It’s hard to talk about mobile or handheld technologies these days without the conversation turning to iPhones and iPod Touches. Yes, Apple devices will eventually have a place in pharma (click here for more). But neither they, nor BlackBerries or Treos, are exactly the type of rugged device that you’re usually looking for in an industrial environment, much less a GMP facility. Fortunately, there are plenty of good, safe, robust handheld devices on the market.
Some would say too many. A typical pharmaceutical manufacturer might have as many as a dozen or more handheld devices in use throughout its plants, says Joe Granda, Executive VP for Marketing for Syclo, a provider of mobile computing applications and platforms. In the plant, for instance, they’re using rugged laptops for inspection-type activities for which operators like a full screen and workable keyboard for filling out forms, and handhelds for work-ticket types of activities. (“Guys with toolbelts usually want the portable handhelds,” he says for clarification.)
It’s hard to keep track of all the sexy new portable devices out there. And every new technology comes with its own unique set of implementation challenges. With this in mind, here is a look at some of the devices that drug manufacturers are putting into their workers’ hands, and how vendors are making them user-friendly.
In and Around the Plant
Syclo has just released version 5.1 of its Agentry mobile platform, says Granda. Agentry allows manufacturers to run myriad devices—from laptops to Blackberries to rugged devices from Motorola, Intermec and others—on a fixed, uniform platform.
For the first time, Agentry includes mobile device management (MDM) capability. Syclo has made a name for itself helping manufacturers manage their handheld applications—it works with 12 of the top 15 drug manufacturers, Granda notes. “Now, we help them manage the devices as well,” he says. MDM capability allows manufacturers to monitor and maintain their hundreds or even thousands of devices scattered across their facilities, and to troubleshoot remotely.
Syclo also provides applications. It has recently released a version of its SMART Work Manager for Maximo version 7, and one for SAP as well.
Also, Granda says, expect to see more applications using GIS and GPS technologies coming out, for improved product or event tracking. “You can find out not only that something was signed off at this time, but also at this place.”
This summer, Intermec began shipping its CN50 rugged mobile computer with 3G wireless network capability. The device’s Flexible Network Radio supports both voice and data exchange with cell phone and network connections.
“Intermec takes another step toward blurring the line between commercial smartphones and ruggedized computing devices,” says Jeanine Sterling, an industry analyst with Frost & Sullivan, which awarded the device one of its innovation awards.
Thermal imagers are getting continuously more robust and sensitive. Operators can take an infrared imager into the field to scan electrical, mechanical, and steam equipment for reliability. Fluke’s Ti32 imager comes with analysis and reporting software, the ability to annotate images with voice recordings, and even has telephoto and wide-angle lenses for special applications. FLIR’s T Series thermal imagers are also excellent for monitoring pumps, valves, storage tanks, and so on. FLIR also has improved its GasFindIR for gas leak detection.
Plant Rounds from Alpha Handheld Systems is a plant database system, based upon two modules—the Data Recording module runs on a Pocket PC and collects and stores tag readings. The other module is the desktop Data Controller, which maintains tag databases and histories. The systems do barcode scanning for warehouse applications, as well as management of instrumentation connected to distributed control systems (DCS), says Alpha’s Jerry Wolff.
Parsec Automation has just introduced its next generation LeanTrak mobile “productivity solution.” In one suitcase, operators can get a PC and connections to hook up to plant equipment (“without installation, wiring, programming, infrastructure changes, or production disruption”) in order to monitor productivity levels, qualify new equipment, or troubleshoot.
Another cool development in industrial technology is the ability to do remote videoconferencing. Operators can take a durable handheld videocamera such as Librestream’s Onsight and transfer a direct video feed to a plant manager somewhere else on site, or a facilities manager somewhere else on a manufacturing campus. Librestream continues to upgrade the cameras with recording capabilities and lower bandwidth requirements.
For the places that you just can’t see with the naked eye, Aqua Communications has just unveiled Snake Eye III, its latest mobile video inspection equipment. Using an LED camera at the end of a wand and cable, operators can look into ductwork or plumbing and watch the proceedings on a 5-inch LCD display. The III allows recording of the images onto an SD memory card as well.
Emerson Process Systems has released its latest Field Communicator, the 475, a rugged field device that can handle multiple configurations and challenges (photo). Like many mobile devices, the 475 is smaller, sleeker and faster than its predecessors, and has a color graphical interface. The 475 works with a library of 1,200 “DD’s”, or device descriptions, says product manager Alan Dewey. “We’re very conscientious that the Communicator checks out with every field device application out there,” he says.
An example: The device can be used to scan a pressure transmitter, detect a problem in the sensor module, and present a color image highlighting exactly where the problem lies, explains Dewey. The uses of the device are only limited by the extent of the DD’s that vendors create.
Used in concert with a PC-based asset management device manager, the 475 can record changes to a device or piece of equipment in the field and transfer it to a database, ensuring updated equipment records.
For pharma and the device industry, Thermo Scientific’s Niton XL3t Series Analyzer provides fast, nondestructive chemical analysis of common alloys, as well as superalloys, stainless steel, and—for the first time, the company says—other light elements such as magnesium, aluminum, and sulfur. The precision of this latest analyzer, the GOLDD model, makes it “ truly a laboratory-quality instrument,” says Bob Wopperer, director of business development for the product. The Niton also has data storage and live video capabilities, with RoHS and 21 CFR Part 11 compliance.
