Setting up for Small Batches

Compact, flexibly changed machines are meeting market needs for efficient, lower-volume blister runs.
 
By David Vaczek, Senior Editor
 
Small-batch production needs are driving the market in blister machines. For manufacturers frequently changing between new blister configurations, materials, and labeling, small-format models offer less-expensive tooling and fast changeover capability that reduce production costs.
These scaled-down machines feature lightweight, easy handled forming tools. Interfaces with simple controls support machine set up and operation.
 
The small-format units borrow the sensor-based servo-control for moving station processes and adjusting web indexing inherent on higher capacity models.
“The pharma companies are looking for machines that can be changed over in 20 minutes or faster, and that can be run by less trained operators. We have found there is a huge market need in the 300 blisters per minute range,” says Dirk Corsten, managing director, Uhlmann Packaging Systems (www.uhlmannpackaging.com).
 
“Customers will have certain machines allocated for larger batch sizes, and use our Blister Express Center 300 (BEC 300) for smaller batch requirements. If you are over 250,000 in batch size and you have a lot of batches, we would recommend using a faster machine,” Corsten says.
 
“Unfortunately, the long runs are getting fewer and fewer. The market has changed dramatically. Our customers do not buy many large machines anymore,” Corsten adds.
At centers of excellence where pharma companies are consolidating production, machines that can be flexibly configured for delivering large numbers of SKUs are in demand, Corsten says.
 
Offering simple handling features and quick toolless changeover, the BEC 300 blister/cartoner features a rotary continuous motion blister machine producing 300 blisters per minute integrated with a 150-carton-per-minute cartoner in standard configuration.
 
“With the BEC 300, we really struck a nerve in the market. The machine hits a sweet spot in performance, price, and customer acceptance. We have sold over 50 lines in Europe and the United States since the launch in September 2009,” Corsten says.
 
The TF1e blister machine from Pharmaworks Inc. (www.pharmaworks.com) brings Pharmaworks’ TF1 line of platen sealing intermittent motion machines up to size with a larger format for handling larger blisters used for devices, hospital unit-dose blisters, and other applications.
DOWNSIZING CAPACITY
Small pharma manufacturers and start up contract packagers aiming for quick and easy market entry as well as larger pharma companies looking to run smaller batch sizes are promising markets for small-format machines, says Ben Brower, vice president and sales director, Pharmaworks.
 
“[Overall] there is quite a bit of activity in quick-turn batches. Where a few years ago you saw batches in the millions of blisters, that has fallen in size by factors of five, ten, or more.
“We have seen a lot of interest in the TF1e from the large pharma companies on the ethical side of the business. The TF1e can be a perfect solution for a small contract packager catering to these customer requirements for small batch production,” Brower says.
“Customers are looking for a high degree of flexibility in a blister machine. That is why we believe the platen intermittent motion machine is important [because] you have to serve multiple markets.”
 
Accommodating the range of blister materials, the TF1e handles not only traditional dry solid products, but also provides the draw capacity to accommodate syringes, vials, and other devices that are increasingly going into blisters, Brower says.
 
Smaller batches support companies’ lower inventory holding requirements, says John Thomas, senior vice president, operations, A+Secure Packaging (www.apluspak.com).
“As drugs have become more efficacious, they also tend to be more on the edge—they don’t last as long on the shelf. Companies will focus on appropriate packaging to protect these products, but they are also looking to put less product at risk for exceeding expiration dates,” Thomas says.
 
A start up custom contract packager, A+ Secure Packaging is launching blister production with the purchase of two TF1e blister machines.
PharmaWorks handled the installation and integration of HAPA Easy Flex UV printer and Lynx scanware vision inspection. One unit is installed in a dedicated environmentally controlled suite at the firm’s 34,000-sq-ft LaVergne, TN, facility. The packager is preparing for delivery of the second unit in March, says Ronnie Smith, president, A+Secure Packaging.
 
“This is the right machine for meeting the prevailing trends in the market now.
“The TF1e gives our customers a lot of options. It runs any kind of thermoform material as well as cold form.”
SENSING THE WEB
“The large format will allow us to meet market requirements for 20/30 count blisters at good volume, and the machine lends itself well to devices. We are working now on blister packaging a powder that requires the deeper draw,” Smith says.
“As a start up contract packager, we saw an opportunity to provide services to manufacturers from standpoints of quality, efficiency, and cost. The initial purchase price and tooling costs of the TF1e make it very cost effective for producing the volumes we need. Its simplicity will help us control our labor costs,” Smith adds.
 
Equipment complexity, besides tool changeover, is an important consideration, notes A+ Secure Packaging’s Thomas.
The unit’s small footprint enables using a smaller suite that in turn supports faster line clearance. “With faster line clearance and cleaning, there is less chance of contamination,” Thomas says.
Featuring full servo control of station functions with a single servo web indexer situated at the die punch station, the TF1e shares control features with Pharmaworks’ higher output TF3 blister machine (see sidebar at left).
 
