Medical Device Link.

Originally Published PMPN October 2004

Form-Fill-Seal-Packaging

Christina Elston
Contributing Editor

Abbott’s FlexPack, a diagnostic pregnancy kit, is packaged on a Bossar horizontal form-fill-seal machine with an integrated design feed system.

In the healthcare sector, the search for cost savings is endless. As part of that search, more medical and pharmaceutical product manufacturers find themselves focusing on the value chain. Where packaging is a part of that chain, in-line operations offer several ways to improve efficiencies and lower costs.

In-line packaging streamlines production by combining several processes into a single application, according to Doug Slomski, director of the medical consumer and industrial division of Multivac (Kansas City, MO). This minimizes the amount of space and time between raw materials processing and packaging finished products. “In-line machines are becoming very adaptable because they follow the concept of straight-line manufacturing,” says Slomski.

Multivac is one of several suppliers offering equipment and upgrades that help companies get the most from their packaging operations.

Breathing More Value into Form-Fill-Seal

Companies using EtO sterilization for their products have traditionally had two packaging options: form-fill-seal packaging with a porous top web or premade breather bags with a vent of porous material. But new equipment that can produce thermoformed breather bags in-line offers a third option with significant opportunity for savings.

For device companies using premade breather bags, converting to in-line packaging can save storage space. “Most medical companies have a huge variety of products that go into different bags,” says Greg Rochon, president of Greydon Inc. (York, PA). “The warehouse to store the packaging material is often bigger than the actual production area.”

A second area of savings is labor costs, since form-fill-seal packages are faster and easier to fill than premade bags. Manual loading of premade bags can also result in scrap and rework from damaged packages, the folding or bunching of sterile draping around products, or misaligned product inserts. With in-line form-fill-seal options such as Multivac’s Sterile Vent, “you’re actually placing a product into a formed pocket rather than manually stuffing an envelope,” Slomski says. “You can typically cut your labor aspect of filling these packages in half,” with even further savings if loading is automated.

For device makers currently producing form-fill-seal packaging with an all-porous top web, moving to an inexpensive film lid with a breathable port could reduce materials costs 15 to 25%, according to Ray Johnson, president of Doyen Medipharm (Lakeland, FL). This is because breathable lids use 80% less paper or Tyvek than do all-porous lids.

In-Line Retrofit

A new pouch or thermoform machine that produces breather bags in-line with automatic product loading can cost $300,000 to $400,000, according to Johnson. However, Doyen and other manufacturers can upgrade existing pouch or thermoforming machines with a stand-alone module to convert top-web rollstock to include the breather bag feature for approximately $100,000. The labor, pack size, and material savings will pay back this initial investment in six to 12 months, Johnson says.

Tiromat Medical Packaging (Frisco, TX) also makes a separate unit that can be integrated with existing Tiromat or other form-fill-seal machines to create breather bags in-line, says project manager Steve Ventura. “The attractions to this product offering are that we save the customer’s material cost and that the system [can be converted] to most horizontal form-fill-seal machines,” Ventura says.

Integration costs depend upon companies’ production lines. “We will be able to standardize on the base system and add the package-specific items as required,” Ventura says. “This will depend on the package being run, the package array, cycle time, etc.” Tiromat estimates that most customers will realize a return on investment in 12 to 18 months.

Profit from Print

A flexographic printer, like this in-line, full-web flexographic printer on Doyen’s surgical glove packaging machine, can help reduce packaging costs.

Another upgrade that can reduce packaging costs is the addition of an in-line flexographic printer. Single-color in-line flexographic printers generally cost $40,000 to $50,000, with two-color in the $80,000 to $90,000 range, Johnson says.

