Medical Device Link.

In this competitive environment, some suppliers are adopting the strategy of providing new packaging materials that offer enhanced properties. One such material is IntegraPeel LCP, which is produced by Rexam Medical Packaging (Bristol, UK). IntegraPeel LCP, described by the company as a "premium product," is a coextruded four-layer film laminate that can be sealed to virtually any material, including uncoated Tyvek.

Nic Hunt, marketing and technology director at Rexam, explains that IntegraPeel LCP represents the launch of the company's Core-Peel technology on the European market. "Core-Peel technology is a unique peelable system, suitable for high-speed equipment," he says. "It offers an extremely wide operating range on the packaging machine, and gives a peel strength that is virtually independent of sealing conditions." Apart from consistent peels, says Hunt, further advantages of this technology include reduced particulate contamination (IntegraPeel LCP is an all-resin system), and separate film layers that allow OEMs to control and optimize both the seal and the peel of their packages. Furthermore, says Hunt, the material runs at the same speeds as coated products on a rotary machine.

Price Pressures Rising

Developing a premium product that will stand out in the martketplace is one way to remain competitive. But suppliers are also focussing on their internal operations and sourcing activities in order to give medical manufacturers the best value. "Our main challenge is to contain costs in the face of rising material prices," says Carl Marotta, president of Tolas Healthcare Packaging (London). "We help OEMs [contain costs] by improving our internal operating efficiencies through continuous improvement programmes, and via an ongoing screening and evaluation programme to discover more cost-effective materials."

Tolas is an ISO 9002–certified supplier of high-quality medical and pharmaceutical packaging materials. The company's materials are designed to perform as a protective barrier for healthcare products and to maintain package integrity throughout sterilization, shipping, and storage, until a product's end use. The firm's most recent product, developed in response to a customer's needs, is the Dispos-A-Vent pouch, which provides barrier packaging for EtO sterilization.

Suppliers have learned that technological innovation must go hand in hand with good fiscal sense. "The main challenge in medical packaging is to be able to offer new competitive, technically sophisticated, and safe packaging materials to meet [our clients'] productivity and budget targets," says Heikki Weijo, managing director of Wipak Medical (Nastola, Finland), a global packaging supplier that is currently exporting its medical packaging to more than 70 countries worldwide. He notes that Wipak Medical maintains a wide range of standard materials to suit the requirements of various application areas, adding that the firm uses the latest film-making technology at high volumes to keep its production costs competitive.

Although cost will always be a consideration, working in the medical industry means that there is no room for compromise when it comes to quality. Clearly, packaging suppliers must maintain advanced quality assurance systems to meet the critical demands of their clients. Weijo notes that Wipak has a continuous assessment system in place to monitor the efficiency of the company's quality system, as well as an internal training programme aimed at attaining the firm's qualitative and quantitative targets. Wipak also recently installed a new IT system to enhance the firm's ability to plan and manage every aspect of its operations in response to customer needs.

Strength in Numbers

In a nod to evolutionary theory, suppliers such as Wipak have found that success lies in diversification. The company offers a wide range of sterilizable flexible and rigid forming webs along with recommended lidding webs, as well as nonforming materials for flat-type packaging processes. Upon request, the company also provides materials with high barrier properties for special applications, and tailor-made medical pouches constructed of various materials.

A specialty at the firm is the production of coextruded film webs to be sealed with uncoated breathable top web materials, a technique that offers clean peels with remarkably high seal strengths. According to Weijo, this has been made possible by Wipak's long history of investigation into combinations of different sealant layers with uncoated materials.

In another boon to device OEMs, the carefully designed compositions of Wipak's new flexible bottom webs offer the possibility to downgauge without increasing the risk of pack damage in aggressive thermoforming applications. "This is now made possible by a unique coextrusion method with up to 11 different material layers," says Weijo. "This technique allows us to optimize the use of mechanically strong and valuable materials in order to achieve strong and competitively priced films." Weijo notes that currently, the majority of coextruded flexible bottom webs contain three to five layers, with limited possibilities for new properties. According to Wipak, the company's approach allows standard materials to be fine-tuned to the technical requirements of a customer's forming process, yielding increased packaging-line efficiency.

