In for the Long Haul

Switching to an automated form-fill-seal operation is a big job. But it can have big payoffs.

Eric Pearson, manager, packaging engineering, Boston Scientific, put it best in our May 2009 issue: “Potential users of form-fill-seal (FFS) machinery may experience a bit of ‘sticker shock,’ but if they have a long-term strategy and look at overall benefits, the capital expense may be worth the investment.”

Multivac runs sample packages for its customers on models of its machines set up in its Kansas City, MO, prototyping lab.

Developing such a “long-term strategy” is absolutely critical. To truly realize the efficiency and economy of an FFS operation, you’ve got to be looking at the long term. Not only could the procurement process take several months to a year, but also so could qualifying and validating the machinery after installation. The products you had in mind when you first set out to adopt FFS could very well be joined by new products or increased volumes, so you’ve got to plan ahead.

“Allow adequate time for your packaging project,” advises Ed Wood, director of sales, medical-consumer-industrial division of Multivac. “You can’t be up and running in 60 days.” Adds Wil Caraballo of Multivac: “The FFS machine may be of a standard platform, but the tooling is always custom.”

Machine life, too, is lengthy. While a long lifespan certainly justifies such a capital investment, it also means that you have to prepare your strategy well in advance for increasing capacity and flexibility to handle whatever future projects come your packaging department’s way.

"The lifespan of these machines is 15-plus years, so it is critical to think at least five years ahead,” explains Caraballo. “You need to know where your operations will be in a few years so you don’t under-buy machine capacity. Otherwise, you’ll have to add that capacity later on, and it could cost more.”

SWITCHING FROM MANUAL TO AUTOMATIC
If you are considering FFS technology, chances are your company has been manually loading and sealing bags or pouches and interested in increasing volumes and decreasing labor.

Sidebar: Material Provider Weighs In

Such a process change also involves a package change, and evaluating such a change will take some study. “Moving from a premade pouch to a FFS package will change your package size as well as opening features,” explains Wood. “As a result, you should consider any potential changes to secondary and end-of-line packaging as well as how your new packaging will be used and stored at end use. You may also be considering changes to your sterilization processes.”

Jason Angel, vice president of sales for Ossid LLC (Rocky Mount, NC), says that end-users may find a FFS package easier to use than bags for certain medical devices. A recent Ossid customer changed its scrub kit with several devices from a bag to FFS package design. End-users who previously had to dump bag contents out favored the package change that only required users to pull back lids on FFS packages and present contents to nurses.

Such opening features are essential to consider. You’ll want to see whether opening features currently used on your bags or pouches can be employed with FFS, enhanced, or replaced. “If you use tear notches or chevron die-cuts or zippers, can you design a FFS with similar features? If not, you’ll need to determine their importance,” says Mike Summersett, Ossid’s director of operations, MH product line. “In addition, what about puncture guards?” he asks.

You’ll also need to do a volume assessment, says Caraballo, to determine the machine model you’ll need. “How many packages per day or shift do you need, and will you need in the near and long term?”

While executing changes to entire packaging systems will require package requalification and validation and therefore involve cooperation from all involved technology providers, there are distinct benefits beyond the expected process efficiency and reduction in manual labor. “With reduced-footprint FFS packages, you can put more packages into sterilizers and into shippers,” says Caraballo. “You have the chance to reduce costs in both areas.”

Prototyping
During your evaluation, you should obtain enough prototypes for a range of tests, advises Wood. “You’ll want to do some market research with the prototypes,” he advises. “You can also start some forms of package testing with prototypes, such as aging and shipping performance.”

Multivac has several models of its FFS machines set up to run prototypes for customers at its Kansas City, MO, facility. “Our customers can adjust their designs and materials to drive costs out,” says Wood. Booked months in advance, the prototyping lab is usually put to use by device manufacturers studying package changes, but material suppliers often use it, too.

