Going with the Flow

Formost Fuji is testing a chevron-type seal for four-side-seal packaging.

Medical device manufacturers (MDMs) continue to seek cost reductions. Viable solutions involve reducing material and labor costs. To drive down costs per package, some companies are turning to flexible packaging automation that can change the process flow for high-volume products.

Many MDMs have typically used what Keith Knox, U.S. technical sales representative, pharmaceutical/medical, for Formost Fuji Corp., calls “pods” to package products such as syringes, tubing, medical kits, and IV bags. In these pods, MDMs often set up multiple tables with operators assembling medical devices and hand loading packages, such as bagging and sealing. “Operators are touching products multiple times, utilizing header bags or pouches. Fewer touches amount to reduced costs, so MDMs are considering automating many processes. However, manufacturers may have fragile or uniquely shaped devices for which automation may be difficult,” he says.

For automation, a package redesign is often involved. Options include using form-fill-seal (FFS) packaging, flow wrapping, and four-side-seal packaging (4SS).

Formost Fuji has been testing medical device packaging options on its flow wrappers and four-side-seal machines using films with Tyvek vents (patch) from Amcor Flexibles. (Tyvek is provided by DuPont Medical Packaging.) The firm also has experience running and performing additional testing of film with a Tyvek strip.

Leveraging film coextrusion, resin-based peel systems, and breathable vents, Amcor offers a range of Tyvek vented peelable films that are designed to run on a wide range of FFS and 4SS equipment with consistent seal strengths over a wide temperature range and a contaminant-free peel, reports Michael Barr of Amcor.

Amcor can incorporate the Tyvek vents in a variety of materials, depending on the application requirements and sterilization methods. The higher film/film seal strengths achieved with a vented film/film pack are ideal for large pack configurations, such as FFS top webs for large kits or procedure packs.

Barr reports that Amcor is the first to introduce a range of vented films for high-speed flow wrap applications undergoing EtO or autoclave sterilization. Previously, MDMs could only consider flow wrap packaging for gamma sterilization applications or non-sterilized applications, the company reports. Customers are currently requesting vented flow wrap for CSR wrapped gowns and drapes and other medical devices not requiring aseptic presentation.

GETTING STARTED
To help MDMs understand potential processes, Formost Fuji runs samples at its Seattle facility, videotapes the process, and sends samples back to the customer for testing. The firm recently ran clinical masks that are typically packaged in bulk but were a candidate for flow wrapping given end-user interest in individually packaged single-use masks. Although bulk business continues to be strong, there is continued interest in the market for a single-use individually wrapped mask.

Formost Fuji's solution for flow wrapping syringes and other medical devices features a Tyvek strip.

There are substantial costs to making a package and validation change, says Knox. “It could be $250,000 and up. But it can make sense financially, given proper evaluation of the manufacturing and packaging process combined with an analysis of material and labor cost.”

Formost Fuji offers qualification and validation assistance and works with film suppliers, such as Amcor. “When going to automation, the customer needs to keep in mind the heat resistance of the outside layer of the material,” reports Barr. “Higher heat resistance allows the machines to run faster because they can run at a higher sealing temperature and shorter dwell time. This allows customers to increase production speeds and achieve an overall packaging system cost savings. This is particularly important for flow wrap equipment with line speeds of 100-200 cycles/minute. Amcor offers extrusion-coated sealant technologies for high-speed flow wrap applications.”

Barr adds that “when transitioning from preformed pouches or bags to automated

packaging, the MDM should also look for materials that deliver consistent seal strengths over a wide temperature range to accommodate variations in equipment type and equipment age, in addition to operator training.”

Opening features of flow-wrapped packages have typically differed from those of header bags, pouches, and even FFS packages. “Flow wrappers create fin seals and end seals and typically involve one material web with or without a Tyvek vent or strip, whereas pouches, FFS packages, 4SS packages, and bags often have top and bottom webs or components, and often employ a porous material,” says Knox.

For sterilized devices, the decision between flow wrapping and FFS equipment has typically been dependent on whether aseptic presentation is required as part of the opening feature, Barr says. “In the past, flow wrap has not been able to offer this feature. Recently, flow wrap machine companies [Formost Fuji] have introduced flow wrap equipment that incorporates a peel seal, thus allowing aseptic presentation.”

Explains Knox: “We can add easy opening features to the end seals of our flow wrappers, such as notch, tear strip, or another method to make it easy for the end-user to open.”

Knox says he has seen some consider flow wrapping and 4SS packaging as an alternative to thermoform-fill-seal. Four-side-seal packaging works for flat or low profile devices, whereas flow wrapping is appropriate for medical devices with low to medium profiles. “FFS works with heavier-gauge films,” he says, as well as for packages that require full widths of Tyvek. A flow wrapper can be a good solution to reduce the heavier-gauge film and Tyvek material cost plus less waste of materials.”

Flow wrap offers the advantage of lower capital investment and reduced tooling costs compared to FFS equipment, reports Barr. The incorporation of a peel seal in flow wrapping equipment will contribute to its increased popularly in the future.

For its 4SS machine, Formost Fuji is testing films with Tyvek vents (patch) (mentioned earlier) as well as film-to-film packages with a chevron seal to obtain the opening benefits of pouches.

Four-side-seal equipment tends to be not as wide as FFS machines and are primarily used for flat products, adds Barr. The primary growth area for 4SS packs has been in pharmaceutical applications requiring a moisture barrier, such as oral-dissolve strips or transdermal patches, he says. ■