PRODUCT UPDATE
Packaging Materials Suppliers Adapt to Changing Market
Benjamin Lichtman
Suppliers of medical packaging materials are scrambling to meet mounting environmental and quality assurance demands.
Environmental issues continue to exert great force on the packaging materials industry, and polyvinyl chloride (PVC) is still in the spotlight. Sengewald Medical Packaging product manager Michel Jansen highlights the influence that such concerns have on the marketplace. "PVC is a topic that remains on the agenda," he says. "Both the chlorines used in its production and the by-products of its incineration pose environmental question marks," he adds.
Leonardo Maghetti, marketing manager at S.I.F.RA EST (Trieste, Italy), argues that for manufacturers, environmental concerns are of primary importance: "Especially in northern Europe, governments are pushing packagers to switch to an easily recyclable material."
In a related trend, Jansen sees a growing demand for clean production facilities. "Five years ago, it was acceptable to supply packaging films that were produced under the same conditions as in the food industry. This is no longer acceptable, and I believe that five years from now, customers will insist that packaging be produced in a controlled atmosphere. There is a rise in the use of CGMPs on the part of our customers, and they want us to follow suit."
Documents, Please
Suppliers of packaging materials are also assuming increased responsibility for validation processes. Nic Hunt, global product director at Rexam Medical Packaging (Bristol, UK), says, "We're seeing a significant rise in the level of validation required by manufacturers. This is interesting," he adds, "because on the one hand, it allows medical device manufacturers to ensure quality production. On the other hand, it can make it harder to change packaging in the future, as the company must revalidate its system." Rexam is responding to this trend by undergoing certification to rigorous international standards. In early March, the company was certified to ISO 9001. Hunt says, "Now our validation protocol is as thorough as that of our customers."
According to Hunt, there is an increased demand for sterilization data as well as for information on the reproducibility of manufacturing processes. "Companies are asking for more detailed technical reports on the materials they are purchasing," he says.
Martin Jeurissen, product manager at Oliver Products GmbH (Mannheim, Germany) echoes these comments. "Especially in the Class III market, where manufacturers are under more stringent requirements, they are asking more of suppliers. Whereas in the past, everybody accepted that certain devices received a standard film coating, customers are now asking us to provide technical justification for this standard."
In order to meet the needs of the medical packaging market, Oliver is beginning to offer validation documents for full packaging systems including machines, lids, and trays. "Typically, a manufacturer has to validate each element of a packaging system separately," says Jeurissen, "so, effectively, the medical device industry is duplicating its validation efforts."
Jansen makes a similar point by comparing current market demands to the scenario that existed only a few years ago. "You can't just deliver a roll of film and a receipt," he says. "Customers are now requiring that we send a certificate of compliance as well as test data with our product." According to Jansen, device manufacturers are also demanding shorter delivery times, with more shipments in smaller quantities. "Manufacturers are seeking to reduce the amount of time that their products sit on the shelf. Consequently, just-in-time production is becoming more prevalent," he adds.
Jes Greenwood, business development manager at Perfecseal, A Bemis Co. (Londonderry, UK), observes a greater onus on suppliers to validate materials, while the industry simultaneously places pressure on suppliers to provide new materials. "Historically, the packaging materials industry has been conservative, and reluctant to adopt changes in materials. Now, manufacturers are demanding such changes to cut costs." Perfecseal has responded to this demand by forming a network of rapid development centres to aid customers in performing validation tests specific to their applications. The company has four such centres around the world, each specializing in different applications.
Paul Anderson, regional business manager at Eastman Chemical B.V. (The Hague, Netherlands), also addresses the increasing responsibility taken by suppliers of packaging materials to ensure quality control in their products. Specifically, he points out that Eastman's Eastar PETG compound has been developed to undergo quality control with a light-refraction test to detect manufacturing defects. "This is possible because the material has excellent transparency," notes Anderson.
What Lies Ahead?
In reference to the future of the packaging materials market, Jeurissen notes a movement toward integration, citing recent mergers as well as his own company's cooperation with machine manufacturers in the validation process. "It's a very price-driven market. This is only logical, because Europe is a social market, and costs are critical."
Hunt foresees a globalized approach to packaging. "We may see a movement toward common approval of products, and the globalization of manufacturing services." In this light, Hunt notes the addition of an air-knife coater to Rexam's Winterbourne facility, enabling the company to manufacture IntegraPeel TA in the UK. (The material had been produced only in the United States.)
All industry observers agree that the packaging materials sector must continue to adapt to market needs in the coming years. "The industry needs to professionalize," says Jansen. He further predicts that the coming market will favour large companies. "Small players will be in a difficult position as the market begins to require more logistical support and cleaner production systems, which require large investments, and therefore a certain critical mass."
S.I.F.RA EST S.p.A.
A company that manufactures medical-grade PVC bags for infusion, dialysis, and drainage has developed a 100% polypropylene film for the fabrication of medical bags.
Multiflex film is a chemically inert, chlorine-free coextruded film developed by S.I.F.RA EST S.p.A. (Trieste, Italy) for superior performance in autoclaving solutions. The film has extremely low levels of extractables in a wide range of solutions and retains excellent clarity, even after autoclaving.
Marketing manager Leonardo Maghetti emphasizes the environmental benefits of Multiflex film, which is undergoing certification in Italy, Germany, and the Czech Republic. "It is a multilayer film, but the layers are of the same family. This means that your waste is composed of only one material," Maghetti says. "This simplifies recycling in countries like Germany, where manufacturers are required to separate the layers before recycling," he adds.