The web is looped after it is pulled off the roll, before the forming station. The “compensation loop” avoids material stretching when the web is pulled directly off the roll. A sensor controlled servo is used to meter the loop to the heating station, rather than mechanical dancer arms or pendulums that create drag on the web, Brower says.
 
“When you put weight or drag on the web prior to the heater station, the web will start to shrink or ‘neck’ as it is warmed. Packagers will oversize the web to compensate for this shrinkage. This sensor technology enables some serious savings on material—in the range of five to ten percent,” Brower says.
Multizone contact heating supports gradual warming of the material as the web is indexed at least three times through the heater station. Heater plates squeeze the indexed web at the heater station prior to forming. “Squeezing the web allows you to transfer heat into the material more efficiently prior to the forming station, which allows you to lower your heating temperature,” Brower says.
 
The unit features station stroke and pressure adjustment at the seal station while running the machine. In sealing, a load cell monitors for incorrect sealing pressure and seal overload or high back pressure that occurs if a hard tab or object is left on top of the web. In an overload occurrence, the blister is marked as bad and noted in the tracking register during sealing.
SIMPLE HANDLING
At the die punch station, servo driven lowerators capture the cut blisters for controlled handling. Lowerator vacuum tubes make contact with the top of the blister just as the die punch moves to cut them and sets them down in a controlled manner. High-speed rejectors knock faulty blisters to a sensing chute for positive reject
verification.
 
In developing the BEC 300, Uhlmann designers for the first time were tasked with working under a pre-set price ceiling accounting for machine manufacturing costs. The unit is manufactured in lots of five to ten allowing a shorter six-month delivery lead time, Corsten says.
 
“Our philosophy was to meet a very attractive price/performance ratio.” For holding costs in check, the standard configuration is offered with a scaled back catalog of options, and only 12 format parts.
The B1330 rotary sealer used in the BEC 300 features a format that is one quarter the size of the forming area of Uhlmann’s B1880 top capacity 1300-blisters-per-minute model.
Supporting production of all thermoform materials and cold form, the unit features servo control on all components. Blisters are pulled automatically into the cartoner magazine.
 
The operator calls up a recipe on an intuitive HMI, and presses a button to unclamp the tooling. Easily handled 22-lb tools are coded to ensure proper tool placement.
“The BEC 300’s simpleness is its outstanding feature. This is a self-regulating machine that doesn’t require operator intervention,” Corsten says.
Built in in-process control addresses requests from pharma customers for automated sampling. The line continues to run as a set number of blisters are shunted at programmed times to a compartment.
 
The BEC 300 achieves a balance of capacity and cost that enables customers to efficiently run batch sizes in a range of 1000 to 250,000.
“The batch size you can still run economically on a machine grows with the machine output. The minimum batch size you can economically run depends on the change over time alone,” Corsten says.
 
For small-to-medium batch packaging of solid doses, the Giant1 blister/cartoner from IMA Safe features single-lane production of up to 350 blisters and 175 cartons per minute. The line’s Touch and Change format changeover system enables easy automated change over adjustments via a touch screen interface.
“The Giant1 is our state-of-the-art technology in a small footprint machine designed to support customers’ just-in-time inventory requirements. Step-by-step computerized changeover to a different product is accomplished in 20 minutes,” says Darren Meister, vice president of sales, IMA Safe division of IMA North America (www.ima.it).
“There are very few parts to change over and all parts—which fit mostly in the palm of your hand—are less than 20 lb,” he adds.
Giant1 handles all thermoform and foil materials with no waste between blisters, thus reducing consumption and material cost, Meister says.
 
Features of the Giant1 include separation of mechanical parts from the production area to facilitate cleaning and easy integration of multiple feeding systems.
A blister recovery magazine that automatically fills for automatic placement of good blisters in place of rejected bad blisters. A photo diagnostic system shows the location and image of machine-related faults on a help screen, with a trouble shooting screen for resolving the fault.
 
Cutting and blister rejection occur at the same station where a unique servo system supports a patented cutting solution. Rejected blisters are cut in a different configuration and not further transferred.
“We leave additional material waste on the rejected faulty blister which ensures it cannot be reinserted back in the further packaging process. This guarantees the elimination of the faulty blister and avoids operator mistakes that could lead to potential product recalls later on,” Meister says.
 
Customers of the Giant1—which has been on the market for four years—typically run 5000 to 20,000 cartoned batch sizes.
“The long campaign runs of a week long with the same product really are not typical any more. Since the average blister production lines are changed over daily, the trend is to machines with a reasonable output that are extremely flexible, quickly changed over, easy to clean, and operator friendly.
“You are reducing the time and energy required to produce multiple batches and keep up and running, which relates directly Overall Equipment Effectiveness and cost of ownership,” Meister says.
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