Medical Device Link.

Originally Published EMDM October 2004

Product Update

The peel quality of HDPE-Allegro remains constant over a wide sealing and processing window.

Tyvek has many desirable properties for medical device packaging. Cost is not among them. This section profiles a peelable film that is described as an alternative to Tyvek as well as a packaging system that allows users to reduce the amount of porous venting material in their packages. A machine that employs horizontal dwell and wrap technology to convert oral strips is also featured.

A user-friendly alternative to paper, Tyvek, or conventional plastic-based peel packaging has been introduced by Kobusch-Sengewald (Halle, Germany). HDPE-Allegro is a peelable film that forms a seal against polyethylene (PE) to create sterile-product packaging. 

“The main features of HDPE-Allegro are high break strength and outstanding peeling capacity,” says Reinhold Kranzbühler, medical packaging product manager at Sengewald Klinikprodukte (Rohrdorf, Germany). This sister company to Kobusch-Sengewald has been using HDPE-Allegro successfully for more than a year. The material’s peel quality remains constant over a wide sealing and processing window. Similar to paper or Tyvek, the film also provides a 100% barrier to germs. “HDPE-Allegro resists puncturing, minimizing the risk of package damage during transport or storage, and it combines improved durability with an attractive appearance,” adds Kranzbühler. But unlike paper, it offers sharp print quality and eliminates fibre tear. “The end result is a package with a smooth and soft peel and a bright, white surface.”

Another advantage is the white peel marking that is created when the packaging is opened, indicating that the seal has been tampered with. The material is also eco-friendly. “HDPE-Allegro can be combined with PE support films to create packaging that is made up of a single material and can therefore be disposed of more easily,” says Kranzbühler. 

Doyen’s oral strip unit uses slitters and rotary cutters to convert and package bulk reels of the product.

The white-coloured film can be used for packing disposable medical products that require gamma sterilization, such as surgical gloves, drapes, and gowns. HDPE-Allegro is a joint development by Kobusch-Sengewald, Sengewald Klinikprodukte, and film manufacturer Rollprint Packaging Products (Chicago, IL, USA).

If you’re not interested in scrapping Tyvek but would welcome the opportunity to use less of it, then TiroBreathe may be worth investigating. Developed by Tiromat Medical Packaging (Biedenkopf-Wallau, Germany), the TiroBreathe system requires only a small window of porous vent material in packaging to allow EtO sterilization of the device. Traditionally, breathable material has been used to fabricate the entire packaging lid. This system can run with most form-fill-seal equipment, and can substantially reduce lidding costs, according to the firm. For more information on this product, turn to the article on Tiromat.

Tiromat Medical Packaging

Medical device packagers can consume as much as 80% less porous material and cut lidding costs significantly with a system that can be integrated with the manufacturer’s and most other makes of in-line horizontal form-fill-seal (FFS) equipment. The TiroBreathe system, offered by Tiromat Medical Packaging (Biedenkopf-Wallau, Germany), creates and prints a flexible package that has a small window of porous vent material such as Tyvek that allows EtO sterilization of the enclosed device. 

Packages produced on typical horizontal FFS machines have had lids made entirely of breathable material. With TiroBreathe, most of the lid can be made of inexpensive easy-to-open film. The system unwinds porous material at a right angle to the film lidding stock, cuts the porous web, and places the material over a precut window in the lidding to produce the breathable vent. A Greydon Micromax two-colour flexographic platen printer prints on both the nonporous film and the porous vent material. 

Amaco Ing. Vonach GmbH

Established in 1982, Amaco Ing. Vonach GmbH (Dornbirn, Austria) is a full-service supplier of printing and coding products, many of which are suited for in-line use. They can be easily installed on thermoforming packaging machines. The systems are suited for large-area flexographic printing, and can process fixed and variable production data, logos, pictograms, and bar codes. 

An economic line of flexoprinters for modest-speed applications is available, while the TT20 thermal-transfer printer is designed for maximum flexibility. Suited for operations that require frequent changes in production data, continuous traceability, or bar code printing, this printer receives its input directly from a PC or via a memory card. 

Medical Engineering Technologies Ltd.

Four-side-seal pouch-making machines, blister tray sealing machines, and pouch sealers are designed for cleanroom use. Available from Medical Engineering Technologies Ltd. (Folkestone, Kent, UK), the units come with a full installation and validation service. The machines include many features that simplify operation, such as external thermocouple connectors and pressure signals for easy calibration. Printing or web-cleaning stations, as well as labelling stations, can be seamlessly integrated. Web and tray materials are also supplied.

Createchnic AG

A full-service contract manufacturer offers medical device OEMs capabilities in engineering, production concept and tooling, injection moulding, assembly, finished-product packaging, and sterilization. With more than 20 years of experience in manufacturing plastic components, Createchnic AG (Nürensdorf, Switzerland) carries out production in cleanroom areas certified to ISO Class 5, 7, or 8, depending on the device requirements. Such sterile products as single-use devices, introducers, and bioresorbable implants are supplied to customers worldwide. The company is certified to ISO 9001 and ISO 13485.

