Making Pouches In-House
An increase in product volume may point a manufacturer toward an in-house pouching operation, but quality and validation concerns could be the determining factors.
by Jenevieve Blair Polin
Most medical device manufacturers start out by packaging low volumes of products into premade pouches. When their output grows, many may consider an investment in in-line pouching equipment.
In the best scenario, the manufacturer who implements an in-line packaging system sees increased production, improved quality, and reduced labor and material costs. In the worst case, the savings the manufacturer saw on paper never materialize, quality and productivity slide, and the company ends up switching back to buying premade pouches while its expensive capital investment gathers dust.
Medical tweezers are put into film-and-paper pouches with the Vivapack from Packaging Systems International.
The equation for calculating whether or when to invest in in-line packaging equipment is complicated and multifactorial. Manufacturers must consider not only the obvious variables—volume and size of pouches purchased annually—but also more-subtle factors, including product and package characteristics, labor, validation and quality considerations, and the need for flexibility and customization.
DOING THE MATH
The decision whether to buy pouches outside or produce them and pack in-house is usually based mainly on volume. A manufacturer should determine what it will cost to make a pouch in-line based on the cost of raw materials, then calculate the savings per pouch by comparing this figure to the present cost per premade pouch, and finally multiply this savings by the number of pouches the company will use per year. A million pouches a year is widely thought to be the volume at which a firm can probably cost-justify an entry-level machine with about a 1- to 2-year payback, explains Ray Johnson, president of Doyen Medipharm Inc. (Lakeland, FL). Such a machine from Doyen, an entry-level four-side-seal machine, costs $100,000 to $150,000 and produces 60 pouches a minute.
The size of the pack, however, is an important factor. "The bigger pouches are where you can actually save 8 or 10 cents," Johnson reveals, "and if you save 10 cents a pouch on a million pouches, that's $100,000."
Jay Strandberg, manager of enterprise resource planning systems at Quidel Corp. (San Diego), says that because the pouches for his company's diagnostic devices are so small—between 3 x 4 and 4 x 5 in.—they must be pouching greater than 7 million annually to justify an investment in in-line pouching equipment. He calculates payback for each product line individually and has four dedicated in-line pouching systems for four different products. The rest of his products are still pouched manually in purchased preformed pouches.
On the other end of the spectrum, however, is a new type of entry-level machine that may be cost-justified for manufacturers pouching as few as 300,000 units a year. The Vivapack intermittent pouching machine from Packaging Systems International (Lafayette, CA), which costs only $40,000, has a maximum speed of 25 pouches a minute, so it would probably not be an option for the manufacturer who pouches more than a million units a year. It does, however, offer a considerable boost in productivity over manual pouching and bar sealing, which has a top speed of about 5 to 6 pouches a minute.
Alain Descoins, sales manager for Packaging Systems International, says one medical device manufacturer is using the Vivapack to package two products separately into two different sizes of pouches, with a total combined annual output of only 500,000. The manufacturer will achieve payback on the machine in 8 months.
Height is the major determinant of whether a product is a good candidate to be pouched in-line. Generally for the standard four-side-sealed medical pouch, only products up to an inch high can be pouched in-line without having to specify an excessively large package size. Top candidates include surgical gloves, wound-care dressing materials (e.g., gauze pads, sutures, and hydrogels), drapes and towels, catheters and guidewires, diagnostic devices, and commodity items such as condoms.
Manufacturers of bulkier items must either continue to put them into preformed pouches manually or consider investing in thermoforming equipment for horizontal form-fill-seal packaging. "You could package a syringe on a four-side-seal pouch machine," says Johnson, "but the package would have to be almost the size of a half sheet of paper. On a thermoform machine, it's a quarter of that size or less."
Quidel Corp. purchased this four-side-seal machine for in-house pouching from Doyen.
Companies that have cut packaging costs by switching to premade pouches constructed of downgauged, lighter-
caliber materials may find it problematic to package in-line with these materials. "If the web is thinner, it can become more extensible," explains Marie Tkacik, engineering manager at Tolas Health Care Packaging (Feasterville, PA). This extensibility can spell problems with print register and sealing unless machines are equipped with advanced tension control. The large-capacity pouch-making machines that converters use have been customized to minimize drag by the addition of more nip or drive rollers, special web guides, and lightweight idlers. Conventional in-line packaging systems, in contrast, may not be equipped to handle the newest gossamer-thin webs.
"Also," Tkacik continues, "the heat-sealing methods used to close a premade pouch may be different from those required for in-line packaging at high production levels." The need for peelability, for instance, may not be an important issue for the final seal, but it is a critical need for the delivery end of many packages. The crossover from making one seal with one method to making all four seals with another must still result in a pouch that will have all the aspects of premade pouches such as smooth, continuous, peelable seals.
Kathleen Daly Mascolo, vice president and director of sales and marketing at Beacon Converters Inc. (Saddle Brook, NJ), agrees. "One of the challenges of manufacturing preformed packaging has been to meet the minimum seal strength requirements while maintaining a peelable seal. Sophisticated process control systems are generally used by converters to accomplish this. Manufacturers have normally only been responsible for the final nonpeelable seal."
With an in-line pouching system, manufacturers may choose to continue having operators place the product to be pouched in-line manually, or they may invest in a system that incorporates automated loading of the product. Optimizing output through process automation, and minimizing labor as a result, is the goal.
Even the manufacturer using the low-end Vivapack system, says Descoins, has cut labor costs in half and increased output. With a state-of-the-art automated system, Johnson says, the manufacturer can take out 80 to 90% of the labor relative to manual packing.
