Medical Device Link.

BLISTERS

The TF1 thermoformer from Micron PharmaWorks features full servo control in a small-format machine.

As firms manufacture for international markets and face varying re­quirements for package labeling, production batch sizes have trended smaller. Solutions have emerged for efficient production of smaller runs that are responsive to supply demand.

The “make-to-stock” concept supporting late-stage customizing enables reduction of obsolete packaging stock and shorter lead times for meeting customers’ orders.

Hapa has introduced the Hapa 807 BlisterJet digital UV Drop-On-Demand ink-jet system for late-stage customizing of precut pharma blisters. Hapa representatives say it is intended for customers with an extreme demand for small batches, created by high variability in packaging.

The system employs printer modules and a blister magazine and transport system. Large-volume runs are partially printed, with bar codes or 2-D codes applied for identification in storage. Packs are then customized with market-specific and variable information before cartoning and dispatch.

Machine changeover is simplified because the same blank stock can be used from one batch to the next. The system “actually improves delivery times in that blisters have already been produced in anticipation of customer orders. Batch sizes are allied to forecast demand rather than customer orders,” says Tibor Gal, sales director.

Small-batch requirements are also supported by small-format blister machines.

Micron PharmaWorks Inc. (Odessa, FL) has launched a small-format blister thermoformer with advanced servo-control functions. The TF1 blister packaging thermoformer features an 80 × 130 mm forming area, in a 9-ft-length unit (3581 mm, including a 1000-mm feed area). The machine is capable of producing 100 blisters per minute, says Ben Brower, vice president, sales and marketing.

“The TF1 is designed to be affordable, but with all the features you would get in a big-format machine. We consider the machine to be state of the art for a small blister thermoformer,” says Brower.
Brower says the unit can be employed by big pharma companies with small-volume drugs and offers an efficient production alternative in instances where packagers’ large blister machines are underutilized. The TF1 is also targeted to the clinical packaging setting, where the unit can be outfitted with a slitter for making blister strips.

Contract packagers can deploy smaller machines to capture lower-volume business.

“Theoretically, as the volume grows, the contract packager or pharma company can run two or three of the smaller machines,” he says.

One Card at a Time

“You are starting to see smaller production machines emerge to address what we see as an under­developed part of the blister market,” Brower says. “Companies are adopting blister packaging for protecting sensitive drugs, but the volumes often don’t warrant investment in large blister machines. The development of drugs targeted to specific therapies creates smaller batch requirements. Customers want the ability to nimbly respond to demand, while holding less inventory on their shelves.”

The TF1 is designed to make one blister card or hospital unit dose (HUD) per every index, or machine cycle. The company has sold the units to a major pharma company and a contract packager.

Brower says the pharma firm was running a big machine six or seven times a year. “They can run the same blister with our machine. The only difference is in shear production numbers. They are accepting the fact that the unit puts out less product in order to gain cost and production efficiency.”

Tooling for the TF1 costs under $25,000, or one-fourth the cost of tooling for a large-format unit. Setup time is 10 minutes, versus an hour and a half for the larger unit. The lighter-weight tooling supports quick tool changeover.

The forming, feeding, sealing, perforating, and die-cutting stations, and the indexing are all servo-driven. Settings are adjustable as the machine is running. In sealing, dwell and pressure are controlled with servomotors, for example. Operators can draw on stored sealing recipes and set alarm windows for high and low parameters. A sensor detects sealing pressure, which is graphically displayed on the HMI.

“We have direct control of the pressure through the servomotor. Through the use of servomotors in the TF1, we can control how far we can close stations, so you are avoiding creating pressure on the blisters. These are features you normally find only in a more expensive, larger machine,” says Brower.

The smaller format allows forgoing some technology, thus simplifying user operation and machine maintenance. Servocontrol of the indexing is sufficient for ensuring blister alignment. “The beauty of the small format is you don’t have the material shrinkage factor you have with a large machine, so you don’t need additional alignment technology,” he says.

Micron PharmaWorks favors an Allen Bradley PLC machine control platform.

“You want to keep a small machine simple because the pharma customer might not always have IT personnel available. With fiber-optic motion control, you can run all the servos right out of the PLC. Unless you have an extensive need for data collection, or are interfacing with a lot of up- and downstream equipment, you don’t have to throw an industrial PC at it,” he says.

Film Solutions

The acquisition by Perlen Converting AG of ac-Folien GmbH creates a company with a full range of films for primary packaging. The merger positions the Lucerne, Switzerland–based company as a leading supplier of pharmaceutical films, vaulting it into the number two position worldwide, says Fredy Brunner, director of sales North America, Perlen Converting LLC (Whippany, NJ).

ac-Folien has supplied Perlen with PVC mono films for conversion into coated and laminated barrier film products. The Mullheim, Germany–based firm also markets PVdC-coated film supplied by Perlen as well as Aclar-laminate films.

“This acquisition is an ideal technological fit and brings market activities and core competencies under one roof,” Brunner says.

“Perlen Converting now offers a full product range in blister films, from mono films up to ultra-high-barrier Aclar, with a combined sales and marketing force that provides one point of contact for the customer,” he adds.

Perlen PVdC-coated PVC products, such as Perlalux Starflex and Tristar Ultra laminates, feature barrier performance comparable to higher-barrier Aclar laminates. The improved PVdC product line now provides customers with more choices in the ultra-high-barrier segment, says Brunner.

“Historically, the United States is a sizable Aclar market. However, we have seen a tendency, especially among larger pharma companies, to want more alternatives in barrier materials, so they are putting product up in multiple configurations for stability testing. Tristar Ultra, which Perlen recently developed, gives the customer alternatives to Aclar 2000, which Perlen can also provide,” he says.

Upstream integration gives Perlen improved control of the supply and pricing of the mono and laminate films. Perlen can now react quickly to market needs and better serve the Canadian, U.S., and South American markets from its Whippany, NJ, facility. The facility features a Class 7 slitting and logistics center and houses consignment inventory for next-day shipment after customers place orders. For shipping product from Europe, “we have the shortest lead time on the market, at less than 10 days,” Brunner says.

Perlen Converting AG is one of four divisions of the holding company CPH Group, a fourth-generation family-owned business.

After a damaging fire in 2004, ac-Folien expanded its PVC production with the latest technology in resin extrusion and inspection. At its facility in Lucerne, Perlen is completing installation of the largest PVdC line worldwide, with the addition of a fifth coating station.