September/October 2006, Vol. 26 No. 5

This article
describes Wireless Framework for Enterprise
management
strategies to Excellence: Managing, Securing, and
overcome
uncertainty, Validating
cost, and
regulatory
vulnerability in by Janice Abel, Hesh Kagan, and Ian McPherson
wireless
implementations.

T
he radio spectrum is an asset that phar- the system is implemented at the enterprise
maceutical and biotechnology indus- level.
tries are now beginning to exploit, and The most significant challenges to pharma-
the emergence of secure, affordable ceutical companies wishing to take advantage
wireless technology is making it easier for of wireless technology are in managing the
them to do that every day. limited available bandwidth, integrating mul-
Wireless technologies include wireless ac- tiple communication protocols and standards,
cess points (gateways), transmitters, receivers, and maintaining and supporting the ongoing
antenna, protocols, powering options and serv- security requirements of wireless networks.
ers, and security technology ranging from intru- Solving these problems requires resource plan-
sion detection devices to data encryption. Per- ning, performance management, and a com-
formance and reliability of wireless technology mon wireless systems management platform.
has been improving steadily, to the point at This finite, relatively available resource
which it has become a very feasible cost saving means that today - and for many years to come
option for many industrial applications. Unlike - reaping the many control benefits of wireless
cell phone networks which span many miles, communications will challenge technology
most industrial settings are contained, repeat- management much more so than technology
able, and thus very manageable, provided that performance.

Figure 1.Typical
interrelated applications
with different RF “needs.”

©Copyright ISPE 2006 SEPTEMBER/OCTOBER 2006 PHARMACEUTICAL ENGINEERING 1

 Wireless Technology
point A to data point B, enabling timely
information sharing for a wide range of
application and reporting functions.
But because of the low cost of wireless
sensors, and the no-cost of running
wires, more points can be connected far
more cost-effectively than wired net-
works. Wireless networks enable de-
tailed measure of process variables,
including measures of quality which
could not be measured at all before, for
example, increasing process perfor-
mance in applications which previously
required mandatory laboratory analy-
sis. Freed from the restrictions of wires,
it is possible to set up measures for
virtually any point of the enterprise
Figure 2. Potential wireless application areas for pharmaceutical facilities. and receive this information in real
time.
Figure 1 illustrates the broad range discrete processes,” said Mike Howden Because of the finite amount of ra-
of manufacturing areas that are now an Invensys Validation Technologies dio spectra at its disposal, care must be
implementing some type of a wireless consultant, adding that Invensys has taken upfront to determine where the
solution. For years, the medical device developed new programs to train tech- technology will be most beneficial. Fig-
industry has been using wireless tech- nical staff in expanding validated wire- ure 2 shows some of the areas in which
nology in such applications as intrave- less applications in pharmaceuticals. wireless technology could benefit phar-
nous pumps, pacemakers, wheelchairs, Other common wireless applications maceutical and other bioscience manu-
and more recently for metering insulin manage personnel access for security facturers. Following are more examples
injections via a patch that calculates purposes. of benefits that wireless implementa-
sugar intake and sends a wireless sig- If wireless proliferates in the phar- tions could deliver the pharmaceutical
nal to the patch for dosing, with very maceutical industry as it has in other enterprise:
good results. In September 2000, the industries, those who purchase and
Center for Device and Regulatory implement point solutions will likely Enterprise Management
Health (CDRH) issued a guidance for enjoy some initial success. But as use • real-time monitoring of parts and
industry, entitled Wireless Telemetry spreads to different departments and finished goods, across the entire
Risks and Recommendations. different locations, the joys of wireless value chain
As a result, the FDA has been exam- freedom will likely begin to fade. Users • tighter process monitoring by in-
ining the use of telemetry and may begin experiencing increased in- creasing the number of checkpoints
ElectroMagnetic Interference (EMI) in terference on the links. Transmission across the enterprise or in remote
medical devices – especially since the may be interrupted. There may be avail- locations (e.g., cold chain applica-
FCC opened up radio frequency usage ability problems, data loss, and perfor- tion)
in December 2005 for a previously re- mance degradation. Furthermore, this
stricted medical device radio spectrum ad hoc approach fails to consider the Logistics
and has advised switching frequencies varying criticality and time sensitive • Radio Frequency Identification
on some devices to avoid interference. aspects of disparate application data (RFID) for supply chain to prevent
More applications are just beginning that are contending for use of the spec- counterfeiting of drugs or improve
to emerge in this industry. trum. If this growth continues product tracking and security
“Pharmaceutical industry, business unmanaged, the technology that would • improved management of shipping
systems, such as Enterprise Resource potentially offer a method to improve receipts and returns processing
Planning (ERP) software, which seeks productivity, efficiency, and cut costs, • improved inventory management,
to integrate financial and operations also could add uncertainty, cost, and forecasting, and planning
data company-wide, have been suc- regulatory vulnerability.
cessfully using wireless technologies Safety and Security
in the pharmaceutical industry for The Need for Systems • managing plant and system person-
many years. The functional scope and Management nel access
range of these applications for the most Fundamentally, wireless networks de-
part has been isolated to providing liver the same basic business benefits Production
control flexibility and validation for as wired networks: they connect data • improved process execution by en-

