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Pharmaceutical Manufacturing and Packing Sourcer

Handle With Care

As air cargo services evolve to meet the challenges of transporting high-value pharmaceuticals, hard-to-achieve new regulatory challenges emerge including a 100 per cent screening requirement – but solutions are available, explains aviation writer Robert W Moorman

Shipping temperature-sensitive pharmaceuticals is logistically challenging for every element of the supply chain – drug manufacturers, airlines and forwarders alike. Each must abide by numerous regulations to carry out business, including the much-debated US law requiring 100 per cent of US originating belly cargo to be screened by August 2010.

For a couple of years, the US Transportation Security Administration (TSA) has been enrolling participants in the Certified Cargo Screening Program (CCSP), which is offered to American shippers as a way to meet the demands of the federal mandate. The TSA established the CCSP to allow manufacturers, shippers, forwarders, airlines and even third parties to screen cargo before it is tendered at the airport. With this programme, manufacturers can continue to manage the screening process at their own facilities and bypass additional inspections by airlines. The CCSP programme is intended to reduce bottlenecks at airport facilities and avoid flight delays.

Most airlines and their partners met the 50 per cent screening threshold required in February 2009 without much trouble. But meeting the 100 per cent mandate will be much more difficult, in part because the air cargo industry is bouncing back from the downturn in the global economy. This year, however, volumes are increasing significantly. Some carriers are already screening 100 per cent of their cargo on narrow body aircraft, and are now making plans to throttle up for 100 per cent screening of all cargo by the August deadline.

At the same time, several airlines are planning to increase shipments of temperature-controlled pharmaceuticals. These sensitive products pose a challenge if tendered unscreened, because the shipments require special handling and care according to strict guidelines.

Because the pharmaceutical industry already adheres to rigorous regulatory guidelines, the extra step for screening is seen merely as an added step in the process for companies such as Pfizer which, under TSA oversight, have created a programme to screen their products at the factory – securing them with tamper evident seals.

“For the pharmaceutical industry, air shipments are the norm for temperature/time sensitive materials,” said Brad Elrod, director of Global Conveyance Security, Pfizer Global Logistics Compliance. “A delay due to screening could invalidate the temperature control protocols for cold chain products.”

Elrod pressed on: “Further, if any type of physical inspection is needed, the cold chain packaging requirements would be compromised and the controls required for shipment would likely be lost. This is why participation in the CCSP process is critical to this industry.”

Many shippers have prepared themselves for the August deadline by joining CCSP. However, many have not – believing that the deadline for compliance can be moved back like a proposed regulation. As a result, they have not taken the necessary steps to ensure their products will move through the supply chain uninterrupted.

“This is not a TSA regulatory deadline,” said Chris Battle, partner with the Washington DC-based consultancy, Adfero Group, and the former chief of staff of the US Immigration and Customs Enforcement. “This is a congressionally mandated law.”

The major players in the pharmaceutical industry understand this and are being very proactive. Led by Pfizer, the industry worked closely with the TSA to help establish standards for the CCSP and Pfizer is among the 600 shippers that have signed up to participate.

“Some shippers think this is a forwarder problem,” said Brandon Fried, executive director of the Airforwarders Association, also based in Washington DC. “But without participation in the programme, shippers are potentially subjecting their shipments to being opened during the screening process.”

Airlines encourage all shippers of temperature-sensitive pharmaceuticals to become involved in the CCSP programme by becoming a Certified Cargo Screening Facility (CCSF). For now, TSA is paying for the threat assessment of those employees to encourage shippers to join the CCSP programme. But that won’t last, said Fried.

HELPFUL GUIDE

Airlines and drug companies have specific guidelines to ship temperature-sensitive pharmaceuticals. Chapter 17 of the International Air Transport Association’s (IATA) Perishable Commodity Regulations (PCR) is the bible for airlines, while drug companies follow those developed by the Parenteral Drug Association (PDA). Many shippers of healthcare products also choose to test the effectiveness of containers and individual airline shipping programmes in both the lab and through trial shipments.

In addition, the PDA and the Pharmaceutical Cold Chain Interest Group (PCCIG), in conjunction with the TSA, have formed a task force that is drafting soonto- be-released guidelines incorporating acceptable distribution practices with the implementation of the 100 per cent screening law. Moreover, the US Pharmacopeia, which publishes a template for standards of shipping pharmaceuticals, is seeking input for changes to enhance the content of Chapter 1079.

