Data Loggers & TSA Screening

The impact of X-ray and ETD testing on pharma shipments

By Henry Ames
Sensitech

On August 1, 2010, the TSA’s 100% cargo screening initiative for all cargo shipped via passenger aircraft took effect. As a result, pharmaceutical supply chain professionals are asking a number of questions relative to the transportation of temperature-sensitive cargo and the use of associated temperature and humidity monitoring devices.

Questions Posed by Industry

For shippers of temperature-sensitive cargo, the use of X-ray and Explosive Trace Detection (ETD) screening methodologies has raised concerns. As such, our company conducted a research study intended to alleviate industry concerns by answering the following questions:

1. Could the TSA cargo screening methods present a risk of corrupting the data contained in the monitoring device?

2. Could residue remaining from the manufacture of monitoring devices potentially lead to a “false positive” indication related to the ETD testing?

3. Could the use of a monitoring device increase the risk for a potential shipping delay or initiate more invasive cargo screening?

4. What can a shipper do to mitigate risks associated with using monitoring devices on cargo transported by passenger aircraft?

Testing Process

We collaborated with Varrick J. Smith, Program Manager Screening Technology Lead DHS/TSA. Mr. Smith guided us through the testing process, arranging visits to three Certified Cargo Screening Facilities (CCSFs) each using a different type of X-ray screening equipment for inspecting shipments of varying size — pallet, large box, and carton/case.

The test protocol included all variants of our data logger and all four devices from our family of electronic indicators. Three representative units of each device were used to simulate the three possible conditions experienced during air transport:

a. Pre-started mode – simulating a bulk shipment of pre-deployed monitors

b. Operating mode – simulating a monitor used to ensure the quality of a shipment

c. Stopped mode – simulating a monitor that has been stopped and returned for download or post-validation

Full cartons and case-level shipments of pre-deployed devices were also tested together with simulated shipments of pharmaceutical product using a passive insulated shipper.

In addition, the ETD test included swab-sampling of each device to test for the possibility of creating a “false positive” scenario that could lead to subsequent screening and possible delays.

Results

The test protocol contained a verification of the data integrity and file structure contained in each device pre- and post-exposure. This testing included a full calibration and post-exposure validation of each unit. All test devices passed, demonstrating the monitor data is unaffected by X-ray exposure. In addition, the ETD results revealed no indication of illicit substances. These documented results answered questions 1 and 2 above.

For question 3, a close examination of the X-ray screening images presented to the technician revealed some interesting results. (See Figure 1.)

Figure 1

While the ultimate decision to subject a shipment to additional screening is determined by the screening technician (according to TSA-mandated program guidelines), the X-ray screening technology is designed to help focus attention to specific areas of potential concern. The testing showed that shipments of temperature-sensitive material — such as pharmaceutical products — have the possibility of being identified as a potential risk. For example, an insulated package, containing a temperature data logger with a sensor probe, embedded next to pharmaceutical product surrounded by conditioned gel packs, and vacuum insulated panels (VIPs), tended to generate an X-ray image that elicited closer scrutiny by the technician. This potential for an enhanced examination was initiated by an algorithm within the X-ray system. Furthermore, printed circuit boards utilized within the monitor are prone to a higher level of review due to an inherently high content of organic material. Hence, shipments of temperature monitors in a case or carton format may cause an inspector to initiate additional examinations. Lastly, as one might expect, anything that looks like an anomaly to an inspector could potentially lead to additional screening. Unlike passenger baggage, where it is common to have varied items positioned together within a single bag or suitcase, cargo shipments tend to be more uniformly and symmetrically packed. However, for temperature-sensitive shipments, it is common to pack electronic temperature monitors next to the payload, resulting in variation of the X-ray image presented to a technician. Given this inherent uncertainty within the TSA screening process, there are potential risks surrounding the air shipment of temperature-sensitive products.

