For nearly half a century, Americans have coughed, hacked, wheezed and sneezed their way through flu season with no prospect of protection other than the traditional flu shot. That's about to change. This fall, as several new strains of flu threaten to attack nasal passages across the country, Wyeth Pharmaceuticals will launch a brand new weapon in the cold wars: a flu vaccine available in nasal spray form. The product, which is actually a live (though weakened) virus that is frozen at the point of manufacture, will be the first flu vaccine not administered by injection. That means that with some of their patients, physicians can drop the needle once and for all (at least where influenza is concerned).
Right now, rows of FluMist injectors sit frozen—not in time, but in the chilly (minus 22 degrees For minus 30 degrees Celsius) interior of a distribution center on the outskirts of Louisville, Ky. The spray received final regulatory approval from the FDA this spring, and it's now ready to emerge from the deep freeze.
The highly automated 86,000-square-foot facility was built last year in anticipation of FDA approval that didn't come in time for last year's flu season. But Jim Cafone, who leads the distribution and transportation function for Wyeth Pharmaceuticals, puts the best face on the delay: "It's true that the building has been a frozen asset for us," he says, "but the good news is the delay allowed us to stress-test the systems and make sure things were running smoothly."
Though technological breakthroughs could someday ease the distribution challenges, right now, FluMist is definitely not ready to come in from the cold. Because the product is actually a live virus, it is stored prior to distribution at temperatures no higher than minus 22 degrees F. Exposure to ambient temperatures could affect product stability.
That meant starting from scratch where DC construction was concerned. "There was no real prototype DC out on the market," says Cafone. "If we were just building a typical DC, we could easily go out and look at material handling options and different labor strategies. You can benchmark freezer applications like ice cream storage, but there's no way to go out and benchmark deep frozen applications for pharmaceutical distribution. We've got very strict regulatory requirements to follow."
Given the absence of hard guidelines, it seemed prudent to call in the pros. The Wyeth team hired WEPCO, a Pittston, Pa.-based material handling integration firm, to design and implement many of the systems used in the DC. After testing prototypes at its own facility, WEPCO drew up the center's floor plan. Once the floor plan was set, the DC was essentially built around it.
The focus, of course, was on creating a fail-safe operation as well as accommodating the product's unique requirements, which meant much of the equipment had to be custom designed. When the vaccine (which is manufactured near Philadelphia) arrives at the Louisville DC in deep frozen tractor-trailers, the trucks back up to one of two specially designed dock doors,and an inflatable dock seal,custom made by Bondor Manufacturing, forms an airtight grip around the truck. Once the warehouse doors are opened, a vertically stored dock leveler made by Overhead Door Corp.'s McGuire division is lowered into the truck, and the narrow buffer area—or vestibule—between the truck and the warehouse is quickly cooled to minus 22 degrees F. At that point, product can be moved from the truck into the receiving freezer and ultimately into the storage freezers with no exposure to ambient temperatures.
The freezer dock door system "isn't rocket science," admits Christopher Paulsen, chief executive officer of WEPCO, "but to our knowledge it's never been done before. Basically we had to design something that would ensure that ambient temperatures never came in contact with the product."
Once unloaded and checked in, pallet loads of product are eased onto conveyors designed and manufactured by Hytrol Conveyor Co. and transported in freezer tunnels to one of two 13,500-square-foot main freezers, each capable of holding 1,200 pallets. Inside the main freezers,two ASRS cranes fromWoodson Inc. maneuver the pallets through the system. Once the shipping cycle begins, pallets are moved from the freezers on conveyors through the freezer tunnels to a depalletizing station, where a pair of hightech robots manufactured by Fanuc Robotics place individual cases of FluMist on a second conveyor system.
All of this automation is aimed at minimizing human exposure to the harsh storage environment. "We didn't want to put a human into this environment for a prolonged period," explains Cafone. "OSHA will allow limited exposure to such extreme temperatures, but we tried to engineer the human out of the deep frozen conditions as much as possible by using AS/RS, robots, conveyor systems and a patented pick module." In fact, the cold environment is too harsh for even the robots to handle; they sport space-age parkas that keep them 50 degrees warmer than the actual interior temperatures.