2 PHARMACEUTICAL ENGINEERING SEPTEMBER/OCTOBER 2006 ©Copyright ISPE 2006

 Wireless Technology

Figure 3. Wireless standards and technologies now in use.

abling remote electronic capture of Maintenance and line. Other applications for wireless
process data (e.g., remote valida- Infrastructure Management sensors might include temperature
tion protocol execution via wireless • eliminating wiring related costs in monitoring of product in storage and
tablet PCs) upgrading or installing control sys- transportation.
• electronic product authentication tems In contrast, a company whose strat-
and electronic pedigree documenta- • improved plant safety and security egy is to get to market faster, reliably,
tion through proactive perimeter moni- and securely, might find that the added
• improved equipment availability toring, Weapons of Mass Destruc- cost of an RFID product tracking sys-
and reduced maintenance costs tion (WMD) detection, and person- tem would improve their competitive
through proactive condition moni- nel tracking position. According to a Gartner re-
toring, for example, implementing port, “industries with the greatest op-
wireless vibration sensors to indi- Although it is quite feasible for each portunities to use RFID include retail
cate system malfunctions department to present a strong busi- and aerospace and defense, while the
• improved flexibility for quick pro- ness case for using wireless networks healthcare, logistics, and pharmaceu-
cess unit changeover in its own operation, these consider- tical industries will adopt RFID the
• reduced downtime and costs for wire- ations must be made at the enterprise fastest.”1
less sensors on skids by eliminating level. Data integration, process inte- The US Food and Drug Administra-
the need to connect instruments and gration, and knowledge sharing are tion (FDA) has stepped up its efforts to
computers to field networks some key performance enhancers in improve the safety and security of the
• faster process changes through pharmaceutical production. Process, nation’s drug supply by promoting the
reconfigured operations security, or logistics needs must be use of RFID technology. The FDA
• better tracking of clean-in-place evaluated in the context of the overall launched this effort by publishing a
components enterprise strategy. Compliance Policy Guide (CPG) for
• improved utilization of process A company whose strategy is driven implementing RFID programs that are
equipment through more precise by reducing costs might want to deploy designed to enhance the safety and
measurements of process variables wireless vibration sensors to determine security of the drug supply. This action
such as temperature and pressure when assets are not operating opti- continues the FDA’s commitment to
• greater efficiency in enabling PAT mally. They would then look for sav- promote the use of RFID by the US
solutions ings on maintenance in the bottom- drug supply chain by 2007.