There are also regulatory guidelines for the shipment of temperature-sensitive pharmaceuticals. Regulatory bodies include: the Federal Aviation Administration (FAA); European Aviation Safety Agency; the FDA; World Health Organization; MHRA, the FDA-equivalent for the UK; and Health Canada, which was one of the first government agencies to develop specific guidelines for the transport and care of temperature-sensitive pharmaceuticals.

Much of what is recommended for the proper carriage of temperature-sensitive pharmaceuticals depends on the country in which an airline operates. Once there were only four countries providing regulatory guidance. Now, as many as 15 countries have published their own regulatory guidelines.

It isn’t just the temperature-sensitive 2-8°C shipments that interest regulators. Forwarders and airlines must continually improve the processes for the shipment of even basic items, such as pain relievers, according to one air cargo executive.

Maintaining the chain of custody is of paramount importance. The chain begins at origin, or the shipper site, where the drugs are packaged and begin their journey. The freight-handling or forwarding facility, or the airline’s airport facility, typically is the second leg of the trip. The third is on the aircraft, for which the airlines must follow government-approved handling and storage procedures for the proper shipment and care of temperature-sensitive pharmaceuticals. The fourth area of concern is at Customs exportation or importation site. The requirement of a strong back-up plan in the event the process breaks down at any point is a must.

Shipping pharmaceuticals has evolved significantly over several years. In the past, airlines shipped mostly ‘hard pharmaceuticals’, such as pills or raw materials used to make drugs. Today, pharmaceutical companies are more involved in shipping time- and temperature-sensitive pharmaceuticals such as liquid vaccines via air.

“The increased scrutiny by shippers and regulatory authorities is prompting us to invest in the future,” said Dave Brooks, president of American Airlines Cargo division. “We have invested millions of dollars in infrastructure, equipment and software to ensure safe and secure shipment of ‘cold chain’ products.”

An eight per cent growth in spending for temperature-sensitive logistics technology and equipment is anticipated for the air cargo industry over the next five years.

Factors driving growth in temperature sensitive logistics include the increasing number of vaccines coming to market that must be kept between 2 and 8°C; regulators’ growing concerns over control room temperature (CRT) shipments that would broaden the market; and US legislation that could allow biologics, such as vaccines, blood and blood components, to be sold as generic products.

REVENUE POTENTIAL & TRENDS

Despite the regulatory and logistical challenges, airlines see the potential of shipping more temperature-sensitive pharmaceuticals by air and have instituted or enhanced premium services to increase their market share in this area. Pharmaceuticals are less likely to be affected by the fluctuations of the marketplace because of their value and immediate need. Consequently, shipping these products could act as a counterweight to the drop in shipping of other items during bad economic times.

Some forwarders have seen an opportunity from the 100 per cent screening requirement and have invested heavily in explosive trace detection (ETD) equipment, which provides for noninvasive screening – a viable solution for those shippers that cannot meet the August deadline for 100 per cent screening. These services will maintain shipment integrity for cold chain products, as well as opening up another source of revenue.

Just as the air cargo industry has evolved to meet the requirements of pharmaceuticals, so have the container manufacturers. Twenty years ago, shippers simply loaded dry ice in with the cargo. Around that time, Envirotainer introduced better temperature control by developing a self-circulating system. A dry ice bunker would cool air that would descend, absorb heat and then rise to be cooled again. Later Envirotainer invented active technology that used a fan and thermostat to circulate conditioned air only when it is needed. Envirotainer now manufactures and manages a fleet of containers that are leased to carriers and forwarders for the transport of temperaturesensitive healthcare products. Carriers have worked with Envirotainer to offer three types of active and passive temperaturecontrolled containers, including LD3, LD7 and ‘E’ type containers, which can also be shipped on narrow-body aircraft.

How has the 100 per cent screening requirement affected the shipment of temperature-sensitive pharmaceuticals? Thomas Persson, CEO of Envirotainer, believes the law has created a need to review procedures of pharmaceutical companies, and logistic partners now have to establish procedures for the correct handling of containers and temperature-sensitive cargo. “As far as I can see, these revised procedures probably put more cost on transportation, but it seems not to have affected volumes, at least not so far,” said Persson.

 


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Robert W Moorman has written about various facets of the aviation industry for over 25 years. During his career, he has covered commercial and military aviation as well as the aviation committees in the US Congress and related regulatory agencies. He now runs his own communications and writing business based in the Washington DC metropolitan area. His clients include numerous aviation trade publications as well as corporate clients. He has been interviewed by national and local print and broadcast media on various aviation related topics.
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