An example of the company’s competencies is the development of an inlay for one of the leading companies in the orthopaedic/trauma market to protect blister packaging. Heavy implants made of stainless steel or titanium often damage the blister during transport. The material of the inlay has to meet certain requirements—such as be flexible, sterilizable, and conform to USP Class VI. To achieve these requirements, Createchnic developed an inlay made of SEBS-polymer Cawiton PR 6307, supplied by Wittenburg BV (Hoevelaken, Netherlands). The production of the inlay is done in a clean environment by injection moulding. 

Bischof + Klein GmbH & Co. KG

A packaging material for cleanroom applications ensures product safety and quality. The Cleanflex product-system, provided by Bischof + Klein GmbH & Co. KG (Lengerich, Germany), can be used for a variety of packages such as single-wound and tubular films, bottle-shaped bags and liners, Tyvek and HDPE autoclavable bags, and two- and three-ply bags and liners. The company’s Class 5 cleanroom production facilities, certified to ISO 14644-1, are available for the low-particle production of films, bags, sacks, and liners. 

The company recently inaugurated a new cleanroom production facility at its Lengerich plant to enhance production efficiency. Film extrusion, printing, and conversion systems, as well as a studio for manual product processing, have been installed. 

Pronova AB

Systems comprising packaging machines and easy-to-tear packages meet the quality and reliability requirements of the medical industry. The Joker systems, manufactured by Pronova AB (Halmstad, Sweden), process bags that are linked together in a continuous chain that runs along a pair of opening rods (Joker Classic) or rails (Joker Sesam). 

A horizontal unit is available for packaging heavier products that require careful handling and positioning. One or more bags can be automatically filled depending on the product. 

For manual nonsterile filling, the company offers the 310V unit. It comes with a worktable, but the equipment can be adapted for in-line production.

Independent Machine Co.

A slitter with a three-tier rewind is suitable for cutting high-quality medical diagnostic media and nonwoven materials in narrow widths. The 12-in.-wide machine, offered by Independent Machine Co. (Fairfield, NJ, USA), achieves slitting widths as narrow as 0.032 in., and can rewind media onto cores or dedicated reels. The assembly is equipped with a range of shear tooling with a slit accuracy of ±0.05 mm.

The three-tier assembly features S-wrap pull roll sections that provide three-zone tension isolation and adjustable draw control during slitting. “There are three tension zones: the unwind, the rewind, and the slitting section,” says vice president Bruce Butler. “S-wrap pull roll stations are used to isolate the unwind and the rewind sections from the slitting section.” These pull roll sections are driven by the main speed reference drive through individual clutches. “This feature allows you to slit and unwind the material at a different tension, or to rewind it at a different tension than [the one used during] slitting and unwinding, depending on what you want to achieve.” 

The three-tier rewind has cantilevered shafts, each of which is capable of both center and differential winding. The cantilevered unwind includes an automatic edge guide and programmable constant tension. The rewind section is driven by a follower drive, and each rewind shaft is driven through individual, adjustable electric clutches with separate torque adjustment. 

Doyen Medipharm Ltd.

A quick-changeover four-side-seal packaging machine is suitable for medical and pharmaceutical companies needing a flexible, validatable machine. The 4SS Model 100, manufactured by Doyen Medipharm Ltd. (Barton, Cambs, UK), is a rotary converting and pouching machine that self-monitors to eliminate packs with critical defects. Capable of 100 packs, or 15 m, per minute, the machine includes, as standard, a quality system with reject stations and full system defect monitoring. 

The strip-converting and packaging production equipment is designed to comply with US FDA validation requirements. The length of the strip can be varied through the servo-controlled cutting station. In addition, the width of the product can be changed by adjusting the primary slitter station. “Because the dosage level and thereby the size of some of these products can be critical, the slitting is accomplished using a slitting die roll assembly that controls the width of the strips accurately,” says company spokesperson Noel Blake. “For less-sensitive products, more-flexible slitting systems such as commercially available rotary shear or crush cut systems are available for use on the converting machine,” he adds. 

Like all Doyen four-side-seal packaging machines, the 4SS Model 100 can easily be changed over to a different product in minutes. It offers the flexibility to pack a wide range of medical products. “The quality system monitors for critical machine and material elements that impact product or package quality,” says Blake.

Kobusch-Sengewald

A peelable lidding film that forms a seal against formed polyethylene features high break strength and puncture resistance. Offered by Kobusch-Sengewald (Halle, Germany), HDPE-Allegro is a user-friendly alternative to paper, Tyvek, or conventional plastic-based peel packaging. It provides a 100% barrier to germs, and combines high durability with an attractive appearance. The material is white, and has a smooth, opaque surface.

Copyright ©2004 European Medical Device Manufacturer