By Paul Thomas, Managing EditorThe general public has grown accustomed to wireless technology through the use of cell phones, wireless PDAs and WiFi-enabled computers. Meanwhile, pharmaceutical manufacturers are just beginning to dip their toes in the wireless waters. Only now are wireless technologies becoming practical and robust enough for adoption on shop floors and in warehouses.But there is little consistency of equipment offerings. Most vendors are utilizing a scattershot approach to target any and all industries showing interest in wireless, says Jake Millette, an analyst with Venture Development Corp. (Natick, Mass.). Pharma-specific trends or vendors concentrating only on this market have just not materialized yet.From the manufacturers perspective, validation and collecting and integrating wireless data with current IT systems are real concerns. Regulatory prodding and high-profile applications have ushered in the era of Radio frequency identification (RFID), a wireless application for product track and trace purposes. But for ambient monitoring or process monitoring in the plant, the wireless explosion has yet to materialize. For process control, adoption is much further off.In 2004, the pharmaceutical industry made up just 4.3% of total purchases in the as-of-yet small $154.1 million market for wireless monitoring and control products in discrete and process manufacturing, according to Venture Development. However, that figure is expected to increase to 5.1% of a total $419.3 million market in 2007, and rise measurably thereafter.Well see an accelerated acceptance of wireless in the pharmaceutical industry, says Frank Williams, VP of Elpro Technologies (Brisbane, Australia), a provider of wireless modems, I/Os and other devices. Elpro specializes in monitoring valves, remote temperatures and tank levels, and has done applications with Merck, Pfizer, Pharmacia and Roche, Williams says. Theres always a gestation period that must occur with new technology, he adds, but more aggressive manufacturers are truncating the typical two- or three-year implementation cycle to 18 months.Were not really doing anything with wireless right now, says one pharmaceutical process control specialist. But I see us making the leap to wireless fairly soon, probably for monitoring remote areas for materials storage.A hodge-podge of pharma applicationsIndeed, for remote storage areas and large warehouses where wiring is difficult and line of sight is easy, wireless makes sense, especially for ambient temperature and humidity monitoring.But wireless sensors can also keep close tabs on pharmaceutical processes, particularly those that involve rotating or mobile equipment. And as the industry moves toward modular construction and nimble manufacturing practices, ready-to-move wireless equipment will gain more appeal. Wireless technology will enable many process analytical technologies, and dovetail nicely with FDAs PAT initiative.Manufacturers are experimenting with unique in-process uses, and vendors are diversifying their products:
- Abbott Laboratories suspected that an accumulation table on one of its packaging lines was causing slight damage to bottles and vials. Abbott sent samples of the containers to Sensor Wireless, Inc. (Charlottetown, P.E., Canada), which made an acrylic replica embedded with tiny accelerometers on a circuitboard. Abbott ran the replica through its bottling line, and took readings using handheld devices to measure the impact of bottles jostling against one another. Abbott used the data to adjust its line speed and correct the problem, says Tammy Wall, Sensor Wirelesss VP of operations.
- Mathis Instruments (Fredericton, N.B., Canada) recently unveiled a wireless version of its thermal effusivity sensor for monitoring powder blend uniformity. AstraZeneca studies showed that the sensor could operate reliably transmitting up to 50 feet and through three different walls, says company president Nancy Mathis. Mathis envisions that companies will use the device for process control as well as monitoring stopping a blend when the end point has been determined, for instance. The control stuff is there in terms of our capabilities, she says. But its not quite there for users readiness. Companies need time to come to trust wireless sensors and measure them against other control devices, she says.
- Accutech (Hudson, Mass.) markets a wireless ultrasonic sensor for clean-in-place monitoring. The sensor resides on the outside wall of a vessel, and creates an ultrasonic signature pattern of the interior that indicates whether cleaning has been done properly. The company also makes a self-contained temperature probe that is mounted on rotating dryers for measuring batch temperatures, which can then be correlated to the dryness of the cake inside. It also has a line of wireless sensors to monitor safety showers and eye-wash stations.
- Honeywell offers a light-induced fluorescence sensor that mounts on rotating blenders, and has installed 17 units at various drug facilities, says Ted Dimm, Honeywell business director. The sensor measures the degree of fluorescent light emanating from a blend to determine when mixing is complete.
Cutting the Cord for Temperature MonitoringRoche Diagnostics has created a wave new world in its Indianapolis warehouses
By Paul Thomas, Managing Editor
Two years ago, Roche Diagnostics decided to upgrade the temperature monitoring in the warehouses of its Indianapolis facility. It wanted a reliable, networked system of sensors that could be installed quickly and automatically stream data to a central process control system for optimal monitoring and archiving.
Site managers had considered a wired application. After all, the manufacturing area had recently been equipped with an integrated system of electronic temperature and humidity monitors, which was working well.
But wireless won out for the warehouses because it could change with the facility. If, for example, Roche wanted to reconfigure its warehouse operations or move equipment or coolers, wireless instruments could move, too. We needed to design for flexibility, not just optimization, says Chris Upwards, director of distribution at the facility.
