Originally Published MPMN July 2004

SPOTLIGHT

Testing and Inspection Equipment and Services

Medical pouching machine

Capable of packaging a range of medical devices, a machine seals pouches on four sides at speeds up to 100 units per minute. The 4SS 100 model offers the same sealing stations and servo controls as prior units, but is a compact version at a lower price. The equipment includes a pusher-type in-feed, tension-control web unwinders, multiaxis servo drives, a full-function programmable logic controller, and an integrated quality system with an automatic reject station.Doyen Medipharm, Lakeland, FL www.doyenmedipharm.com 

Band sealer

A continuous dual-heat band sealer validates temperature, speed, sealing, and cooling bar pressure. With the VBS-DH-3/8-10-V model, pressure validation is achieved through the use of self-contained compressed air. Uniform pressure on all sealing and cooling surfaces creates consistent quality validatable seals. Quad-digital temperature controls maintain consistent heat, generated from rear and front heaters. The unit is equipped with 10-in.-long heatingand cooling zones. The machine is designed to handle materials such as Tyvek, Mylar, nylon, polyethylene, polypropylene, and foil.All Packaging Machinery Corp., Ronkonkoma, NY www.allpackagingmachinery.com 

Vertical and horizontal cartoner

With a footprint measuring 40 ¥ 38 in., a cartoner handles blisters, bottles, vials, and small medical devices at rates up to 60 units per minute. The Carton King uses a rotating turret and modular design components to accommodate a range of carton blank sizes. Options for printing, embossing, labeling, and leaflet insertion are possible. Hot-melt or tuck-in closures are provided, and bar code verification can also be incorporated. Various degrees between semiautomatic hand feeding of the product to fully automatic in-feeding are available. Both vertical and horizontal models accommodate a range of products.Technik Packaging Machinery, Covington, GA www.technikpackaging.com    

Instrumentation carrying case

Soft-sided carrying cases for the packaging and transporting of portable instrumentation are available in 18 sizes with a modular divide system. The sizes range from small handheld designs to large cases that take two people to lift. Using different types of fabric and foam, the manufacturer works with drawings or sketches to build a case to customer specifications. A line of hard cases made from blow-molded and injection-molded pick-and-pluck foam is available.Fieldtex Products Inc., Rochester, NY www.fieldtex.com  

Packaging services

A designer and manufacturer of finished, disposable medical devices offers packaging services as a part of its full product life-cycle management from design to sterile goods. The company's facilities include Class 10,000 and Class 100,000 cleanrooms for complex device assembly, as well as controlled manufacturing environments. A variety of packaging options include form-fill-seal, rigid tray, and flexible pouch packaging, as well as filling of liquids and gels in syringes, tubes, bottles, cups, and foil pouches. Custom packaging design and validation are also available.Avail, Fort Worth, TX www.availmed.com 

Filling and capping machine

A system is designed for filling vials, inserting lyophilization or injection plugs, and overseal capping of aluminum caps. Withan output of up to 85 units per minute, the FMB210 is suitable for sterile filling of liquid volumes between 0.1 and 100 ml with anaccuracy of ±1%. All format parts are mounted by finger screws to enable fast and easy machine clean-up. An operator can completea format change in approximately 1 minute. A color touchscreen on the control box selects the desired function from up to 30 stored recipes. The equipment is suitable for clinical trials, small-batch production, and filling of shear-sensitive products.Flexicon America Inc., Burlington, VT www.flexiconamerica.com 

Sterilization indicators

A manufacturer of color-changing sterilization throughput indicators offers self-adhesive paper dots to apply to products prior to gamma, E-beam, steam, and EtO sterilization. During the process, the products change colors upon exposure to a specific sterilant. Biological indicators challenge the sterilizer with highly resistant bacterial spore indicator organisms. The process is considered to be successful if all the indicator organisms are killed.Etigam b.v., Apeldoorn, The Netherlands www.etigam.nl 

EtO sterilization technology

An EtO sterilization technology combines all-in-one processing, parametric release, and electronic data interface. According to the company, EO Express makes possible the sterilization and release of product to market within one day. Products can be sterilized in chambers from 1 to 28 pallets in size. Services are available in each of the company's eight sites nationwide.Cosmed Group Inc., Queensbury, NY www.cosmedgroup.com 

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