The catch to this labor savings may be in the type of operators needed. "You need a guy with a wrench who knows the way mechanical things work," says Johnson. Even the most entry-level in-line machine, he stresses, "can be a very complicated mousetrap." The technicians must know how to lubricate and adjust the equipment and how to troubleshoot. These personnel are critical to the success of the installation. "A customer may buy a high-end machine with every available option, but if they have no idea how to maintain it, it becomes a flop," Johnson warns.
Companies may also need to increase the size of their staff. "In the case of one in-house machine on one shift, what should be considered is how the machine will be operated when the operator is sick or on vacation," says Jerry Bennish, global marketing director for Rexam Medical Packaging (Mundelein, IL). "The manufacturer should consider questions such as will there be a backup operator who is cross-trained or will additional inventory be necessary to ensure that the pouches are available?" Contingencies such as a major machine breakdown must be planned for as well.
A skilled workforce is essential to another variable that must be factored into the choice between preformed pouches and in-line pouching: quality. "We've had several customers who purchased equipment but were unsuccessful in making their own pouches," says Terry Collins, marketing manager—converting of Perfecseal, a Bemis Co. (Philadelphia). "They couldn't keep the quality up to the standard that they were accustomed to seeing in premade pouches, so they went back," he adds.
Eloy Cantu Jr., global business director—medical business for Oliver Products Co. (Grand Rapids, MI), points out that pouching machinery has dramatically improved in the last five years, especially in terms of quality and control. Nonetheless, he has seen frustrated users. "With the preformed pouches, they only had to worry about the final seal," he explains. "Now they have to worry about the seal on the whole perimeter."
Device manufacturers who invest in in-line pouching equipment are essentially going into the packaging business. They must quickly scale the learning curve and master the technology and packaging art that the converters have been perfecting for decades. "The things that we have dealt with in the past every day now become their problems," Cantu says.
One problem historically has been product placement. "Part of the magic," says Quidel's Strandberg, "is to get your product between those two rolls and not seal over the product but rather around the product." Descoins says his company has addressed this challenge by incorporating a locating template into the Vivapack machine. The operator positions the product against the template, so the risk of mispositioning the product is minimized.
Manufacturers of in-line packaging equipment point out that the quality issue cuts both ways. When operators seal pouches by hand, there is a greater chance of wrinkles. "It's not only a question of looks, it's a question of integrity," Descoins points out.
Manufacturers of bar sealers, however, have upgraded their own machines in response to this criticism. The Sencorp Series AS/2 medical pouch sealer, marketed by Sencorp Systems Inc., a division of DT Industries Packaging Group (Hyannis, MA), offers digital control of temperature, pressure, and dwell time. These three sealing parameters are also alarmed. At output ports on the side of the machine, an operator can plug in a calibrated meter—either a calibrated temperature-reading instrument, a calibrated pressure-reading instrument, or a calibrated timer—to monitor the accuracy and repeatability of the three control parameters. "It gives them all the data they need to build their validation package," explains Kent Hevenor, Sencorp's product manager, laboratory machinery.
Considerations of quality lead to the much larger issue of validation. The manufacturer who makes his own pouches in-line must develop a process that is capable of producing repeatable results and must have a protocol for determining whether the process is indeed providing repeatable results.
Changeovers in particular raise the question of validation. "A good machine should allow you to change pack sizes and not require revalidation of the machine or the process," says Johnson, "but most machines don't do that." On a totally validatable machine, the manufacturer can guarantee consistency of temperature, pressure, and seal strength. Doyen offers this on all but its low-end model by incorporating a computer that monitors the sealing temperature and pressure at the sealing surface.
The shift from preformed pouches to in-line packaging may also have "an unexpected impact on whoever does the testing, whether it's the operators, the inspectors, or quality assurance technicians," warns Tolas's Tkacik. If the sealing die of the in-line machinery seals multiple cavities at once, the sample size is going to be different from the one developed for pouches that were sealed individually. Quality assurance personnel should formulate a detailed protocol before such a change is implemented.
With a wide range of accessories, the device manufacturer can customize an in-line packaging machine to make the package of his dreams. Special features, such as thumb notches, special angles, or adhesive strips, can be created through the addition of machine accessories.
Converters argue, however, that while such features might have been considered special and raised the cost of the purchased pouch several years ago, they are now standard. "The increased price for those is so incrementally small that it's hardly worth talking about," says Cantu. Adds Collins: "In fact, if a customer doesn't specify it and tells us to provide a 6 x 10-in. pouch, we would probably include a thumb notch and a tack seal because that is, as we've determined, standard."
The ultimate in-line packaging system is part of a fully automated product-handling operation. "I've seen totally automated operations, packaging gloves for instance, where human hands hardly touch the things," Cantu says. "But in cases like that, you're spending millions on automation, and that's dependent on whether you have the volume to justify the capital investment."
However, Tkacik stresses the importance of realistically calculating the financial impact of customization. "Anytime you add features, flexibility, and accessories," she says, "it translates directly into increased capital expense and lengthens the return on investment time."
PREDICTING FUTURE NEEDS
The move to in-line packaging may be inevitable at some point in a medical device company's growth. "When you're an $8 million company, you can get away with preformed pouches and manual assembly," says Quidel's Strandberg. "But as you grow to a $20 million, $30 million, or $50 million company, automation and packaging equipment pay for themselves."
Payback, of course, is affected by machine utilization. If the in-line equipment is not fully utilized, payback is slower, says Mascolo.