©Copyright ISPE 2006 SEPTEMBER/OCTOBER 2006 PHARMACEUTICAL ENGINEERING 3

 Wireless Technology
The FDA believes that anti-coun- equipment, dynamic changes in the Web-based interfaces also have in-
terfeiting is a major benefit of RFID. characterization of the RF site, and the creased the need for secure access con-
However, the benefits of RFID go well range on non-compatible RF devices trol to address compliance and liability
beyond the fight against counterfeit generally available. concerns.
drugs. The pharmaceutical industry And as wireless usage expands, com-
relies upon the integrity of many forms petition for the wireless spectrum Managing System Policies
of data throughout the process of drug within and around the plant will be- and Standard Operating
trials, manufacturing, distribution, and come the major issue. One network Procedures
retail sale. RFID’s ability to uniquely user might be taking wireless process The policies and Standard Operating
identify each item and securely cap- measurements from a temperature Procedures (SOPs) in place for wire-
ture data without line-of-sight through- transmitter. Another person in the less networks must define all methods
out the supply chain has many benefits same plant might be running a wire- using, sharing, and securing the avail-
in the pharmaceutical industry. less video camera for perimeter secu- able bandwidth. This has implications
RFID in the pharmaceutical supply rity. A third might be running an RFID for planning, implementation, opera-
chain is seen as a technique to enhance inventory tracking application. Be- tion, maintenance, and expansion.
patient safety and security and ad- cause they are in different departments Policy management and validation also
dresses emerging regulatory require- and locations and doing different things tie into the end user's existing IT re-
ments like Florida’s anti-counterfeit- on different protocols, they might think quirements – one company might have
ing law. Preventing drug counterfeit- they are isolated, but in reality, those IT policies in place that are very differ-
ing, for example, calls for drug prod- radio waves are co-mingling creating ent from another in the pharmaceuti-
ucts to carry a genealogy of their his- tremendous potential for performance cal industry. The system must be de-
tory. With drug counterfeiting on the problems and mismanagement. signed to comply with corporate re-
rise, pharmaceutical RFID security is Coordination of diverse wireless quirements for activities like reporting
critical. needs is critical, but not likely to emerge errors, observing network behaviors,
Implementation of wireless tech- by consensus. If each department want- and performance based on that infor-
nologies also aligns with the FDA’s ing to deploy a wireless solution had to mation. It must cover every aspect of
efforts to increase efficiencies within check with every other department to the operations, from initial configura-
the development and manufacturing see how their wireless activity would tion to ongoing optimization.
sectors under their 21st Century Initia- impact them, there would be gridlock. Commissioning and qualification of
tive as well as Process Analytical Tech- There must be a higher level frame- the wireless network would be compa-
nology (PAT). Not to be mislead by the work that respects what people need to rable to commissioning and qualifica-
name, PAT allows pharmaceutical do to perform their roles and responsi- tion of any network, but with added
manufacturers to optimize the manner bilities in the context of the business emphasis on security and interference.
they use to manage their plant assets strategy and the related job responsi- Interference would be addressed first
to produce specific drugs with the ob- bilities. At the same time, customers during the RF site survey, which uses
jective of reducing the price that the must have assurance that if they imple- scientific tests to measure RF in the
consumer pays. PAT also allows phar- ment select technologies and practices plant and in the local area surrounding
maceutical manufacturers to apply new that conform to company policy they the plant.
technologies such as advanced process will enjoy reliable, secure, validated Additional security and RF inter-
control and wireless networks. network operations. ference testing also must be built into
When considering the use of wire- routine maintenance procedures to
Managing Secure less technologies in the pharmaceuti- account for changing internal and ex-
Integration in a Regulated cal industry, security and validation ternal conditions. Events ranging from
Environment are at the forefront of most people’s a microwave oven at a new convenience
The greatest threats to wireless secu- mind. Security is mandated by the store to full-blown competition for the
rity are not from malicious interfer- FDA’s 21 CFR Part 11 regulation on RF spectrum from a new plant being
ence, but from otherwise well-inten- electronic signatures/electronic built next door all represent potential
tioned people engaged in sloppy net- records. Because the wireless technol- RF and security threats that must be
working practices, such as not chang- ogy typically does not interface with detected and may require re-valida-
ing passwords according to policy, us- the product directly, validation issues tion and re-qualification.
ing obvious passwords such as initials, would be comparable to wired network Policies and SOPs that meet regula-
adding or deleting devices improperly, technology. However, there is a need to tory requirements also must be in place
and any number of other lapses. Wire- assure that interference and security for handling problems. Once the sys-
less networks are also subject to inter- are managed. tem detects interference, for example,
ference from other non-malicious fac- Financial reporting and disclosure what does it do? Will it reroute traffic,
tors, environmental or accidental Ra- regulations required by the Federal change frequencies, or reconfigure an-
dio Frequency (RF) noise, broken RF Sarbanes-Oxley act, and the use of tennas to be active or inactive? Some of

