Pharma Firms Set Up Cargo Screening

Pfizer seeks certification for the upstream screening of air freight.

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By David Vaczek
Senior Editor

 

As the airlines plan for mandated 100% screening of cargo transported on passenger aircraft, pharmaceutical manufacturers are looking for compliant alternatives to invasive screening and delays by screening cargo at their own facilities.
The 9/11 Commission Act of 2007 requires the airline industry to screen 100% of cargo at the piece level by August 2010. The industry was required to attain 50% screening by February 2009.
Pharmaceutical manufacturers are pursuing certification as Certified Cargo Screening Facilities (CCSFs). The program was set up by the Transportation Security Administration (TSA) to alleviate the screening burden on the airlines by enrolling others in the screening process across the supply chain.
Pharma is among the industries given extensions to develop alternative screening practices. Procedures for screening pharma shipments were required by September 1 of this year.
Pfizer Inc. is seeking certification for seven manufacturing facilities by Sept. 1 and plans certification for several additional plants, says Bradley Elrod, senior manager, global logistics security, Pfizer.
"By Sept. 1, if we do not establish an acceptable and compliant alternative screening process, we will be subject to the current procedures, potentially compromising the integrity of our product. We are seeking to implement a process that will support and align with the security goals articulated by TSA while [also] ensuring patient safety," Elrod says.
"The screening requirements, as defined, will require the airlines to invest significant amounts of time and manpower. We are concerned about the impact that will have with respect to the protection of our product, and the timing of its availability to patients," Elrod says.
Physical search at the airport is one concern, as FDA regulations stipulate that packaged pharmaceuticals can’t be opened or otherwise compromised once they leave the pharma facility. For boxes subject to screening technology, the concern becomes guaranteeing product integrity and eliminating shipment delays, Elrod says.
"I think explosive trace detection will be one of the most common methods and one of the least expensive methods. It is also the method with the most false readings. You can get false positives when previous [scan] results register," Elrod says.
X-ray is another approved technology that requires time-consuming screening on a box-by-box basis. Elrod says X-ray screening can render empty and full gel caps sticky, affecting efficacy and usability.
"For biologicals that are subject to X-ray screening, we would have to go through an entire validation process," he adds.
Inspection will alter Pfizer’s pallet packaging, which is designed to keep the product transported in a stable, secure manner under the designated temperature and product handling standards. Fifty to 60 boxes are interwoven on a pallet to dispense the weight. "Pallets that are broken down and reassembled offer significant opportunity for damage, theft, quality, and safety concerns. Certain products can pose handling risk if they are damaged."
Pfizer has taken a lead role in a consortium of pharma companies working with TSA to define acceptable alternative screening standards for pharma facilities.
"TSA has been very helpful and up front with us. We are very supportive of what they are trying to do as we already have very tight quality controls on our processes," he says. Following validated CGMP and FDA requirements, drug manufactures track by lot number, which allows tracing product to where and when it was packaged, and by whom. Product is handled by authorized personnel with controlled internal access.
"We perform content verification and final inspection on all packaging, and we can do that with a high degree of assurance because of the reporting requirements we have for FDA purposes," Elrod says.
Once the product leaves the facility, CCSFs have to ensure an unbroken chain of custody and control.
Manufacturers will apply CCSP-
recognizable external labels to packages, and sign off on a chain of custody process with others validated and verified as authorized to work in the CCSP program, Elrod says.
Packaging requires tamper-evident materials and high-security seals. "We do that anyway as a part of the CTPAT program in which we have participated in since 2002. We can leverage the fact that we already have very solid supply chain security programs in place," Elrod says.
TSA has rolled out the voluntary CCSP program on a limited basis,
currently in 18 cities.
"If CCSP isn’t embraced on a fairly broad scale, a remarkable amount of resources will be needed with responsibility put on airlines to screen the cargo," says Dave Brooks, president of American Airlines Cargo, a primary transporter of pharmaceutical shipments.
American Airlines Cargo has thus far invested several million dollars in infrastructure and training for meeting the 50% screening mandate, Brooks says. "The screening hasn’t created any significant delays at this point. But 100% screening is another thing entirely."
"It is imperative that drug manufacturers understand how the game changes in September. Unless the drug manufacturers win approval to screen their product themselves, the airlines will be required to do the job. This will likely entail the opening and physical inspection of shipments," Brooks says.
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