100% inspection of pharma air cargo has been relatively uneventful, say logistics providers

The US biopharma industry, indeed, all shippers and their logistics service providers saw it coming, and seem mostly to have been prepared when the Aug. 1 deadline arrived for inspecting all cargo placed on passenger aircraft. The “100% rule,” part of the post-9/11 response by the federal government, requires inspection to prevent explosives or other terrorist devices from being passed through. The pharma industry, once the impact of the rules was recognized, realized that inspections could involve opening sealed cases or packages, which could compromise temperature-controlled or other sensitive shipments. While that might still be occurring for some pharma shippers, many manufacturers and their service providers have met the requirements of a Certified Cargo Shipping Facility (CCSF) and, in effect, can perform their own inspections.

“From my contact with other manufacturers, my impression is that many of the major ones have at least one, and most have three or four of their sites approved as CCSFs,” says Bradley Elrod, director of global conveyance security at Pfizer Global Logistics Compliance (Collegeville, PA). “Many pharmaceutical companies have joined the process and are being certified.” Elrod and others worked tirelessly in the past year with TSA to iron out the process of getting pharmaceutical shipping procedures aligned with the federal agency.

“For the majority of our healthcare clients, which became CCSFs, it has been a very smooth transition to 100% screening,” says Bob Gahan, sales VP at DB Schenker. He adds that DB Schenker itself has won CCSF status at eight facilities in the US, where screening also takes place. Certification required equipment purchases (presumably, x-ray or similar scanning) and training for document preparation, recordkeeping and reporting.

Gahan says that non-CCSF shippers with cold chain requirements have been handled by revising packaging procedures at the front end, or by re-routing those shipments to all-cargo flights of in DB Schenker’s network. “The biggest challenge the industry is facing is those shippers which did not become CCSF and are shipping in active cargo containers,” he notes. “These containers have to be screened before they can be tendered to the passenger airlines.”

“UPS is certified and is not experiencing any delays with healthcare products due to the screening process. We are moving significant volumes on behalf of pharma companies,” says Bill Hook, president of UPS Healthcare Logistics. FedEx Custom Critical, which moves most of its cargo either by dedicated cargo flights or with dedicated ground vehicles, is not a CCSF, according to Karl Kussow, validation manager there. The company is ensuring that a continuous tracking process is in place so that screened materials are appropriately secured while in transit.

TSA has said that over 900 facilities have met the CCSF requirements, which generally require packaging to occur in a secure, monitored environment by personnel with appropriate clearances. A CCSF at a logistics facility or at an airport might also involve x-ray scanning or spectrophotometers for chemical analysis. Manufacturers thus have the option of performing their own inspections; having it performed at a CCSF; or waiting in line at an airport to have it performed there.