4 PHARMACEUTICAL ENGINEERING SEPTEMBER/OCTOBER 2006 ©Copyright ISPE 2006

 Wireless Technology
the options depend on the capabilities
of the technology, but within that
framework, policy and network man-
agement is necessary to guide imple-
mentation and network operation.
Performance, availability, and uti-
lization are also among the reporting
criteria covered by systems manage-
ment and also must be considered when
validating. Policies, such as alarm alert
handling which dictates alarm related
operator actions, are part of the sys-
tems management function.

Managing the System

Architecture
Optimum execution of any enterprise-
wide policy requires a network archi-
tecture that can accommodate technol-
ogy of every possible network vendor,
emerging standards, regulatory guide-
lines, and best wireless integration
practices. The architecture must be
based on a secure model covering au-
thentication and role-based access con-
trol. This should provide for common Figure 4. Measuring wireless benefits.5
addressing, routing, messaging, and
device management. The architecture education, guidance documentation, sender or receiver. This type of identity
also should provide consistent data and interoperability of sensor networks management can be done by a number
structures, storage, and reporting, and within the industrial environment.4 of methods including certificates and
a common point of configuration for all tokens. Both can authenticate devices
business rules and workflow. Managing and Validating with a unique identifier. Management
Figure 3 illustrates the array of stan- System Traffic must determine how those certificates
dards now impacting wireless commu- Unlike wired networks, which can be are assigned, distributed, and evalu-
nications. Some have been developed fairly well isolated, closed by function ated, and what privileges that identi-
by industry standards groups compris- or protocol and kept independent of fier would have. They must define ex-
ing vendors and users. Bluetooth and other networks, wireless signals can- actly how to treat each user or device as
WiFi are two of the better known, yet not be managed physically. Wireless an object with its own unique proper-
these are seen as better for voice and traffic is controlled by agreements and ties or attributes. This is a much better
graphics applications. ZigBee is a low- rules, requiring buy-in from everyone method for assigning a unique identi-
power, slow-data standard that has with access to the bandwidth spectrum. fier than IP or other alternatives. This
many supporters for remote monitor- The data may transmit across the is a well understood technology, but its
ing. Predictable, long-lasting power is same virtual wire or air link, but would effectiveness decreases significantly
key for wireless monitoring, and ZigBee not necessarily have to be interspersed without enterprise-wide coordination
supports battery life of 1,000 days or with like data. A process packet and an and validation of wireless applications.
more. Internet Protocol (IP) packet would not From a technical and practical
Members of IEEE, ISA, and WINA necessarily have to be on the same standpoint, there must be a single point
are currently working together on stan- link. Instead, rules could limit access of access to the whole network of net-
dards that they hope will gain accep- to process data to users on the process works, using a common network and a
tance by the International side of the house; or transmit data to common lexicon.
Electrotechnical Commission (IEC). receivers on the same side. The com-
Just over a year ago, a new ISA stan- pany has the power to dictate what Managing System Growth
dards committee, ISA-SP100, was goes where and to configure the rules. From a network management perspec-
formed to further standards and tech- One key to flexible, secure opera- tive, it shouldn’t matter if signals trans-
nical documentation in the automa- tion is the ability to validate any packet mit across wires or not. The network
tion and control arena. Project teams of information moving across the net- management center should see the
have formed to focus on issues such as work with a recognized and authorized wireless path as just another network