In fact, many of the prototyping projects involve comparing different material options. Often evaluated is the use of paper versus Tyvek, but also studied are newer, lower-cost films. “Monetarily, the change to lower-cost films can be compelling,” says Caraballo. But users have to study material performance during processing. “Traditional, higher-cost films are the most forgiving and accommodating to variances in processes,” says Wood. “If you use lower-cost materials, which can be less forgiving of typical processing variances, it is critical to control operating parameters including temperatures. In some cases, you may need to add more heating zones in the forming area, because air can pull heat away from certain materials faster than others. More heating zones can mean more capital cost but result in long-term film savings.”

Other potential FFS package modifications involve minimizing the amount of breathable material needed for EtO sterilization. Some companies have adopted machinery modifications for making header bags inline, using two top web materials—Tyvek and film. (DuPont provides Tyvek.) Another option is to apply a patch of breathable material—often Tyvek in the Sterile Vent design—to minimize such material use even further, but that requires a new machinery purchase altogether.

Angel says Ossid also runs prototypes for customers. Summersett reports that the firm just completed delivery of 5000 sample prototypes with actual products for one potential medical device customer. “Sometimes you need such quantity to gage market reaction,” says Summersett. “It is much cheaper than making a mistake in machine investment.”

There may also be additives to bags or pouch materials that will need to be evaluated in the FFS environment, adds Summersett, particularly their performance during forming.

Prototyping should help medical device makers determine ultimate suitability of the FFS package. “A bag can often be a one-size-fits-all option for your product families. But one FFS package may not offer that versatility,” says Summersett.

AUTOMATION
Potential users will also need to decide whether to obtain preprinted materials to run on an FFS machine or to institute inline printing.

Answering this question brings up the topic of adding ancillary equipment to a FFS machine. “When formulating your automation requirements for a line, you’ll want to build in synchronizations early on for such processes as printing, inspection, and robotics,” explains Wood. “It can be much less troublesome than adding them on later.”

Summersett is seeing a surge in requests for integrated vision systems that capture bar code inspections and communicate results to a database. ”It is not necessarily new, but it hasn’t been widely used in medical device packaging. And bar code verification is new. Some customers are asking us to preserve pictures of individual bar coded products for future reference.” Ossid has been working with Cognex Vision Systems.

And if medical device manufacturers need to run several different products on one machine, they are advised to explain that up front to machinery builders. “Companies want us to build flexibility into machine to handle different products,” says Angel.
Adds Summersett: “Flexibility is hand in hand with adjustability. Index length and depth of draw are computer controlled and can be changed using menu options. In addition, users can change web width easily on some of our machines manually by adjusting bolts.”

However, when looking at changing packaging processes, you’ll need to determine—with the help of colleagues in other departments—what changes may need to be made to both upstream and downstream equipment. “FFS packaging lines offer tremendous labor savings, but other operations have to keep up with such packaging automation. Otherwise, you haven’t accomplished anything. Your company may need to upgrade an entire facility, ” says Angel.

VALIDATION
Machinery providers are continuing to increase their support of validation work. “With scale backs at companies, there are no more rooms filled with engineers. As a result, these companies are putting more and more documentation requests back onto vendors,” says Summersett. “For instance, the initial structure for validation procedures is being requested from us rather than given to us. We are being asked to include writing some of the IQ/OQ/PQ in our quotes.”

Wood says Multivac’s validation package “becomes a bible for the machine. Not only does it document that the machine functions as specified, designed, and expected, but it also gives users a document to rework during their process validations, depending upon their protocols.”

Such heavy vendor involvement makes sense, given their firsthand knowledge of the machinery. “But device manufacturers need to do their own PQ,” says Summersett. “We make it clear that we provide the documentation, but machine use and responsibility rests solely with them, such as how it interfaces with their products as well as when validating packaging processes.”
Angel and Summersett report that medical device companies can spend months preparing such qualifications. “We shipped a machine over a year ago, and the company has just finished validating the final two packages of the four it planned to run. That’s why we don’t mind preparing much of the documentation pertaining to machine function. The more we can do, the less they have to do while it is sitting on their factory floor,” they say. ■
 

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