Reducing Risk

Answering question 4 proved a bit easier than originally thought, although there are some key points to keep in mind. To help alleviate bottlenecks in the supply chain, the TSA developed the Certified Cargo Screening Program (CCSP), enabling freight forwarders and shippers to pre-screen cargo and avoid delays, provided certain pre-conditions are met, including a secure chain of custody.

It is clear that the best option is for manufacturers and shippers of pharmaceutical products to become CCSFs and — unless they are direct shippers — work with qualified freight forwarders to handle their screened air shipments. Not only does this program enable a more streamlined supply chain but it also potentially eliminates the need to have an air cargo shipment subjected to invasive screening beyond the shipper’s physical control.

Jill M. Corbett, security coordinator at Falcon GlobalEdge, a freight forwarder whose affiliate, Falcon Global Distribution, was the first TSA-certified CCSF in the country, remarked, “Shippers who become CCSFs will find that it is important to take a proactive role in managing their supply chain, because they will be directly responsible to TSA for the security of their screened shipments.”

Some manufacturers of biologic-based medicinal products have raised concern that X-ray energy could impact the quality or efficacy of a drug in the exact same way concerns were raised about the accuracy and performance of a temperature-monitoring device. In response, some manufacturers have exposed their products to the X-ray screening process and then subsequently tested the product to ensure its quality was not impacted negatively.

Jim Bacon, Talecris Biotherapeutics’ senior director, Global Demand Planning and Customer Operations, led this initiative for its biologic-based products. A recognized industry expert in cold chain best practices, Mr. Bacon stated, “We decided to take proactive steps to insure the safety and integrity of our products is maintained as these new screening methods are implemented. Talecris became CCSF certified to provide pre-screening prior to shipping from our facility and has also performed testing under certain conditions to measure any impact to our product, if by chance it is subjected to screening. It is vitally important that we provide products to our customers and patients that are of the same quality and integrity as when they left our facility.”

Going forward, there are several relatively simple things shippers of temperature-sensitive products can do to help reduce risk. The easiest is to establish effective communication with your freight forwarder and/or air carrier, setting common objectives around overall transit time, screening processes, standard operating procedures, and other cold chain challenges. “Whether a shipper becomes a CCSF or outsources its screening to a third party CCSF, it is more important than ever for shippers to develop and maintain strong relationships with qualified supply chain providers who screen, transport, and tender their shipments to air carriers,” said Ms. Corbett.

Delta Air Lines took the position in early 2009 that “the shipper must indicate on the Air Waybill in the handling information box all shipments containing active data loggers, [as well as] the manufacturer, and model number of the data logging device.” While Delta’s concern was originally driven by the use of electronic devices containing lithium batteries and compliance with both the U.S. Department of Transportation (DOT) Hazardous Materials Regula-tions and compliance with electromagnetic interference (EMI) requirements as defined by the FAA, the documentation of “certified” devices assists the process. By enforcing that only a “certified” monitoring device is allowed and by requiring this device to be listed on the Air Waybill, there is a unified understanding of what is contained in the shipment and therefore what the inspector can expect to see when evaluating the shipment relative to the cargo screening program. Hence, while additional risks may exist when shipping temperature-sensitive cargo, these risks can be mitigated.

Ultimately, the responsibility for screening cargo resides with the air carrier. However the risk of a shipment delay leading to damaged product, lost revenue, or an impact to patient safety is shared by all supply chain partners. Manufacturers of temperature- and humidity-monitoring devices should ensure documented compliance with regulatory expectations and performance claims, in addition to certifying the accuracy and operation of their devices. Critical elements of concern include interoperability with equipment and procedures encountered in the air transport screening processes.

Henry Ames is director of Strategic Marketing for Sensitech, a provider of temperature- and humidity-monitoring equipment. He can be reached at [email protected]

Acknowledgements

The author would like to acknowledge the following for their assistance in overseeing the testing process including: the Department of Homeland Security, Transportation Security Administration, Horizon (www.horizon-air.com), Worldwide Perishables (www.shipwwp.com), Boston Freight Terminals (www.bostonfreightterminals.com), and Falcon GlobalEdge (www.falconglobaledge.com).