Handling printing in-house allows companies to make print changes on packaging without discarding and wasting preprinted rollstock, says Greydon’s Rochon. In-line printing also can reduce the cost of printing 5 to 15%. Greydon’s Micromax Rotary Platen Printer, used in the Tiro Breathe system, prints in-line without creating drag on the top-web material. Rather than putting the web through rollers, the printer rolls a plate across the web when it is stopped, Rochon explains. The Micromax prints in two or three colors and uses ink that can stand up to steam sterilization.

Adding an in-line printer is a good investment for lines with a large number of product codes. The addition is often suited for operations with a large volume in aggregate, a minimum number of colors, a large number of text changes, and a minimum number of forming tool configurations, according to John Merritt, CPP, Universal Protective Packaging.

Rochon advises companies that have several packaging lines with variable type to consider adding a thermal-transfer, thermal ink-jet, or continuous-flow ink-jet printer.

This reduces the cost of new print plates and the time needed to change plates. The flexographic printer handles fixed printing, such as company logos, while the programmable printer handles variables like part numbers or bar codes.

Letting Savings Roll In

Increasing the packaging material roll diameters that a machine can accommodate can also add value to form-fill-seal lines. Changing rolls of material can take 5 to 10 minutes, resulting in 7 to 10% downtime in each shift and wasted material on the end of each roll, says Johnson. For some materials, increasing roll diameters from 14 to 18 in. can double the amount of material on a roll, cutting roll changes, downtime, and waste in half.

Jumbo unwind stands to increase roll diameter cost $5000 to $7000, according to Merritt. However, Merritt cautions manufacturers to be careful of ergonomic issues. Increasing roll size by just two inches can add significant weight. Once you reach roll weight of 60 or 70 pounds, “you’re really putting employees at risk and asking for lost-time accidents,” Merritt says.

Sealing Cost Savings

Because most existing thermoformers use “last-generation technology,” an upgrade of the seal head can also offer cost savings, Johnson says. Upgraded seal heads can mean precise temperature and pressure controls that expand the operating window and allow for changeover from Tyvek coated with premium laminate to cheaper materials, such as uncoated Tyvek or a lower-gauge seal laminate.

This, however, is not a small investment and can cost from $40,000 to $60,000. Doyen offers a standard seal upgrade system for thermoforming machines that can be adapted to most makes and models of thermoformers currently in operation. The material cost and improved seal quality often justify these upgrades within 12 months, according to Johnson.

Ready-made Integration

The compact design of Bosser’s BPH 2800 meets stringent pharmaceutical sanitary standards for high-speed pouch applications.

Another area of potential cost savings is in preintegrated packaging lines. Device and pharmaceuticals companies generally have to use internal engineering staff to integrate pouch machines, conveyors, cartoners, case-packing machines, and palletizers from different suppliers. Bossar USA Inc. (Sarasota, FL) saw the need for an alternative.

“Companies are cutting down on their engineering departments,” says Roger Stainton, president of Bossar. This means that they are looking for turnkey packaging solutions that offer one-stop shopping. Bossar has partnered with Econo-Pak to combine Bossar horizontal form-fill-seal pouch machines with Econo-Pak product-handling conveyors, cartoners, case- packing machines, and palletizers. This enables Bossar to offer companies a complete and preintegrated line. “We can pretest the machine before we ship it,” Stainton says. “It means they can survive with a reduced engineering department.”

Bossar is just starting to get into the business of providing turnkey solutions, but interest has been high. “We’re starting to get serious inquiries from customers,” Stainton says. “It’s where the market is basically forcing us to look.”

For all medical companies, the market is forcing tremendous scrutiny of value chains to produce cost savings. A few changes to equipment in the packaging line can often mean significant savings, improved efficiencies, and quick return on investment. The interest level in this type of packaging has increased significantly in recent years with the trend to reduce packaging costs. It is an especially good solution for large implant kits and surgical drapes and gowns. In the last year, Multivac has been working with four of the leading healthcare companies in the world to implement this process by using rigid or flexible packaging.

Copyright ©2004 Pharmaceutical & Medical Packaging News