©Copyright ISPE 2006 SEPTEMBER/OCTOBER 2006 PHARMACEUTICAL ENGINEERING 5

 Wireless Technology
that must be managed for performance Solution for Wireless integrated operating approach that will
and security. But today, and probably System Infrastructure and ensure that wireless installations will
for many years to come, wired and Management be scalable, secure, and extensible.
wireless networks will likely be man- Thanks to standards and innovation, Solutions must include architecture
aged by different technology. Even wireless technologies offer a compel- and management software, perfor-
though IT and telephone networks may ling mix of cost and performance that mance monitoring and reporting, and
be managed by a company’s IT organi- will spur adoption throughout the en- security management as a single solu-
zation, for example, they typically use terprise. “When asked how their orga- tion - Figure 5.
different management systems. Voice nization would measure the return on
over IP is only now driving the need for wireless investments, respondents Managing Implementation
integrated management and valida- listed increased productivity, improved While implementing a management
tion of IT and telephone systems, even (internal) customer satisfaction, and infrastructure of this sort requires sev-
though these technologies have been reduced expenses/costs of doing busi- eral months of preliminary cross-com-
evolving for years. ness most frequently - Figure 4.”5 pany planning, implementation of the
Even though wireless technology is Moving beyond prototyping to con- technology itself can usually be done in
clearly in a transitional phase, it is trol-a future at which some companies one or two weeks. Few companies have
highly unlikely that there will ever be in other industries have already ar- the resources to maintain staff neces-
a standard wireless protocol and fre- rived-requires an overarching frame- sary for initial implementation, espe-
quency. Protocols and frequencies are work to accommodate and apply mul- cially because the demand for special-
optimized based on very different ap- tiple wireless technologies. Since there ists with relevant skills is very high.
plication requirements and vendor is great heterogeneity to the applica- Companies that do not have the re-
technologies. The requirements for tions and no “one size fits all” wireless sources typically required to imple-
power management, distance, site char- technology solution, monitoring, man- ment a managed wireless network may
acteristics, bandwidth, cost, and secu- agement, and security must span the find outsourcing to one of the emerging
rity will always result in the need for a entire enterprise. This will ensure the specialist firms to be a cost-effective
wide range of technologies, standards, most efficient use of resources, while solution.
procedures, and excellent validation allowing the disparate applications to The following is a check list that
methodologies. share the spectrum within the context process manufacturers should consider
What is needed is an integrated, yet of their importance, time sensitivity, when assessing wireless needs and de-
flexible network management strat- and mission criticality. signing a wireless network system that
egy that can deliver benefits today while Like the networks themselves, such is consistent with their wireless strat-
adapting to businesses and technolo- a regulated wireless infrastructure egy, policies, and quality system:
gies as they evolve and change. must be evolving, dynamic, and flex-
ible. This environment demands an • Survey the entire company to deter-
mine where wireless technologies
can best support your business strat-
egy.

• Create an enterprise-wide policy

that will control wireless deploy-
ment.

• Design an architecture that will

achieve these goals effectively.

• Conduct an RF site survey to iden-

tify potential sources of RF interfer-
ence and locate wireless communi-
cations devices, both internally and
externally to the plant.
• Work with a validation specialist
with experience in wireless tech-
nologies and networks.

• Select and purchase hardware and

software that is most cost-effective,
Figure 5. Secure wireless architecture for the plant network. proven, and scalable.

