Medical Device Link.

Spotlight on Packaging Supplies and Services

Solvent-free hot-melt adhesive A solvent-free grid-patterned hot-melt adhesive was recently introduced. The porous material exhibits consistent peel strength and is formulated for use on medical-grade papers, thereby allowing device manufacturers to reduce the environmental impact of their packaging. The grid-coated paper is manufactured in a way that maintains the integrity of the substrate and ensures that the final package is not compromised by expansion or shrinkage. The adhesive can be used to seal medical paper to a wide variety of trays and pouches and withstands most forms of sterilization. The company's medical packaging is available in die-cut or rollstock form; printing services are available. Oliver Products GmbH, Mannheim, Germany.

Leakproof containers

Protective leakproof containers are fitted with a highly absorbent material that can soak up the entire sample contents in the event of an accidental spill. The cellulose and cotton-fibre material is only a few millimetres thick when dry but is able to absorb more than 4 L/m². The containers are available in four sizes, the largest of which can accommodate samples up to 50 ml. Engel Laboratories, Medical Div., Frankfurt, Germany.

Contract services

A company involved in the subassembly and packaging of sterile medical devices offers a range of services in its fully equipped Class 10,000 cleanroom. Capabilities include blister and vacuum packing, pouch sealing, fluid filling, and shrink wrapping. The firm can also provide ultrasonic cleaning and printing services. Quality systems are certified to ISO 9002 and EN 46002. Hunt Developments, Midhurst, W Sussex, UK.

Easy-tear bag Made from coextruded HDPE sealed to a noncoated Tyvek vent, a bag is fitted with an easy-tear opening to ensure content sterility. The open HDPE/HDPE side can be heat-sealed after it has been filled, allowing the end-user to open the bag without generating particle contamination. Cleanliness is certified to Class 200 according to MIL-STD-1246C. The proprietary packaging system can be manufactured in client-specified dimensions; printing on the easy-tear notch can also be customized. Newform Protective Products N.V./S.A., Hoegaarden, Belgium.

Thermoforming A company that specializes in the design and manufacture of thermoformed packaging for medical instruments also makes blister sealing equipment. To optimize device packaging, company engineers can provide assistance in material selection, packaging design, sterilization requirements, and sealing properties. The firm's new generation of sealing equipment allows precise pressure, compression time, and temperature settings that enable 100% repeatability. Product data are stored in the form of receipts that can be called up when necessary. In addition to calibration parameters, the date, article and batch numbers, and operator name can also be stored. Nelipak Thermoforming, Venray, Netherlands.

Closure system A proprietary closure system that fits standard 20-mm injection-vial necks is composed of a transparent 1-ml container and a tamper-evident overcap. The Digimix system enables automatic filling of two products in one tightly sealed package. To blend the contents of the Digimix container with those in the vial, the user simply presses on the overcap and shakes the vial. Applications include powders and liquids that require isolated packaging until use. The company also supplies a variety of dosing pumps, droppers, applicators, and caps. SOPAC, Goussainville, France.

Medical papers A line of paper products is specifically designed for the packaging of medical instruments and health-care products that are exposed to steam, EtO, or gamma sterilization. Royal Medical G, Royal Medical S, Royal MedPack, and Royal MedWrap papers provide an effective microbial barrier, a clean peel, and optimal porosity. They also feature excellent conversion characteristics, and their surfaces are suited for heat-seal processing. The company currently is certified to ISO 9001 and is in the process of obtaining certification to ISO 14001. All products are tested according to relevant European standards. AssiDomän Skärblacka AB, Skärblacka, Sweden.

Glove packaging A recent project of a supplier of packaging and printing services was the design of packs that identify eight styles of surgical gloves. Each package features a unique colour scheme on a white background to enable surgeons to easily distinguish among the various types of gloves. To accommodate sterilization and barrier requirements, heat-seal film-to-film and cold-seal paper-to-film materials were specified. The heat-seal film is a polyester laminate, while the paper-to-film cold-seal package uses a clean-peeling adhesive that cannot be resealed once the package has been opened. The company supplies a variety of packaging and materials including cold-seal coatings, heat-seal coatings for sterile disposable devices, film and foil laminates, forming films, and cohesive bands. Printing and design and development services are also available. Phoenix Health Care Products LLC, Milwaukee, WI, USA.

Packaging services Coated Tyvek, coated papers, polymeric film structures, pouches and bags, and rigid thermoformed trays are manufactured by a company with facilities worldwide. Adhesive and extrusion lamination, precision slitting, and flexographic and gravure printing are among the company's capabilities. The ISO 9002­certified firm is equipped with a clean production area. Perfecseal, A Bemis Co., Londonderry, Northern Ireland, UK.