What direction will the medical packaging market take in years to come? If history is any indication, research into new materials is bound to drive the market. On this note, Hunt reports that Rexam is developing high-barrier technologies, including those based on cycloolefin polymers. "This technology promises to use coextrusion to surpass the performance of laminates," he predicts.

Indeed, some see change as the only constant in the packaging industry. "We see a continuing need for high-performance packaging containing new functional features and utilizing the latest state-of-the-art material technologies," says Marotta. "Our success is dependent upon our ability to meet the changing requirements of the market."

Flexible Medical Packaging Ltd.

Long recognized as an experienced printer and converter of medical packaging materials, Flexible Medical Packaging Ltd. (Lancaster, UK) now offers medical device manufacturers additional contract packaging facilities in its Class 100,000 cleanroom. The company provides a complete turnkey service, from design through packaging, sterilization, and regulatory process validation. Working with leading raw materials suppliers, Flexible Medical Packaging can also provide the independent producer with a comprehensive range of rollstock and pouches, using the latest material technology including hot-melt-coated Tyvek papers, peelable films, grid-coated papers, and cold-seal products.

In addition to packaging, sterilization management, and distribution, the company provides component sourcing, cleanroom injection moulding, and assembly services.

Medipack AG

Thermoforming, heat sealing, and other contract packaging services are offered to medical OEMs by Medipack AG (Schaffhausen, Switzerland).

"Our aim is to realize—in close cooperation with our customers and with the help of our extensive experience—the various wishes and requirements that are expected of sterile packaging, and to convert them into a secure, economical, ecologically justifiable and creative solution," says managing director Reto Artusi.

Medipack thermoforms PETG, PS, Barex, and PP in its three Class 100,000 cleanrooms for blister-pack applications. The firm can make blisters up to a maximum size of 1300 x 620 mm. Both small and medium quantities are produced. Each pack is visually checked for air pockets and particle contamination and sealed into double polyethylene bags. Die-cut Tyvek lidding can be supplied with or without printed matter.

In two separate cleanrooms, at Class 100 laminar-flow stations, the company cleans customer products and packs them into blisters or pouches on a contract basis. Services such as label printing, documenta-tion and organization of bioburden tests, and sterilization are also offered. The company is certified to DIN/EN/ISO 9001.

Rexam Medical Packaging Ltd.

A film laminate incorporates a company's newly patented Core-Peel technology. IntegraPeel LCP from Rexam Medical Packaging Ltd. (Bristol, UK) is the first product manufactured in Europe to incorporate the new peel technology.

IntegraPeel LCP is a laminate of polyester to a coextruded peelable polyolefin film that has been developed for sealing to a variety of polyethylene-coated partner webs. According to marketing and technology director Nic Hunt, the product offers medical OEMs a variety of benefits, including significant increases in running speeds on packaging lines and reduced contamination risks.

"Uniquely consistent and controlled peels are achieved by separating the peel and seal functions into two layers," says Hunt. "This allows the use of low sealing temperatures and permits manufacturers to overcome significant variations in operating conditions." Rexam reports that other products incorporating Core-Peel technology are in advanced stages of development and will be launched in the near future.

Rexam's production capabilities include film coextrusion, gravure and air-knife coating, printing, and adhesive lamination. The company's facilities for R&D include a production pilot plant and packaging machinery identical to those used by customers, ensuring that newly developed products will perform well on customers' equipment.