6 PHARMACEUTICAL ENGINEERING SEPTEMBER/OCTOBER 2006 ©Copyright ISPE 2006

 Wireless Technology
• Develop a prototype in an area with easily incorporated. The bottom line is Master’s degree in Business Adminis-
high ROI potential for immediate that there is a potential wireless explo- tration (MBA) from Worcester Poly-
payback such as cycle time reduc- sion on the horizon due to the enor- technic Institute. She is available at
tions or counterfeiting exposure for mous benefits that can be gained from Janice.Abel@ips.invensys.com.
high profile drugs. using this technology and companies Invensys, 33 Commercial St., B51-
need to be ready to validate and imple- 1A, Foxboro, MA 02035.
• Build requirements and design docu- ment.
ments for a pilot wireless prototype Harris (Hesh)
application running separately from References Kagan is Technology
the process for system validation. 1. “RFID is the Limit,” Gartner Re- Director, New Ven-
port, December 14, 2006. tures, Invensys Pro-
• Pilot a project for integration to an cess Systems and
existing application. 2. Basta, Nick, “A Track-and-Trace- President of the Wire-
Future,” Pharmaceutical Manufac- less Industrial Net-
• Integrate to the existing business turing, August 2003. work Association
and operations systems. (WINA). He leads the Invensys wire-
3. Paul, Thomas, “Inside GSK’s New less technologies program, which as-
• Measure and evaluate ROI effec- RFID Pilot”, Pharmaceutical Manu- sists companies in integrating wire-
tiveness of application. facturing, May 2006 less networks for enterprise asset per-
formance management, and for the last
• Collect lessons learned, measure 4. “A World without Wires?” Pharma- 15 years, Kagan has been leading the
cost-effectiveness of improvements, ceutical Manufacturing, April 2006. effort to coordinate development and
reassess the strategy, and plan next technology across Invensys. He has
steps, including additional sites, 5. “Applied Wireless: Making Wireless worked in the automation and controls
plants, and global solutions for a Work in business,” CIO Focus, industry for more than 25 years. He is
rollout. www.TheCIOStore.com. available at Hesh.Kagan@ips.invensys.
com.
• Conduct ongoing monitoring, main- Acknowledgements Invensys, 33 Commercial St., N05-
tenance, support, and optimization Special thanks to Mike Howden, Con- 3A, Foxboro, MA 02035.
services, and incorporate relevant sultant, Invensys Validation Technolo-
security, regulations, standards, and gies and Mark Cupryk, General Man- Ian McPherson, Vice
technologies as they emerge. ager, Invensys Validation Technolo- President of Market-
gies, for their guidance and excellent ing for Apprion, has
Summary comments. more than 15 years of
Technology is enabling a vast number experience in research,
of wireless capabilities across the phar- About the Authors development, and de-
maceutical enterprise. The nature of Janice T. Abel is Di- ployment of network
wireless applications requires a high rector of Pharmaceu- infrastructure and en-
level of technical understanding for tical and Biotechnol- terprise wireless technologies. Most re-
implementing and validating wireless ogy Industries for cently, he was the Founder and Presi-
network applications. Invensys Process Sys- dent of the Wireless Data Research
As a result, it is important to estab- tems. She has been Group, providing syndicated primary
lish a strategy and plan before going involved with the research and advisory services for
forward with wireless just for the sake pharmaceutical and emerging wireless technologies and ma-
of going wireless. The plan should in- biopharmaceutical industries through- chine to machine communications. He
clude benefits that will be gained from out most of her 20-year professional is available at Ian.Mcpherson@apprion.
using these new technologies whether career. This includes consulting with com.
tangible or intangible. Some of the steps clients on regulatory requirements, en- Apprion, NASA Research Park,
and guidelines for implementing wire- terprise control, risk management, and Moffett Field, CA 94035.
less include working with an experi- PAT. Her experience includes the au-
enced and knowledgeable company and tomation and application of bioreactors
working with a wireless infrastructure and other processes in the pharmaceu-
and plan that will incorporate present tical and biopharmaceutical industries.
and future wireless needs. The infra- Abel has a Bachelor’s degree in chem-
structure needs to be flexible enough istry from Clark University, a Master’s
that new wireless technologies, meth- degree in chemical engineering from
odologies, and new regulations can be Worcester Polytechnic Institute, and a

©Copyright ISPE 2006 SEPTEMBER/OCTOBER 2006 PHARMACEUTICAL ENGINEERING 7