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Pharmaceutical Manufacturing and Packing Sourcer

The Big Screen

The air cargo industry displayed incredible foresight in its preparations for new domestic screening requirements, allowing business to proceed without interruption or difficulty. Despite this early success, however,we may only be experiencing the calm before the true storm arrives. Following the most recent cargo plot from Yemen, several members of the US Congress have resolved to broaden legislation requiring 100 per cent screening of all cargo, in order to cover both passenger and freight flights in the US and abroad.

Domestic Screening: Only the First Hurdle?

Securing the supply chain has been a top priority for airforwarders and regulatory agencies for decades, long before 9/11 and recent attempted bomb plots. Given the volume of international air cargo and the ‘just in time’ nature of the business, implementing security measures has been a complex process. The sheer variety of cargo necessitates multiple different screening methodologies. Some commodities – particularly pharmaceuticals with temperature requirements and FDA paperwork – are extremely timesensitive and simply can’t wait for the next flight out.

These concerns were at the forefront of the most recent screening debate in the US,which resulted in 100 per cent screening of cargo on all passenger aircraft originating from inside its borders. Following enactment of the law, forwarders worked closely with their shipper customers to better understand what impact screening could have on their products. As a result, screening through the Certified Cargo Screening Program (CCSP) has remedied many potential pitfalls. Shippers and forwarders alike were able to become certified and through existing best practices for product handling, those in the pharmaceutical cool chain industry were spared some pain.

The risks inherent in screening time- and temperaturesensitive cargo, particularly of a highly regulated commodity such as pharmaceuticals, are immense. A poorly devised screening programme could cause shipment delays leading to damaged product. A false-positive reading from a screening machine could require the screener to physically investigate the cargo, which would mean opening up the box. As a result,warranties, FDA and other agency requirements, as well as the integrity of the shipments, could be invalidated. Finally, if packages are not handled correctly and carefully, the product could be seriously compromised and cause a risk to patient safety.

Screening: a Painful Process

Millions of people depend on pharmaceutical shipments on a daily basis and their health could be affected by shipment delays or damaged products. The critical components of transporting pharmaceuticals, such as maintaining the necessary temperature and delivering within the time constraints of the packaging, are now magnified by the challenge of handling cargo in accordance with newly mandated security standards and screening requirements.

The screening requirements outlined by the US Transport Security Administration (TSA) include the use of a number of screening methods, such as x-ray screening technology and explosive trace detection (ETD). Pharma shipments, however, have unique attributes which create challenges when it comes to screening. For example, due to the sensitivity of cool chain shipments, devices are placed in the packaging to monitor and maintain the temperature throughout the duration of transportation. Sensitech, a supplier of temperature and humidity monitoring equipment, sponsored a research study that addressed the concerns and risks of screening pharma using these methods. The need for specialised packaging creates the potential for screening methods to corrupt data contained in monitoring devices within the packaging. The possibility also exists for residue remaining from the manufacture of the device to lead to a ‘false-positive’ through ETD testing. In general, the use of devices could lead to more invasive cargo screening.

Furthermore, Sensitech’s research study brought attention to the fact that temperature-sensitive shipments have a higher chance of being identified as a potential risk for multiple reasons. The specialised packaging itself often includes insulation with data logging devices, temperature sensors, gel packs and vacuum insulated panels (VIPS) all situated next to the product. Unlike passenger baggage, where it is common to have a variety of items positioned together, cargo shipments tend to be more uniformly and symmetrically packed. So, this specialised packaging creates variation on the x-ray image that would cause the screening technician to further examine the image and then determine whether or not additional screening is necessary.

Screening technicians are responsible for making the ultimate decision about additional screening. If further screening is deemed necessary, x-ray screening technology is frequently used as it can focus attention on specific areas of potential concern. The initial concerns about the x-ray screening method affecting product quality are legitimate. However, Sensitech’s research study showed that both the monitoring data devices and the quality of the product are unaffected by x-ray exposure. This was confirmed after a group of manufacturers tested for quality after products were exposed to the x-ray screening process; it was determined that the screening does not affect the quality of the product.