Tolas Health Care Packaging

Certified to ISO 9002, a supplier of high-quality medical and pharmaceutical packaging provides protective barrier materials that maintain package integrity throughout sterilization, shipping, and storage. Tolas Health Care Packaging (London) converts medical-grade Tyvek, latex-reinforced and surgical papers, laminated and coextruded films, and multilayer foil constructions. Capabilities include printing, die-cutting, pouching, slitting, and sheeting.

The company's most recent product, developed in response to customer needs, is the Dispos-A-Vent pouch, which provides barrier packaging for EtO sterilization. The new pouch is designed with a disposable Tyvek vent for maximum airflow during EtO sterilization and a high-barrier foil pouch area for easy conversion after sterilization.

"Benefits of the pouch include excellent light and oxygen barriers, a superior moisture barrier, an uncoated Tyvek vent for porosity during sterilization, outstanding puncture resistance, and the prospect of cost reductions through the elimination of double packaging," says company president Carl Marotta. The Dispos-A-Vent is available with peelable seals or as a tear-open pouch. In addition to its London location, Tolas has manufacturing facilities in Feasterville, PA, USA.

Wipak Medical

A company's Steriking range of packaging materials includes sterilizable film for thermoforming and film designed for IV and medical pouch applications. Bottom webs are sealable and peelable against uncoated papers. Wipak Medical (Nastola, Finland) also supplies peelable lidding film that withstands gamma sterilization and peelable bottom webs for use with Tyvek.

Wipak pioneered the use of coextruded thermoforming films and is continuously developing new materials and investing in new production machinery. Its uncoated lidding materials are offered as an economical and environmentally friendly alternative to costly coated substrates.

"Our production and R&D staff are in direct contact with the world's leading suppliers of raw materials," says marketing manager Peter Rasmussen. "This cooperation, together with our polymer know-how gathered over the last 30 years, gives us a basis for developing products for the next millennium."

About Packaging Robotics Inc.

Open-fill-seal systems for premade pouches and bags are supplied by About Packaging Robotics Inc. (Boulder, CO, USA). The Pouchmaster ABS system is a miniature, robotic, PLC-controlled system with a compact and modular design. It has four robotic workstations that easily open and process a variety of barrier packaging materials. The system is cleanroom compatible, and can be integrated with automatic fillers. The Pouchmaster satisfies US FDA process validation guidelines and can process flat pouches, reclosable zipper pouches, and gusseted bags.

The system incorporates pick-and-place technology and state-of-the-art bar heat sealing methods. The Pouchmaster ABS system picks the filled pouches from the indexing head and places them into the jaws of the bar sealer. Dwell is controlled by a digital timer with 0.01-second increments. The seal pressure is controlled by an air cylinder regulator and gauge system. A magazine can hold 24 in. of pouches or bags. The pouch magazine feed system side rails are adjustable to accommodate various pouch widths.

Emplex Systems Inc.

Comprising tabletop, stand-alone, and conveyorized versions, the MPS 6300 series of continuous rotary-band heat sealers from Emplex Systems Inc. (Scarborough, ON, Canada) use air-pressurized heating and cooling bars for the sealing process. Sealing parameters are maintained by digital temperature, pressure, and tachometer controls on the front panel, and validation is further ensured by audio alarms, an external thermocouple jack, and a reverse-feed motor. Optional upgraded control packages and data acquisition systems are also offered for quality assurance and analysis.

Designed to increase production efficiency, the MPS 6300 series units are equipped with an internal safety interlock switch and a gas-spring floor stand.

Carolex S.A.

Caroclear MDL films from Carolex S.A. (Longué, France) are specially designed to package medical products such as implants, syringes, compresses, and disposable kits. Two ranges of films are offered. Caroclear MDL 60 films are extruded from a PETg resin, and Caroclear MDL 50 films are extruded from an APET resin. All films are transparent and can easily be tinted.

The films are extruded to medical standards on an isolated line in a dust-free area. The films are packaged to suit the requirements of cleanroom thermoforming, and feature double-film protection, as well as plastic cores and plugs.

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