Roche turned to Honeywell, which it had partnered with on an Experion Process Knowledge Systems installations to control operations at the site. A decision was made to install another Experion platform for warehouse operations, and to allow Honeywell engineers to provide a temperature solution for the warehouses that would link to Experion.
The cost would be higher than initially expected, but management approved it based on the fact that the system could grow with the facility and serve as a model for future applications. A 10-member team of Honeywell experts, an outside validation consultant, and key Roche IT and operations personnel was set up to tackle the project.
Easy does it
Sensor installation may have been the easiest part of the implementationrequiring roughly half a day for each warehouse. Roche installed nearly 100 Honeywell XYR500 wireless temperature sensors, as well as some strategically placed humidity sensors made by third-party manufacturers, among the three warehouses. Most sensors weigh less than a pound and were affixed to interior walls with simple mounting brackets.
Some of the sensors were mounted inside coolers, which must be kept between 2° and 8° C. For freezers requiring temperatures consistently well below zero, to prevent sensor damage transmitters were placed outside and connected to internal probes. We extended the wiring from the outside of the freezer where the transmitters are mounted, says Larry Mills, senior project leader, service operations for Honeywell. The probes are plug-in. If one of them were to go bad, we could unplug it very easily and replace it pretty quickly.
Temperature probes were also used for one room designated for hazardous materials storage. The toughest part was just pulling the wire through the conduit to connect the sensor to the wireless transmitter, says Mills.
Each building was equipped with base radios receiving transmissions from the network. Like any radio communication, sensors and bases require short distances, line of sight and permeable materials to communicate. One 90,000-square-foot warehouse sectioned by concrete walls required three bases.
Honeywells wireless equipment transmits by frequency hopping, in which sensors and bases communicate through randomly alternating frequenciesin this case, the 900 MHz range. Frequency hopping is a common industrial practice that makes it nearly impossible for outsiders to tap into a frequency and steal data, and it reduces the likelihood that interference upon any given frequency will block transmission. The wireless community is currently engaged in debate over what frequencies are optimal for the transmission of radio frequency data in industrial applications, and whether or not clearer standards are required.
Can you hear me now?
To date, transmission at Roche has been clear and uninterrupted, Mills claims, even for sensors located down long corridors or around corners from their bases. Even in the warehouse, with all the metal shelving, it still seems to be fine, he says.
Another issue was making sure that the system would work without interruption, such as might occur during a power outage. The Honeywell sensors are each equipped with standard 3.6-Volt lithium batteries, ensuring that theyll work even when the power grid is down.
To guarantee information redundancy and constant uptime for the system, the base radios were connected by coaxial cables to Kingfisher remote transmission units (RTUs), manufactured by RTUnet, an Australian firm specializing in supervisory control and data acquisition (SCADA) applications. When power is restored following a plant shutdown or rare outage, the RTUs send a history backfill to the corporate network.
The RTUs pass data to Experion along Roches local area network (LAN). Usually the process control systems have their own LAN, says John Atwell, Honeywell senior account manager. But since there are buildings all over this large campus, we used their existing LAN that connects the entire site. Having to install another network to connect these buildings, with more coming on in the future, would have been cost-prohibitive.
The equipment was installed quickly, but validation took much longer. Because the system was on the Roche LAN, we needed Roches approval and involvement, and had to validate the computer system first, says Atwell. Then we had to show that the software, the controllers, sensors and the whole system was operating like its supposed to. Still, the implementation and validation process, which began in August of 2004, was completed by the end of the year.
Up and running
The system now essentially runs itself. The base radios send data each minute, as programmed by the RTUs ladder logic. The Honeywell base radios can handle up to 50 floating point values (whether temperature, humidity or other values), which conforms to Distributed Network Protocol (DNP) standards. Were looking at actual values and taking them into Experion every five minutes, says Mills, one of four technical experts from Honeywell working on-site for Roche in Indianapolis.
There are plenty of behind-the-scenes applications that operators can access and manipulate, Upwards adds. The system monitors not just temperature and humidity, but also sensor battery life. Should temperatures move out-of-spec, or should a battery run low, a pop-up alert appears on control monitors logged into Experion. Whenever an alarm situation arises, the RTU signals off-site Honeywell security, who notify key Roche personnel on a designated call list.
The wireless system has been up and running less for than a year, but Upwards says the benefits are clear. First of all, there are no more paper charts to be managed, freeing up employees to attend to more pressing concerns.
Another benefit is that any operator can easily access critical warehouse data, and do it from anywhere via a PC. An Experion E-Server linked to the main server helps ensure that information is continuously available in managers and supervisors offices, and in any remote location.
The systems web functionality paid off when a warehouse experienced a heating system malfunction over the New Years holiday last year. Operators monitored key parameters from home. We were able to maintain data, and the quality folks went back in after and were able to demonstrate with peace of mind that none of products fell out of required storage temperatures, Mills says.
Even when pressed, Upwards says there have been no problems with the wireless system. Roche has tweaked the Experion system to adapt to the wireless implementation, he says, but has not had to touch the sensors. We know that we have a system that complies with regulatory requirements and provides us with the ability to generate data when we need to, says Upwards. The people on our quality team find this a very useful tool.
If anything, Roches wireless monitoring has proven so dependable that its now taken for granted, Upwards says. The novelty has worn off.