Taking the Pain out of Production
A capsule filler with automatic monitoring capabilities enabled a blockbuster drug to reach the market on time.
With the introduction of the prescription medication Celebrex, Searle made the lives of many arthritis sufferers a lot easier by reducing their pain, inflammation, and stiffness. Similarly, MG America (Fairfield, NJ) also made the jobs of Searle's engineers who were putting the drug on a fast-track production schedule a lot easier with the installation of a high-speed capsule filler.
During the spring of 1997, Jose Ramon Perez, a project engineer at Searle's Puerto Rico facility, was charged with scaling up production of Celebrex. Searle was just finishing the drug's early validation runs using MG America's Model G100 capsule filler. "We were extremely happy with the performance of the G100 during this phase of our operation," Perez explains. "When the time came to move into more high-speed validation runs, we called on MG America to install its Model G120 capsule filler." The unit is capable of filling up to 120,000 capsules per hour.
But increasing production speed wasn't Searle's only need. To reach its production goals and product launch deadline, Searle needed a system that required minimal operator surveillance. The G120 met Searle's need with a host of automatic monitoring systems.
The first one is the VR automatic capsule-weight control and monitoring system, which carries out continuous and cyclical sampling of all the machine's dosators, ensuring a stringent statistical control of the filling process. The system consists of a PC, a printer, an analytical balance mechanism, dedicated software, and both mechanical and electrical parts for capsule pickup from production. The PC is connected to the PLC that handles the machine control.
When the average capsule weight is determined to be statistically out of specification, the VR system adjusts the machine's dosing chamber to keep the weight within a specified tolerance. If there are any problems with the quantity of the product or with the sampling device, the machine stops operation, eliminating the risk of producing out-of-spec capsules.
The constant inspection allows unattended operation. The VR screen continuously displays the weights of measured capsules as well as the range of weights produced by each dosator.
Other machine-monitoring systems allow the machine to run unattended. Faulty capsules, single lids and single bodies, unopened lids and bodies, and capsules with double lids and bodies are all automatically rejected. Automatic capsule bush cleaning eliminates the blockages caused by gelatin fragments and drug product deposits. Product and capsule levels are controlled by external mechanisms that automatically feed the drug product and capsules to the filling stations. Finally, automatic vacuum units clean various filler areas.
Millions of prescriptions have been written for Celebrex since its FDA approval in December 1998. To keep up with such demand, Searle now has several G120 capsule fillers that run 24 hours a day, 7 days a week. "With this sort of volume, responsive service from the capsule filler vendor is a necessity," says Perez. MG America has been able to fill that need as well. "No matter what time of the day or night, I'm always able to get in touch with Nick Desantis, MG's service manager," he says. "I have the utmost confidence in MG America."