Finally, looking for a rugged phone that you can drop down a flight of stairs or run over with a forklift? Sprint Nextel and competitors have been pushing the Motorola r765IS as the hottest new top-of-the-line model in industrial “intrinsically safe” phones.
Materials Verification
The shipping and receiving dock is a testing ground for handheld product tracking devices, based on barcode or RFID technologies. In addition and despite the economy, business is booming in the market for handheld raw materials identification technologies. The PIC/S initiative (http://www.picscheme.org/) and the trend towards harmonized GMP standards are driving manufacturers towards 100% raw materials inspection, at a time when several viable and relatively inexpensive products have come to market.
Non-contact, point-and-shoot technologies based upon both Raman and NIR spectroscopy are hot in pharma (as well as for CSI-like chemical identification). While there is competition between them, NIR and Raman can also be viewed as complementary technologies. (And both can also be used for field-based anticounterfeiting efforts, as well as factory-based PAT applications.)
When Polychromix introduced its NIR-based handheld Phazir Rx for material quality inspection three years ago, there was “surprise and skepticism,” says company VP Dan Klevisha. Now there’s general acceptance that the product works and that ROI is fairly quick. “Beyond standard identification, we are also doing more advanced raw material analysis including identification of various hydrates (such as lactose), identification of different grades of MCC (based on particle size), and additional on-site determination of the moisture content of raw materials.”
Polychromix has just introduced a micro version of Phazir—about 2.7 lbs and the size of a small hair dryer, says Klevisha. “We’ve pushed the device to its logical conclusion, as small as we could while maintaining its full functionality.”
Phazir is also becoming increasingly popular in the plant, for at-line PAT applications for drying, blending, and other unit operations. Manufacturers want to improve upon their traditional lab-oriented sampling methods but don’t want to go to the time or expense of in-line monitoring. At-line NIR and competing technologies are a happy medium, Klevisha says.
Things are also dramatically different today than when Ahura Scientific’s TruScan came on the market a few years ago, says Duane Sword, the company’s VP of product management. Few knew the company name nor associated Raman spectroscopy with materials analysis. Now TruScan has been deployed in more than 100 companies worldwide, Sword says, and Ahura continues to work with customers to upgrade the device’s capabilities—increasing the sensitivity and spectral resolution, for example.
TruScan’s software now enables “fleet deployment” worldwide as well. “If you build the library in one location, for excipients and API’s, someone else anywhere in the world can download the validated methods” and apply them locally, Sword says.
TruScan is now being used more frequently for final product authentication as well, Sword says, to determine if API in a product has degraded. A complimentary FTIR product, the TruDefender, is used to screen compounds that are not conducive to Raman, though it does require contact with the sample.
BaySpec has recently joined the market with a Raman handheld of its own (in addition to its benchtop equipment). Like other manufacturers of Raman technologies, it started in the telecom market (fiber optic sensing, etc.), but is trying to distinguish itself in pharma with devices like the Portability-3. It is betting on performance—an ability to identify common and even rare chemicals at concentrations as low as 30%, says Eric Bergles, VP of Sales and Marketing, but also on the fact that it offers solutions at various wavelengths, from 532 to 1064 nm.
“Manufacturers typically deal with a wide variety of samples, some of which tend to fluoresce,” rendering the reading inaccurate, says chief technologist Dr. William Yang. Biologic samples will often fluoresce at 785 nm, but not at 1064.
Another player in the market is the Inspector Raman from DeltaNu (which also has just released its Rapid ID for handheld identification of industrial plastics).
ELN Update
Electronic Laboratory Notebooks (ELN’s) continue moving pharma on an arc towards paperless drug development and QA/QC. All major manufacturers are now using ELN’s, says Symyx VP of Services Chris McKenna, while smaller and mid-tier manufacturers are following suit. The devices they’re using to run these systems are divided between laptop PC’s (favored by development scientists) and handheld tablets (favored by QA/QC lab folks).
ELN’s have evolved quickly, McKenna notes. Whereas in the past they were disparate and specified—for process chemistry, formulation, or analytics, for example—they are now supporting varied applications on the same enterprise-level platform.
The trend conforms with larger industry trends such as Quality by Design and the overall breaking down of silos within global organizations, but there is still an adoption curve at work. “At this point, it’s more of a human issue than a technical one,” he says. Going paperless is a business transformation that requires scientists, regulatory professionals, and others to share information they traditionally have not had to share.
The future means more change, McKenna says. There will be a gradual integration between ELN’s and Laboratory Information Management Systems (LIMS), he predicts. “Operators want to work from one portal,” he says. “The two will eventually become one.”
VelQuest Corp.’s recent product improvements are indicative of this movement towards integration. It has just released Adapter for Excel for its SmartLab execution system. Data captured in the ELN is automatically ported to an Excel workbook, and resulting calculations are then returned to the ELN. Another recent upgrade is the SmartLab CDS Adapter for Agilent’s OpenLAB and ChemStation CDS, for improved sample prep and more seamless data integration.
Click here for best practices for implementing new handheld devices at Three Rivers Pharmaceuticals
