Currently, Apotex produces more than 210 generic pharmaceuticals in approximately 750 dosages and formats that are used to fill more than 42 million prescriptions a year in Canada. By the end of 2002, early projections had the company producing 8 billion individual doses. By 2007, that's expected to hit 12 billion individual doses.
To keep pace with its bullish growth and forecasts, Apotex officials realized it needed a new plant to handle its current production volumes while at the same time allowing for future growth. The project would also require a new approach to material handling.
"We realized an efficient materials handling system would be needed in order to achieve our productivity demands," says Ron McArthur, Apotex's senior vice president of operations.
To help them achieve the vision of an advanced material handling system, Apotex enlisted the Canadian office of FKI Logistex's Automation Division.
A Moving Decision
Completed in 2001, Apotex's newest manufacturing operation in Toronto is a tribute to Sir Isaac Newton and his apple. Gravity is the force behind the movement of drug powders between factory floors.
That's right. This building is a multi-story production facility, not a ground-level operation common in the pharmaceutical industry. Production operations are located on the first three floors, and the fourth floor is used solely to move materials from the attached warehouse and the production building.
Stainless steel chutes in the plant's dispensing rooms on the main floor (ground level) are used to deliver drug powders to the receiving bins in processing rooms on the lower level (below ground). Similar chutes on the third level allow tumbled materials to be dispensed to main-floor processing areas. Vertical conveyors and lifts from the Mathews Operations of FKI Logistex's Automation Division and automatic guided vehicles (AGVs) from FMC Corp. handle the automated movement of materials between levels.
The bin-handling system, designed by FKI Logistex, is at the heart of material movement in the four-level facility. Housed in its own elevator shaft, the vertical conveyor provides 65 feet of lift with a footprint of only 50 square feet. Shuttle cars are used to move the stainless steel bins, which weigh up to 6,000 pounds, from the vertical lift to loading and unloading areas.
The new facility uses radio frequency identification (RFID) and barcode technology to track all materials and products, keep resources evenly distributed and prevent production logjams. The barcodes are found on bins used during the manufacturing process and the smaller plastic totes used for shuttling finished product to the packaging plant in the warehouse.
"The system has really reduced our losses in product," McArthur says. "Our yields have jumped significantly, while our residual waste levels have dropped."
Track the Material
To get a better idea of how material flows in the Apotex facility, let's follow the materials.
Measured materials from the warehouse make their way down from the fourth level to the main floor where they are steered to dispensing rooms. Dumped into stainless steel chutes, materials wind up in steel handling bins on the bottom floor. An AGV then moves each container, which is tagged with an individual barcode, to the tumbling area.
Once the material is tumbled, the AGV delivers the bin to the integrated conveyor and vertical lift. The bin is destined for the third level.
When the bin arrives, another AGV pulls the bin from the lift and carries it to a feeding station. The bin's bottom opens up over a chute, and gravity takes over, delivering the material to the main floor for either compacting, tabletting or encapsulating.
Materials that need to be milled and compacted go directly to the compacting area. When the process is completed, the medications are delivered via chute to receiving bins on the lower level. An AGV carries the bin to the vertical lift for delivery to the third level, where the medications will be dispensed to the main-floor tabletting or encapsulating areas.
In the tabletting room, machines form the drug powders into pills that are then fed into receiving trays. Pills not requiring coating are transported by AGV to the vertical lift for delivery to the fourth level. For tablets requiring coating, AGVs transport the load to the adjacent coating room where the coating process takes place.
In the encapsulation room, compounds and compacted drug powders are placed into capsules and fed into receiving trays, identical to those in the tabletting rooms. After thorough inspection, an AGV delivers the plastic totes of encapsulated medicines to the vertical lift for a ride to the fourth level.
At the fourth-level drop-off station, product totes are placed on a conveyor that moves them into the warehouse.
Regulation and Contamination
Apotex is eyeing entry into the U.S. market and has applied for U.S. Food and Drug Administration (FDA) approval of its manufacturing site. Of course, to gain that approval, Apotex has taken several steps to persuade FDA regulators that cross-contamination will never be a problem in its plant.
Apotex has segregated all of its production rooms, sealed material handling away from the processing floor and put an automated process in place to thoroughly wash containers after every use. Additionally, the newly automated plant reduces human interaction, thereby lowering the risk of contamination even further.
"We built this new facility to meet the demands of the marketplace as well as the demands of pharmaceutical compliance," says Fred Grafe, Apotex's director of logistics.
A Healthy Future
Apotex officials report that its new facility already has the capacity to produce 12 billion doses in a year's time despite being only two-thirds of the way into their plan for automating operations. That's good news as the company begins to ramp up expansion efforts in the United States, where citizens certainly will be clamoring for its high-quality generic pharmaceuticals.
"Our goal has always been to provide a quality product to the patients that need it and now we can do that on a much larger scale," McArthur says. "By automating our process with the FKI Logistex conveyor systems, we not only increased productivity but we also enhanced the safety and security of the drugs we produce. Automating our system has made us a world-class manufacturer ready to compete on a global level."
Vertical lifts and automatic guided vehicles are used to shuttle 6,000-lb., RFID-tagged hoppers among levels of the four-story building. Wherever possible, gravity is used to flow powders from processing areas on higher levels to lower floors.
Now an integral part of the material handling system, the washing of totes has been streamlined from a manual operation taking as much as 24 hours to an automated process taking only 15 minutes.
Best Little Warehouse
The material flow on the production side of the business wasn't the only area improved. Company officials spent the appropriate time and energy to ensure material flow in the warehouse, which stands next to the new manufacturing plant, went just as smoothly.
As active drug powders and non-active excipients are delivered to the warehouse door, they are tested. Small specimens are taken and tested in sampling rooms next to the docking area. The bulk quantities of incoming raw materials wait on plastic pallets in quarantine racks until testing is completed and the inventory is given the "okay."
From there, warehouse personnel move the pallets to reserve storage racks. A handheld scanner is then used to read the barcode and feed the raw materials information into the Apotex's warehouse management software system.
When paper orders are generated for the transfer of raw material from storage to the production facility, swing reach trucks move the raw materials to one of six dispensing rooms between the warehouse and the production floors. The material is unloaded to the exact weight needed for manufacturing, and the unused portions are placed back in storage.
When the material is needed on the floor, it's sent down stainless steel chutes from the dispensing room into steel bins on the facility's bottom floor.
Employees can now focus most of their attention on manufacturing the finished product.
"Our employees were spending 75% of their time handling materials," says Ron McArthur, Apotex's senior vice president of operations.
The 200,000-square-foot facility is a multi-story building.
Other pharmaceutical-manufacturing facilities are mostly sprawling, ground-level operations.
Raw materials are organized in a "pull" environment, where ingredients for manufacturing are taken from storage as orders are received.
In a "push" environment, common in many facilities, large amounts of raw materials, waiting to be used, sit around the plant floor. This increases the risk of cross-contamination.
Materials and products are tracked using radio frequency, barcode technology.
Without such a tracking system, materials are not always properly handled and sometimes misplaced.
With its new wash area, totes can be washed and dried in as little as 15 minutes.
Previously, it might take 24 hours to hand-wash and dry totes.
Automatic guided vehicles shuttle materials between floors.
In Apotex's original facility, employees used hand-driven trucks to move drug powder storage units.