Given that additional screening also regularly causes a delay in shipment, products could be damaged and revenue lost if the package is not handled properly or not maintained at the required temperature. The issue of timeliness becomes even more significant with the screening procedures, as shippers of pharmaceuticals could lose the product, not just capital, with even a short delay. Prescreening of temperaturecontrolled ULDs has become the most viable option for the air carrier and may be the best procedure for maintaining shipping integrity.

CCSP: Building Customer Relationships

Many airforwarders have voluntarily chosen to become part of the CCSP, enabling them to prescreen cargo. The CCSP and active participation by airforwarders ensures that lifesaving drugs and temperature controlled products are screened effectively, but not delayed. In order to become a Certified Cargo Screening Facility (CCSF), air forwarders have invested millions of dollars in acquiring the necessary equipment to train screening personnel. Those employed by airforwarding companies have security and hazardous cargo certifications which must be updated on a regular basis. Forwarders are experienced professionals who maintain full control over cargo in secured facilities until it is delivered directly to the plane for transport.

While many forwarders and a great number of pharmaceutical manufacturers have become CCSFs, there is much that supply chain partners can do as well. In fact, the role of each supply chain partner is more significant now than ever in maintaining shipping integrity and security. It is essential that each cool chain partner in particular upholds their responsibilities in order to properly handle temperature-controlled cargo and to maintain the flow of cargo.

For this reason, the selection of transport service providers should be given careful consideration. Shippers who participate in the CCSP still often rely on their forwarders to manage the TSA’s cargo security requirements. So when selecting cool chain partners it is imperative that the forwarder understands and executes the mandated screening procedures. That means the forwarder must be able to communicate the process effectively in order to meet the goals of the shipper and guarantee the integrity of the shipment.

Cost control is just one factor that should be given serious consideration when selecting partners in the cool chain, as quality management is also a top priority. In a recent article by Eric Kinaitis, he points out a few ways to evaluate the costs of temperature-controlled shipping (1). Kinaitis suggests that the cost of past losses, excursion management expenses (like quarantine delays) and packaging costs should also be factored into the final decision. He says that it is important to consider the sensitivity of the freight, tolerance for loss and the quality assurance/regulatory environment too, as it may be that the most cost-effective solution does not have the lowest cost by mile or weight.

International Screening: Bring the Painkillers

The lessons learnt in the US could provide valuable information for regulators looking at solutions to the international security question. Various approaches pose different and unique sets of concerns for the cool chain pharmaceutical shipper.

One suggestion has been to dramatically increase the range of time of cargo manifest data that must be submitted to the government. For many shippers, this may be the easiest pill to swallow as these are planned shipments. However, it may increase the time that product is with the forwarder or airline rather than securely stored at the home facility. Do we have the technology or facilities to handle additional waiting times of up to 12 hours?

Another idea has been to replicate the 100 per cent screening system for the international community. This will require shipping facilities to be inspected either by the TSA or by civil aviation authorities before products can be shipped. Establishing new security protocols at each international facility is an expensive and timeconsuming process. If shippers rely on other agents, be it forwarders or carriers, for most of their international security and shipping compliance, they will need to ensure their facilities are certified before working with them. The last resort – relying on the carrier to screen at the airport – may not be an option at high-traffic ports where delays may result from screening that jeopardises the temperature controls for cool chain shipping.

Conclusion

There are encouraging signs that the international aviation community is prepared and willing to be an aggressive advocate for a risk-based system that can accommodate the complexities of the global supply chain. It is also reassuring to see members of Congress, such as Republican Charlie Dent, speaking to the media candidly on the impracticalities of a system without real security improvements from screening regimes.Whatever the future holds for international screening, the forwarding community stands ready to serve its cool chain partners in order to comply with the law with minimal disruptions.

Reference
  1. Kinaitis E, Buyer’s Guide to Cold-Chain Shipping, FORWARD – Official Publication of the Airforwarders Association: pp22-23, Winter 2010



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Brandon Fried is the Executive Director of the Airfowarders Association (AfA). As a 25-year air freight industry veteran, he was appointed to lead AfA in 2005 after holding the position of Chairperson. Before joining AfA in 2000, Brandon was a sales representative and also founded, owned and operated the Washington office for the global freight forwarder company Adcom Worldwide. He then became a consultant for air cargo companies in 2005. Brandon graduated from Syracuse University and is currently working towards an MBA. Email: bfried@airforwarders.org
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