After leaving the robots, the cases of product move to one of eight custom-designed airlocks, which were made by Tinsley Design & Fabricating Inc. The airlocks give order pickers working in an ambient pick/pack room access to the cases of FluMist, which must be kept at freezer temperature while indivi dual orders are picked and packed . Though the pick/pack room's temperature is a constant 65 degrees, the humidity levels cannot go above 50 percent to avoid frost buildup on the equipment. (Wyeth's warehouse management system monitors temperatures here and throughout the building.)
"Pick/pack is the most critical phase of the operation," says Dennis Gniazdowski, FluMist distribution center project director. "We have less than 90 seconds to complete the pack-out process, including picking the doses, packing them in a special expanded polystyrene (EPS) foam shipping box with dry ice and dunnage,and sealing the lid. All of the steps are automatically measured by timers, scales, photo eyes and bar-code scanners so we can monitor the process for compliance." (All of those controls were provided by Dynamic Automation Ltd., which also provided the user interface software.)
Once the lid is applied to the shipping carton, the carton is dispatched to another Hytrol conveyor for a five-minute ride to the dock door, where it goes through a final manifesting process before being loaded onto a truck.
The ice men goeth
Once product is ready to be shipped, the clock again starts to tick. Shipments of FluMist must reach their final destination— physicians' offices and pharmacies across the country—within 30 hours of the time they're packed.
To manage the critical transportation segment, Wyeth partnered with UPS Supply Chain Solutions and Total Quality Logistics. Total Quality Logistics built three specialty trailers with satellite tracking systems that let Wyeth monitor environmental conditions during the inbound shipping process."If we notice that a temperature is veering outside of our limits, a variety of people are notified immediately via satellite beeper so that someone can rectify the situation," says Cafone. "This is another activity that is unique to this logistics process."
UPS Supply Chain Solutions, which also handles order fulfillment for the Louisville facility, carries out the actual next-morning deliveries to Wyeth's customers. FluMist is over-packed in dry ice and shipped in a specialized shipping container. But dry ice, which gives off carbon dioxide, is considered a hazardous material. Therefore, if shipments reach a certain volume, Wyeth risks exceeding the dry ice hazmat "shipping budget" for UPS's nightly air sortation and delivery process. Staying within those limits adds another daily logistical challenge.
Before Wyeth and UPS start the daily picking and packing process, all daily order volume is mapped against a hazmat budget for the destination delivery ZIP code. Then, orders that are slated for delivery the next morning are batched and sent in waves to the floor for picking. "We want to make sure that if an order is picked, it absolutely arrives at the customer's doorstep by 10: 30 a.m. the following day," says Mark Hale, director of UPS-SCS Health Care Operations. "If the order volume exceeds the nightly dry ice airlift budget, then shipments could be rerouted."
Double or nothing
Losing a day's worth of shipments to spoilage would be a problem. But losing a DC's worth of inventory would be a catastrophe. Early in the planning process, the Wyeth and WEPCO executives found themselves brainstorming ways to prevent product spoilage resulting from an equipment failure, power failure or other natural disaster. Given the high value of the items being stored, they opted to build in redundant equipment at all phases of the operation.
As a result, the DC today features double conveyor lines, double freezers, double picking zones—even doubles of all the material handling equipment. Electricity is supplied via two separate power feeds from two different substations. The redundancy drove up construction costs considerably, but the team felt the investment was justified given the value of the inventory involved.
"We wanted the highest level of customer service,"Cafone recalls with obvious pride. "[Building this DC] was definitely a highlight for our team. Most people don't get projects like this in their entire careers. Some people might say 'I built three DCs,' and although that's always a monumental undertaking, they generally had benchmarks to guide them. That wasn't the case here. We were pretty fortunate to be part of it. Not many people can put this type of thing in their dossiers."