Blistering needs

Pharmaceutical & Medical Packaging News staff

When scaling up production for Risperdal MTAB, Janssen Ortho’s Jose Denis Santiago had some specific requirements. To package the delicate lyophilized tablets, Santiago needed a compact blister machine with a fairly wide web of 170 mm and a fairly long indexing stroke of 170 mm. “We told two major providers of blister machinery that we needed more length in the stroke of their standard machines, and they said they could sell us bigger machines. But we didn’t want a bigger machine.” Santiago also needed a long infeed area on the machine to accommodate robotic placement of the tablets as well as manual and automatic filling.

Santiago had approached Micron PharmaWorks (Tampa, FL) for a machine rebuild, and he had heard that the integrator-turned-machine-builder had just produced its first blister packaging machine for Cardinal Health, the TF2. “After working with so many companies on machine rebuilds, we realized that every user always wants something different,” says Ben Brower, vice president of Micron PharmaWorks. “We’ve had a lot of opportunities to look at a lot of other brands. We decided to build a machine and keep it as flexible as possible.”

Ingo Federle, Micron PharmaWorks’ technical director, says that his firm decided to make several features that are usually only available on large machines standard on a compact one. Many of these met Santiago’s requirements.

For instance, in addition to seeking a specific web and stroke size, Santiago wanted adjustable stations. Micron PharmaWorks delivered them with the TF2X. “We devised a forming station that can move left to right,” says Brower. Janssen “wanted to be able to use this station for other processes in the future, such as cold forming.”

Santiago says that the TF2X met his requirements for “flexibility in design.” In addition, the stroke of the machine matches that of his Hapa printer from Romaco Inc. (Pompton Plains, NJ). The machine can run very slow for special applications and also run very fast, with minimal setup changes.

Although Brower admits that most machines today feature toolless changeover, he says that his machine accomplishes such changeover through the use of dovetail-mounted forming tools with forming stations opening to the front. “Most blister machines use posts around the tooling,” he says.

The TF2X features a U-shaped format turned on its side, with the forming taking place at the bottom of the machine and sealing at the top. After forming, the formed blisters are indexed up and through an expandable infeed area and then to the sealing station. This design helps keep the machine as compact as possible, says Brower.

Contact heating in multiple zones and contact cooling are used for better process control, and servomotor-driven indexing moves the material out of the contact cooling clamps for process repeatability, says Brower. A laser works with this indexer to guide the formed blisters into the sealing station so that they are not crushed. Pressure in the sealing station is monitored using four spring packs with load cells for uniformity.

Multiple stations can be added after sealing, such as those for perforating, embossing, and die-punching.

A graphical human-machine interface guides users through every machine function, using blocks with text explanations to represent machine stations, and colors to indicate machine status. The HMI can adhere to 21 CFR Part 11 requirements if requested.

Federle adds that Micron PharmaWorks has made it easy to make machine or process adjustments on the fly. “But if you have to shut the machine down, it is designed to restart with minimized material waste,” he says. Maintenance of the TF2X is also easy. The entire back of the machine can be exposed easily when needed for maintenance. “We have taken so much care to think about accessibility for maintenance that we like to show packaging engineers and mechanics the inside of our machine just as much as the outside,” says Brower.

Micron PharmaWorks handled integration with Janssen’s printing systems and robotic and control systems. Santiago shipped his Epson EL653 from Puerto Rico to Tampa, where it remained for four weeks during factory acceptance testing, integration, and software programming. The robot was upgraded by Janssen and Micron PharmaWorks in Tampa with new pneumatic cylinders from Festo Corp. (Hauppauge, NY), which increased its speed and improved its accuracy. New linear-motion controls and SCARA (Selective Compliant Assembly Robot Arm) robotics from Epson (Carson, CA) were also added. Micron PharmaWorks also provided the system’s vision system and all other subsystem integration, including printers, feeder systems, and the robot.

At press time, Santiago reports that Janssen was very close to finishing line validation. He has since placed an order for a second TF2X, due for delivery in February 2006.