Ann Arbor, Michigan 6. April, 2001 - With a workload that has increased more than 400% over the past decade, the Clinical Pharmacy Operation of Pfizer (starting out as Parke-Davis, acquired first by Warner-Lambert then by Pfizer) had been searching for a way to improve the efficiency of its packaging operations for clinical trials without sacrificing 100% accuracy. They found the solution with the Trialpack 600 robot-based blister packaging system.
The unique system has reduced the time required to produce a batch of 300 clinical trial blister packages of multiple strengths or multiple drugs from 3 days to 6 hours. The number of people needed to make those 300 blisters has also been cut from 4-5 people down to one. The system incorporates a Klockner EAS unit-dose blister packager and a unique robot-based filling system, capable of accurately placing up to four different products in complex, double-blind, randomized clinical trials.
Clinical trials typically consist of complex regimens of multiple drugs or different strengths of the same medication. "The unit dose package is a convenient delivery systems and it helps ensure compliance with the trial regime," explains Dan Beechuk, who has worked in the clinical trials area for 35 years and has managed the Clinical Pharmaceutical Operation for the past 20 years. His group at Parke-Davis has been given more and more work as its responsibilities first came to include clinical trials for Warner-Lambert companies and most recently for Pfizer companies worldwide. Last year his group prepared approximately 300 trials. "The workload has nearly doubled in the last 3-4 years," he notes, "and quadrupled – at a minimum – since the early 90s."
Because clinical trials deal with human health, the accuracy of drug delivery is of utmost importance. "As pharmacists, we must be certain that we're not only delivering the correct drug, but also the correct amount of medicine for every dose the patient takes," says Beechuk. For years, though, he was convinced that there was a way to improve packaging speed without sacrificing accuracy and even worked with students from an engineering school to look at the possibility of using robots and mechanical placement. Finding the Fleximation system – through a Warner-Lambert unit in Europe – was the solution at the end of a long search.
The traditional way of creating clinical trial packages with multiple different substances required several steps and manual assembly. First, each different drug is blister packaged in its own tray. If there are three different drugs or strengths, then three different sets of trays are created, handled separately, inventoried, stored, then cut into strips and hand assembled into the final configuration on a unit-dose card according to the trial regimen. Besides the time-consuming manual assembly process, there is a substantial amount of handling in this process.
"The new robotic Trialpack system actually takes more time to create each unit-dose package with multiple drugs than a conventional blister packaging machine takes to create a tray of one type of drug," says Beechuck. "But it is eliminating all those subsequent steps and handling, as well as the manual assembly of cards that gives us the big time savings. With the robotic system, we can work with the different drugs simultaneously and create the final package in one step."
While the trials have varying complexities and therefore distinctive packages, Pfizer's Clinical Pharmaceutical Operations Packaging Engineer Rick Klepek estimates that for a package with a medium complexity level it generally took a total of 3 days and 2-3 people to produce, handle, inventory and cut up the trays and another 2 people to hand assemble the final unit dose packages. This compares to the approximately 6 hours that Trialpack requires to create the same number of packages.
"This is a unique system," says Klepek. "No other clinical trial packaging system can randomly place different products in a complex pattern. Other systems can only run rows of the same product."
Instead of allocating, inspecting and cutting apart trays of single product, the preparation process before a production run using the Trialpack system includes half an hour of designing the packing pattern on PC-based software. This consists of defining the pattern of tablets/capsules and the wording to be printed (such as morning, noon, evening and day 1, day 2, etc). The production file is then loaded onto the Trialpack system. With prompting from the system, the operator loads up to four different tablets and capsules into safety-locked feeders. The feeders require no change parts to accommodate different types of products, so set-up time is under 20 minutes.
The product travels on conveyors from the feeders to the robot with a vacuum-operated gripper, which locates each tablet/capsule on the conveyor using information from the integrated vision system and places it in the appropriate blister cavity. The robot can handle up to 54 products/minute. Each blister cavity is checked before placing product inside, and correct placement is verified with the vision system using data from the production file. If the system detects an error, it automatically rejects the blister package. All errors and other quality-related events are automatically logged to provide full documentation for every batch. The system can also print information on the foil lidding material on the back of the blister. Approximately six hours after the pattern design process begins, 300 packages are accurately packed, labeled, inspected, and verified.
"Up until now we've had two operators on the new robotic system, one to watch the machine and keep the product and material levels full, the other to inspect every blister," says Klepek. "But the truth is, the machine is totally automatic and so efficient that it's boring. We can cut it down to one person."
Rick Klepek with Pfizer's Trialpack 600
showing a mixed product blister
The Warner-Lambert/Pfizer operation in Ann Arbor was the first Trialpack system in North America, and Klepek was key in fine-tuning this prototype to meet their own needs. "Fleximation was very responsive to all our requests," notes Klepek, who headed a QA team with physicians, pharmacists, operators and technicians.
Not only is the new system saving time and labor costs; "We're running at 98% and higher efficiencies, some days 100%," says an enthusiastic Klepek. "On two production runs this past week, one of 300 packages, the other of 240, we had zero scrap. The only time we've had any waste was during QA tests when we tear apart packages to check them."
"Now that we're part of Pfizer, we're going to get even busier," predicts Klepek. "With the efficiency of the Trialpack system, we'll be able to bring Pfizer's clinical trials inhouse." Klepek estimates this will cut the cost of packaging Pfizer's trials in half. As for Beechuk, who had the vision to pursue a more efficient, robotic solution: "We always thought robotics were the way to go. We're very pleased that we finally have a machine that allows us to have a very sophisticated model for handling as complicated a study as we can design, one that lets us handle more than one drug at a time and can due it accurately and reliably. "
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