Medical Device Link.

Originally Published PMPN November 2001

PRODUCT UPDATE

Versatile bags and pouches also provide breathability for gas sterilization.

A converter of flexible packaging materials supplies a range of products and converting services for medical, pharmaceutical, and diagnostic kit manufacturers. The company can provide laminations in aluminum foil and films for high-barrier applications. Also available are Tyvek and papers suitable for the packaging of sterile disposable devices. The converter offers printing and slitting capabilities, and it can produce preformed pouches in several stock and custom laminations. Stock-size pouches are available for immediate delivery. Technipaq, Crystal Lake, IL.

Header bags developed specifically for demanding medical device packaging applications are based on coextruded blown films. Integra Pack Tuf 2000 bags feature properties derived from several polymers, including the tear resistance, impact strength, and puncture resistance of nylon, and have coated-Tyvek headers. The peelable Tyvek-to-film heat seal provided by the coating makes possible high porosity, a low sealing temperature, and uniform seal transfer. The coating eliminates the problem of contamination from fiber tear upon opening and gives reliable evidence of seal integrity. The bags' contact clarity makes visual identification of package contents easy. Rexam Medical Products, Mundelein, IL.

A two-stage barrier pouch for EtO sterilization provides good oxygen and moisture barrier characteristics while making the use of a double pouch unnecessary. The Pre-Vent pouch incorporates barrier composites and uncoated Tyvek in a gas-sterilizable package that is designed for optimal venting during sterilization and a long shelf life after the barrier component is sealed. Once the closed pouch has completed the sterilization cycle, a secondary seal in the foil area of the pouch is added and the Tyvek vent discarded; the result is a sterile device in a barrier package. The pouch can be supplied in a variety of uncoated foil composites with a film sealant layer that uses seal-peel technology. Nonpeeling structures are also available. Mangar Industries Inc., New Britain, PA.

Medical device packaging pouches are available for applications requiring barrier packaging and involving EtO sterilization. Dispos-A-Vent pouches are designed with a disposable Tyvek vent that provides a high level of airflow during the sterilization process. The pouches can easily be converted from porous to high-barrier, thus making repackaging following sterilization unnecessary. They have characteristics that create barriers to light, oxygen, and moisture. The pouches come in a variety of high-quality foils, and with peelable or nonpeelable seals. Tolas Health Care Packaging, Feasterville, PA.

A global strategic partnership has been formed to supply medical device packaging based on shared state-of-the-art technology. The European and U.S. companies also plan to establish a supply capability for Asian markets. The partners' intention is to use the synergy of their technological, manufacturing, and marketing strengths on two continents to provide a high level of service for medical product manufacturers worldwide. Product lines that are available in expanded form are Allegro peelable sealants, ClearFoil high-barrier structures, and Propyflex IV bags. Rollprint Packaging Products/Pactiv Sengewald, Addison, IL.

High-porosity header bags use custom adhesive technology to maximize the circulation of air and gas during sterilization procedures and thus minimize cycle times. X-hale header bags with DotCoat adhesive provide a consistently high-quality seal and promote rapid degassing and dissipation of odor after sterilization. They are available in a variety of sizes, film types, and gauges, and can be supplied with hanging holes and loading lips. Printed and unprinted Tyvek headers offer tear and puncture resistance, and retain their integrity when subjected to several popular sterilization methodologies. Oliver Medical Products, Grand Rapids, MI.

Foil barrier pouches with headers designed for EtO sterilization have been added to the product line of a supplier of sterilizable packaging materials. The product offering also includes rollstock; header-type and flat bags; folded pouches; and pouches made with Tyvek, papers, foils, films, and laminations, all of which are suitable for all types of sterilization. Available as well are custom die-cut plastic insert cards for organizing and containing multiple components within a peel pouch or header bag. The cards are made of virgin-grade polyethylene or polypropylene, produce no dust or fiber, and tolerate all popular sterilization methods. Suitable for small- and large-volume production, they can be imprinted with part numbers and logos. Beacon Converters Inc., Saddle Brook, NJ.

Medical packaging paper for the manufacture of heat-sealed peelable pouches is designed to meet requirements for package integrity while offering an economical alternative for packaging low-profile devices. HSP63 and HSP103 weigh 39 and 63 lb per ream (63 and 103 g/m²), respectively, and provide correspondingly different degrees of strength. HSP pouches using advanced adhesive coatings provide a controlled fiber-free peel with consistent coating transfer, and display very good barrier properties. Offering a good print surface for in-line printing, the material can also be custom-printed with the manufacturer's ink system. HSP pouches can be sterilized via EtO, gamma, or E-beam methods. Bomarko Inc., Plymouth, IN.

Self-sealing sterilizable, breathable pouches are available in sizes ranging from 3 x 9 to 12 x 18 in. The unprinted pouches consist of a 42-lb bleached surgical Kraft Paper Back sealed to a polyester laminate and blue-tinted polypropylene, and they include a /-in. medical-grade tape for easy, effective closure. They can withstand both autoclaving and EtO sterilization. The pouches can be labeled by the customer or can be supplied preprinted on a custom basis. Qosina, Edgewood, NY.

Printed and unprinted premanufactured pouches and rollstock are available from stock and supplied via a fast-turnaround material-stocking program. Inventoried materials include polyester, nylon, foil, metallized films, polyethylene, coextrusions, and a variety of coatings used in medical, pharmaceutical, diagnostic, and health and beauty applications. Pouches and rollstock can be printed in as many as eight colors and can be provided with a variety of fitment options. Pouches can be enhanced with zippers, bottom and side gussets, hanger holes, reclosable caps, pressure-relief valves, and tear notches. Xtreme Printing & Packaging Services, Westwood, NJ.

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