Maghetti explains that the company's goal was "to make a bag that looked exactly like a PVC bag and had the same characteristics." Multiflex film bags can be autoclaved with or without an overpouch. Compared with PVC films, Multiflex exhibits improved water-barrier properties, allowing the overwrap layer to be reduced or eliminated.
Although S.I.F.RA currently supplies the material only in finished bags, Maghetti notes that the company has received inquiries, and might consider supplying the film to manufacturers in the future under the right economic conditions. The company also supplies medical-grade granules and EVA bags for parenteral nutrition.
Perfecseal
A leading global supplier of medical packaging that is certified to ISO 9000 worldwide has introduced a line of forming films that seal and peel to all styles of coated or uncoated Tyvek lid stock.
Jes Greenwood, business development manager at Perfecseal (Londonderry, UK), says, "One of the strong points of the Perfecflex films is the property of cohesive failure, which ensures a fibre-free peel." When used with uncoated Tyvek, the CPT sealant films offer visual verification of seal integrity and a wide heat-seal range.
The Perfecflex line also allows for downgauging from traditional forming film thicknesses. The films are EtO sterilizable, making them suitable for porous applications. Finally, the Perfecflex films are more easily recycled than coated Tyvek.
The films are available in several different types, including EVA/Surlyn/CPT and PP/nylon/CPT. The company also supplies coated paper, peel pouches, vacuum-metallized laminates, tubing, and header bag packaging.
Eastman Chemical B.V.
Designed for rigid applications, Eastar PETG copolyester 6763 features high clarity and thermoformability. Supplied by Eastman Chemical B.V. (The Hague, Netherlands), Eastar is tough, heat-sealable to Tyvek lid stock, and suitable for form-fill-seal applications as well as conventional thermoforming. 
Paul Anderson, regional business manager for specialty plastics in Europe, emphasizes the compound's suitability for thermoforming applications. "This is very important for the irregular shapes required in the medical industry," he notes, adding, "the draw properties of Eastar are unmatched." Sheet extruded from Eastar is thermoformed into intricate configurations required for sterile-content packaging. The compound is sterilizable by both EtO and gamma methods. Finally, it can be safely incinerated, releasing only CO2 and water as by-products.
In addition, Eastman recently introduced an ultralow-density line of polymers and plastomers called Mxsten, which employs metallocene-catalyst technology to achieve new properties in clarity, impact strength, and autoclavability.
Rexam Medical Packaging
A new direct-sealing hard pack film was recently introduced by Rexam Medical Packaging (Bristol, UK). IntegraForm DS, which was designed for the syringe- and needle-packaging market, combines abrasion resistance, formability, and transparency.
Nic Hunt, global product director, explains the origins of the film. "What we were going for was the best possible peel quality," he says. "IntegraForm DS combines a clean, low-fibre peel with Rexam's nylon polyethylene film technology, which is widely used in Europe," he notes.
In less demanding formings where the standard thickness would traditionally be 70 or 80 µm, IntegraForm DS can be applied at 60 µm, allowing for cost reduction. "The market," notes Hunt, "is always looking for better performance at lower cost, and it is now moving toward direct-seal products to meet that need."
Rexam Medical Packaging is a leading specialist in healthcare packaging materials, with manufacturing facilities in the UK, Ireland, Poland, Brazil, Singapore, and the United States.
Sengewald Medical Packaging
PVC-free lay-flat tubing for IV bags is supplied by Sengewald Medical Packaging (Halle/Westfalen, Germany). Propyflex fulfills all requirements for IV-bag applications. 
It is nontoxic, autoclavable, flexible, transparent, and has a low level of extractables. The polypropylene material is produced in cleanroom conditions and is supplied in tubular film or bag format.
"The material's main advantage is its collapsibility," says product manager Michel Jansen, noting that Propyflex can collapse with no air intake, thereby reducing the exposure of the contents to airborne contaminants. "Propyflex offers the benefits of PVC (flexibility, transparency, light weight) in a material that is biologically and chemically inert, without the presence of plasticizers," he adds.
According to Jansen, the film also provides a significantly stronger water-vapour barrier in comparison to PVC, allowing manufacturers to keep products on the shelf for a longer period of time by inhibiting evapouration. This feature should also allow manufacturers in some countries to cut costs by reducing or eliminating the overwrap layer in applications such as IV bags. "One of our customers has completely eliminated the overwrap layer, and most are simply cutting back on the thickness of this layer, which is already a great cost reduction," he says.
Oliver Products GmbH
Adhesive-coated packaging materials for sterile medical devices are designed and manufactured by an ISO–9001 certified supplier. Oliver Products GmbH (Mannheim, Germany) recently developed the blue-tinted 10MP heat-seal adhesive for use with Tyvek 2FS. 10MP allows for quick, in-line visual verification of adhesive transfer. It also makes it easier for production personnel to detect any tooling imperfections or uneven temperatures during production. Applied to Tyvek 2FS, this coated material is cost-effective in thermoform-fill-seal and pouching applications.
According to product manager Martin Jeurissen, "This product is going to be widely used, certainly in the European market, for Class II devices." 
Jeurissen notes a gap between expensive Tyvek products on one end and less costly materials on the other. "We are trying to fill that gap with higher-performance papers such as 2FS Tyvek and a range of reinforced coated papers in the 50–75-lb range," he adds. Tyvek 2FS, a new lower-weight spunbonded olefin, is specifically designed for less-demanding flexible packages. It offers enhanced processing, improved heat transfer, simplified printing, and high resistance to bacterial penetration and moisture.
Oliver also supplies lids, preformed pouches, and header bags. The company's exclusive Dot-Coat technology ensures reliable, fibre-free, peelable seals with improved sterilization properties and shorter production time.
