Spotlight on Packaging and Sterilization

Originally Published MPMN April 2002

SPOTLIGHT

Feeding mechanism

A feeding mechanism enables basic products to be fed reliably with accuracy. Friction feeders can process products including surgical drapes, bandages, pouches, bags, foam-rubber pill holders, liquid-filled pouches, and blister pill packs. The feeders can be integrated with bar code readers and ink-jet printers. Accessories are offered to provide accumulation and dropping of stacks of product, as well as increased product capacity. Multifeeder Technology Inc., 4821 White Bear Pky., St. Paul, MN 55110-3325.

Hydrogen peroxide sterilization systems

Systems are designed to ensure the just-in-time sterilization of packaged medical devices at the point of manufacture, integrating the sterilization process with assembly and packaging operations. The fully automated vaporized hydrogen peroxide (VHP) process provides proven efficacy, compatibility with a broad range of materials, rapid sterilization cycle times, fast turnaround, and low operating cost. There are no toxic residuals, and a lengthy aeration process is not needed. Inventory requirements can be reduced. Options and accessories for the VHP MD series include customized chamber sizes, double door and pass-through configurations for installation though a cleanroom wall, racking systems, and cycle development and process validation services. Steris Corp., 5960 Heisley Rd., Mentor, OH 44060.

Packaging services

An outsourcing company provides automated and semiautomated packaging services, including form-fill-seal, liquid fill, and foil packaging, and pouch and tray sealing. The company's technical expertise and multiple manufacturing facilities enable economical packaging. The company is ISO 9001 compliant, with 11 locations in the United States and Mexico. The plants include Class 10,000 and Class 100,000 cleanrooms, as well as controlled manufacturing environments. Each operates under tight quality system regulation control with dock-to-stock certified supplier programs. Avail, 7594 Trade St., San Diego, CA 92121.

Automatic open-fill-seal systems

Open-fill-seal systems are available for premade pouches and bags, with or without zipper closures. The Pouchmaster ABS is a miniature robotic PLC-controlled system with four robotic workstations that process a variety of barrier packaging materials. The 4 x 5-ft system is cleanroom compatible and can process flat pouches, reclosable zipper pouches, and gusseted bags. The unit incorporates pick-and-place technology to pick the filled pouches from the indexing head and place them into the jaws of the bar sealer, which uses a PID digital temperature controller. The dwell time is controlled by a digital timer with 0.01-second increments, and the seal pressure is controlled by an air cylinder and gauge system. About Packaging Robotics Inc., 6661 Arapahoe Ave., Ste. 2, Boulder, CO 80303.

Sterilization systems

Just-in-time sterilization systems are designed primarily for medical device manufacturers. The Sterrad sterilization systems use low-temperature hydrogen peroxide gas plasma to safely and rapidly sterilize most medical devices and instruments. The company's core product for the medical device market is the Sterrad 200 GMP, which has 7.3 cu ft of capacity. Other features include double doors for pass-through applications and programmable software to selectively modify cycle parameters to best match product, packaging, and load configurations. Cycle development, validation assistance, regulatory, and technical support services are also offered. Advanced Sterilization Products, 33 Technology Dr., Irvine, CA 92618.

Label printer and applicator

A label printer features an optional label applicator designed for small, delicate, high-precision print-and-apply applications. The Apollo 1 offers a stand-alone feature that enables label printing with or without a computer attached. The unit consistently applies labels as small as 0.25 x 0.20 in. with an accuracy of ±0.02 in. Other features include 300-dpi resolution, running at 8 in. per second with a 4.2-in. width, an internal rewind and ribbon saver, and a high-speed 32-bit processor with 2 Mbyte of RAM. Tharo Systems Inc., 2866 Nationwide Pky., P.O. Box 798, Brunswick, OH 44212-0798.

Medical sealing systems

A machine uses air-pressurized heating and cooling for sealing. Available in tabletop, stand-alone, and conveyorized versions, the MPS 6300 series maintains sealing parameters by digital temperature, pressure, and tachometer controls on the front panels, and validation is further ensured by audio alarms, an external thermocouple jack, and reverse feed on the motor. The unit is also equipped with an internal safety-interlock switch and a gas-spring floor stand for infinite head-height adjustment. Etched Teflon bands are used to produce consistently strong, clean seals. Emplex Systems Inc., 2045 Midland Ave., Toronto, ON, Canada M1P 3E2.

Disposable products packaging and sterilization

Customized packaging and sterilization services are available for many disposable medical devices. An ISO 9002– and EN 46002–certified and FDA-registered company offers an on-site sterilization specialist to help customers manage specific needs. The company also provides extrusion of medical tubing, assembly, and bag-manufacturing services. Command Medical Products Inc., 15 Signal Ave., Ormond Beach, FL 32174.

Sterilization services

A contract sterilizer's on-site laboratory helps to decrease the cost and delays of transporting samples off-site. The company can accommodate all product volumes from a few pieces to truckload quantities. Complete protocol development and regulatory support are also offered. A new facility opening in Yuma, AZ, in July 2002, will offer several chambers for quick turnaround times to help better serve both West Coast and Mexico production sites. All of the company's facilities are ISO 9002 and EN 46002 certified and EN 550 compliant. Centurion Sterilization Services, 301 Catrell Drive, Howell, MI 48843.

Well bottle

A bottle is molded with a well in its base to allow for a minimum amount of surface contact when nearing completion of product. The 7.5-ml bottle is available in amber- or flint-colored glass, and its internal diameter is reduced from approximately 13 to 2 mm at the base. The well bottle can be fitted with a pump or dropper. O. Berk Co., 3 Milltown Ct., P.O. Box 1690, Union, NJ 07083.

Plastic packaging

More than 2500 types of plastic packaging made of durable recyclable polyethylene and polypropylene are available for medical devices. Both standard and customized products are offered to protect against damp conditions, as well as physical impact during shipment or storage. rose plastic USA LP, P.O. Box 698, California, PA 15419.

Small-item packaging

Specifically designed for small items such as diagnostic test kits, sutures, needles, slides, and solid and liquid medications, a machine provides an opportunity for manufacturers to manage pouch packaging in-house, regardless of the quantity of the product. The SmallPak two-web system forms and labels each pouch as the item is filled, then seals the pouch. Printing options range from ink stamping to labels with graphics and registered printing. Sensors are available for various needs, as well as some self-diagnostics and package validation. Many items can be sterilized by gamma or EtO radiation if needed. Odessa Packaging Smallpak, 202 N. Bassett St., Clayton, DE 19938.

Rollstock packaging system

A thermoform-fill-seal rollstock system packages syringes, catheters, and other medical devices in high volumes. The R530 can produce 600–1000 Multivac Packs per minute, depending on film gauge and type and package size and shape. The system incorporates Allen-Bradley controls to facilitate integration into production lines and seamless interface with automatic loaders and assembly equipment. Web widths of 320 to 650 mm are available, and the unit comes equipped with customized dies for many medical devices. Multivac Inc., 11021 N. Pomona Ave., Kansas City, MO 64153.

Copyright ©2002 Medical Product Manufacturing News