Potential alternatives to Barex appear to be under increased discussion ever since INEOS Barex AG announced that its Barex plant in Lima, OH, would close during the first quarter of 2015. At press time, the closure was still planned, an INEOS representative told PMP News.
Exhibitors at Pack Expo and Pharma Expo 2014 presented their alternatives, and some current users reportedly have evaluations underway.
Rollprint Packaging Products Inc. showcased the second high-barrier structure in its Exponent film family. Called Exponent 2, the structure combines the company’s ClearFoil technology and a coextruded non-crystalline polyester sealant. Rollprint expects the first uses to be premade or inline pouching, lidding, and flow wrap packaging.
“With Ineos’s recent announcement that it is exiting the Barex acrylonitrile-methyl acrylate copolymer business, we wanted to let the industry know immediately that there is an alternative clear, high-barrier structure,” said Dwane Hahn, VP sales and marketing, Rollprint, in a release. “In fact, Exponent 2 offers improved sealing characteristics over Barex due to easier-to-create hermetic seals and improved line speeds.”
To make Exponent 2, Rollprint coextrusion-coats its ClearFoil barrier-coated polyester with a non-crystalline polyester sealant. Exponent 2 consists of a reduced number of layers and gauge when compared with traditional foil-based high-barrier structures, offering cost-savings and an improved environmental profile, reports Rollprint. Oxygen barrier levels are available as low as 0.0008 cc/100 in²-24 hr and water vapor barrier properties are available down to 0.0008 g/100 in²-24 hr, the company reports.
“We have engineered the Exponent family of films to meet performance requirements for pharma and other chemically sensitive products, but use less material to help manufacturers meet their cost objectives. We also wanted to offer clarity attributes not possible with foil-based structures and give companies an alternative to glass vials,” stated Hahn.
In addition to Exponent 2, Rollprint has developed Exponent 3 for the most aggressive of products requiring extra durability and inertness, Hahn adds.
Bemis Healthcare Packaging offers PerfecPharm P616 (CXB Sealant) and PerfecPharm P619 (PET Sealant), which are “strong alternatives to Barex,” says Georgia Mohr, marketing director–pharmaceuticals, Bemis. “They have performed favorably during testing with nicotine products, demonstrating low absorption and low drug uptake.” These formulations also meet the chemical resistance and barrier property requirements for most transdermal packaging, Bemis reports, and they have drug master files (DMFs) registered with FDA.
These PerfecPharm polymers also “have very secure supply chains,” notes Mohr. “We expect no capacity issues. We’ve reached out to our raw material suppliers, and we have no restrictions. Bemis has more than 120 blown film lines, and we see no constraints to extrusion lamination.” Bemis had introduced PerfecPharm P616 (CXB Sealant) in 2013 and has marketed PerfecPharm P619 (PET Sealant) for the past five years, Mohr stated. “We’ve done our homework and have commercially available products. I can’t say that these alternatives will work for every drug, but we are ready and prepared for qualification and stability studies with three-side-sealed pouches and rollstock.”
Tekni-Plex offers a portfolio of materials that could be considered as Barex alternatives for either pouches or thermoforming applications, says Angela Roggenhofer. “Every case requires an individual approach,” she says. “As there is no single film that exactly matches all features that Barex offers, the alternatives frequently consist of laminates or coextrusions. We work with each client individually to create the structure that in the end combines all the desired characteristics—some users need barrier, and others need chemical resistance. Users need to find a material that does the same job.” Possible candidates from Tekni-Plex include foil-based materials as well as transparent films.
Amcor Flexibles is working to identify an alternative or new sources of resin, the company reported in a news release. Since 2012, Amcor “has invested heavily to develop an alternative film targeted to have the same inert properties as Barex, improved extractable and sealing properties, and which supports a more sustainable manufacturing process,” it reports. In the meantime, Amcor has secured three years’ supply of Barex.
To help packaging professionals determine what alternative may meet their product needs, Hahn asks users to “consider why they are using Barex in the first place,” he says. “Barex is such a legacy product that some companies have been using it for decades with no one left remembering exactly what attributes were initially important. It is usually one of three reasons, but
usually not all three: high oxygen barrier, chemical resistance, and a chemically neutral material with no leachables. There are many options for each of these needs, so since companies need to go through new validations anyway, we suggest exploring why Barex is being used and what it is trying to achieve.”
Hahn says such a change may provide users an opportunity to consider other needs as well, such as visual inspection using clear alternatives, possible line speed improvements and processing improvements, along with value for price.
Mohr expects after initial qualification study costs, users of either PerfecPharm P616 (CXB Sealant) and PerfecPharm P619 (PET Sealant) will ultimately see double-digit cost savings.
Hahn says he is seeing a “multifaceted approach” to evaluations. “Many companies are pouring resources into this, simultaneously putting multiple materials through initial screening, line trials, and up on stability,” he says. “This process normally takes years, and these companies don’t have the luxury of time for one material to fail and then have to start over if in fact Barex does cease to exist.” One customer is currently evaluating both foil and ClearFoil versions of Rollprint’s Exponent 1, 2, and 3 structures, for a total of six simultaneous evaluations.
Bemis Healthcare Packaging “is developing a one-to-one solution, which means analyzing each drug’s unique chemical structure to produce a drug-oriented barrier,” says Mohr. “Bemis Healthcare Packaging is using solubility modeling software to provide theoretical guidance to identify the best polymer-drug combinations, because we know that drugs, excipients, and solvents may each perform differently with different sealant films. This is only one of the tools to help identify the best alternative,” she says. “Next we will move from a theoretical approach to an analytical approach in order to determine the level of drug uptake within the film. Armed with this theoretical and analytical knowledge, we can move to the next step which is to complete application testing. Bemis Healthcare Packaging is taking a scientific approach to determine which alternative material is a suitable replacement for Barex.”
Replacing Barex could serve as a long-term lesson. “Our message to Barex users has been to consider alternatives for risk mitigation,” Mohr says.
Adds Hahn: “In an ideal world, companies would have the time and resources available for performing more sophisticated risk analysis and having developed plan B when appropriate. There’s always X amount of risk, and companies need to be in position to deploy resources lowering that risk by activating previously designed mitigation strategies, whether it is from a material or a product. Of course, there are supply agreements that take into account unforeseen acts of God and financial surprises, but they never seem to allow for enough time to comfortably work through the issues.”
“And going forward, companies will more likely triangulate the needs of their regulatory departments, quality assurance departments, and operations teams,” he says. Hahn’s colleague, Henk Blom, Rollprint’s director of technical services, spoke about managing material changes at HealthPack 2013 in “A Hitchhiker’s Guide to the Material Change Galaxy.”